A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Evaluate Impact of Sunobinop (V117957) on Alcohol Craving in Subjects Diagnosed With Moderate to Severe Alcohol Use Disorder and Seeking Treatment

The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol craving in subjects with moderate to severe alcohol use disorder and these subjects are seeking treatment.

Start Date28 Jan 2025

Sponsor / Collaborator

Knoa Pharma LLC

[+1]

NCT06545916

/ CompletedPhase 2

A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Evaluate Impact of Sunobinop (V117957) on Alcohol Consumption in Subjects Diagnosed With Moderate to Severe Alcohol Use Disorder and Seeking Treatment

The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol consumption in subjects with alcohol use disorder.

Start Date14 Oct 2024

Sponsor / Collaborator

Knoa Pharma LLC

[+1]

NCT06024642

/ CompletedPhase 1

Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to Investigate Effects of V117957 in Female Subjects With Overactive Bladder Syndrome

The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with overactive bladder syndrome, compared to placebo.

Start Date30 Jun 2022

Sponsor / Collaborator

Imbrium Therapeutics LP

[+1]

100 Clinical Results associated with Sunobinop

100 Translational Medicine associated with Sunobinop

100 Patents (Medical) associated with Sunobinop

Literatures (Medical) associated with Sunobinop

01 Jul 2026·JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY

A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Interactions Between Alcohol and Sunobinop in Healthy Participants

Article

Author: He, Ellie ; Harris, Stephen C. ; Zhou, Mingyan ; Kapil, Ram P. ; Whiteside, Garth T. ; Cipriano, Alessandra ; Apseloff, Glen ; Shet, Manjunath S.

Background::

Sunobinop is a potent, selective partial agonist at nociception/orphanin-FQ receptors with therapeutic potential in a variety of clinical disorders. This study assessed safety, tolerability, pharmacodynamics, and pharmacokinetic interactions of sunobinop and alcohol in healthy adults.

Methods::

This was a single-center, randomized, blinded, crossover study in 48 participants. Single doses of placebo, sunobinop 2 mg (therapeutic), and 6 mg (supratherapeutic), were administered in the morning with alcohol or placebo. Pharmacokinetic and pharmacodynamic profiles were compared.

Results::

Coadministration with alcohol did not alter the pharmacokinetics of alcohol or of sunobinop at either dose. A dose-effect relationship in the magnitude/duration of impairment in psychomotor/cognitive parameters was observed, with transient additive effects at 2 mg and greater-than-additive effects at 6 mg that resolved by 5 hours post administration. The most common treatment-emergent adverse event was somnolence, which was mild to moderate.

Conclusions::

A single oral dose of sunobinop was safe and tolerated alone and in combination with alcohol. No pharmacokinetic interaction between sunobinop and alcohol was observed. An additive or greater-than-additive effect was observed for psychomotor/cognitive measures consistent with sunobinop’s sleep-promoting effect, and would peak and resolve during a typical night’s sleep.

19 May 2026·CURRENT MEDICINAL CHEMISTRY

Design, Synthesis, and Pharmacological Characterization of Substituted Quinoxalines as NOP Receptor Ligands

Article

Author: Tanaka, Nobuyuki ; Ueno, Tatsuhiko ; Kyle, Donald J. ; Fuchino, Kouki ; Hummel, Michele ; Tsuno, Naoki ; Yemawaki, Kenji ; Shinohara, Shunji ; Kato, Akira ; Bhargava, Shweta ; Knappenberger, Terri ; Whiteside, Garth T. ; Tafesse, Laykea ; Yamada, Toru ; Hasebe, Nobuyoshi ; Iso, Yasuyoshi ; Crumley, Gregg ; Taoda, Yoshiyuki ; Shan, Shen

Introduction::

The goal of this work was the discovery of moderate-efficacy, selective, partial agonists of the nociceptin/orphanin-FQ peptide (NOP) receptor.

Methods::

A novel collection of quinoxaline-containing molecules was designed, synthesized, and assayed against NOP and mu-opioid receptors in vitro to establish the relationship between structural modification and pharmacological activity. The lead molecule identified was further assessed in vivo to determine brain penetration, analgesic effects in rodent models of pain, and motor deficits.

Results::

This SAR approach revealed that the phenyl portion of the quinoxaline is highly sensitive to modification. The unsubstituted phenyl produced a potent partial agonist (5), whereas most other substitutions created presumed antagonists or molecules that bind poorly to the receptor. Compound 5 was analgesic in rodent models of inflammatory and neuropathic pain at doses that did not produce motor deficits.

Discussion::

The goal of this work was achieved in discovering moderate-efficacy, selective, partial agonists of the NOP receptor. The analgesic efficacy of compound 5 is consistent with the effects of other NOP agonists in animal pain models. The partial agonist nature of 5 likely imparts a wider preclinical therapeutic index compared to full agonists.

Conclusion::

The discovery of sunobinop (compound 5), a NOP partial agonist highly selective for NOP in vitro, was significant. Compound 5 produced antihyperalgesic efficacy in rodents and has progressed to clinical trials.

01 May 2026·JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY

Human Abuse Potential of Single Oral Doses of Sunobinop, a Novel, Highly Potent, and Selective Partial Agonist for Nociceptin/Orphanin-FQ Peptide (NOP) Receptors

Article

Author: He, Ellie ; Harris, Stephen C. ; Schoedel, Kerri A. ; Apseloff, Glen ; Whiteside, Garth T. ; Cipriano, Alessandra ; Shet, Manjunath S.

Background::

Sunobinop is a selective, partial agonist of the nociceptin/orphanin FQ peptide receptor and has multiple potential indications, including insomnia, bladder disorders, and alcohol use disorder. The purpose of this study was to examine the abuse potential and pharmacodynamic effects of sunobinop compared with triazolam in healthy adults with a history of nonmedical use of central nervous system drugs with depressant/sedative properties.

Methods::

This was a single-dose, randomized, double-blind, double-dummy, placebo-controlled and positive-controlled crossover study. Each participant received 6 treatments: sunobinop 1 mg, 6 mg, and 10 mg plus triazolam placebo, sunobinop placebo plus triazolam 0.5 mg and 1 mg, and sunobinop placebo plus triazolam placebo. The primary endpoint for the treatment phase was “at this moment” drug-liking visual analog scale (VAS) maximum effect (0 to 100).

Results::

Fifty participants completed the study. The mean “at this moment” drug-liking VAS scores for sunobinop 1 mg remained within the neutral range (40 to 60) with a peak score of 54.1 and comparable with placebo at all time points. In contrast, “at this moment” drug-liking VAS scores for triazolam control doses increased over time, peaking ∼2 hours following dosing at a mean score of 65.0 and 63.4 for triazolam 0.5 mg and 1.0 mg, respectively.

Conclusions::

Drug-liking following sunobinop at a potential therapeutic dose was not different from placebo and was significantly lower compared with triazolam at a recommended dose. In addition, its good tolerability profile suggests sunobinop may be a useful new treatment option, particularly in at-risk populations.

News (Medical) associated with Sunobinop

22 Jun 2026

·www.prnewswire.com

Knoa Pharma to Present Pipeline Assets at BIO International Convention 2026

The Company will showcase its pipeline and invite conversations with potential partners at the biotechnology industry's premier global event, June 22–25. STAMFORD, Conn., June 22, 2026 /PRNewswire/ -- Knoa Pharma LLC ("Knoa Pharma"), a public health-focused pharmaceutical company dedicated to supporting patients and improving public health, will present its pipeline assets at the BIO International Convention 2026 in San Diego, Calif., on Tuesday, June 23, at 10:30 a.m. PT in Theatre 1. Knoa Pharma is actively seeking partnerships to advance the development of investigational therapeutics for multiple assets across several disease areas including genitourinary disorders, substance use disorders, and oncology. The company is discussing two assets, sunobinop and tinostamustine, both of which could present substantial revenue opportunities.* Tinostamustine is a novel, first-in-class investigational drug combining DNA alkylating activity and HDAC inhibition in a single molecule. It has the potential to be a first-line agent to treat patients with glioblastoma (GBM), a highly aggressive form of brain cancer. In Phase 1 studies as an adjuvant to standard chemoradiation, tinostamustine showed promising activity in difficult-to-treat newly diagnosed patients. The drug has received orphan drug designation from FDA and has the potential to be the first new pharmacologic treatment option for GBM in more than 20 years. In Phase 1/2 clinical trials, tinostamustine has also shown promise in multiple other solid and hematological tumors. Currently, tinostamustine is also a part of GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment – NCT03970447), sponsored by the Global Coalition for Adaptive Research. This is a seamless phase 2/3 study conducted under a master protocol enabling multiple therapies or combinations of therapies to be evaluated simultaneously against a shared control arm. With its innovative design and efficient operational infrastructure, data from GBM AGILE can potentially be used as the foundation for new drug applications and registrations to the U.S. FDA and other health authorities. Sunobinop is a novel, first-in-class nociceptin receptor agonist. The orally active investigational drug is in Phase 1/2 clinical development for multiple indications, including alcohol use disorder (AUD), interstitial cystitis/bladder pain syndrome (IC/BPS), and overactive bladder (OAB). Related to AUD, sunobinop is the only agent intended to address alcohol craving, consumption, and sleep issues; it has the potential to be the first new modality in AUD in almost 20 years. Related to OAB and IC/BPS, sunobinop is a novel, first-in-class agent that targets the sensory nerves in the bladder to affect urination and pain, in addition to reducing nocturia. Both conditions, OAB and IC/BPS, have significant unmet need. "Our approach is grounded in rigorous R&D and a deep exploration of disease biology to advance innovative therapies for patients facing complex and underserved conditions," said Dr. Julie Ducharme, Chief Scientific Officer, Knoa Pharma. "There are meaningful opportunities to collaborate along the way, and we look forward to partnering with those who share our ambitions." "At the BIO International Convention, we will showcase our promising pipeline assets that have potential to benefit patients with unmet medical needs," said David Saussy, Head of Licensing and Business Development at Knoa Pharma. "We look forward to and welcome the opportunity to engage with potential partners who share in our commitment to scientific innovation and developing meaningful treatment options." Companies interested in learning more about Knoa Pharma's pipeline and partnership opportunities are encouraged to connect with the team during the BIO International Convention 2026. For more information on pipeline products, e-mail [email protected]. View the BIO presentation here. *This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that sunobinop or tinostamustine will successfully complete development or gain FDA approval. About Knoa Pharma LLC Knoa Pharma makes important medicines safely and responsibly, while innovating to benefit patients and the public health. The company is dedicated to safely distributing medicines that are critical to patient care, enhancing its robust generics portfolio, addressing unmet medical needs, and supporting initiatives to address the opioid crisis. Our public minded mission enables us to expand access to lifesaving overdose reversal medicines and affordable treatments for opioid use disorder – at no profit. Owned by a not-for-profit foundation, everything we do is centered on improving public health, saving lives, supporting recovery, and bringing forward medicines that make a meaningful difference. Learn more at . SOURCE Knoa Pharma 21% more press release views with Request a Demo

Phase 1Orphan DrugClinical Result

01 Jan 2026

·www.businesswire.com

Insomnia Market Opportunity Assessment and Forecast Report 2022-2032: Z-Drugs Remain First-Line as Sparse Pipeline Adds $288 Million From Late-Stage Entrants - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Insomnia: Opportunity Assessment and Forecast Update" report has been added to ResearchAndMarkets.com's offering. This report covers the 7MM and provides an Excel-based forecast model for the Insomnia market through 2032. Z-drugs are the most common first-line treatment for insomnia across the US and 5EU. The insomnia pipeline in the 7MM is sparse but varied, containing products with varying mechanisms of action. There are five pipeline products in Phase II and III stages of clinical development for insomnia. The insomnia market across the 7MM was valued at $3.1 billion in the 2022 baseline year. Over the 10- year forecast period, the market is projected to grow at a compound annual growth rate (CAGR) of 2.1%, reaching $3.8 billion by 2032. The entry of the two pipeline products during the forecast period will have a significant impact on the market. They are anticipated to contribute $288 million in sales by 2032. Report Scope Reasons to Buy Key Topics Covered: 1. Preface 1.1. Contents 1.2. Abbreviations 1.3. Related Reports 2. Executive Summary 2.1. Summary of Updates 3. Disease Overview 3.1. Overview of Insomnia 3.2. Insomnia SWOT Analysis 3.3. Pathophysiology of Insomnia 3.4. Classification of Insomnia 4. Epidemiology 4.1. Total Prevalent Cases of Insomnia, Both Sexes, Ages 15 Years, 2022-32 4.2. Age-Specific Trends in the Total Prevalent Cases of Insomnia, Both Sexes, 2022 4.3. Sex-Specific Total Prevalent Cases of Insomnia, Both Sexes, Ages 15 Years, 2022 4.4. Sex-Specific Total Prevalent Cases of Acute Insomnia, Ages 15 Years, 2022 4.5. Sex-Specific Total Prevalent Cases of Chronic Insomnia, Ages 15 Years, 2022 4.6. Sources and Methodology for Acute and Chronic Insomnia Prevalence 4.7. Sources and Methodology - Total Prevalent Cases of Acute and Chronic Insomnia 5. Current Treatment Options 5.1. Treatment Paradigm 5.2. Current Treatment Options 5.3. Product Profile: Benzodiazepines (e.g., estazolam, temazepam, flurazepam) 5.4. Product Profile: Z-Drugs (zaleplon, zolpidem, zopiclone, eszopiclone) 5.5. Product Profile: Melatonin Receptor Agonists (ramelteon and melatonin ER) 5.6. Product Profile: Low-Dose Antidepressants (doxepin, trazodone, trimipramine) 5.7. Product Profile: Antihistamines (e.g., diphenhydramine, promethazine, hydroxyzine) 5.8. Product Profile: Gabapentinoids (e.g., gabapentin and pregabalin) 5.9. Product Profile: Merck & Co's Belsomra (suvorexant) 5.10. Product Profile: Eisai's Dayvigo (lemborexant) 5.11. Product Profile: Idorsia's Quviviq (daridorexant) 5.12. Product Profile: Taisho Pharmaceutical's Borzi (vornorexant) 5.13. Patient Flow: Insomnia in 2022 Across 7MM 6. Unmet Needs and Opportunities 6.1. Unmet Needs in Insomnia 6.2. New Therapeutic Options with Improved Efficacy 6.3. Improved Physician Awareness of Insomnia Treatments 6.4. Improved Patient Access to CBT-i 7. R&D Strategies 7.1. Trends in Clinical Trial Design in Insomnia 7.2. Trends in Deal-Making in Insomnia 8. Pipeline Assessment 8.1. Insomnia Pipeline Overview 8.2. Late-Stage Pipeline Agents for Insomnia 8.3. Product Profile: EUSOL Biotech's SM-1 8.4. Product Profile: Imbrium Therapeutics's Sunobinop 8.5. Product Profile: Vanda Pharmaceuticals's Hetlioz (tasimelteon) 8.6. Insomnia: Clinical Trials (Phase II/III) Overview 9. Market Outlook 9.1. Insomnia Market Forecast 9.2. Market Drivers and Barriers 10. Appendix 10.1. Primary Research: KOL Information 10.2. Primary Research: High-Prescriber Survey Information 10.3. Bibliography 10.4. About the Authors Companies Featured For more information about this report visit https://www.researchandmarkets.com/r/dns27p About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Phase 2

16 Jun 2025

·www.businesswire.com

Imbrium Therapeutics to Showcase Pipeline Assets Open for Partnership at the BIO International Convention 2025

STAMFORD, Conn.--(BUSINESS WIRE)--Imbrium Therapeutics L.P. (“Imbrium”), a clinical-stage biopharmaceutical company, is presenting pipeline developments at the BIO International Convention on Wednesday, June 18, at 9:15 a.m. in Room 153B. Imbrium is actively seeking partnerships to advance the development of investigational therapeutics for multiple indications across several disease areas including genitourinary disorders, substance use disorders, and cancerous malignancies. Imbrium is discussing two investigational agents, sunobinop and tinostamustine, both of which could present substantial revenue opportunities*. Sunobinop is a novel, first-in-class, nociceptin receptor partial agonist. The orally active investigational drug is in Phase 1b/2a clinical development for multiple indications, including alcohol use disorder (AUD), interstitial cystitis/bladder pain syndrome (IC/BPS), and overactive bladder (OAB). Related to AUD, sunobinop’s pharmacological properties offer a unique approach under investigation for alcohol craving, consumption and sleep issues; it has the potential to be the first new modality in AUD in almost 20 years. Related to OAB and IC/BPS, sunobinop has been shown in early studies to target the sensory nerves in the bladder to affect urination, pain, and nocturia. Global or regional rights are available for partnership. Tinostamustine is a novel, first-in-class, investigational drug combining DNA alkylating activity and histone deacetylase inhibition in a single molecule. It has the potential to be a first-line agent to treat patients with glioblastoma multiforme (GBM), a highly aggressive form of brain cancer. In Phase 1 studies as an adjuvant to standard chemoradiation, tinostamustine was shown to improve survival in difficult-to-treat newly diagnosed patients and is on track for accelerated development. It has the potential to be the first new chemotherapeutic to treat GBM in more than 20 years. Tinostamustine has also shown promise in early clinical studies in other solid and hematological tumors. U.S. rights are available for partnership. “We are committed to securing partnerships that further advance promising novel therapies,” said David Saussy, Head of Licensing & Business Development. “We look forward to presenting these pipeline highlights at BIO and moving our research programs forward to help address unmet patient needs.“ Tinostamustine and all proposed indications for sunobinop are open to partnering. For more information, e-mail partnering@pharma.com. For more information about our pipeline, click here. *This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that sunobinop or tinostamustine will successfully complete development or gain FDA approval. About Imbrium Therapeutics L.P. Imbrium is a clinical-stage biopharmaceutical company dedicated to advancing medical science through the development of important new therapeutics. We are pursuing treatments for genitourinary disorders, disorders of the central nervous system, oncology chemotherapeutics, and non-opioid approaches to the management of pain. As a subsidiary of Purdue Pharma L.P., Imbrium strives to develop new medicines that serve the unmet needs of patients, physicians, and health systems worldwide. We have built a robust and diversified pipeline of investigational drug candidates, and we seek to actively collaborate with industry and academic partners to identify and advance future impactful medicines. For more information, please visit www.imbriumthera.com..

Phase 1

100 Deals associated with Sunobinop

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Alcohol Use Disorder	Phase 2	United States	Purdue Pharma LP	23 Sep 2019
Sleep Initiation and Maintenance Disorders	Phase 2	United States	Purdue Pharma LP	23 Sep 2019
Pain, Postoperative	Phase 2	United States	Purdue Pharma LP	01 Jul 2013
Overactive bladder syndrome	Phase 1	United States	Purdue Pharma LP	30 Jun 2022
Cystitis, Interstitial	Phase 1	United States	Purdue Pharma LP	26 May 2022
Neuralgia	Phase 1	United States	Shionogi & Co., Ltd.	31 Oct 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06285214 (CTgov)	Phase 1	Cystitis, Interstitial	47	Placebo (Double-blind Treatment (Period 1))	dqcsigvccn(wtrtspjnil) = vqpvceogsj iuqdhdmwki (ptsntzycie, 1.41) View more	-	09 Mar 2026
				V117957 (Double-blind Treatment (Period 2))	dqcsigvccn(wtrtspjnil) = ufvlstxrhc iuqdhdmwki (ptsntzycie, 2.08) View more
NCT06024642 (CTgov)	Phase 1	Overactive bladder syndrome	51	Placebo (Week 2 (Placebo))	hspvwwlhgx(zupsvsdfwa) = htawxjybnd ijklxsqmza (vtpvukahsk, 1.97) View more	-	26 Jun 2025
				V117957 (Week 8 (V117957))	hspvwwlhgx(zupsvsdfwa) = dfibyozxkr ijklxsqmza (vtpvukahsk, 2.32) View more
NCT06024642 (BusinessWire) Manual	Phase 1	Overactive bladder syndrome	51	Sunobinop 1 mg	jnfiodgpey(jczflkjtpx) = zxvwaceema sgxgrdvacq (jgkievzpob )	Positive	07 Jan 2025
				Placebo	jnfiodgpey(jczflkjtpx) = sxtmbzfync sgxgrdvacq (jgkievzpob )
NCT04035200 (CTgov)	Phase 2	Sleep Initiation and Maintenance Disorders \| Alcohol Use Disorder	114	V117957 tablets (V117957 1 mg)	aokziuwzmb(ezypmtcuyq) = sjsmqkmzaa yjepissyfl (yidjwyfnub, 45.098) View more	-	18 Sep 2023
				V117957 tablets (V117957 2 mg)	aokziuwzmb(ezypmtcuyq) = yyqmnvidyi yjepissyfl (yidjwyfnub, 36.496) View more

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