A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight

The GZPS master protocol will support two independent studies, J2A-MC-GZS1 and J2A-MC-GZS2. Each study will see how well and safely orforglipron works in adult female participants with stress urinary incontinence (SUI) who have obesity or overweight. SUI is leaking urine during movement or activity such as coughing or exercising. Participation in the study will last about 58 weeks from screening to safety follow-up.

Start Date30 Sep 2025

Sponsor / Collaborator

Eli Lilly & Co.

NCT07153471

/ RecruitingPhase 3

A Phase 3 Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee: A Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Trial

The GZPT master protocol will support two independent studies, J2A-MC-GZT1 and J2A-MC-GZT2. Each study will see how well and safely orforglipron works in people with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 74 weeks.

Start Date15 Sep 2025

Sponsor / Collaborator

Eli Lilly & Co.

CTR20252894

/ RecruitingPhase 3

在合并和不合并2型糖尿病的肥胖或超重参与者中评价orforglipron片剂每日一次给药相比安慰剂的有效性和安全性研究

[Translation] A study evaluating the efficacy and safety of once-daily orforglipron tablets compared with placebo in obese or overweight participants with and without type 2 diabetes

本主方案将支持两项独立研究（J2A-MC-GZP1和J2A-MC-GZP2），研究目的是在肥胖或伴至少 1 种其他体重相关合并症的超重参与者接受 40 周直至 72 周治疗后比较 Orforglipron 相比安慰剂对体重减轻的影响。

[Translation]

The master protocol will support two separate studies (J2A-MC-GZP1 and J2A-MC-GZP2) designed to compare the effect of orforglipron versus placebo on weight loss in participants with obesity or overweight with at least 1 other weight-related comorbidity after 40 to 72 weeks of treatment.

Start Date07 Aug 2025

Sponsor / Collaborator

Eli Lilly Suzhou Pharmaceutical Co. Ltd.

[+2]

100 Clinical Results associated with Orforglipron

100 Translational Medicine associated with Orforglipron

100 Patents (Medical) associated with Orforglipron

Literatures (Medical) associated with Orforglipron

01 Nov 2025·DIABETES OBESITY & METABOLISM

Orforglipron, an oral non‐peptide glucagon‐like peptide‐1 receptor agonist, improves markers of β‐cell function and insulin sensitivity in type 2 diabetes

Article

Author: Banerjee, Hiya ; Mather, Kieren J. ; Kazda, Christof ; Rosenstock, Julio ; Eyde, Sarah ; Lin, Yanzhu ; Konig, Manige ; Robins, Deborah A. ; Duffin, Kevin L. ; Wilson, Jonathan M.

Abstract:

Aims:

These participant‐level exploratory analyses evaluated the effects of orforglipron, a once‐daily, orally administered non‐peptide glucagon‐like peptide‐1 receptor agonist, versus dulaglutide and placebo, on β‐cell function and insulin sensitivity biomarkers.

Materials and Methods:

Participants (N = 378) in this 26‐week phase 2 study with inadequately controlled type 2 diabetes (T2D) were randomly assigned to orforglipron (3, 12, 24, 36, or 45 mg), dulaglutide (1.5 mg), or placebo. Treatment effects on β‐cell function and insulin sensitivity markers were assessed, including homeostatic model assessment indices of β‐cell function and insulin resistance (HOMA‐B and HOMA‐IR, respectively); fasting C‐peptide, insulin, serum glucose, and glucagon; adiponectin; insulin‐like growth factor binding protein 2; proinsulin; and the proinsulin/insulin ratio.

Results:

Orforglipron doses of 12 mg and higher were associated with improved β‐cell function and insulin sensitivity. HOMA‐B increased up to 123% (C‐peptide) and 132% (insulin) with orforglipron doses of 12 mg and higher from baseline to week 4 before stabilising. HOMA‐B increases were greater with all orforglipron doses than with dulaglutide. Additional β‐cell function biomarkers, such as fasting proinsulin and the proinsulin/insulin ratio, also improved with orforglipron doses of 12 mg and higher compared with baseline and to a greater extent than seen with dulaglutide. HOMA‐IR values decreased up to 16% (C‐peptide) and 23% (insulin) with orforglipron by week 26. Reductions in HOMA‐IR (insulin) were significant versus baseline only for the highest dose. IGFBP‐2 and adiponectin, corollary biomarkers of insulin sensitivity, were generally improved with orforglipron.

Conclusions:

Increased HOMA‐B and improved metabolic biomarkers suggest that treatment with the orally administered non‐peptide GLP‐1 receptor agonist orforglipron enhanced pancreatic β‐cell function and insulin sensitivity in patients with T2D.

01 Oct 2025·ANNALS OF INTERNAL MEDICINE

In early T2D inadequately controlled with diet and exercise, once-daily orforglipron reduced HbA_1c vs. placebo at 40 wk

Article

Author: Shahid, Maham ; Gandhi, Gunjan Y.

CLINICAL IMPACT RATINGS:

GIM/FP/GP: [Formula: see text] Endocrinology: [Formula: see text].

01 Oct 2025·INTERNATIONAL JOURNAL OF OBESITY

Gastrointestinal adverse events associated with GLP-1 RA in non-diabetic patients with overweight or obesity: a systematic review and network meta-analysis

Review

Author: Abenavoli, Ludovico ; Dumitrascu, Dan L ; Al Srouji, Nahlah ; Boitos, Irina ; Scarlata, Giuseppe Guido Maria ; Leucuta, Daniel-Corneliu ; Popa, Stefan-Lucian ; Ismaiel, Abdulrahman

Abstract:

Introduction:

Overweight and obesity are major global health issues, increasing disease risk and straining healthcare systems. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are effective for weight loss but cause gastrointestinal side effects, affecting adherence. Research often focuses on diabetics, leaving a gap in understanding their effects on non-diabetic individuals with overweight or obesity. This systematic review and dose-response network meta-analysis addresses this gap, analyzing gastrointestinal adverse events from GLP-1 RAs in non-diabetic subjects with overweight or obesity.

Methods:

We evaluated available evidence by searching PubMed and EMBASE databases, according to specific inclusion and exclusion eligibility criteria to evaluate gastrointestinal adverse events associated with GLP-1 RAs in non-diabetic individuals with overweight or obesity. Quality assessment of included studies was conducted using Cochrane Collaboration’s tool.

Results:

Thirty-nine articles were included in the review showing a total number of 33,354 individuals. Nausea, vomiting, diarrhea, and constipation were the most common gastrointestinal adverse effects. All evaluated GLP-1 RAs led to a significant increase in nausea risk, with orforglipron showing the highest risk, followed by exenatide, tirzepatide, semaglutide, and liraglutide. Additionally, liraglutide, orforglipron, semaglutide, and tirzepatide were associated with increased vomiting risk, while cagrilinitide and exenatide showed no significant increase. Exenatide, cagrilinitide, orforglipron were not associated with diarrhea risk. Finally, semaglutide and liraglutide were associated to increased constipation risk, while cagrilinitide and exenatide showed no significant increase.

Conclusions:

GLP-1 RAs showed several adverse gastrointestinal effects in non-diabetic patients with overweight or obesity. Understanding the different risk profiles of GLP-1 RAs helps clinicians make informed treatment decisions by balancing therapeutic benefits with potential side effects.

162

News (Medical) associated with Orforglipron

17 Oct 2025

·www.prnewswire.com

Weekly Recap: 14 Health Press Releases You Need to See

A roundup of the most newsworthy healthcare press releases from PR Newswire this week, including updates in mental health, cancer awareness and the vital importance of washing your hands. NEW YORK, Oct. 17, 2025 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the week's most newsworthy and popular releases, here's a recap of some major stories from the week that shouldn't be missed. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Weekly Health Press Release Roundup, Oct. 13-17, 2025. Hugel Inc. appoints Carrie Strom as Chief Executive Officer Carrie Strom is a 25-year pharmaceutical and aesthetics industry leader who previously served as Global President of Allergan Aesthetics. "My priority is to build on Hugel's leadership in South Korea and transform it into a global aesthetics powerhouse, raising the bar for how we serve customers and patients around the world," she said. Lilly's oral GLP-1, orforglipron, demonstrated superior glycemic control in two successful Phase 3 trials, reconfirming its potential as a foundational treatment in type 2 diabetes In ACHIEVE-2, orforglipron lowered A1C by up to 1.7% compared to 0.8% with dapagliflozin, meeting the primary endpoint. In ACHIEVE-5, orforglipron lowered A1C by an additional 2.1% when taken with insulin glargine, meeting the primary endpoint. Waters Launches Charge Detection Mass Spectrometry Technology to Accelerate the Development of Next-Generation Biotherapeutics Waters Xevo CDMS delivers unmatched characterization for mega-mass biomolecules central to next-generation therapies. Roche's Elecsys® pTau181 becomes the only FDA-cleared blood test for use in primary care to rule out Alzheimer's-related amyloid pathology Developed in collaboration with Eli Lilly and Company, this minimally invasive test provides clinicians with information that can help identify patients in early stages of cognitive decline who are unlikely to have Alzheimer's-related amyloid pathology. Global Handwashing Day 2025 Underscores the Power of Soap and Water to Save Lives Celebrated annually on October 15, this worldwide event reminds people that consistent hand hygiene is critical to preventing the spread of infectious diseases and protecting community health. Kohler Co. Launches Kohler Health, Ushering in a New Era of Health and Wellness in the Home As health and wellness continue to expand to the home setting, the bathroom stands as an untapped hub of vital health data and information. Every day, we flush away insights that could help us better understand our bodies and our health. Kohler Health is challenging people to re-imagine how they think about the bathroom. Friendship is Fitness: New Research From Peerspace Shows Social Connection as Key to Health Healthy social connection depends on getting the right mix of interactions that meet our individual social needs. Peerspace's new quiz introduces eight distinct social connection personality types – from The Deep Diver to The Silly Goose – each reflecting a unique way people experience and seek out connection. Clear Channel Outdoor and Blood Cancer United Team Up on Billboard Campaign to Reach More People Affected by Blood Cancer The out-of-home campaign introduces The Leukemia & Lymphoma Society's new name, Blood Cancer United, to engage more communities and increase awareness of blood cancer. Pink Aid Celebrates 15 Years of Compassion and Support for Breast Cancer Patients Facing Financial Crisis Created in 2011 by Amy Katz, Andrew Mitchell-Namdar, Renee Mandis, and Amy Gross, Pink Aid was born from a critical need: while treatments for breast cancer have advanced, one in three patients still faces financial collapse. Many lose their jobs, delay care, or risk eviction while battling for their lives. The founders envisioned a community of care to ensure patients never have to choose between treatment and basic necessities like food and shelter. 81% of Americans Say Mental Health Support Can't Wait - They Expect It Within Hours, New CallTrackingMetrics Report Finds The report paints a picture of a growing dilemma in access to behavioral health care: timeliness. When care is delayed, it's denied. One in five Americans said they reached out to mental health or addiction treatment providers for help, but never heard back. Twin Health and Peloton Partner to Transform Metabolic Health The unique partnership will bring Peloton's world-class fitness and wellness content to Twin's AI digital twin program, proven to treat diabetes, prediabetes and obesity while reducing reliance on medications. On World Mental Health Day, NAMI Announces New Scientific Advisory Council to Advance Hope Through Research The council unites leading scientists, clinicians, and advocates to ensure that cutting-edge research and lived experience together shape the future of mental health care. Trust and Transparency Rule: How Scientists Choose Antibodies in 2025 Drawing on feedback from hundreds of scientists, the 2025 report highlights evolving trends in antibody selection, purchasing behavior, and usage. Karmanos Shines a Green Light on Liver Cancer in October: Know the Risks, Know the Signs According to the American Cancer Society, more than 800,000 people are diagnosed with liver cancer around the world each year. Here in the U.S., over 42,200 new cases of liver cancer are estimated to occur in 2025. For more news like this, check out all of the latest health-related releases from PR Newswire. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. SOURCE PR Newswire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical Result

17 Oct 2025

·pharma.economictimes.indiatimes.com

US FDA announces recipients of national priority vouchers

By Sneha S K The U.S. Food and Drug Administration on Thursday announced the names of nine products, under a new fast-track review process , which could potentially get approval within one to two months of filing a complete application. The regulator said it has selected Merck KGaA's fertility drug Pergoveris, Sanofi's Type 1 diabetes drug teplizumab, Regeneron's DB-OTO for deafness and ketamine for domestic manufacturing of a general anesthetic. These will have shorter review times compared to the typical timeline of about 10-12 months. The FDA's list also includes Revolution Medicines' RMC-6236 for pancreatic cancer, Disc Medicine's bitopertin for porphyria, Achieve Life Sciences' cytisinicline for nicotine vaping addiction as well as Dompe's cenegermin-bkbj for blindness and augmentin XR for domestic manufacturing of a common antibiotic. Shares of Revolution rose 7.4%, while Disc Medicine rose 19% in extended trading. The FDA in June launched the new Commissioner's National Priority Voucher pilot program under which it could issue vouchers to companies aligned with major national priorities, such as meeting a large unmet medical need, reducing downstream health care utilization, or addressing a public health crisis. The new program will convene experts from the regulator's offices for a team-based review, instead of using the standard review system, where a drug application is sent to numerous FDA offices. Each drug review division within the FDA has been charged with nominating a product while companies can also apply and have their request reviewed, the FDA said on Thursday. The agency expects to announce another group of products under the new program in the coming months. Eli Lilly's experimental weight-loss pill, orforglipron, could be fast-tracked under the new voucher process, analysts had speculated last month. The FDA's list on Thursday did not include orforglipron. Lilly called the program a promising initiative adding, "while it's too early to discuss how this submission pathway might relate to any of our specific programs, we look forward to learning more from the Administration," the company said in an emailed response. (Reporting by Sneha S K in Bengaluru; Editing by Shailesh Kuber)

Fast Track

16 Oct 2025

·pharma.economictimes.indiatimes.com

Lilly's weight-loss pill shows better blood sugar control in late-stage trials

Bengaluru: Eli Lilly's experimental weight-loss pill showed superior blood sugar control in diabetic patients across two late-stage trials , the company said on Wednesday, as it seeks to widen its lead in the rapidly growing market for GLP-1 drugs . The oral drug, orforglipron, is designed to mimic the appetite-suppressing GLP-1 hormone targeted by the company's blockbuster injection tirzepatide, sold under the brand names Mounjaro and Zepbound. Lilly and its Danish rival Novo Nordisk, market leaders with their injectable drugs, are racing to launch oral weight-loss treatments, which still require approval by the U.S. Food and Drug Administration. In one of the studies, Lilly's pill helped lower A1C, a measure of blood sugar over time, by up to 1.7% compared to 0.8% with 10 mg dose of AstraZeneca's drug dapagliflozin, sold under the brand name Farxiga. The head-to-head trial was conducted in adults with type 2 diabetes inadequately controlled on metformin, a widely used drug to treat high blood sugar levels. In the other trial, orforglipron lowered A1C by an additional 2.1% when taken with insulin glargine. In both trials, orforglipron showed weight loss and improvements in multiple cardiovascular risk factors, the company said. Patients received either a 3 mg, 12 mg or 36 mg dose of orforglipron over 40 weeks across the studies. In a previous head-to-head trial in adults with type 2 diabetes, orforglipron lowered average blood sugar and weight more effectively than Novo's older GLP-1 pill Rybelsus. "Together, these results reinforce orforglipron's potential to become a new standard of care for people living with type 2 diabetes," said Jeff Emmick, senior vice president of product development, Lilly Cardiometabolic Health. Results from another trial is expected in the first quarter of 2026. Lilly plans to submit orforglipron for the treatment of type 2 diabetes to global regulatory agencies in 2026, while submission for the obesity treatment is set to occur by this year end. (Reporting by Sriparna Roy and Siddhi Mahatole in Bengaluru; Editing by Shilpi Majumdar)

Clinical ResultDrug Approval

100 Deals associated with Orforglipron

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Urinary Incontinence, Stress	Phase 3	United States	Eli Lilly & Co.	30 Sep 2025
Urinary Incontinence, Stress	Phase 3	China	Eli Lilly & Co.	30 Sep 2025
Urinary Incontinence, Stress	Phase 3	Japan	Eli Lilly & Co.	30 Sep 2025
Urinary Incontinence, Stress	Phase 3	Canada	Eli Lilly & Co.	30 Sep 2025
Urinary Incontinence, Stress	Phase 3	Czechia	Eli Lilly & Co.	30 Sep 2025
Urinary Incontinence, Stress	Phase 3	India	Eli Lilly & Co.	30 Sep 2025
Urinary Incontinence, Stress	Phase 3	Mexico	Eli Lilly & Co.	30 Sep 2025
Urinary Incontinence, Stress	Phase 3	Poland	Eli Lilly & Co.	30 Sep 2025
Urinary Incontinence, Stress	Phase 3	Romania	Eli Lilly & Co.	30 Sep 2025
Urinary Incontinence, Stress	Phase 3	South Korea	Eli Lilly & Co.	30 Sep 2025

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06192108 \| NCT06109311 (ACHIEVE-5, Company_Website) Manual	Phase 3	Diabetes Mellitus, Type 2	-	Orforglipron 3 mg + metformin (ACHIEVE-2)	iqtftijgox(slfvfsrjus) = uqjefupegs btqahvhaje (pffusmbhnr ) Met View more	Superior	15 Oct 2025
				Orforglipron 12 mg + metformin (ACHIEVE-2)	iqtftijgox(slfvfsrjus) = zdiftdqduw btqahvhaje (pffusmbhnr ) Met View more
NCT06045221 (ACHIEVE-3, PRNewswire) Manual	Phase 3	Diabetes Mellitus, Type 2	1,698	orforglipron 12 mg	kqtjfnpuip(gnugfpjkei) = wklxtnoufd ceknjbwvgq (ngzogwwgzy ) Met View more	Superior	17 Sep 2025
				orforglipron 36 mg	kqtjfnpuip(gnugfpjkei) = ksbubydwnh ceknjbwvgq (ngzogwwgzy ) Met View more
NCT05869903 (ATTAIN-1, Company_Website \| N Engl J Med) Manual	Phase 3	Obesity	-	Orforglipron 6 mg	dnuexaijkj(nafonuewgc) = eqbnacidif xyhluhyfrz (sokidgyusi ) Met View more	Positive	16 Sep 2025
				Orforglipron 12 mg	dnuexaijkj(nafonuewgc) = oikyerxxuf xyhluhyfrz (sokidgyusi ) Met View more
NCT05872620 (ATTAIN-2, Company_Website) Manual	Phase 3	Diabetes Mellitus, Type 2 \| Overweight \| Obesity	-	Orforglipron 6 mg	nxxlazugja(laaogdsqel) = tzzynrsnlo noukososks (tihzmkrlhh ) View more	Positive	26 Aug 2025
				Orforglipron 12 mg	nxxlazugja(laaogdsqel) = fbuildzyso noukososks (tihzmkrlhh ) View more
NCT05869903 (ATTAIN-1, NEWS) Manual	Phase 3	Overweight \| Obesity	-	orforglipron	xkhgahpgpg(ehdisqhhle) = orforglipron的三个剂量组与安慰剂组相比均达到了主要终点 vxjfmwupaz (piqcxzimhe ) Met View more	Positive	07 Aug 2025
				安慰剂
NCT05971940 (ACHIEVE-1, Pubmed \| N Engl J Med) Manual	Phase 3	Diabetes Mellitus, Type 2	559	Orforglipron 3 mg	rxmznstcov(flhydrwnla) = tspuxamsgd oojimgabya (mcqrrqddqv ) View more	Positive	21 Jun 2025
				Orforglipron 12 mg	rxmznstcov(flhydrwnla) = mfbvpfhhkz oojimgabya (mcqrrqddqv ) View more
NCT05971940 (ACHIEVE-1, Biospace \| NEWS) Manual	Phase 3	Diabetes Mellitus, Type 2	559	Orforglipron 3 mgOrforglipron 3 mg	kthxdrwaab(xgnwjskqwa) = rfqcvpfkwu llchkmcoun (kcmxpknyes ) Met View more	Positive	17 Apr 2025
				OrforglipronOrforglipron 12 mg	kthxdrwaab(xgnwjskqwa) = smjhsjqrcr llchkmcoun (kcmxpknyes ) Met View more
NCT05051579 (EASD2023)	Phase 2	Overweight \| Obesity	272	Orforglipron (OFG) 12 mg	pxqxbtqpxt(onljhowtjo) = rwyfjobejw wptrqtkddt (xwyhjntjmq ) View more	Positive	03 Oct 2023
				Orforglipron (OFG) 24 mg	pxqxbtqpxt(onljhowtjo) = hlevjclyeo wptrqtkddt (xwyhjntjmq ) View more
NCT05051579 (GZGI, CTgov)	Phase 2	Obesity	272	LY3502970 (24 mg LY3502970)	gsrbcaknxp(narvupheiy) = kcurpdrxfz lbwutsgvoh (ybkuitzjsu, 0.82) View more	-	13 Sep 2023
				Placebo (Placebo)	gsrbcaknxp(narvupheiy) = neybsgaajq lbwutsgvoh (ybkuitzjsu, 0.81) View more
NCT05048719 (ADA 12023 \| ADA 22023) Manual	Phase 2	Diabetes Mellitus, Type 2	383	Orforglipron 3 mg	qglzqhnzmm(ygszeimunn) = rgcmcbhrfo sphtoybmou (sccozvjgzf ) View more	Positive	25 Jun 2023
				Orforglipron 12 mg	qglzqhnzmm(ygszeimunn) = mmncopcech sphtoybmou (sccozvjgzf ) View more

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