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Last update 30 Sep 2026

Pregabalin

Last update 30 Sep 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryPregabalin, commonly referred to as Lyrica®, is a well-known anticonvulsant medication, which has found its footing in the treatment of various medical conditions. Such conditions include but are not limited to anxiety disorders, epilepsy, and neuralgia. The mechanism of action that characterizes pregabalin's utility involves blocking the CACNA2D1 and CACNA2D2 calcium channels, thus effectively targeting these disorders with aplomb. The Upjohn Co. received approval for the medical use of pregabalin in the European Union as far back as 2004, indicating that the medication has been a key feature of medical treatment for some time. Pregabalin's indications primarily target the treatment of neuropathic pain conditions, including fibromyalgia, and partial onset seizures in combination with other anticonvulsant medications. These conditions are managed with pregabalin due to its efficacy in minimizing their attendant symptoms. Pregabalin, therefore, serves as a vital tool in the management of chronic pain and neurological disorders.

Drug Type

Small molecule drug

Synonyms

LYRICA CR, CI-1008, GLA5PR

+ [16]

Target

CACNA2D1 x CACNA2D2

Action

blockers

Mechanism

CACNA2D1 blockers(Voltage-gated calcium channel alpha2/delta subunit 1 blockers), CACNA2D2 blockers(Voltage-gated calcium channel alpha2/delta subunit 2 blockers)

Therapeutic Areas

Immune System DiseasesNervous System DiseasesEndocrinology and Metabolic Disease+ [3]

Active Indication

FibromyalgiaSeizuresNeuralgia, Postherpetic+ [8]

Inactive Indication

Acute herpes zoster neuropathyBreast CancerChronic pelvic pain syndrome+ [36]

Originator Organization

The Upjohn Co.

Active Organization

Viatris Healthcare (Pty) Ltd.

China Resources Double-Crane Pharmaceutical (Jinan) Co., Ltd.Huizhi Pharmaceutical (Dalian) Co., Ltd.

+ [19]

Inactive Organization

Viatris, Inc.MyLan SAS

Shanghai Chenbang Pharmaceutical Technology Co Ltd.

+ [6]

License Organization

Chongqing Succeway Pharmaceutical Co., Ltd.

Coland Pharmaceutical Co., Ltd.

Viatris, Inc.

+ [3]

Drug Highest PhaseApproved

First Approval Date

European Union (05 Jul 2004),

Epilepsies, PartialEpilepsyGeneralized anxiety disorder+ [1]

RegulationPriority Review (China)

Structure/Sequence

Molecular FormulaC8H17NO2

InChIKeyAYXYPKUFHZROOJ-ZETCQYMHSA-N

CAS Registry148553-50-8

1,092

Clinical Trials associated with Pregabalin

CTIS2026-526362-24-00

/ Not yet recruitingPhase 4IIT

Driving under the influence of drugs study (DUID-study) ~ A randomised, controlled, double-blinded clinical trial investigating the influence of abused medicinal drugs on cognitive and driving impairment in healthy adults

Start Date01 Mar 2027

Sponsor / Collaborator-

NCT07752134

/ Not yet recruitingPhase 1IIT

A Multicenter Randomized Controlled Trial Assessing the Efficacy and Safety of Pregabalin Combined With Educational and Behavioral Intervention Program for Bladder Pain Syndrome/Interstitial Cystitis

Bladder pain syndrome/interstitial cystitis (IC/BPS) brings long-term pelvic pain, frequent urination and poor sleep quality, which severely lowers patients' daily life quality. Educational and behavioral management program (EBMP) is a mainstream non-drug treatment for IC/BPS, yet a considerable proportion of patients fail to achieve satisfying symptom relief via EBMP alone. This multicenter randomized controlled trial aims to compare the efficacy and safety of pregabalin combined with EBMP versus EBMP monotherapy in adult IC/BPS patients.
A total of 140 eligible adult participants fulfilling AUA and ESSIC diagnostic criteria for IC/BPS will be randomized at a 1:1 ratio into two groups. The control group receives standalone EBMP intervention, while the intervention group obtains EBMP plus pregabalin with flexible dosage titration. Pregabalin starts at 150 mg per day, and doses can be gradually adjusted up to a maximum daily limit of 600 mg according to patients' tolerance and symptom improvement during the 12-week intervention period.
All enrolled participants will complete standardized symptom questionnaires, pain scoring and voiding diary assessments at predefined follow-up time points. The primary outcome is treatment response measured by Global Response Assessment (GRA) after 12 weeks of intervention. Secondary evaluations cover VAS pain scores, PUF, ICSI, ICPI scales, bladder functional parameters, quality of life, sleep status and depressive symptoms. Researchers will track all adverse events throughout follow-up to judge the safety of combined treatment. Findings from this trial can offer optimized treatment options for adults diagnosed with IC/BPS.

Start Date31 Dec 2026

Sponsor / Collaborator

Beijing Tiantan Hospital

NCT07549490

/ Not yet recruitingNot ApplicableIIT

A Pilot Study for Developing a Comprehensive Signal Detection Approach for the Mechanisms of Action and Analgesic Efficacy of Two Analgesics Using Human Experimental Models of Pain (HEMP)

This pilot study will test an innovative way to establish how pain medicines provide analgesia in healthy adults. The study uses a group of short, controlled pain tests to look at different types of pain responses in the body. The main goal is to find out if this testing approach can show the pain-relieving effects of 2 medicines, pregabalin and naproxen versus placebo, and show how they provide relief of different types of pain.
The study hypothesis is that this pain testing approach administered as a battery would be able to tell the difference between a medicine that works mainly in the brain and spinal cord (pregabalin) and a medicine that works mainly on inflammation in body tissues (naproxen).
Up to 25 healthy adults will take part. Each participant will receive all 3 study treatments, pregabalin, naproxen, and placebo, administered in random order during separate study periods. The order will be assigned by chance. Neither the participant nor the study team will know which treatment is given at each visit.
The study includes several experimental pain tests. These include:
a heat and capsaicin skin test that causes short-term skin sensitivity,
a UVB light test that causes a temporary sunburn-like sensitivity, and
a cold pressor test, in which a hand is placed in very cold water for a short time.
Participants will also have sensory testing to measure how they feel touch, pressure, pinprick, warmth, heat, and cold. Blood samples will be collected to measure study drug levels. Urine samples, vital signs, and other safety checks will also be done.
Each treatment visit includes testing before and for several hours after taking the study drug. There will be a washout period of at least 48 hours between treatments. Total participation may last up to about 10 weeks.
This study is not expected to provide direct medical benefit to participants. The information learned may help researchers improve early testing of future pain treatments....

Start Date04 Oct 2026

Sponsor / Collaborator

National Center For Complementary & Integrative Health

100 Clinical Results associated with Pregabalin

100 Translational Medicine associated with Pregabalin

100 Patents (Medical) associated with Pregabalin

5,513

Literatures (Medical) associated with Pregabalin

31 Dec 2026·COPD-Journal of Chronic Obstructive Pulmonary Disease

Prescribing Patterns of Gabapentinoids in Patients with Chronic Obstructive Pulmonary Disorder

Article

Author: Bullock, Reece ; Dimit, Alexandra ; Patel, Manysha ; Englehart, Anika ; Soric, Mate Michael ; King, Olivia ; Bole, Kelly ; Mara, Nita ; Vergara, Mollie ; Moqbl, Amgad ; Skory, Brandon

In 2019, the U.S. Food and Drug Administration (FDA) issued a warning regarding the risk of serious respiratory depression in patients using gabapentin or pregabalin who have respiratory risk factors, including those with chronic obstructive pulmonary disorder (COPD). With the overall prescribing of gabapentinoids continuing to grow, there is the potential for inappropriate prescribing in this patient population. Data from the National Ambulatory Medical Care Survey (NAMCS) from 2013 to 2018, with the exception of 2017, was used to assess prevalence and predictors of gabapentinoid prescribing in patients with COPD. The data consists of 1,131 unweighted visits, representing approximately 53.6 million ambulatory care visits nationally. Of these visits, 146 patients (10.8%) with a COPD diagnosis were also prescribed a gabapentinoid, which represents more than a million office visits annually when weighted. Patients with an increased risk of receiving gabapentinoids were those with concomitant diabetes mellitus, concurrent opioid use, and those currently using tobacco. Due to increased risk of serious respiratory depression caused by gabapentinoids, prescribers should take caution when prescribing to individuals with COPD and other respiratory risk factors. Based on the reviewed prescribing patterns, more education is needed to inform providers about the risks associated with concomitant COPD and gabapentinoid use.

01 Dec 2026·CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL

Association Between the Use of Gabapentinoids and Exacerbations of Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-analysis

Review

Author: Sridevi, Bhima ; Chittelu, Blessy ; Pelluri, Ranakishor ; Thommandru, Sravani ; Muteti, Paul Kitonga ; Mateti, Uday Venkat ; Royyuru, Lalasa Sri Tulasi ; Varukolu, Suresh ; Rachamanti, Ramya ; Gurram, Prasada Chowdari ; Nalluri, Buchi Naidu ; Gopal, Kannan ; Nalukenge, Birungi Mariam ; Nagasubramanian, Vanitha Rani ; Patnam, Nageswari ; L, Ananthesh

Background:

Evidence on gabapentinoids and its respiratory safety among the patients with chronic obstructive pulmonary disease(COPD) or asthma are remains uncertain.

Objective:

To evaluate the risk of exacerbations with gabapentinoids.

Methods:

A thorough literature search up to January 2026 was done across different databases to find real-world studies examining gabapentinoid exposure and respiratory outcomes. The pooled hazard ratios (HRs), 95% confidence interval (CI) and incidence rate ratios (IRRs) were calculate using random-effects models. Subgroup and sensitivity analysis were also performed for included studies. Quality of studies was evaluated using the Newcastle-Ottawa Scale.

Results:

Four cohort studies (seven reports) included to this analysis. Gabapentinoids use did not associated with exacerbations of COPD or asthma (HR = 1.12, 95% CI: 0.93-1.34; p = 0.23; I² = 90.7%). Further, analysis was stratified by gabapentinoid class and clinical indications. Subgroup analyses showed increased exacerbation risk with gabapentin (HR = 1.27, 95% CI: 1.02-1.58) and pregabalin (HR=1.37, 95% CI: 1.12-1.67), whereas mirogabalin showed no significant association. Elevated risk was consistent across clinical indications (HR = 1.42, 95% CI: 1.35-1.48). Incidence rate analysis demonstrated higher exacerbation incidence among gabapentinoid users (IRR = 1.41, 95% CI: 1.10-1.81; p=0.006).

Conclusions:

Overall, there was no significant association with gabapentinoids. However, gabapentin and pregabalin were linked to increased risk of exacerbations. Therefore, future long-term studies are required to establish this association with underlying biological mechanisms. [PROSPERO ID: CRD420251248968].

01 Dec 2026·Current Pain and Headache Reports

Periosteal Osteosarcoma: Emerging Clinical Concepts, Evolving Treatment Options: A Narrative Review

Review

Author: Kaye, Alan D ; Bratton, Matthew B ; Shekoohi, Sahar ; Islam, Rahib K ; Abd-Elsayed, Alaa ; Pirzadah, Humza A ; Starns, Michael J

PURPOSE OF REVIEW:

Periosteal osteosarcomas are rare bone tumors that comprise less than 2% of all bone malignancies. The tumor was previously thought to affect the diaphysis of long bones solely, but Recent case reports have demonstrated its existence in the clavicle, mandible, and scapula.

RECENT FINDINGS:

Several factors, including stage, grade, and medullary invasion primarily drive survival and recurrence of periosteal osteosarcomas. Related to its rarity, little data currently exists regarding optimum treatment strategies, including limb amputation, surgical resection, and chemotherapy in the neoadjuvant/adjuvant setting. In this regard, bone pain is the most common manifestation. Pain treatment can include medications such as oral or transdermal opioids. Adjuvant drugs can reduce inflammation and neuropathic pain, including corticosteroids, gabapentinoid agents such as gabapentin or pregabalin, lidocaine patches, tricyclic antidepressants such as amitriptyline, nortriptyline, and desipramine, or selective serotonin-norepinephrine reuptake inhibitors such as duloxetine and venlafaxine. More advanced pain treatment interventions can be provided by interventional pain medicine physicians, such as radiofrequency ablation, peripheral nerve stimulation, spinal cord stimulation, or intrathecal drug delivery systems, when conventional opioids and adjuvants do not adequately provide relief. Molecular workups of case reports have shown common mutations, such as the p53 gene, which may provide utility for future molecular targets. The present investigation aims to synthesize currently available data on periosteal osteosarcomas, including common clinical, histologic, and radiographic presentations. In addition, this review aims to further examine the potential for biomarkers and provide recommendations for treatment and future research direction.

125

News (Medical) associated with Pregabalin

15 Sep 2026

·www.prnewswire.com

Braeburn Announces Publication of Postmarketing Safety Analysis Evaluating BRIXADI® in The Journal of Substance Use & Addiction Treatment

PLYMOUTH MEETING, Pa., Sept. 15, 2026 /PRNewswire/ -- Braeburn today announced the publication of a study in The Journal of Substance Use & Addiction Treatment (JSAT) examining adverse events (AEs) reported to the FDA Adverse Event Reporting System (FAERS) during the first 18 months following the U.S. commercial launch of Weekly and Monthly BRIXADI® (buprenorphine) extended-release injection for subcutaneous use (CIII). The full publication, "Adverse events reported to FDA Adverse Event Reporting System for long-acting injectable buprenorphine during the first 18 months postlaunch," is available online at JSAT today. "Clinicians have had to rely primarily on clinical trials to understand the safety profile of long-acting injectable buprenorphine formulations," said Brian Dawson, MD, FASAM, Chief Medical Officer at Ideal Option. "Postmarketing reporting to the FAERS helps give us a fuller picture by providing safety insights across the broader U.S. patient population." "These real-world data help support informed decision-making for healthcare professionals managing this disease," said Joshua M. Cohen, MD, MPH, FAHS, Chief Medical Officer at Braeburn. About the Analysis A retrospective review of the FAERS was conducted examining case reports submitted during the 6-, 12-, and 18-month periods following the U.S. commercial launch of each FDA-approved long-acting injectable buprenorphine product. About BRIXADI® BRIXADI is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support. IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; BRIXADI RISK EVALUATION AND MITIGATION STRATEGY Serious harm or death could result if administered intravenously. BRIXADI forms a liquid crystalline gel upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life-threatening pulmonary emboli, if administered intravenously. Because of the risk of serious harm or death that could result from intravenous self-administration, BRIXADI is only available through a restricted program called the BRIXADI REMS. Healthcare settings and pharmacies that order and dispense BRIXADI must be certified in this program and comply with the REMS requirements. BRIXADI (buprenorphine) extended-release injection (weekly, 50 mg/mL buprenorphine) and BRIXADI (monthly, 356 mg/mL buprenorphine) are different formulations. Doses of BRIXADI (weekly) cannot be combined to yield an equivalent monthly dose. CONTRAINDICATIONS BRIXADI is contraindicated in patients with hypersensitivity (e.g., anaphylactic shock) to buprenorphine or any other ingredients in the solution for injection. WARNINGS AND PRECAUTIONS Addiction, Abuse, and Misuse: BRIXADI contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Buprenorphine is sought by people with opioid use disorder and is subject to criminal diversion. Monitor all patients for progression of opioid dependence and addictive behaviors. Life-Threatening Respiratory and Central Nervous System (CNS) Depression: Buprenorphine has been associated with life-threatening respiratory depression and death. Use BRIXADI with caution in patients with compromised respiratory function. Due to its extended-release characteristics, if BRIXADI is discontinued as a result of compromised respiratory function, monitor patients for ongoing buprenorphine effects for approximately 1 month for BRIXADI (weekly) and for approximately 4 months for BRIXADI (monthly). Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose. Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose: Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene) and discuss the importance of having access to an opioid overdose reversal agent. Because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose, strongly consider prescribing or recommending an opioid overdose reversal agent for the emergency treatment of an opioid overdose, both when initiating and renewing treatment with BRIXADI. If an opioid overdose reversal agent is prescribed, educate patients and caregivers on how to treat with such an agent, and emphasize the importance of calling 911 or getting emergency medical help, even if an agent is administered. Concomitant Use of Benzodiazepines or other CNS Depressants: Concomitant use of buprenorphine and benzodiazepines or other CNS depressants (e.g., alcohol, non-benzodiazepine sedative/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids) increases the risk of adverse reactions including overdose, respiratory depression, and death. Ensure that other healthcare providers prescribing benzodiazepines or other CNS depressants are aware of the patient's buprenorphine treatment and coordinate care to minimize the risk associated with concomitant use. Inform patients and caregivers that potentially fatal additive effects may occur if BRIXADI is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider. Neonatal Opioid Withdrawal Syndrome, Pregnancy, and Lactation: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. NOWS may be life-threatening if not recognized and treated in the neonate. Healthcare providers should observe newborns for signs of NOWS and manage accordingly. Advise pregnant women receiving opioid addiction treatment with BRIXADI of the risk of neonatal opioid withdrawal syndrome. Warn patients that buprenorphine passes into breast milk. Advise the nursing mother taking buprenorphine to monitor the infant for increased drowsiness and breathing difficulties. Adrenal Insufficiency: If adrenal insufficiency is diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. Risk of Opioid Withdrawal with Abrupt Discontinuation: Patients who elect to discontinue BRIXADI treatment should be monitored for withdrawal signs and symptoms with consideration given to the product's extended-release characteristics. Risk of Hepatitis, Hepatic Events, and Use in Patients with Impaired Hepatic Function: Liver function tests should be performed on all patients prior to initiation, during treatment, and if a hepatic event is suspected. Because buprenorphine levels cannot be rapidly decreased, patients with pre‐existing moderate to severe hepatic impairment are not candidates for treatment with BRIXADI. Patients who develop moderate to severe hepatic impairment while being treated with BRIXADI should be monitored for signs and symptoms of toxicity or overdose of buprenorphine and may require a dose adjustment. Hypersensitivity Reactions: Cases of bronchospasm, angioneurotic edema, and anaphylactic shock have been reported in patients receiving buprenorphine-containing products. The most common signs and symptoms include rashes, hives, and pruritus. The BRIXADI needle cap is synthetically derived from natural rubber latex which may cause allergic reactions in latex-sensitive individuals. Precipitation of Opioid Withdrawal in Patients Dependent on Full Opioid Agonists: BRIXADI injection may precipitate opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists such as heroin, morphine, or methadone before the effects of the full opioid agonist have subsided. In patients who are new entrants to treatment, to avoid precipitating an opioid withdrawal syndrome, administer a 4 mg test dose of transmucosal buprenorphine when objective signs of mild to moderate withdrawal appear and monitor for precipitated withdrawal before injecting BRIXADI. Risks Associated with Treatment of Emergent Acute Pain: While on BRIXADI, situations may arise where patients need acute pain management, or may require anesthesia. Treat patients receiving BRIXADI with non-opioid analgesic whenever possible. Patients requiring opioid therapy for analgesia may be treated with a high-affinity full opioid analgesic under the supervision of a healthcare provider, with particular attention to respiratory function. Higher doses may be required for analgesic effect. Therefore, a higher potential for toxicity exists with opioid administration. Advise patients of the importance of instructing their family members, in the event of emergency, to inform the treating healthcare provider or emergency room staff that the patient is being treated with BRIXADI. Use in Opioid Naïve Patients: There have been reported deaths of opioid naïve individuals who received a 2 mg dose of buprenorphine as a sublingual tablet. BRIXADI is not appropriate for use in opioid naïve patients. Patients at Risk for Arrhythmia: Thorough QT studies with buprenorphine products have demonstrated QT prolongation ≤ 15 msec. This QTc prolongation effect does not appear to be mediated by hERG channels. Based on these two findings, buprenorphine is unlikely to be pro-arrhythmic when used alone in patients without risk factors. The risk of combining buprenorphine with other QT-prolonging agents is not known. Impairment of Ability to Drive and Operate Machinery: BRIXADI may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery. Caution patients about driving or operating hazardous machinery until they are reasonably certain that BRIXADI does not adversely affect their ability to engage in such activities. Orthostatic Hypotension: Buprenorphine may produce orthostatic hypotension in ambulatory patients. Elevation of Cerebrospinal Fluid Pressure: Buprenorphine may elevate cerebrospinal fluid pressure and should be used with caution in patients with head injury, intracranial lesions, and other circumstances when cerebrospinal pressure may be increased. Elevation of Intracholedochal Pressure: Buprenorphine has been shown to increase intracholedochal pressure, as do other opioids, and thus should be administered with caution to patients with dysfunction of the biliary tract. Effects in Acute Abdominal Conditions: Buprenorphine may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Unintentional Pediatric Exposure: Buprenorphine can cause severe, possibly fatal, respiratory depression in children who are accidentally exposed to it. ADVERSE REACTIONS Adverse reactions commonly associated with BRIXADI administration (in ≥5% of patients) were injection site pain, headache, constipation, nausea, injection site erythema, injection site pruritus, insomnia, and urinary tract infection. DRUG INTERACTIONS CYP3A4 Inhibitors and Inducers: Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over or under dosing. Serotonergic Drugs: If concomitant use is warranted, monitor for serotonin syndrome, particularly during treatment initiation, and during dose adjustment of the serotonergic drug. USE IN SPECIFIC POPULATIONS Lactation: Buprenorphine passes into the mother's milk. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for buprenorphine treatment and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. Geriatric Patients: Monitor geriatric patients receiving BRIXADI for sedation or respiratory depression. Moderate to Severe Hepatic Impairment: BRIXADI is not recommended for use in patients with pre-existing moderate to severe hepatic impairment. To report SUSPECTED ADVERSE REACTIONS, contact Braeburn at 1-833-274-9234 or FDA at 1-800-FDA-1088 or . Please see the BRIXADI Medication Guide and Full Prescribing Information , including BOXED WARNING, at BRIXADI.com or accompanying this document. About Braeburn Braeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder. At Braeburn, we challenge the status quo and champion transformation of the management of opioid use disorder (OUD) by partnering with the community to create a world where every person with OUD gets the best possible care and opportunity to reach their full potential. Visit braeburnrx.com to learn more. Connect with Braeburn on LinkedIn at linkedin.com/company/braeburn. For additional information, please contact: Sabrina Romano, Senior Manager of Corporate Communications & Advocacy, at [email protected] BRX-1836 August 2026 SOURCE Braeburn 21% more press release views with Request a Demo

28 Jul 2026

·www.prnewswire.com

Targeting the $100 Billion Market: Insilico Medicine Nominates AI-driven Novel PCC ISM9528 for Pain Management

AI-Driven New Mechanism Discovery: Targeting an undisclosed novel mechanism empowered by PandaOmics, the PCC ISM9528 offers a potential first-in-class, brain-penetrant, non-opioid solution for pain management. Superior Therapeutic Profile: In preclinical studies, ISM9528 demonstrated superior efficacy compared to the standard of care, along with a favorable safety profile as an oral treatment, and promising DMPK properties. Proven Reproducibility and Scale: As Insilico's 31st PCC nominated since 2021, ISM9528 further validates the capabilities of Insilico's proprietary Pharma.AI platform to consistently accelerate and empower drug R&D innovation. CAMBRIDGE, Mass., July 22, 2026 /PRNewswire/ -- Despite the widespread availability of analgesics, pain management remains one of the most significant and pervasive challenges in modern medicine, with more than 20% of the global population suffering from chronic pain, especially chronic neuropathic pain characterized by central sensitization. However, the standard of care currently continues to rely heavily on opioids and NSAIDs, which are limited by inadequate efficacy, gastrointestinal toxicity, and the serious risks of dependence and addiction, calling for novel, effective, non-addictive, brain-penetrant analgesics. Insilico Medicine ("Insilico", HKEX:3696), a clinical-stage, generative AI-driven drug discovery company, is addressing this critical unmet need by using AI to uncover novel biological mechanisms and develop innovative therapies. The company recently announced the nomination of ISM9528 as a Preclinical Candidate Compound (PCC) for pain management. Identified by PandaOmics, ISM9528 is a potential first-in-class, brain-penetrant, orally available inhibitor of Target Z that offers a novel, non-opioid treatment approach by acting on a previously unexplored biological mechanism. Notably, this marks the 31st PCC nominated by Insilico since 2021, further validating the company's AI-driven R&D capabilities. "To see a non-opioid candidate outperform morphine in preclinical models is an unprecedented milestone, perhaps one of the most remarkable and unexpected results in our company's history, a result of frontier AI, human ingenuity and scientific serendipity." says Alex Zhavoronkov, PhD, Founder, CEO, and CBO of Insilico Medicine. "Target discovery for highly complex human mechanisms like chronic pain and migraine historically takes over a decade, but PandaOmics precisely mapped this pathway, driving us to our 31st PCC since 2021. By understanding the biology behind, we are not only addressing pain management, but moving one step closer to our ultimate ambition: decoding the biology of aging through our dual-purpose strategy." To find a new path forward for pain management, the team leveraged PandaOmics, Insilico's AI engine for identification and prioritization of therapeutic targets. By analyzing massive datasets of omics, textual and multimodal data, PandaOmics helped the team uncover a new pain-related pattern, highlighting the potential of Target Z in Insilico's current portfolio, a novel target not systematically linked to pain management before, and driving their attention to a compound they had already developed. Subsequent bioinformatics analyses of human and animal model data showed high expression of Target Z in pain-related cell types, strengthening the team's confidence to advance into wet lab testing. Moving swiftly into in vivo validation, The research utilized specialized mice models to imitate human pain mechanisms, demonstrating robust, dose-dependent pain management efficacy, with potential comparable or surpassing current solutions, including morphine. Following target validation, the team aimed at brain-penetrant properties and a balance between efficacy and safety, deploying Chemistry42, Insilico's generative chemistry platform compassing 40+ selective models integrated into several affiliated applications to re-generate compounds with optimized selectivity and ADMET properties for pain indication. After iterative cycles of AI generation, human feedback and refinement, ISM9528 was selected as the lead compound for the project. "The nomination of ISM9528 as the 31st drug candidate of Insilico validates the reproducibility and precision of our end-to-end AI platform," says Feng Ren, PhD, Co-CEO and CSO of Insilico Medicine, "Featuring both a novel mechanism of action and a highly distinct chemical structure, ISM9528 delivers superior efficacy and a favorable safety profile, with promising brain penetrant traits. Looking ahead, we are confident that our continuous integration of generative AI and automation will set new standards, deliver solid proof of concept, and introduce real-world clinical benefits for patients." In preclinical studies, ISM9528 demonstrated superior efficacy compared to standard of care in validated models of acute postsurgical pain and neuropathic pain, as an oral treatment. Moreover, comprehensive in vitro and in vivo safety screenings across multiple panels and animal models confirmed exceptional safety properties, while rapid systemic absorption and excellent blood-brain barrier permeability support a favorable DMPK profile. In the Spinal Nerve Ligation (SNL) rat model for neuropathic pain, ISM9528 dose-dependently restored mechanical allodynia. The middle dose delivered a significant analgesic effect across all time points up till 6h post dosing, which was comparable to Pregabalin, a standard of care for pain at similar dose level. In the postsurgical acute pain model, in addition to the dose dependent efficacy, ISM9528 demonstrated a rapid-acting efficacy at 0.5-hour post-dosing outperforming the equivalent dose of Pregabalin. "There is a tremendous unmet need for non-opioid pain medications, and the preclinical data for ISM9528 is quite promising," says Carol Satler, MD, PhD, Senior Vice President for Clinical Development, Non-Oncology, Insilico Medicine, "This is what we call a 'Eureka' moment, the kind of discovery that completely changes the landscape of how we treat patients. We are fast-tracking this exciting program toward clinical trials in 2027, driven to deliver a medicine that will genuinely transform patient care." As an AI-native biotechnology company, Insilico is redefining the efficiency of preclinical drug development through its advanced AI and automation platform, setting a new standard for the industry. While traditional early-stage drug discovery typically takes 2.5 to 4 years, Insilico has consistently reached preclinical candidate (PCC) nomination in an average of just 12 to 18 months, with only 60 to 200 molecules synthesized and tested per program. Since 2021, the company has nominated 31 PCCs, 13 of which have received IND approval or clearance. While expanding the practical applications of its technology in drug discovery and life science research, Insilico is also continuously enhancing the performance of its AI platform. Drawing on extensive experience and datasets from its training platform, the company has distilled thousands of benchmarks and integrated them into MMAI Gym. Serving as both a "trainer and benchmark" for scientific AI, MMAI Gym enables organizations to train models for domain-specific reasoning while rigorously evaluating their performance on real-world tasks, advancing the path toward pharma superintelligence. To date, Human Longevity and Liquid AI have collaborated with Insilico, joining as partners of MMAI Gym. About Insilico Medicine Insilico Medicine is a pioneering global biotechnology company dedicated to integrating artificial intelligence and automation technologies to accelerate drug discovery, drive innovation in the life sciences, and extend healthy longevity to people on the planet. The company was listed on the Main Board of the Hong Kong Stock Exchange on December 30, 2025, under the stock code 03696.HK. By integrating AI and automation technologies and deep in-house drug discovery capabilities, Insilico is delivering innovative drug solutions for unmet needs including fibrosis, oncology, immunology, pain, and obesity and metabolic disorders. Additionally, Insilico extends the reach of Pharma. AI across diverse industries, such as advanced materials, agriculture, nutritional products and veterinary medicine. For more information, please visit SOURCE Insilico Medicine 21% more press release views with Request a Demo

17 Jun 2026

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MIRA Pharmaceuticals Submits Phase 2a Clinical Trial Protocol to FDA for Ketamir-2 in Chemotherapy-Induced Peripheral Neuropathy

Randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, and dose-response efficacy of oral Ketamir-2 at a leading U.S. cancer center MIAMI, FL / ACCESS Newswire / June 17, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company") , a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced the submission of a Phase 2a clinical trial protocol to the U.S. Food and Drug Administration (FDA) for Ketamir-2, the Company's proprietary oral NMDA receptor modulator, in chemotherapy-induced peripheral neuropathy (CIPN). Addressing a Significant Unmet Medical Need Chemotherapy-induced peripheral neuropathy is one of the most common and debilitating consequences of cancer treatment. It affects an estimated 30 to 40 percent of patients who receive neurotoxic chemotherapy, and approximately 3 million new persistent cases are estimated annually worldwide. For many patients, symptoms including pain, numbness, tingling, and loss of sensation do not resolve when treatment ends. Roughly 30 percent continue to experience them six months or more after completing chemotherapy, often with lasting impact on their ability to function and their overall quality of life. Despite how common and disabling the condition is, there are currently no FDA-approved therapies specifically for CIPN. Oncologists rely on medications such as gabapentin, pregabalin, duloxetine, and tricyclic antidepressants, none of which were developed for this purpose, and many of which provide incomplete relief. In severe cases, CIPN forces dose reductions or the discontinuation of chemotherapy entirely, potentially compromising cancer outcomes. The absence of an approved treatment has remained one of the more glaring gaps in oncology supportive care. About the Phase 2a Study (Protocol Mira-002) The planned Phase 2a study is a randomized, double-blind, placebo-controlled, three-period crossover trial that will evaluate the safety, tolerability, and dose-response relationship of oral Ketamir-2 in patients with moderate-to-severe persistent CIPN. The study will be conducted at a leading U.S. cancer center. Patients will be enrolled and randomized to receive Ketamir-2 at one of two dose levels, 300 mg or 600 mg, or a matching placebo, across three sequential seven-day treatment periods, each separated by a two-week washout. Because each patient moves through all three treatment sequences, the crossover design allows each participant to serve as their own control, producing a more reliable signal with a smaller study population. The primary objectives are to characterize the safety and tolerability of Ketamir-2 at both dose levels and to evaluate its dose-response relationship on neuropathic pain intensity, measured by change from baseline in the weekly mean 11-point Numeric Rating Scale pain score. Secondary objectives include the proportion of patients achieving meaningful pain reductions of 30 percent or more and 50 percent or more, changes in CIPN-related symptoms and functional status measured by the EORTC QLQ-CIPN20, and assessment of central nervous system pharmacodynamic effects. Each participant will be in the study for up to 82 days. To be eligible, patients must have experienced persistent CIPN for at least three months following chemotherapy, report a baseline pain score of 4 or higher on the NRS scale, and have underlying cancer that is clinically stable with no active disease requiring systemic treatment at study entry. The submission builds on results from the successfully completed MIRA-001 Phase 1 study, which enrolled 56 healthy volunteers across single and multiple ascending dose cohorts. No serious adverse events or dose-limiting toxicities were observed at any dose tested, and the pharmacokinetic pro the dose levels and once-daily administration schedule selected for Phase 2a. Management Commentary "CIPN has been overlooked for too long," said Erez Aminov, Chairman and Chief Executive Officer of MIRA Pharmaceuticals . "Millions of cancer survivors are managing real, ongoing pain with medications that were never approved for this condition and that often do not work well enough. Ketamir-2 came out of Phase 1 with a clean safety record, and this Phase 2a study is the next step toward building the evidence base the program needs." Dr. Itzchak Angel, Chief Scientific Advisor of MIRA Pharmaceuticals , commented: "The crossover design we selected for this study is scientifically well-suited to this patient population. Having each participant experience all three treatment periods gives us a more precise read on dose-response while keeping the study size manageable. The Phase 1 data gave us clear guidance on dosing, and Phase 2a is designed to answer the questions that matter most going forward - how Ketamir-2 performs on safety and pain relief in patients who need it." About Ketamir-2 Ketamir-2 is an oral NMDA receptor modulator in development for chronic neuropathic pain. The NMDA receptor pathway is well established in neuropathic pain biology, and ketamine has long demonstrated activity there, but its use for chronic conditions has been constrained by the need for intravenous administration, significant dissociative side effects, Schedule III controlled substance status, and the clinical infrastructure required to administer and monitor it. Ketamir-2 was built to capture the mechanism without those limitations, delivered orally, dosed once daily, and confirmed by the DEA as non-scheduled. MIRA holds exclusive worldwide rights to Ketamir-2 with intellectual property secured across 10 major markets, including the United States, European Union, China, Japan, Canada, Australia, India, Israel, Mexico, and South Korea. Ketamir-2 has not been approved by the U.S. Food and Drug Administration for any indication. Its safety and efficacy have not been established. About MIRA Pharmaceuticals, Inc. MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of investigational therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company's pipeline includes oral drug candidates being evaluated for neuropathic pain, inflammatory pain, obesity, addiction-related disorders, anxiety, and cognitive impairment. For more information, please visit . Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "can," "could," "would," "may," "will," "believe," "estimate," "forecast," "goal," "project," "guidance," "potential," "intend," "seek," "target" and other words of similar meaning, although not all forward-looking statements include these words. Forward-looking statements may include, but are not limited to, statements regarding the development of Ketamir-2; the planned Phase 2a clinical trial, including its design, objectives, enrollment, timing, initiation and potential outcomes; the potential efficacy, safety, tolerability and therapeutic benefits of Ketamir-2; the potential advantages of Ketamir-2 compared to existing treatment options; the potential market opportunity for Ketamir-2; future regulatory interactions; intellectual property protection; strategic partnership opportunities; and the future development and commercialization of Ketamir-2. These forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as management's beliefs and assumptions, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to preclinical and clinical development, the ability to obtain regulatory approvals, the outcome of future studies, reliance on third parties, intellectual property protection, financing needs, market conditions, and the other risks identified under the heading "Risk Factors" contained in the Company's Annual Report on Form 10-K and the Company's other filings with the U.S. Securities and Exchange Commission ("SEC"). Forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update or revise such statements, whether as a result of new information, future events, or otherwise, except as required by applicable law. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at the SEC website and in the "Investors" section of our website at MIRA Investors, for a discussion of these and other risks and uncertainties. Contact: Krystina Quintana info@mirapharma.com (786) 432-9792 SOURCE: MIRA Pharmaceuticals View the original press release on ACCESS Newswire

Phase 2Phase 1Clinical Result

100 Deals associated with Pregabalin

External Link

KEGG	Wiki	ATC	Drug Bank
D02716	Pregabalin	N03AX16	DB00230

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Fibromyalgia	South Korea	Beatrice Korea Co., Ltd.	14 Jun 2005
Seizures	Australia	Viatris Pty Ltd.	13 Apr 2005
Diabetic peripheral neuropathy	United States	Pfizer Inc.	30 Dec 2004
Neuralgia, Postherpetic	United States	CP Pharmaceuticals Ltd.	30 Dec 2004
Neuralgia, Postherpetic	United States	Pfizer Inc.	30 Dec 2004
Epilepsies, Partial	European Union	Upjohn EESV	05 Jul 2004
Epilepsies, Partial	Iceland	Upjohn EESV	05 Jul 2004
Epilepsies, Partial	Liechtenstein	Upjohn EESV	05 Jul 2004
Epilepsies, Partial	Norway	Upjohn EESV	05 Jul 2004
Epilepsy	European Union	Upjohn EESV	05 Jul 2004
Epilepsy	Iceland	Upjohn EESV	05 Jul 2004
Epilepsy	Liechtenstein	Upjohn EESV	05 Jul 2004
Epilepsy	Norway	Upjohn EESV	05 Jul 2004
Generalized anxiety disorder	European Union	Upjohn EESV	05 Jul 2004
Generalized anxiety disorder	Iceland	Upjohn EESV	05 Jul 2004
Generalized anxiety disorder	Liechtenstein	Upjohn EESV	05 Jul 2004
Generalized anxiety disorder	Norway	Upjohn EESV	05 Jul 2004
Neuralgia	European Union	Upjohn EESV	05 Jul 2004
Neuralgia	Iceland	Upjohn EESV	05 Jul 2004
Neuralgia	Liechtenstein	Upjohn EESV	05 Jul 2004

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Leg Ulcer	Phase 3	United States	Pfizer Inc.	15 May 2015
Phantom Limb	Phase 3	United States	Pfizer Inc.	15 May 2015
Refractory chronic cough	Phase 3	Australia	John Hunter Hospital	28 Feb 2012
Cortical Dysplasia-Focal Epilepsy Syndrome	Phase 3	Argentina	Huizhi Pharmaceutical (Dalian) Co., Ltd.	21 Feb 2012
Cortical Dysplasia-Focal Epilepsy Syndrome	Phase 3	Argentina	Pfizer Inc.	21 Feb 2012
Cortical Dysplasia-Focal Epilepsy Syndrome	Phase 3	Austria	Huizhi Pharmaceutical (Dalian) Co., Ltd.	21 Feb 2012
Cortical Dysplasia-Focal Epilepsy Syndrome	Phase 3	Austria	Pfizer Inc.	21 Feb 2012
Cortical Dysplasia-Focal Epilepsy Syndrome	Phase 3	Belarus	Huizhi Pharmaceutical (Dalian) Co., Ltd.	21 Feb 2012
Cortical Dysplasia-Focal Epilepsy Syndrome	Phase 3	Belarus	Pfizer Inc.	21 Feb 2012
Cortical Dysplasia-Focal Epilepsy Syndrome	Phase 3	Belgium	Huizhi Pharmaceutical (Dalian) Co., Ltd.	21 Feb 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04846673 (OPTIMUM, Pubmed \| Diabetes Obes Metab)	Phase 4	Diabetic peripheral neuropathic pain	151	Alpha-Lipoic Acid (ALA) 480 mg/day	mtegjupjof(ogsbadswmr) = tbfhefgzje xalxwsbueg (xozznnkela, 18.94)	Positive	01 Jul 2026
				Pregabalin 150 mg/day	-
NCT07382921 (KY2025-217-03-08, Pubmed \| J Pain Res)	Not Applicable	Fibromyalgia	164	Pregabalin plus Tizanidine	epnmggughd(gsrfyfxwcy) = wdqkgbnfby iffynyxumt (dicupxjidc )	Positive	01 May 2026
				Pregabalin	epnmggughd(gsrfyfxwcy) = uhnbrrmrjj iffynyxumt (dicupxjidc )
NCT05488847 (CTgov)	Phase 4	Shoulder Pain \| Periarthritis scapulohumeralis	83	pregabalin+epinephrine+ropivacaine+acetaminophen+magnesium+oxycodone extended-release+ketorolac+dexamethasone+ibuprofen+celecoxib+tizanidine (Non Opioid, Multimodal Protocol)	xlajtgtzrl(zrqgcxdynf) = rkstfzzrki ncbszxrxxt (bgpayimdtv, 1.7)	-	10 Feb 2026
				pregabalin+epinephrine+ropivacaine+acetaminophen+magnesium+oxycodone extended-release+ketorolac+dexamethasone+ibuprofen+celecoxib+tizanidine (Opioid Protocol)	xlajtgtzrl(zrqgcxdynf) = bdkxoapczg ncbszxrxxt (bgpayimdtv, 1.6) View more
NCT04705480 (CTgov)	Phase 4	Pain	109	Pregabalin 50mg (Pregabalin)	fsculftuig(vasrmnvaym) = cmemcqpyyn pprgtbadbf (ylnmgxqspq, lhmatkedry - ikclblvnzg) View more	-	06 Jan 2026
				Gabapentin 300mg (Gabapentin)	fsculftuig(vasrmnvaym) = vgodbbrugn pprgtbadbf (ylnmgxqspq, baigtfccgn - zqfzckgobz) View more
ACR2025	Not Applicable	Chronic musculoskeletal pain	179,684	Pregabalin	yonzcntctt(aasdpbfahn): HR = 1.23 (95.0% CI, 1.08 - 1.4) View more	Negative	24 Oct 2025
				Duloxetine
NCT05974501 (CTgov)	Phase 4	complications of arthroplasty \| Osteoarthritis, Knee \| Pain, Postoperative	84	Lyrica+Ropivacaine+Acetaminophen+Oxycodone+Dexamethasone+Celebrex+Meloxicam (Preoperative Adductor Canal Block Group)	isfpxrigsk(qthrrwgmsg) = vsogvackoo zzrsunrsgg (mrzapjnpqk, hzappadryd - uzcybczyco) View more	-	12 Feb 2025
				Lyrica+Ropivacaine+Acetaminophen+Oxycodone+Dexamethasone+Celebrex+Meloxicam (Postoperative Adductor Canal Block Group)	isfpxrigsk(qthrrwgmsg) = iimclmmool zzrsunrsgg (mrzapjnpqk, smaenomaou - egztuiobsd) View more
ACR2024	Not Applicable	Chronic musculoskeletal pain	179,562	Pregabalin	zpuonrnfau(upcccortda) = fczuyhiodv grfeqhqcox (cbgziufdyy )	Negative	10 Nov 2024
				Duloxetine	zpuonrnfau(upcccortda) = mbnhgigjzx grfeqhqcox (cbgziufdyy )
NCT04122196 (CTgov)	Phase 2/3	Kidney Calculi \| Postoperative Complications \| Opioid abuse ... View more	118	Pregabalin 300mg (Pregabalin 300mg)	wwbhvsdjtz(pmxqwvhcmf) = bowfgosbde gzuwtodyii (iffjoddkas, drvemgosng - awhbxlckkn) View more	-	24 Oct 2024
				Placebo oral tablet (Placebo)	wwbhvsdjtz(pmxqwvhcmf) = hkthcmmxve gzuwtodyii (iffjoddkas, nmnpqzulpf - xzacedbnay) View more
NCT05624853 (phase 4, Pubmed)	Phase 4	type 2 diabetes mellitus with peripheral neuropathy	130	Sustained-Release Pregabalin 150 mg	xcpcintqzp(kbhafusspq) = iznkdqrudv nvgzuuoiea (uuniozltby )	Positive	14 Jul 2024
				Immediate-Release Pregabalin 75 mg	xcpcintqzp(kbhafusspq) = vngbaaudgs nvgzuuoiea (uuniozltby )
NCT04015908 (CTgov)	Phase 4	-	100	Pregabalin+Acetaminophen+Oxycodone+celecoxib (Multi-modal)	frdohunefc(ksmfljlyzq) = csgzbgsjmr glfxhmwsix (vdrdublvfb, nhbyenvzvy - zpcywalomt) View more	-	08 Jul 2024
				Percocet (Control)	frdohunefc(ksmfljlyzq) = eksnqyaztu glfxhmwsix (vdrdublvfb, giflguzhoo - yuurbsjaim) View more

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