Breathing brief, moderate bouts of low oxygen trigger (low oxygen therapy, LOT) spinal plasticity (the ability of the nervous system to strengthen neural pathways based on new experiences), and improve walking after spinal cord injury (SCI). The greatest improvements in walking ability occur when LOT is administered prior to skill-based walking practice (WALK). However, the enduring benefits of LOT on walking recovery may be undermined by the accumulation of LOT-induced increase in extracellular adenosine. The goal of the study is to understand the extent to which istradefylline (adenosine 2a receptor antagonist) may limit the competing mechanisms of adenosine on LOT-induced walking recovery following SCI.

Start Date01 Sep 2027

Sponsor / Collaborator

The Spaulding Rehabilitation Hospital Corp.

CTIS2024-517336-21-00

/ RecruitingPhase 2IIT

Prospective, randomized, double-blind, placebo-controlled, single-center comparative trial evaluating oral Istradefylline 40 mg once daily for reducing microglial activation in the brain of patients with progressive multiple sclerosis (MS)

Start Date31 Mar 2025

Sponsor / Collaborator

University of Turku

CTR20230645

/ TerminatedPhase 3

伊曲茶碱片用于改善左旋多巴治疗原发性帕金森病剂末现象的多中心、随机、双盲、安慰剂平行对照临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled clinical trial of istradefylline tablets for improving the wearing-off phenomenon of levodopa in the treatment of primary Parkinson's disease

评价伊曲茶碱片用于改善左旋多巴治疗原发性帕金森病剂末现象的有效性和安全性

[Translation]

To evaluate the efficacy and safety of istradefylline tablets in improving the wearing-off phenomenon of levodopa in the treatment of primary Parkinson's disease

Start Date21 Jun 2023

Sponsor / Collaborator

Shandong Chuangxin Pharmaceutical Research & Development Co., Ltd.

100 Clinical Results associated with Istradefylline

100 Translational Medicine associated with Istradefylline

100 Patents (Medical) associated with Istradefylline

390

Literatures (Medical) associated with Istradefylline

01 Mar 2026·PARKINSONISM & RELATED DISORDERS

Long-term outcomes associated with istradefylline versus catechol-O-methyltransferase inhibitors in patients with Parkinson's disease: a nationwide real-world cohort study

Article

Author: Sato, Tsugumichi ; Xiong, Xi ; Foltynie, Thomas ; Kubota, Kiyoshi ; Carroll, Camille ; Schrag, Anette ; Wei, Li ; Ju, Chengsheng

BACKGROUND:

Istradefylline, a selective adenosine A_2A receptor antagonist, is approved as an adjunct to levodopa in Parkinson's disease, but its long-term effects on clinically meaningful outcomes are unclear.

OBJECTIVE:

We aimed to compare the association of istradefylline versus catechol-O-methyltransferase (COMT) inhibitors with mortality, treatment escalation, and disease progression in levodopa-treated Parkinson's disease.

METHODS:

We conducted a nationwide cohort study emulating a target trial using the DeSC claims database in Japan. Patients aged ≥50 years with levodopa-treated Parkinson's disease between 2014 and 2023 were included. Strategies were initiation of istradefylline versus COMT inhibitors. Primary outcomes were all-cause mortality, levodopa-equivalent daily dose (LEDD) escalation to ≥1100 mg, and dementia or psychosis. Secondary outcomes were fractures, cardiovascular events, pneumonia, and depression. Intention-to-treat and per-protocol effects were estimated using Cox models with propensity score-based overlap weighting.

RESULTS:

We identified 3190 istradefylline and 7986 COMT inhibitor initiators. In intention-to-treat analysis, istradefylline was associated with lower risks of mortality (hazard ratio [HR] 0.91; 95 % CI 0.84-0.99) and LEDD escalation (HR 0.83; 95 % CI 0.73-0.94). Associations were stronger in per-protocol analysis (mortality: HR 0.84, 95 % CI 0.72-0.97; LEDD escalation: HR 0.71, 95 % CI 0.59-0.84). Istradefylline was linked to higher fracture risk (intention-to-treat HR 1.13, 95 % CI 1.02-1.25; per protocol HR 1.23, 95 % CI 1.07-1.41). No differences were observed for dementia, psychosis, or other outcomes.

CONCLUSIONS:

Istradefylline was associated with reduced mortality and treatment escalation but increased fracture risk compared with COMT inhibitors, supporting further evaluation of adenosine A_2A antagonists.

01 Feb 2026·Brain and Behavior

Involvement of Adenosine A ₂ A Receptors in Anxiety‐Like Behaviors in Tetrahydrocannabinol‐Treated Mice

Article

Author: Seçilmiş, Deniz ; Akarsakarya, Zeki ; Ün, Burçin ; Seçilmiş, Mehmet Ata ; Ilgaz, Nermin Seda ; Yılmaz, Mehmet Bertan ; Özü, Özlem Yorulmaz

ABSTRACT:

Background:

Previous studies have suggested that adenosinergic system in the central nervous system may play a role in both behavioral changes and the physiopathology induced by Δ 9 ‐tetrahydrocannabinol (THC), and this is thought to be mediated by adenosine A 2 A receptors (A 2 ARs). However, the contribution of the adenosinergic system to the anxiety‐like behaviors in response to THC in mice is not well understood.

Aims:

In this study, we aimed to investigate the possible role of the adenosinergic system in THC‐treated mice.

Methods:

For that purpose, we combined behavioral tests and molecular analyses to investigate the effects of THC in relation with the agonist and antagonist of the adenosinergic system, CGS‐21680 (CGS) and istradefylline, respectively, on both anxiety‐like behaviors and hippocampal gene expression.

Results:

The results demonstrated that THC induced anxiety‐like behavior, and gene expression patterns indicated a significant interaction between the adenosinergic and cannabinoidergic systems. Notably, the data suggest that THC plays a predominant role in this molecular interplay, with its effects being partially modulated by changes in the expression of both cannabinoidergic and adenosinergic receptors, CB 1 R and A 2 AR, respectively.

Conclusion:

These findings contribute to the understanding of THC's complex pharmacological actions, highlighting the importance of receptor cross talk in modulating anxiety and other behavioral outcomes.

08 Jan 2026·INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE

Inhibition of Retinal AdoRA2a Activity Attenuates Myopia Progression

Article

Author: Chen, Wei ; Zhou, Yixin ; Guan, Zhenqi ; Liu, Shengcong ; Wang, Qi ; Zhao, Fuxin ; Qu, Wei ; Qu, Jia ; Li, Wenting ; Zhou, Xiangtian ; Huang, Furong ; Pan, Miaozhen ; Yang, Xingxing

Purpose:

Although 7-methylxanthine, a nonselective adenosine receptor (AdoRs) antagonist, suppresses myopia, the specific receptor subtype and target tissue involved remain unclear. This study aimed to investigate whether the AdoRA2a subtype plays a critical role in the regulation of myopia progression.

Methods:

Monocular form deprivation myopia (FDM) was induced in mice to measure retinal concentrations of adenosine and its synthetic enzymes (CD39/CD73). Retina-specific AdoRA2a knockout (AdoRA2a-CKO) mice and their wild-type littermates were subjected to unilateral FDM or normal, unobstructed vision. Male C57BL/6 mice were randomly divided into FDM and unobstructed vision groups, with each group further subdivided into four subgroups receiving intraperitoneal vehicle or the selective AdoRA2a antagonist KW6002 (0.33, 3.30, or 10.00 mg/kg). The effects of these treatments were also assessed in retina-specific dopamine D2 receptor gene knockout (Drd2-CKO) mice and their wild-type counterparts.

Results:

FDM significantly upregulated retinal adenosine levels and CD39/CD73 expression. Inhibition of AdoRA2a activity, by either AdoRA2a-CKO or KW6002 administration, significantly attenuated FDM progression in mice without affecting normal refractive development. AdoRA2a and Drd2 were colocalized in the retina, and the possibility of interactions between them was supported by the lack of an inhibitory effect of KW6002 on myopia progression in Drd2-CKO mice.

Conclusions:

Our results demonstrate that retinal AdoRA2a plays a pivotal role in myopia progression. Our findings identify the retina as the critical site for AdoRA2a's action and suggest an underlying AdoRA2a-Drd2 interaction mechanism, revealing the possible therapeutic potential of KW6002 in myopia progression.

News (Medical) associated with Istradefylline

18 Feb 2026

·www.biospace.com

Marvel Biosciences Secures Funding to Develop Child-Friendly Liquid Formulation for Neurodevelopmental Disorders

Calgary, Alberta--(News - February 18, 2026) - Marvel Biosciences Corp. (TSXV: MRVL) (OTCQB: MBCOF ), is pleased to announce that it is receiving advisory services and funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to support research and development of a pediatric-friendly liquid formulation of its lead compound, MB-204. The NRC IRAP-supported project will focus on creating a small-volume oral liquid formulation designed for children and adolescents with neurodevelopmental disorders, including autism spectrum disorder, Rett syndrome, and Fragile X syndrome. Many patients in these populations experience significant challenges swallowing pills or rely on feeding tubes, making standard solid oral dosage forms difficult or impractical to administer. "Developing medicines that children can actually take is a very important, yet many times an overlooked part of drug development," said Rod Matheson, CEO at Marvel Biosciences. "This support will allow us to directly address a clinical barrier faced by patients and caregivers and prepare MB-204 dosing to be aligned with future pediatric clinical development." The project will evaluate multiple liquid formulation approaches to ultimately identify a stable and reproducible dosing format suitable for pediatric use. Pediatric-appropriate drug formulations remain limited in Canada, particularly for neurodevelopmental conditions. By prioritizing a child-friendly dosage format now, Marvel hopes to improve treatment accessibility, support adherence, and reduce the burden on families and caregivers. The goal is to develop a formulation that can be administered in very small volumes - such as by oral syringe or feeding tube - without compromising drug exposure or consistency. NRC IRAP's support will enable Marvel to carry out this work with Canadian research partners and service providers, keeping high-value pharmaceutical R&D activities in Canada while generating data to support future clinical trials and regulatory engagement. This pediatric formulation program builds on MB-204's existing preclinical validation and reflects Marvel's broader strategy to expand its intellectual property portfolio and advance patient-centric therapies for neurological and neurodevelopmental conditions. About Marvel Biosciences Corp. Marvel Biosciences Corp., through its wholly owned subsidiary Marvel Biotechnology Inc., is a Calgary-based biotechnology company developing new treatments for neurological diseases and neurodevelopmental disorders. Our lead drug candidate, MB-204, is a novel fluorinated derivative version of Istradefylline, an approved Parkinson's drug and the only adenosine A2A receptor blocker currently on the market. Research shows that blocking the A2A receptor may help treat conditions such as autism, depression, and Alzheimer's disease. Marvel is also exploring MB-204's potential in rare disorders like Rett syndrome and Fragile X syndrome, aiming to bring new options to patients with few effective treatments. Contact Information: Marvel Biosciences Corp. J. Roderick (Rod) Matheson, Chief Executive Officer or Dr. Mark Williams, President and Chief Science Officer Tel: 403 770 2469 Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is deﬁned in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this press release. All information contained in this news release with respect to the Company and its subsidiary,(collectively, the "Parties") were supplied by Marvel, respectively, for inclusion herein and each parties' directors and oﬃcers have relied on each other for any information concerning such Party. This news release may contain forward-looking statements and other statements that are not historical facts. Forward-looking statements are often identiﬁed by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of the Company are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could diﬀer materially from those anticipated in such statements. Important factors that could cause actual results to diﬀer materially from the expectations of the Company and include other risks detailed from time to time in the ﬁlings made by the Company under securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to diﬀer materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. As a result, the Company cannot guarantee that the above events on the terms will occur and within the time disclosed herein or at all. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may diﬀer materially from those anticipated. Forward-looking statements contained in this news release are expressly qualiﬁed by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by Canadian securities law. To view the source version of this press release, please visit

03 Feb 2026

·www.biospace.com

Marvel Biosciences Receives Japanese Patent Covering Composition of Matter for Its Lead Therapeutic Candidate MB-204

Calgary, Alberta--(News - February 3, 2026) - Marvel Biosciences Corp. (TSXV: MRVL) (OTCQB: MBCOF) , and its wholly owned subsidiary, Marvel Biotechnology Inc. ( collectively "Marvel" or the "Company" ), a drug discovery company developing novel therapeutics for autism spectrum disorder and related neurological conditions, is pleased to announce that the Japan Patent Office has granted Japanese Patent No. 2022-554855 , titled "Purine Compounds for Treating Disorders," covering composition of matter and methods of use claims for its lead therapeutic candidate, MB-204. "This represents the second major jurisdiction to grant a composition-of-matter patent for our lead molecule MB-204," said Rod Matheson, CEO of Marvel Biosciences . "Securing patent protection in Japan significantly strengthens our global intellectual property portfolio and further enhances the long-term value of MB-204 as we advance toward clinical development." MB-204 is a novel fluorinated analogue of Istradefylline , an approved adenosine A2A receptor antagonist used in the treatment of Parkinson's disease. MB-204 has demonstrated improved pharmacokinetics relative to the parent compound, has completed preclinical toxicology testing, and has shown robust preclinical efficacy in models of depression and multiple models of autism, including Rett syndrome. The compound is currently being evaluated in Fragile X syndrome models. Autism spectrum disorder affects approximately 1 in 36 children by age eight, underscoring the urgent need for new therapeutic options that address its core symptoms. Marvel believes MB-204's differentiated pharmacological pro expanding global patent coverage position the compound for continued development and potential strategic partnerships. About Marvel Biosciences Corp. Marvel Biosciences Corp., through its wholly owned subsidiary Marvel Biotechnology Inc., is a Calgary-based biotechnology company developing new treatments for neurological diseases and neurodevelopmental disorders. Our lead drug candidate, MB-204, is a novel fluorinated derivative version of Istradefylline, an approved Parkinson's drug and the only adenosine A2A receptor blocker currently on the market. Research shows that blocking the A2A receptor may help treat conditions such as autism, depression, and Alzheimer's disease. Marvel is also exploring MB-204's potential in rare disorders like Rett syndrome and Fragile X syndrome, aiming to bring new options to patients with few effective treatments. Contact Information: Marvel Biosciences Corp. J. Roderick (Rod) Matheson, Chief Executive Officer or Dr. Mark Williams, President and Chief Science Officer Tel: 403 770 2469 Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is deﬁned in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this press release. All information contained in this news release with respect to the Company and its subsidiary,(collectively, the "Parties") were supplied by Marvel, respectively, for inclusion herein and each parties' directors and oﬃcers have relied on each other for any information concerning such Party. This news release may contain forward-looking statements and other statements that are not historical facts. Forward-looking statements are often identiﬁed by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of the Company are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could diﬀer materially from those anticipated in such statements. Important factors that could cause actual results to diﬀer materially from the expectations of the Company and include other risks detailed from time to time in the ﬁlings made by the Company under securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to diﬀer materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. As a result, the Company cannot guarantee that the above events on the terms will occur and within the time disclosed herein or at all. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may diﬀer materially from those anticipated. Forward-looking statements contained in this news release are expressly qualiﬁed by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by Canadian securities law. To view the source version of this press release, please visit

10 Jul 2025

·www.fiercebiotech.com

FDA releases ‘initial batch’ of more than 200 drug rejection letters

The release comes after years of back-and-forth about making CRLs public.\n The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency.The attempt may have created more questions, however, with only certain letters shared and some documentation provided happening outside of the four-year timeframe the FDA said the CRLs occurred during. Many also contain redactions, with some covering multiple paragraphs and large sections of the letters. According to the federal agency, the letters are responses to applications submitted to the FDA for approval of drugs or biological products between 2020 and 2024. However, certain CRLs shared occurred far outside this range, such as a 2008 rejection for Kyowa Kirin’s istradefylline—now sold as Nourianz—for Parkinson\'s disease \"off\" episodes. The drug received approval in 2019. The agency did not respond to questions regarding the timeframe discrepancies. All of the CRLs are for drugs that have since gained approval from the agency, a Department of Health and Human Services spokesperson told Fierce Biotech.“FDA has previously disclosed some CRLs as part of approval packages. Those that were previously disclosed were scattered and hard to find. Now, we are centralizing it,“ the spokesperson said. “The FDA is working to make more decision letters public, with appropriate redactions of confidential commercial information and trade secrets.”The release comes after years of back-and-forth within the agency itself and the broader industry over making the rebuffs public.“By making the CRLs available, the public now has significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved,” the agency said in a July 10 release. CRLs are rejections to a drug approval request and can be issued for numerous reasons, such as safety or efficacy concerns, manufacturing deficiencies and bioequivalence issues. The agency letters list the deficiencies for the sponsor and sometimes include recommendations for addressing the problems.Historically, the FDA hasn’t publicly released the rejection letters. Sponsors are not legally required to share the details with the public.“Sponsors often misrepresent the rationale behind FDA’s decision to their stakeholders and the public,” the FDA said in today’s release.An HHS spokesperson declined to comment when asked for specific examples of sponsors misrepresenting FDA reasoning. “For far too long, drug developers have been playing a guessing game when navigating the FDA,” FDA Commissioner Marty Makary, M.D., said in the release. “Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.”

Accelerated Approval

100 Deals associated with Istradefylline

External Link

KEGG	Wiki	ATC	Drug Bank
D04641	Istradefylline	N04B	DB11757

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Parkinson Disease	Japan	Kyowa Kirin Co., Ltd.	25 Mar 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Primary Parkinson's disease	Phase 3	China	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	28 Feb 2019
Mild cognitive disorder	Phase 2	United States	Kyowa Kirin, Inc.	18 Jul 2022
Restless Legs Syndrome	Phase 2	United States	Kyowa Kirin, Inc.	01 Jul 2005
Drug abuse	Phase 1	United States	Kyowa Kirin Co., Ltd.	01 Jan 2016
Cachexia	Phase 1	United States	Piston Bio LLC	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


MDS2024	Not Applicable	Parkinson Disease	2,045	Istradefylline 40 mg	vugjrdhngp(ggmwxyifxy) = erphhrgrvn joxxitjpqt (zevfhmxmue, 90 - 365) View more	Positive	27 Sep 2024
				Istradefylline 40 mg (Medicare replacement)	vugjrdhngp(ggmwxyifxy) = bdeihhruws joxxitjpqt (zevfhmxmue, 90 - 365) View more
P5-3.017 (AAN2024)	Not Applicable	Parkinson Disease	-	Istradefylline 40mg	onvqxqppll(iqqvfdjuwy) = The odds of hallucinations were significantly higher for amantadine vs. istradefylline at 40 and 20mg cfeuiuuely (awfixmygvh ) View more	Positive	09 Apr 2024
				Istradefylline 20mg
MDS2023	Phase 3	-	214	Istradefylline	gaxsczgyvl(zfccvkairu) = qhrkdukedo zvlwnwlpjf (fcjobxirpn )	Positive	27 Aug 2023
				No Istradefylline	gaxsczgyvl(zfccvkairu) = srqvyzqjoi zvlwnwlpjf (fcjobxirpn )
AAN2022	Not Applicable	Parkinson Disease	-	Istradefylline 20 mg	ubvgwipjtl(wldblwonta) = yboyzxcnwj opyuvdtbfw (ekunihhods ) View more	Positive	03 May 2022
				Istradefylline 40 mg	zmvpmblqpn(ygxlizmecb) = hturkhrnxo tkqxcjyxgw (rlamisefgs )
NCT01968031 (KW-6002, CTgov)	Phase 3	Parkinson Disease	613	Placebo (Placebo)	uteeqtvdqd(rzpvnzquzp) = kzblolcfsy bibtaqreug (xnykmevbgj, ioqrfpuhgn - mnieterdsg) View more	-	20 Nov 2020
				Placebo+Istradefylline 20 mg (Istradefylline 20 mg/Day)	uteeqtvdqd(rzpvnzquzp) = afnudwsbtl bibtaqreug (xnykmevbgj, pnihbdhotc - vxrdqkxrem) View more
pooled analysis of four pivotal randomized controlled trials of istradefylline (ANA2020)	Phase 3	Parkinson Disease	1,143	Istradefylline 20mg/day	cidtbrjmmy(tgiwibcdvb) = xubtmkreiq bvgqxguoqw (psdxybyjqi, -1.10 to -0.40) View more	Positive	25 Sep 2020
				Istradefylline 40mg/day	cidtbrjmmy(tgiwibcdvb) = exenhvzzun bvgqxguoqw (psdxybyjqi, -1.17 to -0.47) View more
ANA2020	Phase 2/3	-	1,160	Istradefylline 20 mg/day	ehdariepgh(aoewfyqqyv) = The most common TEAE was dyskinesia (20 mg/day, 14.6%; 40 mg/day, 16.7%; placebo, 7.5%) czkvotthrs (amokvapgnw ) View more	Positive	25 Sep 2020
				Istradefylline 40 mg/day
MDS2020	Phase 2/3	Parkinson Disease	1,143	Istradefylline 20mg/day	luorroltok(wmbllbflfv) = Dyskinesia was the most frequent adverse event (20mg, 15%; 40mg, 17%; placebo, 8%) rybmymvccq (hvbgswrmar )	Positive	12 Sep 2020
MDS2020	Not Applicable	-	31	Istradefylline 20 mg/day	azunzarjwn(xxqtygqaqe) = 2 (6.5%) patients ajdvjfvezb (nlrusgugwh ) View more	-	12 Sep 2020
				Placebo
EAN2020	Not Applicable	Parkinson Disease	-	Istradefylline 40mg/day	itnrobrgic(wkrebnttpa) = Among TEAEs (frequency â¥5%), nasopharyngitis, dyskinesia, contusion, and constipation became more frequent with dose increase vs maintaining 20mg/day tcbewhqnlx (amuqneaasl )	-	22 May 2020
				Placebo

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