A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Ozempic Solution for Injection 1.34mg/ml (Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea

The aim of this study is to assess the safety and effectiveness of Ozempic initiated according to label in adults with Type 2 Diabetes Mellitus (T2DM) under routine clinical practice conditions. Participants will get Ozempic as prescribed by study doctor. The study will last for about 26 weeks.

Start Date31 Mar 2025

Sponsor / Collaborator

Novo Nordisk A/S

NCT06639464 / Not yet recruitingPhase 2IIT

Semaglutide for the Treatment of Opioid Use Disorder: A Pilot Randomized Controlled Trial

The is a pilot, 12-week, double-blind, placebo-controlled, randomized trial of individuals with opioid use disorder (OUD) newly initiating buprenorphine to receive either weekly injections of semaglutide (n=23) or matching placebo (n=23). The primary aim is to determine the effects of semaglutide on cue-reactivity among individuals with OUD. The secondary aim is to assess the preliminary efficacy, safety, and tolerability of semaglutide for OUD.

Start Date01 Mar 2025

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

NCT05646199 / Not yet recruitingPhase 2/3

The Effect of Semaglutide Compared to Metformin in Obese Women With Polycystic Ovary Syndrome (PCOS): a Randomised Controlled Study (Semaglutide-PCOS Trial).

The goal of this clinical trial is to compare the effect of Semaglutide and metformin on weight loss in obese women with Polycystic Ovarian Syndrome (PCOS) over a 28-week treatment period.
The main question it aims to answer is:
• Which of the 2 drugs, metformin or Semaglutide causes more weight loss when used over a 28 week treatment period in obese women with PCOS?
Participants will be divided into 2 groups by chance. In the first group, participants will be asked to take metformin orally. In the second group, participants will take Semaglutide by injection under the skin weekly.
The maximum duration of participation for the patients in the trial is 32 weeks.
Researchers will compare the weight reduction, quality of life and individuals' wellbeing between the two groups.

Start Date01 Mar 2025

Sponsor / Collaborator

The University of Hull

100 Clinical Results associated with Semaglutide (Novo Nordisk)

100 Translational Medicine associated with Semaglutide (Novo Nordisk)

100 Patents (Medical) associated with Semaglutide (Novo Nordisk)

1,477

Literatures (Medical) associated with Semaglutide (Novo Nordisk)

01 Feb 2025·JOURNAL OF PHARMACY PRACTICE

Problematic Pharmacokinetics: A Case of Recurrent Pancreatitis Post Discontinuation of a Glucagon-Like Peptide 1 Receptor Agonists

Article

Author: Ledford, Jack D. ; Morehouse, Zachary P.

Glucagon-like peptide 1 receptor agonists (GLP-1RA) are guideline recommended agents for the treatment of type 2 diabetes mellitus (T2DM) and select agents (liraglutide and semaglutide) are FDA approved as anti-obesity pharmacotherapy options. These drugs act on the incretin hormone system within the body to revive insulin excretion, delay gastric emptying, and inhibit the production of glucagon from pancreatic alpha cells. Acute pancreatitis is a serious condition that may have a fatal outcome. It has been shown, and is now part of the prescribing information label, that GLP-1RA agents can cause changes in the pancreas that may ultimately lead to pancreatitis. We describe the case of a 53-year-old female patient with uncontrolled type II diabetes mellitus, who experienced multiple episodes of pancreatitis, from what we suspect was due to repeated exposure to the GLP-1 RA agent, semaglutide. After discontinuation of semaglutide, our patient experienced another episode of pancreatitis roughly 15-week later; which we believe may be due to the patient experiencing the effects of a smoldering pancreas brought on by repeated injury and prolonged circulation of semaglutide post-discontinuation.

01 Jan 2025·BRAIN RESEARCH

Principal components analysis on genes related to inflammasome complex and microglial activation in the hypothalamus of obese mice treated with semaglutide (GLP-1 analog)

Article

Author: Marinho, Thatiany S ; Aguila, Marcia B ; Mandarim-de-Lacerda, Carlos A. ; Marinho, Thatiany S. ; Fabiano, Matheus M ; Mandarim-de-Lacerda, Carlos A ; Fabiano, Matheus M. ; Aguila, Marcia B.

We studied the effect of semaglutide (glucagon-like peptide type 1 agonist) on hypothalamic pro-inflammatory genes in diet-induced obese mice. Male C57BL/6J mice were fed a control (C) or high-fat (HF) diet for 16 weeks, then divided into six groups and maintained for an additional four-week study: C, C+semaglutide (CS), C pair-feeding (CP), HF, HF+semaglutide (HFS), and HF pair-feeding (HFP).Weight gain (WG), food efficiency (FE), and plasmatic biochemistry were determined. The hypothalamus was removed and prepared for molecular analysis. Semaglutide reduced WG and FE in the HF group. High cytokines levels (tumor necrosis factor alpha, TNF alpha, monocyte chemoattractant protein 1, MCP1, and Resistin) in HF mice were reduced in HFS mice. High pro-inflammatory gene expressions were seen in HF (toll-like receptor 4, Tlr4; Mcp1; interleukin 6, Il6; Tnfa), inflammasome complex (Pirina domain-containing receptor 3, Nlrp3; Caspase 1, Il1b, Il18), and microglial activation (ionized calcium-binding adapter molecule 1, Iba1; cluster differentiation 68, Cd68; argirase 1, Arg1) but mitigated in HFS. The principal components analysis (PCA) based on these markers in a PC1 x PC2 scatterplot put HF and HFP together but far away from a cluster formed by C and HFS, indicating little significance of weight loss (HFP) but decisive action of semaglutide (HFS) in the results. In conclusion, semaglutide benefits hypothalamic pro-inflammatory genes, inflammasome complex, and microglial activation independent of the weight loss effect. Since GLP-1 receptor agonists such as semaglutide are already indicated to treat obesity and diabetes, the potential translational effects on neuroinflammation should be considered.

01 Jan 2025·CLINICAL ENDOCRINOLOGY

Anti‐Obesity Medication in the Management of Children and Adolescents With Obesity: Recent Developments and Research Gaps

Review

Author: Kelly, Aaron S. ; Ells, Louisa J. ; Lischka, Julia ; Torbahn, Gabriel ; Wabitsch, Martin ; Brown, Tamara ; Weghuber, Daniel

ABSTRACT:

Background:

Paediatric obesity is a global public health concern. While in most countries the incidence keeps rising, the need for effective and long‐term management for children and adolescents living with this chronic, relapsing disease is pressing. Health behaviour and lifestyle treatment (HBLT) is recommended as first‐line treatment.

Methods:

Narrative review.

Results:

A new generation of recently approved anti‐obesity medications (AOM) now has the potential to fill the gap between limited effects on body mass index (BMI) by HBLT alone and large effects by metabolic and bariatric surgery in adolescents with obesity aged 12 years and older. While, for semaglutide and phentermine/topiramate, effectiveness is substantial with relevant, but mostly mild to moderate adverse events, there is a gap in evidence regarding long‐term effects and safety, effects on outcomes beyond BMI reduction and data for certain groups of patients, such as children < 12 years and minority groups. When integrating AOM treatment into national healthcare systems it should be offered as part of a comprehensive patient‐centred approach.

Conclusion:

This article summarizes recent AOM developments, integration into paediatric obesity management, and identifies research gaps.

1,587

News (Medical) associated with Semaglutide (Novo Nordisk)

16 Dec 2024

·www.businesswire.com

True You Weight Loss Announces Two Clinical Trials Exploring Groundbreaking, Non-Surgical Weight Loss Procedures

CARY, N.C.--( BUSINESS WIRE )--True You Weight Loss, the nation’s first dedicated endobariatric weight loss center, today announced two new FDA-authorized clinical trials aimed at providing innovative, non-surgical solutions for long-term weight loss without the need for GLP-1 medications. These studies are part of True You’s growing portfolio of ten active clinical trials, solidifying its position as a global leader in advancing non-surgical weight loss treatments. Earlier this year, True You Weight Loss introduced a ground-breaking weight loss procedure called gastric fundal mucosal ablation (GFMA). This innovative technique debuted at Digestive Disease Week in May with the first-in-human results published in the December 2024 issue of Gastroenterology , gaining national attention and momentum. GMFA is a non-surgical technique in which a gastroenterologist uses an endoscope to ablate (thermally treat) the inner lining of the gastric fundus, the top portion of the stomach. This procedure reduces levels of the hunger hormone ghrelin, resulting in decreased appetite and rapid weight loss. Offered exclusively at True You Weight Loss, the team has now performed nearly 300 GFMA cases with exceptional safety and promising outcomes, leading to two new trials: MAINTAIN and REVAMP. The MAINTAIN Trial The MAINTAIN trial ( M ucosal A blat I o N T herapy A fter IN cretins) is the first-ever study to evaluate the impact of GFMA on weight maintenance after discontinuing GLP-1 medications such as Wegovy/Ozempic (semaglutide) or Mounjaro/Zepbound (tirzepatide). The study aims to determine whether GFMA can prevent or minimize weight regain in adults transitioning off these medications, offering a potential solution for patients who cannot or prefer not to continue lifelong GLP-1 therapy due to cost, side effects, supply issues, or medication fatigue. “This is an important study coming at a critical time, said Dr. Christopher McGowan , founder of True You Weight Loss and lead investigator of the study. While GLP-1 medications are highly effective during use, they do not induce permanent changes in the body. Once the medication is discontinued, hunger and weight often return quickly. With GFMA, we aim to target the body’s strongest hunger pathway—the ghrelin hormone—offering patients long-term appetite control and sustainable weight management. Our GFMA patients report an altered relationship with food—including reduced cravings and food noise—without the side effects and ongoing cost of weight loss medications.” The REVAMP Trial The REVAMP trial ( RE vision of V SG with A blation of the M ucosa P rocedure) is the first study to evaluate whether the mucosal ablation procedure can promote weight loss in patients who have regained weight after vertical sleeve gastrectomy (VSG). This single-session, non-surgical ablation procedure will treat patients who have regained at least 25 percent of their initial weight loss following VSG. “Obesity is a chronic, lifelong condition, and patients deserve lasting treatments,” said Dr. McGowan. “Many patients who undergo bariatric surgery experience weight recurrence over time. REVAMP will explore whether mucosal ablation can help these patients lose weight again without the need for additional surgeries or medications.” Both MAINTAIN and REVAMP will run for one year and are actively enrolling participants. “These trials represent a major step forward in developing non-surgical, effective weight loss solutions,” Dr. McGowan added. “At True You Weight Loss, we are committed to transforming the landscape of weight management by offering innovative procedures that prioritize patient outcomes and safety.” For more information on these innovative studies and other active research projects, please visit https://trueyouweightloss.com/research/ . About True You Weight Loss, PLLC Founded by Dr. Christopher McGowan, True You Weight Loss, PLLC, is the nation’s first dedicated endobariatric weight loss center. True You Weight Loss offers a comprehensive range of endobariatric procedures and support services to help patients lose weight, including endoscopic sleeve gastroplasty (ESG), bariatric revisional procedures, intragastric balloon placement, and medical nutrition therapy. It is the only center in the nation to reach the milestone of 5,000 endobariatric weight loss procedures. To learn more, visit www.trueyouweightloss.com or follow True You on Facebook and Instagram .

Clinical Study

16 Dec 2024

·medcitynews.com

Novo Nordisk Adds to Manufacturing Capacity, Pumping Billions Into New Rare Disease Site - MedCity News

Novo Nordisk, already active in capital improvements to add manufacturing capacity to meet growing demand for its metabolic medicines, is now building infrastructure for the production of rare disease drugs with a new 8.5 billion Danish kroner (about $1.2 billion) site. In the Monday announcement, the Copenhagen-based pharmaceutical giant said the planned new facility marks the first time in this century that the company has broken ground for a new production site in the company’s home country. The production facility and warehouse in Odense, Denmark, will span more than 40,000 square meters (about 430,556 square feet). Construction is already underway and is scheduled to finish in 2027. When complete, the site is expected to have 400 permanent jobs. “The facility will utilize advanced technology and innovative equipment to ensure the highest quality to patients and meet the growing global demand for our life-changing medicines,” Henrik Wulff, Novo Nordisk executive vice president, product supply, quality & IT, said in a prepared statement. presented by Market Trends to Watch for Health Systems and Their Specialty Pharmacies The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients. By Jake Gaffey, MBA, Chief Strategy Officer at Shields Health Solutions Novo Nordisk said the new production facility is designed to be modular and flexible, enabling it to accommodate multiple types of drugs within rare disease both now and in the future. At the BIO Conference this past June, John McDonald, Novo Nordisk’s global head of business development and M&A, said the company’s rare disease focus includes blood disorders such as sickle cell disease and hemophilias. Novo Nordisk’s hemophilia portfolio includes engineered versions of clotting proteins that patients lack. The company has also developed concizumab, an antibody drug designed to bind to TFPI, preventing that protein from blocking factor Xa, a different protein that plays a role in blood clotting. The FDA turned down Novo Nordisk’s application for the drug last year, asking for more information. But concizumab has won regulatory approval for treating both hemophilia A and hemophilia B in Canada, where it is marketed as Alhemo. The drug also recently received a recommendation for approval from a European Medicines Agency committee. Novo Nordisk’s recent manufacturing efforts have focused on metabolic medicines, specifically the GLP-1 agonists Ozempic and Wegovy. A little more than a year ago, Novo Nordisk announced plans to invest more than 42 billion Danish kroner (about $6.1 billion) to expand an existing manufacturing facility in Kalundborg, Denmark. Soon after, the company announced a 16 billion Danish kroner (about $2.3 billion) investment to expand an existing manufacturing site in France. More manufacturing capacity is coming to Novo Nordisk in Europe and the U.S. Novo Holdings, the investment arm of the foundation that holds a controlling stake in Novo Nordisk, early this year struck a $16.5 billion deal to acquire contract manufacturer Catalent. In a separate but related transaction, Novo Nordisk agreed to acquire from Novo Holdings three Catalent sites. These sites in Italy, Belgium, and Indiana, already handle filling of vials for Novo Nordisk’s GLP-1 drugs. Consumer / Employer Health Executives on Digital Transformation in Healthcare Hear executives from Quantum Health, Surescripts, EY, Clinical Architecture and Personify Health share their views on digital transformation in healthcare. By MedCity News The Catalent transactions are on their way to completion. In early December, the European Commission signed off on Novo Holdings’ acquisition of Catalent. That approval also includes Novo Nordisk’s proposed acquisition of the three Catalent manufacturing sites. The commission concluded that following the merger, customers of pre-filled syringes and orally disintegrating tablets will continue to have access to other significant and credible CDMOs. Over the weekend, Novo Nordisk said the requirements for U.S. regulatory review of the deal have been fulfilled. The company said it expects the acquisition will be complete in the coming days. Image by Novo Nordisk

Drug ApprovalAcquisition

13 Dec 2024

·www.drugs.com

U.S. Adult Obesity Rate Fell in 2023, as Use of GLP-1 Meds Rose

FRIDAY, Dec. 13, 2024 -- The U.S. obesity rate declined for the first time in a decade last year, coinciding with the rise of GLP-1 weight-loss meds, a new study finds. Data on almost 17 million adults nationwide showed the obesity rate -- which has been rising for years -- fell from 46.2% of adults in 2021 to 45.6% in 2023, Harvard University researchers report. Obesity was defined as having a body mass index (BMI) of 30 or above. At the same time, the use of GLP-1 medications like Wegovy and Zepbound has surged, although the researchers said it's not possible to confirm a cause-and-effect relationship between the trends. Still, they noted that, "The most notable decrease [in obesity] was in the South, which had the highest observed...dispensing rate," for GLP-1 medications. The study was led by Benjamin Rader , an assistant professor of anesthesia at Harvard Medical School, and published Dec. 13 in the journal JAMA Health Forum . As Rader's team noted, "the prevalence of obesity in the U.S. has increased for several decades. Some long-term forecasts estimate that this upward trajectory will continue, while others forecast a plateau." The introduction of GLP-1 meds like semaglutide ( Ozempic , Wegovy) and tirzepatide ( Mounjaro , Zepbound) into the marketplace has been a perhaps unexpected new factor in recent years, however. Sales of the injected medications have soared, and the results in terms of weight loss have often been impressive. The drugs work by mimicking a hormone in the intestine that, among other things, helps folks feel full. The new study tracked health insurance data from 2013 through 2023 on almost 17 million adults, most between the ages of 26 and 75. The data included almost 48 million BMI measurements, and a subset of participants were also tracked for their use of any GLP-1 medication. Average adult BMI in the United States charted a slow but steady rise from 2013 (29.65 BMI) to 2021 (30.23), before leveling out in 2022 (30.24), the team said. But then in 2023, average BMI dipped to 30.21 -- the first decline in a decade, according to Rader's team. The percentage of Americans who were obese also declined slightly that year. Declines were steepest in the South and among older people (ages 66 to 75), the research showed. The rate of obesity among women fell more sharply than among men. It's too early to credit GLP-1 meds with the welcome drop in obesity rates. Rader's team pointed out that, in the South, especially, the pandemic may have also played a role, since COVID was more often fatal for obese individuals. Still, the overall news for Americans' health is good. "While obesity remains a considerable public health concern, the observed reductions in obesity prevalence suggest an encouraging reversal from long-standing prior increases," Rader and team wrote. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

100 Deals associated with Semaglutide (Novo Nordisk)

External Link

KEGG	Wiki	ATC	Drug Bank
D10025	Semaglutide (Novo Nordisk)	A10BJ06	DB13928

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Myocardial Infarction	CA	Novo Nordisk Canada, Inc.	27 Nov 2024
Obesity	US	Novo Nordisk, Inc.	04 Jun 2021
Overweight	US	Novo Nordisk, Inc.	04 Jun 2021
Diabetes Mellitus, Type 2	US	Novo Nordisk, Inc.	05 Dec 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic Kidney Diseases	NDA/BLA	CN	Novo Nordisk A/S	26 Aug 2024
Vascular Diseases	Phase 3	US	Novo Nordisk A/S	01 Mar 2023
Vascular Diseases	Phase 3	JP	Novo Nordisk A/S	01 Mar 2023
Vascular Diseases	Phase 3	AR	Novo Nordisk A/S	01 Mar 2023
Vascular Diseases	Phase 3	AU	Novo Nordisk A/S	01 Mar 2023
Vascular Diseases	Phase 3	BR	Novo Nordisk A/S	01 Mar 2023
Vascular Diseases	Phase 3	BG	Novo Nordisk A/S	01 Mar 2023
Vascular Diseases	Phase 3	CA	Novo Nordisk A/S	01 Mar 2023
Vascular Diseases	Phase 3	CO	Novo Nordisk A/S	01 Mar 2023
Vascular Diseases	Phase 3	DK	Novo Nordisk A/S	01 Mar 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04251156 (STEP7, CTgov)	Phase 3	Diabetes Mellitus, Type 2 \| Obesity	375	Semaglutide (Semaglutide 2.4 mg)	dyyetjwyyv(uzyzogzjkw) = aahaqkwfyj xkjvkfprhj (bsgtnjhdvo, wmmjpwoays - jfxzlpbipq) View more	-	29 Nov 2024
				placebo+semaglutide (Placebo)	dyyetjwyyv(uzyzogzjkw) = qhnmnunjkp xkjvkfprhj (bsgtnjhdvo, etkdpfqgna - gveyrchyar) View more
Pubmed Manual	Not Applicable	Alcohol Use Disorder	227,866	Semaglutide	wkboxgsnoo(vdumankqar) = A total of 133 210 individuals (58.5%) experienced AUD hospitalization. Semaglutide (4321 users) was associated with the lowest risk (AUD: adjusted hazard ratio [aHR], 0.64; 95% CI, 0.50-0.83) and use of liraglutide (2509 users) with the second lowest risk (AUD: aHR, 0.72; 95% CI, 0.57-0.92) of AUD hospitalization. imrqsscqjc (fuxogyfwyj ) View more	Positive	13 Nov 2024
				Liraglutide
STRIDE (NEWS \| Corporate Publications) Manual	Phase 3	Peripheral Arterial Disease	-	Ozempic (semaglutide)	oowpocwvdy(xalyuoivoz) = edtojoaltv ysxnhhixzz (qopbkfdvzm )	Positive	07 Nov 2024
				Placebo	oowpocwvdy(xalyuoivoz) = jejyfxybpl ysxnhhixzz (qopbkfdvzm )
NCT06489457 (Pubmed \| Diabetes Obes Metab)	Phase 3	-	25	Semaglutide 1 mg/week	iacuksprwe(phlmrvmqkr) = nrnayasnmu vqabyuqnsd (rlytspcqxg, 2 - 5.5)	Positive	07 Nov 2024
				Testosterone undecanoate 1000 mg/10-12 weeks	iacuksprwe(phlmrvmqkr) = zvmcctnfwf vqabyuqnsd (rlytspcqxg, 2 - 3.5)
NCT05564117 (OASIS 4, Obesity Week) Manual	Phase 3	Obesity	-	Oral Semaglutide 25 mg	mzuorzgmqs(fdkqvucbsf) = vmjpqssgts bwgyiqdukb (hvidjpgiyw ) View more	Positive	06 Nov 2024
				Placebo	mzuorzgmqs(fdkqvucbsf) = akjyzevuoz bwgyiqdukb (hvidjpgiyw ) View more
NCT05486065 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Overweight	245	Semaglutide (Semaglutide 2.0 mg)	fdnkatcjhs(kzdihalqpa) = annlmxjuff mraphaavkp (nldllmhrkh, nvtvcaztlb - avodlrspxb) View more	-	05 Nov 2024
				Semaglutide (Semaglutide 8.0 mg)	fdnkatcjhs(kzdihalqpa) = apcqdgjuak mraphaavkp (nldllmhrkh, qtnsxwhdoo - xgdtrkudum) View more
NCT03574597 (SELECT, PRNewswire) Manual	Phase 3	Overweight \| Obesity	-	Semaglutide 2.4 mg	tlsgmwzvsl(okwikcxzrv) = bknvhekstj xsnmjgwdfg (eopdujdqyf ) View more	Positive	03 Nov 2024
				Placebo	tlsgmwzvsl(okwikcxzrv) = qoxvuofaux xsnmjgwdfg (eopdujdqyf ) View more
NCT05064735 (STEP 9, Pubmed) Manual	Phase 3	Obesity \| Osteoarthritis, Knee	407	Semaglutide 2.4 mg	lexvgppdke(xycccrqacm) = voqtkenqrh xwdmtidcsp (vkxlgznwjk ) View more	Positive	31 Oct 2024
				Placebo	lexvgppdke(xycccrqacm) = ebmwkzlnyt xwdmtidcsp (vkxlgznwjk ) View more
NCT05040971 (STEP 10, CTgov)	Phase 3	Prediabetic State \| Obesity	207	Semaglutide (Semaglutide 2.4 mg)	xqpntqexei(kxmigvcrty) = wedhdtgvfu hgbfneadpo (ivihjgjyej, pplncplrke - okmcvlmczc) View more	-	28 Oct 2024
				Semaglutide+placebo (Placebo)	xqpntqexei(kxmigvcrty) = lrofaalprr hgbfneadpo (ivihjgjyej, rcvbrfxxjk - rldombzykf) View more
Pubmed Manual	Not Applicable	Alzheimer Disease \| Diabetes Mellitus, Type 2	-	Semaglutide	qyjwjsqxcm(wdymqsjwub): HR = 0.33 (95% CI, 0.21 - 0.51), P-Value = 0.33	Positive	24 Oct 2024
				Insulin

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