Efficacy, Safety, and Pharmacokinetics of Orforglipron Once Daily Oral Versus Placebo in Adolescent Participants Who Have Obesity, or Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (ADVANCE-ATTAIN-ADOLESCENTS)

The main purpose of this study, performed under Master Protocol J4M-MC-PWMP, is to evaluate the efficacy, safety, and pharmacokinetics of orforglipron once daily oral versus Placebo in adolescent participants with obesity, or overweight with related comorbidities. Participation in the study will last about 18 months.

Start Date01 Dec 2024

Sponsor / Collaborator

Eli Lilly & Co.

NCT06692348 / Not yet recruitingPhase 1

A Phase 1, Open-Label, Multiple-Dose Study to Investigate the Comparability of the Pharmacokinetics of Orforglipron (LY3502970) Single Capsule and Multiple Capsules in Healthy Participants

The main purpose of this study is to assess and compare a single capsule and multiple capsules of Orforglipron based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants under fasted and fed conditions. How the body handles and eliminates the study drug after meals and on an empty stomach will be measured. Information about any adverse effects experienced will be collected and the safety and tolerability of Orforglipron will also be evaluated. The study will last approximately 21 weeks, including a screening period.

Start Date01 Dec 2024

Sponsor / Collaborator

Eli Lilly & Co.

NCT06672549 / Not yet recruitingPhase 3

A Master Protocol for a Randomized, Controlled, Clinical Platform Trial to Investigate the Efficacy and Safety of Interventions for Chronic Weight Management in Pediatric Participants With Obesity or Overweight

The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.

Start Date01 Dec 2024

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Orforglipron

100 Translational Medicine associated with Orforglipron

100 Patents (Medical) associated with Orforglipron

Literatures (Medical) associated with Orforglipron

01 Dec 2024·METABOLISM-CLINICAL AND EXPERIMENTAL

Seven glucagon-like peptide-1 receptor agonists and polyagonists for weight loss in patients with obesity or overweight: an updated systematic review and network meta-analysis of randomized controlled trials

Review

Author: Li, Mengting ; Cao, Weiling ; Zheng, Guimei ; Deng, Weishang ; Xie, Zeyu ; Liang, Zhuoru

PURPOSE:

This study aimed to provide evidence-based support and a reference for the efficacy and safety of seven glucagon-like peptide-1 (GLP-1) receptor agonists and polyagonists for weight loss in patients with obesity or overweight through a network meta-analysis.

METHODS:

Relevant randomized controlled trials (RCTs) with an intervention duration of at least 16 weeks assessing seven GLP-1 receptor agonists and polyagonists (mazdutide, 6 or 4.5 mg; retatrutide, 12 or 8 mg; tirzepatide, 15 or 10 mg; liraglutide, 3.0 mg; semaglutide, 2.4 mg; orforglipron, 45 or 36 mg; and beinaglutide, 0.2 mg) in patient with obesity or overweight was searched using three databases (Cochrane Library, PubMed, and Embase) from creation to August 30, 2024. The primary outcome was the percentage change in body weight from baseline. Secondary outcomes included changes in waist circumference, hemoglobin A1c, and fasting plasma glucose level from baseline; adverse events, serious adverse events, adverse event withdrawal, and hypoglycemic events. We conducted a frequentist random-effects network meta-analysis to analyze the data extracted from the RCTs using Stata 16.1 software.

RESULTS:

Twenty-seven RCTs of seven GLP-1 receptor agonists and polyagonists and 15,584 patients were included in the network meta-analysis. In terms of efficacy, compared with placebo, retatrutide 12 mg (-22.10 % in body weight and - 17.00 cm in waist circumference), retatrutide 8 mg (-20.70 % and - 15.90 cm), and tirzepatide 15 mg (-16.53 % and - 13.23 cm) were the three most efficacious treatments for reducing body weight and waist circumference. However, these treatments were less effective in patients with type 2 diabetes mellitus (T2DM). In addition, patients with a high body mass index (BMI) or longer treatment cycles exhibited significantly greater weight loss than those with a low BMI or shorter treatment cycles. In terms of safety, patients without T2DM had a higher incidence of adverse events than those with T2DM. None of the interventions increased the incidence of serious adverse or hypoglycemic events (˂54 mg/dL). There was no significant difference in the incidence of adverse event withdrawal for all interventions in head-to-head comparisons. In addition, disparities in race, BMI, and treatment cycles did not significantly increase the incidence of adverse events. Finally, the sensitivity and publication bias analyses indicated that the basic analysis results were reliable.

CONCLUSION:

Retatrutide (both doses) and tirzepatide exhibited superior efficacy compared to other GLP-1 receptor agonists and polyagonists in reducing body weight and waist circumference. Patients without T2DM, those with a high BMI, and individuals undergoing longer treatment cycles demonstrated significantly greater weight loss and reductions in waist circumference. Dual or triple receptor agonists (GLP-1 plus glucose-dependent insulinotropic polypeptide and/or Glucagon receptor) are more effective for weight loss than GLP-1 receptor agonists.

01 Oct 2024·Current diabetes reviews

Future is Brighter: New Potential Paradigm-Shifting Medications and Regimens for Diabetes and Obesity

Review

Author: Aliter, Hashem F. ; Al-Horani, Rami A. ; Aliter, Kholoud F.

Abstract::

Diabetes is a chronic illness that can become debilitating owing to its microvascular and macrovascular complications. Its prevalence is increasing and so is its cost. Diabetes, particularly type 2, appears to have a very close relationship with obesity. While lifestyle modifications, exercises, and current therapeutics have substantially improved clinical outcomes, the need for new therapeutics and regimens continue to exist. Several new medications and regimens for diabetes, obesity, and diabesity are showing promising results in advanced clinical trials. For type 1 diabetes mellitus (T1DM), they include teplizumab, ustekinumab, jakinibs, and cell therapies, whereas for type 2 diabetes mellitus (T2DM), they include once-weakly insulin, tirzepatide, high oral dose of semaglutide, orforglipron, retatrutide, CagriSema, and survodutide. Given their structural and mechanistic diversity as well as their substantial efficacy and safety profiles, these medications and regimens are paradigm shifting and promise a brighter future. They will likely enable better disease prevention and management. This review will provide details about each of the above strategies to keep the scientific community up to date about progress in the fields of diabetes and obesity

11 Sep 2024·Archives of Endocrinology Metabolism

Effects of once-daily oral orforglipron on weight and metabolic markers: a systematic review and meta-analysis of randomized controlled trials

Review

Author: Sande-Lee, Simone van de ; van de Sande-Lee, Simone ; Hohl, Alexandre ; Chavez, Matheus Pedrotti ; Ferreira, Rafael Oliva Morgado ; Pasqualotto, Eric ; Dos Santos, Henrique Vilar ; Ronsoni, Marcelo Fernando ; Petris, Ilmar ; Wille, Julia Murbach ; Santos, Henrique Vilar dos ; Lütkemeyer, Carine

The aim of this study is to assess the effects of once-daily oral orforglipron on weight and metabolic markers in adult patients. PubMed, Embase, Cochrane Library, and ClinicalTrials.gov databases were systematically searched until February 2024 for randomized controlled trials (RCTs) comparing orforglipron versus placebo or other anti-obesity medications in adult patients. Weighted mean differences (WMDs) for continuous outcomes and risk ratios (RRs) or risk differences for binary endpoints were computed, with 95% confidence intervals (CIs). Heterogeneity and risk of bias were assessed with I² statistics and Rob-2, respectively. Statistical analyses were performed using R, version 4.2.2. A total of four studies were included, comprising 815 patients, of whom 620 (76.1%) were prescribed orforglipron. Compared with placebo, orforglipron reduced body weight (WMD -6.14 kg, 95% CI -9.62 to -2.66 kg), body mass index (WMD -2.87 kg/m², 95% CI -4.65 to -1.10 kg/m²), and waist circumference (WMD -5.32 cm, 95% CI -9.13 to -1.51 cm). More patients treated with orforglipron than placebo achieved a weight loss of ≥ 5% (RR 3.31, 95% CI 2.23-4.93), ≥ 10% (RR 5.24, 95% CI 2.07-13.31), and ≥ 15% (RR 9.53, 95% CI 1.26-71.89). The most common adverse events were related to the gastrointestinal tract. In this meta-analysis, the use of once-daily oral orforglipron by adult patients was associated with a significant decrease in body weight, as compared with placebo, with an increase in non-severe gastrointestinal adverse events. Phase 3 RCTs are expected to shed further light on the efficacy and safety of once-daily oral orforglipron over the long term.

News (Medical) associated with Orforglipron

09 Dec 2024

·www.prnewswire.com

Biolexis Therapeutics Announces Positive Results from Expanded Diet Induced Obesity (DIO) Model Study for BLX-7006

Study Demonstrates 16.6 % at day 7 to 29 % on terminal day 28 Weight Loss and Superior Efficacy Compared to peptide-based approved or clinical stage oral Obesity Drugs in the DIO Model LEHI, Utah, Dec. 9, 2024 /PRNewswire/ -- Biolexis Therapeutics, a leading metabolic drug discovery company focused on improving the lives of patients with chronic metabolic conditions, including obesity, diabetes, and related diseases, today announced the successful completion of an expanded diet -induced obesity (DIO) trial for its candidate drug, BLX-7006. The results demonstrate significant weight loss and superior efficacy compared to leading obesity therapies, including Semaglutide and Orforglipron, providing robust support for BLX-7006's potential as a transformative treatment for obesity & diabetic indications. The newly completed study builds upon a previous DIO study in which BLX-7006 demonstrated a promising 15.6 % weight loss. In the expanded study, BLX-7006 achieved a substantial 29% weight loss, attributed to evaluating higher dosage levels. These higher doses were well tolerated, with no observed toxicity, marking an important milestone in the development of BLX-7006 for obesity management. "We are extremely encouraged by the results of our expanded DIO study, which show a significant improvement in weight loss with BLX-7006 compared to our initial study," said Dr. Hariprasad Vankayalapati, Chief Scientific Officer at Biolexis Therapeutics. "The higher dosage levels are well tolerated, have yielded a 29% weight loss, which is not only a strong indication of the potential therapeutic benefits of BLX-7006, but also underscores its safety profile, with no evidence of toxicity at these elevated doses in non-clinical animal models. Our findings place BLX-7006 in a competitive position in the obesity treatment space." In addition to the DIO study, Biolexis has completed a non-human primate study to assess BLX-7006's oral bioavailability profile. The study demonstrated high exposure levels, further validating BLX-7006's potential translation into future human clinical trials. "These results are a testament to the strength of our BLX-7006 program and the dedication of our team in developing novel metabolic therapeutics," said Keith Marmer, Chief Business Officer of Biolexis Therapeutics. "With the growing global prevalence of obesity and related metabolic disorders, there is a pressing need for more effective oral treatments over current injectables. The compelling results from both our expanded DIO study and the non-human primate study position BLX-7006 as a promising future clinical candidate to address this critical unmet need." Biolexis will present these findings and additional data at the upcoming Innovation in Obesity Therapeutics Summit in San Diego, CA, on December 11-12, 2024. Biolexis Co-founder Dr. David Bearss will present the latest data on BLX-7006's efficacy and its potential to provide a safe, effective, and oral alternative for patients struggling with obesity and related metabolic conditions. "We are excited to share these groundbreaking results with the scientific community at the Innovation in Obesity Therapeutics Summit," said Dr. Bearss. "As we continue to advance BLX-7006 through clinical development, we remain committed to improving patient outcomes and bringing innovative solutions to the market that can have a meaningful impact on the lives of those affected by chronic metabolic diseases." About Biolexis Therapeutics Biolexis Therapeutics is a biopharmaceutical company focused on discovering and developing innovative metabolic drugs to address chronic diseases such as obesity, diabetes, and related conditions. The company's pipeline includes novel small-molecule oral therapies designed to improve patient outcomes with enhanced efficacy and safety profiles. Biolexis is committed to advancing the treatment of chronic metabolic disorders to enhance patients' lives worldwide. For more information about Biolexis Therapeutics and its pioneering research, please visit biolexistx.com. Forward-Looking Statements This press release contains forward-looking statements regarding the clinical development of BLX-7006, including its potential safety, efficacy, and market positioning. These statements are based on current expectations and are subject to risks and uncertainties. Actual results may differ materially from those anticipated due to various factors, including clinical trial results, regulatory approval, and market conditions. SOURCE Biolexis Therapeutics Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical Result

06 Dec 2024

·www.pharmaceutical-technology.com

New study finds obesity costs US industry $347bn a year

The study published in Nature shows the drastic economic cost of obesity through medical expenses and lost productivity. Credit: zimmytws/Getty Images A new study published in Nature Nutrition & Diabetes estimates the economic burden associated with obesity on major US industries to have been in excess of $347bn in 2023. Published on 4 December 2024, the study considered economic and health data from national surveys to describe a population of 158 million American employees working in the country’s seven major industries. By modelling the productivities and costs associated with healthy weight, overweight, and obese Americans, the authors projected that average weight loss from 5%—25% among workers would yield five-year medical savings of $153.3bn—$326.1bn, respectively. The authors calculated an average annual cost of $6,472 per obese employee and $1,244 for those overweight. The chief causes were identified as excess medical cost, decreased productivity, worker absenteeism, and disability payments. In the paper, authors stated their results “highlight the need for resources dedicated to treatment and prevention, which can result in reduced medical expenses and improved productivity.” The study was authored by analysts at GlobalData, the parent company of Pharmaceutical Technology . The significant economic burden of obesity demonstrated coincides with a ballooning of the obesity medicines sector in recent years, spearheaded by glucagon-like peptide 1 receptor agonists (GLP1-RAs) from biopharma giants Novo Nordisk and Eli Lilly. While the industry as a whole has seen a mild decline in revenues in 2023, GlobalData analysis shows leading companies in the obesity space boast high revenue growth, 31.3% and 19.6% for Novo Nordisk and Eli Lilly, respectively. Leading the charge are Novo’s diabetes and obesity drugs Ozempic and Wegovy (semaglutide), estimated by GlobalData to bring in global 2024 revenues of $17.8bn and $8.4bn, as well as Lilly’s diabetes and obesity drugs Mounjaro and Zepbound (tirzepatide), projected to generate $11.8bn and $5.4bn, respectively. Lilly’s Zepbound has recently taken precedence, eliciting 47% greater weight loss than Wegovy in the Phase III SURMOUNT-5 trial (NCT05822830). Chasing an anti-obesity market estimated to grow to $30bn by 2030 across the seven major markets (France, Germany, Italy, Japan, Spain, UK, and the US ), other biopharmas like AstraZeneca , Amgen , and Roche are also pursuing metabolic therapies. A high unmet clinical need is further fuelling interest in oral GLP-1RAs to replace current injected formulations, with Phase III candidates Rybelsus and NN-9932 from Novo and orforglipron from Lilly aiming at approval. On 26 November, the Biden administration made moves to open the growing potential market for such therapies by proposing an expansion of Medicare and Medicaid access to GLP-1RAs to recipients with obesity alone, an estimated 42% of the US population. Elsewhere, however, there remains resistance to metabolic therapies. The UK government announced it will limit access to Mounjaro starting next year. The drug is recommended for those with a body mass index (BMI) above 35, which would cover 3.4 million people from the adult population. However, patients who meet additional criteria for the “highest clinical need” will be prioritised by the UK NHS, which would cover approximately 220,000 patients in the three-year rollout period.

Phase 3Clinical Result

04 Dec 2024

·endpts.com

Lilly beats Novo in bellwether head-to-head weight loss study

The market for first-generation weight loss treatments has been dominated by two major players, Eli Lilly and Novo Nordisk. But new data provide the clearest evidence yet that one may have an edge. On Wednesday, Lilly reported the first data from a head-to-head Phase 3 trial testing Zepbound against Novo’s Wegovy, finding that Zepbound was the superior weight loss agent. By week 72, patients given Zepbound lost 20.2% of their body weight on average, compared to 13.7% for Wegovy, the study’s primary endpoint. That equated to a 47% greater relative weight reduction, Lilly said. The percentage changes in weight translated to Zepbound patients losing an average of 50.3 pounds. For patients given Wegovy, the average weight loss was 33.1 pounds. Lilly highlighted one secondary endpoint, finding that 31.6% of people given Zepbound lost at least 25% of their body weight, compared to 16.1% for Wegovy. Lilly said it beat Wegovy on four other secondary endpoints and that more results will be published and presented in 2025. The topline figures spell a resounding victory for Lilly, which bet on itself when it launched the randomized, controlled trial — called SURMOUNT-5 — more than a year and a half ago in April 2023. At that point, tirzepatide had not been formally approved for weight management in the US, though its diabetes-branded equivalent, Mounjaro, was being used as such off-label. In the head-to-head trial, the weight loss percentage data are fairly similar to both drugs’ performances in their respective pivotal studies. Wegovy underperformed slightly in SURMOUNT-5, posting a 1.2-percentage point difference in overall weight loss compared to its pivotal trial. Zepbound also showed a 2.3-percentage point gap in weight loss versus its pivotal SURMOUNT-1 trial. However, the slightly weaker efficacy for both drugs could be due to the lower doses used in the latest study. The data are a lift for Lilly after a bruising third-quarter earnings report sent its shares down 10%. The company lowered the top end of its guidance by $600 million and sales missed Wall Street’s expectations by roughly $800 million. Now, it can take the data to doctors and payers. Leonard Glass, SVP of global medical affairs for the pharma’s cardiometabolic unit, said in a release that the study was conducted to “help health care providers and patients make informed decisions about treatment choice.” SURMOUNT-5 randomized 751 participants in the US and Puerto Rico to receive the maximum tolerated dose of either Zepbound or Wegovy, more than the 700 that were expected to enroll. Lilly did not design the trial to test long-term durability, saying that it would last around 74 weeks. Instead, it’s using the enrollees for another Phase 3 study, testing its oral candidate orforglipron as a maintenance option for people previously given injectables. People who complete SURMOUNT-5 will be eligible to enter the study of orforglipron, randomized to receive either the pill or placebo, with that trial slated for a readout next year. The Indianapolis pharma reported no specific side effect figures for SURMOUNT-5, saying that the safety profile of Zepbound was consistent with other studies of tirzepatide. The most common adverse events for both drugs were gastrointestinal-related and were “generally mild to moderate in severity,” Lilly said. Additional reporting by Elizabeth Cairns.

Phase 3Clinical Result

100 Deals associated with Orforglipron

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Sleep Apnea, Obstructive	Phase 3	US	Eli Lilly & Co.	22 Oct 2024
Sleep Apnea, Obstructive	Phase 3	CN	Eli Lilly & Co.	22 Oct 2024
Sleep Apnea, Obstructive	Phase 3	JP	Eli Lilly & Co.	22 Oct 2024
Sleep Apnea, Obstructive	Phase 3	AR	Eli Lilly & Co.	22 Oct 2024
Sleep Apnea, Obstructive	Phase 3	BR	Eli Lilly & Co.	22 Oct 2024
Sleep Apnea, Obstructive	Phase 3	CZ	Eli Lilly & Co.	22 Oct 2024
Sleep Apnea, Obstructive	Phase 3	DE	Eli Lilly & Co.	22 Oct 2024
Sleep Apnea, Obstructive	Phase 3	IN	Eli Lilly & Co.	22 Oct 2024
Sleep Apnea, Obstructive	Phase 3	MX	Eli Lilly & Co.	22 Oct 2024
Sleep Apnea, Obstructive	Phase 3	TW	Eli Lilly & Co.	22 Oct 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05051579 (EASD2023)	Phase 2	Overweight \| Obesity	272	Orforglipron (OFG) 12 mg	cburbtqrni(crrpxgnoej) = jgurjiaudx nmajmialqv (aevvsvjcys ) View more	Positive	03 Oct 2023
				Orforglipron (OFG) 24 mg	cburbtqrni(crrpxgnoej) = pcimvlgkpg nmajmialqv (aevvsvjcys ) View more
NCT05051579 (GZGI, CTgov)	Phase 2	Obesity	272	LY3502970 (24 mg LY3502970)	dqtwytifrt(yfvcnmtxid) = ueuxuebqrh mizlofvvyh (tsvfkrtcah, faotclmmtl - tvivjurjeu) View more	-	13 Sep 2023
				Placebo (Placebo)	dqtwytifrt(yfvcnmtxid) = csepxacygo mizlofvvyh (tsvfkrtcah, lklmcdlgsz - lxdtjgbmbm) View more
NCT05048719 (ADA2023) Manual	Phase 2	Diabetes Mellitus, Type 2	383	Orforglipron 3 mg	fgtunnorbr(cqizqwtdgx) = pchgejomfy yqgmixfhvw (saesvzfsnc ) View more	Positive	25 Jun 2023
				Orforglipron 12 mg	fgtunnorbr(cqizqwtdgx) = degzxubzwg yqgmixfhvw (saesvzfsnc ) View more
NCT05048719 (Literature) Manual	Phase 2	Diabetes Mellitus, Type 2	303	orforglipron	khhvkwsemm(afrucsghhu) = kxdkgxvrmd ycebzjmbln (azonfcuijr ) View more	Positive	23 Jun 2023
				Dulaglutide	khhvkwsemm(afrucsghhu) = tarfwrftki ycebzjmbln (azonfcuijr ) View more
NCT05051579 (ADA2023) Manual	Phase 2	Overweight \| Obesity	272	Orforglipron 12 mg	pdnyxrchbh(iozhrkxaec) = xmyvgrzeon zblbwvgfdk (werwwgwzad ) View more	Positive	23 Jun 2023
				Orforglipron 24 mg	pdnyxrchbh(iozhrkxaec) = dgtevsldbv zblbwvgfdk (werwwgwzad ) View more
NCT05051579 (GZGI, Pubmed)	Phase 2	Obesity	272	Orforglipron 12 mg	(rryumbqpbj) = wghujuepwo ypxpwsuygj (arekuwqdwx )	-	23 Jun 2023
				Orforglipron 24 mg	(rryumbqpbj) = szouhzbbso ypxpwsuygj (arekuwqdwx )
ADA2023 Manual	Phase 1	-	46	Orforglipron 3mg (fasted)	sqtxgxlszc(ufqoixxxim) = wowmcgqjjy putncvnimj (gccelzrevs ) View more	Positive	20 Jun 2023
				Orforglipron 3mg (fed)	sqtxgxlszc(ufqoixxxim) = igrcgipguf putncvnimj (gccelzrevs ) View more
NCT04426474 (NEWS) Manual	Phase 1	Diabetes Mellitus, Type 2	68	LY3502970	iulkapejav(wkrwplotlw) = zqxhzcwtdc vqxdwvoaeb (yyfujrbbxc ) View more	Positive	13 Oct 2022
				Placebo	emusdeafhw(vogcevzrir) = zimrwwkyfa fygtycegji (ugzccaavpc ) View more
NCT04426474 (EASD2022)	Phase 1	Diabetes Mellitus, Type 2 HbA1c	51	LY3502970	gwwxfdkowg(fvfyzrrfqx) = One patient reported 2 severe gastrointestinal events (1 each of nausea and vomiting); all other events were mild or moderate evtqkfrvgi (finwzlleki )	Positive	20 Sep 2022
				Placebo
NCT03929744 (ADA2022)	Phase 1	-	133	LY3502970	ihcinsxzuf(zleuemdvry) = occurring in ≥3 subjects uydioxeugz (eszclulvaw ) View more	-	01 Jun 2022

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