Nabilone Use for Acute Pain in Inflammatory Bowel Disease Patients With Chronic Opioid Use Undergoing Gastrointestinal Surgery: A Single-centered Randomized Controlled Trial

This is a clinical trial of nabilone for patients with Inflammatory Bowel Disease (IBD) who are undergoing IBD-related surgery (Any abdominal surgery lasting for more than one hour). This study would include a total of 80 patients undergoing general surgery who will have Intravenous Patient Controlled Analgesia (IVPCA) after surgery. It is the intention to randomize these patients postoperatively into 2 groups of 40 patients:
1. Patients who are chronic opioid users for chronic pain and have been exposed to cannabis or cannabinoid products, treated with IV PCA and nabilone as per protocol.
2. Patients who are chronic opioid users for chronic pain and have been exposed to cannabis or cannabinoid products, treated with IV PCA and placebo as per protocol.
The goal is two-fold. One is to demonstrate that patients will benefit from post-operative nabilone administration to achieve/maintain the opioid-sparing and pain modulation effects. Second is to demonstrate patients will benefit from the anti-inflammatory and immunomodulatory effects of nabilone to alleviate IBD symptoms and enhance recovery.

Start Date01 Dec 2023

Sponsor / Collaborator

Samuel Lunenfeld Research Institute

NCT05885685

/ RecruitingPhase 4IIT

Investigating the Effects of Nabilone on Endocannabinoid Metabolism in the Human Brain

The purpose of this study is to learn about the effects of a cannabis-like substance, nabilone, on the levels of endocannabinoid enzyme fatty acid amide hydrolase (FAAH) in brain of healthy individuals. Using magnetic resonance imagine (MRI) and positron emission tomography (PET), the main questions we aim to answer are: 1) Does nabilone decrease levels of FAAH in the brain? and 2) Are changes in levels of FAAH associated with clinical response to nabilone? Participants will complete:
* An in-person interview (
4 hours)
* Two brain imaging scanning sessions (
11 hours)
* A one week 2 mg titrated dose of nabilone
* Virtual check-ins (up to
1.5 hours)

Start Date31 Oct 2023

Sponsor / Collaborator

Centre for Addiction & Mental Health

NCT05742698

/ RecruitingPhase 2

Double Blind Crossover Clinical Trial of Nabilone for Agitation in Frontotemporal Dementia

The primary goal of this study is to test the hypothesis that oral nabilone treatment will reduce agitation compared with placebo in patients with Frontotemporal Dementia (both behavioural variant frontotemporal dementia and primary progressive aphasia). The study population is defined as patients with probable Frontotemporal Dementia that meet the International Psychogeriatric Association criteria for agitation in cognitive disorders.

Start Date07 Mar 2023

Sponsor / Collaborator

Douglas Mental Health University Institute

[+1]

100 Clinical Results associated with Nabilone

100 Translational Medicine associated with Nabilone

100 Patents (Medical) associated with Nabilone

434

Literatures (Medical) associated with Nabilone

11 Aug 2025·PHARMACOPSYCHIATRY

The Endocannabinoid System in PTSD: Molecular Targets for Modulating Fear and Anxiety.

Article

Author: Lyndon, Stanley

Fear and anxiety perform essential protective roles, yet when they become dysregulated, they can trap trauma survivors in persistent hypervigilance and distress. Post-traumatic stress disorder (PTSD) manifests as intrusive memories, avoidance, and heightened arousal long after the precipitating event. Although current pharmacotherapies - including selective serotonin reuptake inhibitors, adrenergic blockers, benzodiazepines, and atypical antipsychotics - provide relief for some, many patients contend with residual symptoms or intolerable adverse effects. Recent discoveries position the endocannabinoid system as a pivotal regulator of fear acquisition, consolidation, and extinction. Clinical observations of altered anandamide levels and cannabinoid receptor CB₁ upregulation in individuals with severe PTSD underscore the therapeutic potential of restoring endocannabinoid tone. Preclinical studies demonstrate that direct CB₁ agonists, fatty acid amide hydrolase (FAAH) inhibitors, and phytocannabinoids such as tetrahydrocannabinol (THC) and cannabidiol (CBD) can facilitate extinction learning and attenuate anxiety-like behaviours. Preliminary human trials report that nabilone alleviates trauma-related nightmares and that acute cannabinoid administration modulates amygdala reactivity to a threat. Yet optimal dosing strategies, sex-specific responses, and ideal THC:CBD ratios remain to be defined. Self-medication with cannabis can offer transient relief but carries a risk of cannabis use disorder and potential worsening of PTSD symptoms. By elucidating molecular targets - including CB₁, CB₂, FAAH, and monoacylglycerol lipase - this review outlines a strategic framework for next-generation cannabinoid-based interventions. Harnessing the endocannabinoid system promises to expand the therapeutic arsenal for PTSD, offering hope for more effective and better-tolerated treatments.

01 Jun 2025·CANADIAN JOURNAL ON AGING-REVUE CANADIENNE DU VIEILLISSEMENT

Patterns of Nabilone Prescriptions in Canadian Long-Term Care Facilities

Article

Author: Winters, Emily M ; Hadjistavropoulos, Thomas ; Gordon, Jennifer L

Abstract:

The purpose of the current study was to understand the prevalence and patterns of cannabinoid use among LTC residents across Canada. We gathered data on cannabinoid prescriptions among LTC residents for one year before and after recreational cannabis legalization. Multi-level modelling was used to examine the effects of demographic and diagnostic characteristics on rates of cannabinoid prescription over time. All prescriptions were for nabilone. There was a significant increase in the proportion of residents prescribed nabilone following the legalization of recreational cannabis in Canada. Residents with relatively more severe pain (based on the Minimum Data Set pain scale), a diagnosis of depression, or a diagnosis of an anxiety disorder were more likely to have received a nabilone prescription. Our results provide valuable information regarding the increasing use of synthetic cannabinoids in LTC. The implications for clinical practice and policy decision-makers are discussed.

01 Apr 2025·Movement Disorders Clinical Practice

Pharmacological Treatment of Neuropsychiatric Symptoms in Huntington's Disease: A Systematic Review

Review

Author: Andriessen, Ruben L. ; Oosterloo, Mayke ; Leentjens, Albert F.G. ; Daemen, Maud M.J. ; Molema, Jory ; Linden, David E.J.

ABSTRACT:

Background:

Studies focusing on the treatment of neuropsychiatric symptoms (NPS) in Huntington's disease (HD) are scarce and show a wide variation in design, outcome measures and methodological quality. The effectiveness of pharmacological treatment of NPS in HD has not been systematically reviewed so far.

Objective:

To provide an overview of the available literature on the effectiveness of pharmacological treatment of NPS in HD.

Methods:

PubMed and the Cochrane library were systematically searched for studies assessing the effects of pharmacotherapy of NPS, both as a primary and as secondary outcome. A risk of bias assessment was performed for each article.

Results:

Fifteen articles qualified for critical evaluation: 10 randomized controlled trials (RCTs) (five placebo‐controlled and five cross‐over) and five open label studies. One RCT reported improvement of the overall NPS with nabilone treatment; another RCT reported that fluoxetine slightly improved irritability. Lower‐level evidence from open studies suggests that the atypical antipsychotics cariprazine, olanzapine and risperidone may improve overall NPS, and that cariprazine, venlafaxine XR and olanzapine may improve depression. In addition, olanzapine may improve obsessive thoughts, aggression, anxiety and irritability.

Conclusions:

We conclude that although NPS in HD are common, hardly any clinical trials have addressed their treatment. As a result, convincing evidence that could guide clinical practice is lacking. More focused, and larger, multicenter trials focusing on NPS are urgently needed to generate the knowledge necessary to support the development of evidence‐based clinical treatment guidelines.

News (Medical) associated with Nabilone

19 Jun 2025

·www.prnewswire.com

PLEOPHARMA, INC. Presents Positive Cannabis Withdrawal Clinical Trial Results at The College on Problems of Drug Dependence Annual Meeting

Positive Phase 2b Results from the CAN-002 Study of PP-01, an investigational product intended to mitigate Cannabis Withdrawal Syndrome in patients with Cannabis Use Disorder PHOENIXVILLE, Pa., June 19, 2025 /PRNewswire/ -- PleoPharma, Inc., a privately held company focused on cannabis-related health issues, announced today, the presentation of data from their Phase 2b multicenter, randomized, double-blind, multi-dose, placebo-controlled clinical trial of titrating doses of PP-01 for the mitigation of Cannabis Withdrawal Syndrome (CWS) in participants with Cannabis Use Disorder (CUD) at the 2025 annual meeting of The College on Problems of Drug Dependence in New Orleans, LA. PleoPharma, Inc. presented both a poster presentation "Predictors of Cannabis Abstinence in a Clinical Trial" on June 17, 2025 and an oral presentation "PP-01 Significantly Mitigated Cannabis Withdrawal Symptoms with a Decrease in Cannabis Use" on June 18, 2025 from their Phase 2b study data. This study evaluated the safety and effectiveness of PP-01, a novel once daily, oral, dual-mechanism investigational agent containing tapering and titrating doses of nabilone and gabapentin in mitigating cannabis withdrawal symptoms in participants with moderate to severe CUD. Adult treatment-seeking participants in the CAN-002 Study reported average baseline cannabis use of 4.6 grams/day and mean age of first use ~16.5 years (range 7 to 46). By DSM-5 criteria, 84% had severe CUD and 16% had moderate CUD. PP-01 significantly reduced Cannabis Withdrawal Scores compared to placebo (P value < 0.02). A secondary endpoint evaluated cannabis abstinence and PP-01 demonstrated 5-fold greater abstinence two weeks post-treatment compared to placebo. Data also showed that reduction of cannabis withdrawal symptoms during the first week of treatment was predictive of abstinence. PP-01 was well tolerated. The most common adverse events were mild and included headache, somnolence, fatigue, nausea, and dizziness. There were no serious adverse events. "We are excited to be developing PP-01, which was granted Fast Track designation by the FDA, and has the potential to be the first FDA approved product to help people suffering from CWS with CUD, a rapidly growing patient population in need of treatment. We are currently preparing for PP-01 to enter Phase 3", stated Shelli Graham, PhD, Senior Vice-President of Medical/Clinical Research. About cannabis withdrawal/cannabis use disorder The US Government reported that in 2023 (samhsa.gov), ~19.2 million Americans had CUD with 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The number of individuals who received treatment for cannabis related health problems has grown by an average of 28% annually from 2018 to 2023. People with CUD commonly experience significant withdrawal symptoms, known as CWS, that can make it extremely difficult to reduce or discontinue cannabis. There are currently no FDA approved medications for the treatment of CWS or CUD. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space with a lead asset, PP-01, that is being developed as the first FDA approved treatment of CWS in people with CUD. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma, please visit or email Dawn Halkuff, head of Investor Relations at [email protected]. This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. SOURCE PleoPharma, Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Fast TrackPhase 3Clinical ResultDrug Approval

18 Nov 2024

·www.prnewswire.com

PLEOPHARMA, INC. Presents Positive Cannabis Withdrawal Clinical Trial Results at AAAP Annual Meeting

Pharmacodynamic Results from the CAN-001 Phase 1b Study of PP-01, an Investigational Product, intended to Mitigate Cannabis Withdrawal Syndrome PHOENIXVILLE, Pa., Nov. 18, 2024 /PRNewswire/ -- PleoPharma, Inc., a privately held company focused on cannabis-related health issues, announced today, the presentation of data from their Phase 1b Pharmacokinetic and Pharmacodynamic study of Cannabis Withdrawal Syndrome ("CWS") in participants with Cannabis Use Disorder ("CUD") at the annual meeting of the American Academy of Addiction Psychiatry (AAAP) in Naples, Fla. "We are pleased to present our proof-of-concept study that evaluated the safety and effectiveness of PP-01, a novel, dual-mechanism investigational agent containing tapering and titrating doses of nabilone and gabapentin in mitigating cannabis withdrawal symptoms in participants with moderate to severe CUD. We are excited to be developing PP-01 with the goal of being the first FDA approved product to help people suffering from CWS, a rapidly growing patient population in need of treatment. We are currently preparing for PP-01 to enter Phase 3", stated Shelli Graham, PhD, Senior Vice-President of Medical/Clinical Research. Participants in the CAN-001 Study reported using an average of 3.5 ± 2.2 grams/day of cannabis with a mean age of first use 14 years (range 6 to 22). By DSM-5 criteria, 64% had severe CUD and 36% had moderate CUD. Compared to placebo, PP-01 administered once daily significantly reduced mean CWS ratings beginning 4 hours post first dose of PP-01 (first measured timepoint). This effect was sustained through Day 5 (P values < 0.0009; all timepoints). Participants experienced fewer cravings, better sleep and were also less bothered by their withdrawal symptoms when treated with PP-01 than with placebo (P values < 0.007; all timepoints). PP-01 was well tolerated. There were no serious adverse events, and all adverse events in the PP-01 group were mild in severity. About cannabis withdrawal/cannabis use disorder The US Government reported that in 2023 (samhsa.gov), ~19.2 million Americans had CUD with 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The number of individuals who received treatment for cannabis related health problems has grown by an average of 28% annually from 2018 to 2023. People with CUD commonly experience significant withdrawal symptoms, known as CWS, that can make it extremely difficult to reduce or discontinue cannabis. There are currently no FDA approved medications for the treatment of CWS or CUD. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space with a lead asset, PP-01, that is being developed as the first FDA approved treatment of CWS in people with CUD. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma, please visit or email Dawn Halkuff, head of Investor Relations at [email protected]. This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. SOURCE PleoPharma, Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Clinical ResultDrug ApprovalPhase 2

02 Feb 2024

·www.pharmaceutical-technology.com

IGC Pharma heads towards a Phase I study for Alzheimer’s disease

TGR-63, being developed to target amyloid-beta plaques, has shown preclinical potential in reducing Alzheimer’s-related anxiety. Credits: AtlasStudio/Shutterstock.com With positive preclinical data for its Alzheimer’s disease drug candidate TGR-63, IGC Pharma has announced that it plans to advance this small molecule into early clinical development in the course of 2024. TGR-63 is an amyloid beta peptide-targeting drug designed to decrease plaque aggregation by preventing the misfolding and aggregation of amyloid-beta peptides. In the preclinical mouse models designed to assess behavioural responses in transgenic mice, subjects treated with TGR-63 demonstrated statistically significant reductions (43%) in overall movement as determined by an Open-Field behavioural test. As per the 1 February press release, the data reinforces “its [TGR-63] potential as a promising treatment” for reducing levels of anxiety and improving emotional wellbeing. The Timonium, Maryland-based pharmaceutical company is also actively evaluating its cannabinoid-based lead candidate IGC-AD1 as a treatment for Alzheimer’s dementia-associated agitation in a Phase IIb study (NCT05543681). In December 2023, the company announced a partnership with Los Andes University’s Center for Research and Training in Artificial Intelligence (CINFONIA) to incorporate generative AI analyses into the Phase II trial. IGC Pharma is in the process of training algorithms with the goal of identifying clues for reducing misdiagnoses and false negatives, which is important as misdiagnoses and false negatives tend to be high in the Alzheimer’s indication, CEO Ram Mukunda told Pharmaceutical Technology . By addressing these issues, the company aims to improve trial success rates and ultimately accelerate the development and delivery of economic, effective treatments for Alzheimer’s patients, he adds. See Also: Sanofi backs development of Graviton’s treatments for serious diseases Tyra Biosciences’ TYRA-300 gains FDA rare paediatric disease status Despite making headway with its lead pipeline candidate, IGC Pharma has faced difficulties in trial enrolment and finances for IGC-AD1 due to its active ingredient being the psychoactive substance tetrahydrocannabinol (THC). THC is federally regulated and therefore the study or use of it requires a special permit as it is not covered by a DEA license that could be used for a drug like morphine, Mukunda explained. While Otsuka Pharmaceuticals’ Rexulti (brexpiprazole), an atypical antipsychotic, is the only FDA-approved medication for Alzheimer’s-associated agitation, other small molecules are in clinical development for Alzheimer’s agitation. Otsuka is evaluating AVP-786, a dextromethorphan/quinidine combination treatment for Alzheimer’s agitation, in multiple global Phase III studies. Similar to IGC Pharma, Sunnybrook Health Sciences Centre is also conducting a Phase III trial (NCT04516057) of cannabinoid based Nabilone for the treatment of agitation. GlobalData forecasts Rexulti to bring $3.9 billion in sales in 2028. GlobalData is the parent company of Pharmaceutical Technology .

Phase 1Phase 2Clinical ResultPhase 3Drug Approval

100 Deals associated with Nabilone

External Link

KEGG	Wiki	ATC	Drug Bank
D05099	Nabilone	A04AD11	DB00486

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Chemotherapy-induced nausea and vomiting	United States	Bausch Health US LLC	26 Dec 1985

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Agitation	Phase 3	Canada	Alzheimers Drug Discovery Foundation	01 Feb 2021
Alzheimer Disease	Phase 3	Canada	Alzheimers Drug Discovery Foundation	01 Feb 2021
Aphasia, Primary Progressive	Phase 2	Canada	Douglas Mental Health University Institute	07 Mar 2023
Aphasia, Primary Progressive	Phase 2	Canada	Alzheimers Drug Discovery Foundation	07 Mar 2023
Frontotemporal Dementia	Phase 2	Canada	Alzheimers Drug Discovery Foundation	07 Mar 2023
Frontotemporal Dementia	Phase 2	Canada	Douglas Mental Health University Institute	07 Mar 2023
Neuralgia	Phase 2	Canada	Valeant Canada Ltd.	01 Jan 2009
Phantom Limb	Phase 2	Canada	Valeant Canada Ltd.	01 Jan 2009
Muscle Spasticity	Phase 2	Canada	Valeant Canada Ltd.	01 Jul 2007
Spinal Cord Injuries	Phase 2	Canada	Valeant Canada Ltd.	01 Jul 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03773796 (NMS-Nab2, CTgov)	Phase 3	Parkinson Disease	22	Nabilone 0.25 mg	atpljajgfu = jbfaktqjrm bmtzfnemsn (zyahjdbtmg, kektqbqjpj - vmjjnkgptm) View more	-	02 Mar 2021
NCT03769896 (NMS-Nab, CTgov)	Phase 2	Parkinson Disease	48	Nabilone 0.25 mg (Treatment Group)	vitanmnttt(zvtjfdfmjg) = esalwpkhni pguanjyxwf (ysfehcpodf, lmpkygctsn - srtmxvxkbe) View more	-	02 Mar 2021
				Placebo (Placebo Group)	vitanmnttt(zvtjfdfmjg) = pkusrynnpk pguanjyxwf (ysfehcpodf, mezdgrhihb - rhhznokyrs) View more
NCT03251326 (CTgov)	Phase 1/2	Stress Disorders, Post-Traumatic \| Marijuana Abuse \| Wounds and Injuries	4	Plac+Nab (Active Nab > Plac Prop > Plac Cann)	nlbsyldrrb(asicnccana) = alppwwfmnc tguxqpnpgw (qlwwppfdso, ofnnylucvw - eecafulegs) View more	-	12 Oct 2020
				Nab (Plac Nab > Act Prop > Plac Cann)	nlbsyldrrb(asicnccana) = byrfhvgutl tguxqpnpgw (qlwwppfdso, rlmsqstoeu - vprmbrpnio) View more
NCT03769896 (NMS-Nab, MDS2020)	Phase 2	Parkinson Disease	48	Nabilone	mzqljzaeoi(izpqqeooqi) = Similar proportions of patients in each group had adverse events (placebo-group: 42%; nabilone: 32% of the group) qmkvojrnwa (likrskhusl ) View more	Positive	12 Sep 2020
				Placebo
NCT03769896 (Pubmed \| Ann Neurol)	Phase 2	Parkinson Disease	47	Nabilone	wjedqxnmti(yoemscpcgl) = yejygvkpmv xekdvvooel (rgrxrjbyfi )	Positive	05 Aug 2020
				Placebo	wjedqxnmti(yoemscpcgl) = lretkdgoyr xekdvvooel (rgrxrjbyfi )
NCT02802540 (WCLC2018)	Phase 2/3	Lung Cancer	47	Nabilone	dpfygtzozc(gdqozvvjnj) = had a significantly improvements zrvsomrdrp (pqgmjcrqlw )	-	24 Sep 2018
NCT02802540 (Pubmed \| Support Care Cancer)	Phase 2/3	Lung Cancer	65	Nabilone	vizbuuinfw(jhoyhdxdfb) = gmtdgmrphn alotqcdvhz (aszxgmcjtb ) View more	Positive	01 Sep 2018
NCT01347762 (NAB CAN, CTgov)	Phase 2/3	Marijuana Abuse	84	Nabilone (Nabilone Titrated 2 mg Daily (Phase 1))	dupxxahusw(eovpmxkgvp) = jnvicnfkio jrgcrvjtrz (hbfbcchtpk, 183.0) View more	-	01 Jun 2018
				Placebo (Placebo (Phase 1))	dupxxahusw(eovpmxkgvp) = shshhmmhev jrgcrvjtrz (hbfbcchtpk, 349.7) View more
NCT02115529 (Pubmed \| Can J Anaesth)	Phase 2	Postoperative Nausea and Vomiting	340	Nabilone 0.5 mg	scyjovscwr(zaufsfgeng) = uittplhrud lgxydjeobl (tvavnvymaq )	Negative	01 Apr 2017
				Placebo	scyjovscwr(zaufsfgeng) = wmfrtfwtot lgxydjeobl (tvavnvymaq )
NCT03422861 (Pubmed \| Pain)	Not Applicable	Diabetic peripheral neuropathic pain Adjuvant	-	Nabilone	qvirsxcbdr(kseoxrwmbm) = led to discontinuation in 2/37 subjects during single-blind nabilone treatment vouhlctenl (hupbonqmpq ) View more	Positive	01 Oct 2012
				Placebo

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