AVPR1A agonists(Vasopressin V1a receptor agonists), AVPR1B agonists(Vasopressin V1b receptor agonists), AVPR2 agonists(Vasopressin V2 receptor agonists)

Therapeutic Areas

Digestive System DisordersUrogenital DiseasesOther Diseases

Active Indication

Bleeding esophageal varicesHepatorenal SyndromeHemorrhage+ [1]

Inactive Indication

AscitesDecompensated cirrhosis of liverFibrosis+ [1]

Originator Organization

Mallinckrodt Pharmaceuticals Ireland Ltd.

Active Organization

BioVie, Inc.Ferring Pharmaceuticals Pty Ltd.Ferring GmbH

+ [1]

Inactive Organization

Ferring Pharmaceuticals A/S

Keenova Therapeutics Plc

License Organization

Ferring Holding SA

Zhejiang Medical Technology Development Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

Australia (14 May 2012),

Bleeding esophageal varicesHepatorenal Syndrome

RegulationOrphan Drug (United States), Fast Track (United States)

Structure/Sequence

Molecular FormulaC54H78N16O17S2

InChIKeyBYDVFOPTAIPAGA-LCGYVTRFSA-N

CAS Registry914453-96-6

Sequence Code 440876

Source: *****

131

Clinical Trials associated with Terlipressin Acetate

NCT07304466

/ Not yet recruitingNot ApplicableIIT

Comparison of the Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation

The goal of this clinical trial is to compare the effects of somatostatin and terlipressin on lowering portal pressure in patients with portal hypertension undergoing liver transplantation, and to investigate whether there are differences in clinical outcomes between the two drugs. The study will evaluate the decrease in portal pressure from baseline following drug administration at defined time points. It will also compare the effects of these drugs on hemodynamics, bleeding, and transfusion requirements. After baseline intraoperative direct portal pressure measurement, a bolus dose of the study drug will be administered, followed by continuous intravenous infusion intraoperatively and for 24 hours postoperatively. Direct portal pressure will be measured again 5 minutes after the bolus dose, after the portal vein anastomosis, after the hepatic artery anastomosis, and, if performed after splenic artery ligation. Hemodynamic parameters will be recorded, and the drugs will be compared in terms of their intraoperative hemodynamic effects. As elevated portal pressure is associated with increased bleeding, intraoperative blood loss and transfusion needs will also be assessed between the groups. Patients will be followed for 7 days postoperatively for clinical and laboratory outcomes.

Start Date29 Dec 2025

Sponsor / Collaborator

Istanbul Medipol University

NCT07252401

/ Not yet recruitingNot ApplicableIIT

Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Gastrointestinal Bleeding and Acute Kidney Injury: A Multicenter Randomized Controlled Trial

Acute gastrointestinal bleeding (AGIB) is a common complication in the decompensated stage of liver cirrhosis, of which approximately 70% is acute variceal bleeding (AVB) caused by portal hypertension. Existing evidence suggests that both terlipressin and somatostatin can be used to control AVB in cirrhotic patients, but terlipressin may be the first-line treatment for cirrhotic patients with AGIB complicated by acute kidney injury (AKI). Herein, a multicenter randomized controlled trial (RCT) has been designed to compare the efficacy of terlipressin and somatostatin in the treatment of cirrhotic patients with AGIB complicated by AKI.

Start Date25 Dec 2025

Sponsor / Collaborator

The General Hospital of Shenyang Military Region

CTRI/2025/08/092559

/ RecruitingNot Applicable

Effect of low-dose Terlipressin with Albumin on Major Adverse Kidney Events in patients with Septic Shock: A Randomised Controlled Trial - NIL

Start Date18 Aug 2025

Sponsor / Collaborator-

100 Clinical Results associated with Terlipressin Acetate

100 Translational Medicine associated with Terlipressin Acetate

100 Patents (Medical) associated with Terlipressin Acetate

1,205

Literatures (Medical) associated with Terlipressin Acetate

01 Apr 2026·AMERICAN JOURNAL OF EMERGENCY MEDICINE

Early inotropic support in pediatric shock: evidence and challenges in prehospital setting and interfacility transport

Review

Author: Beretta, Virginia ; Cannavò, Laura ; Capitanio, Leonardo ; Perrone, Serafina ; Raitano, Vincenzo

BACKGROUND & AIM:

Pediatric shock requires rapid recognition and timely intervention. In the prehospital and interfacility transport setting, the challenge is further compounded by limited vascular access, limited monitoring capabilities, and the need for rapid decision-making in dynamic, resource-constrained environments. The aim of this review is to summarize the available literature on the use of vasoactive agents in pediatric shock, provide guidance for evidence-based decision-making, and identify key gaps for future research.

METHODS:

A literature search was conducted using electronic databases, including PubMed and Medline. Only articles published in peer-reviewed journals, written in English, and focusing on the use of vasoactive drugs in the pediatric population were selected, bringing the total number of articles selected to 63, of which 21 were original studies (randomized or observational). Two independent reviewers extracted the data, which were then organized thematically in a narrative synthesis given study heterogeneity.

RESULTS:

This review provides a comprehensive summary of the current evidence regarding vasoactive support in pediatric shock in the prehospital and transport setting. Although fluid administration is the first therapeutic step, there is a growing trend towards early initiation of inotropic/vasoactive agents. Overall, epinephrine and norepinephrine remain the agents of choice for fluid-refractory pediatric shock. Inodilators may offer potential benefit in selected patients with myocardial dysfunction. Evidence regarding adjunctive therapies, such as vasopressin, terlipressin, and catecholamine-sparing agents, remains limited. Available evidence supports the feasibility and safety of timely vasoactive support via peripheral and intraosseous routes with dilute preparations of vasoactive agents.

CONCLUSIONS:

In the context of prehospital and transport settings, central venous catheterization is no longer a prerequisite, and early initiation of inotropic/vasoactive therapy, which is increasingly suggested by literature in different clinical scenarios, may improve outcomes in critically ill children.

01 Mar 2026·CRITICAL CARE MEDICINE

Vasoactive Medications and the Microcirculation in Septic Shock: A Scoping Review

Article

Author: Sachar, Saloni ; Nero, Neil ; Siuba, Matthew T. ; Tonelli, Adriano R. ; Berro, Jana ; Bauer, Seth R. ; Hamzaoui, Olfa ; Sathianathan, Shyama

Objectives::

To summarize knowledge and identify gaps in evidence regarding the effects of vasoactive medications on microvascular perfusion in septic shock.

Data Sources::

We conducted a comprehensive search of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials.

Study Selection::

Studies included adult patients with septic shock who received vasoactive therapy with corresponding microcirculatory measurements between 1946 and May 7, 2025.

Data Extraction::

Data extraction was performed in Covidence by two independent reviewers. Data items included study design, patient population, vasoactive medication, macrohemodynamics, and microcirculation measurements and techniques.

Data Synthesis::

Thirty-three studies were included evaluating several vasoactive medications and microvascular measurement techniques. Despite heterogeneous study design, studies that recruited patients within 24 hours tended to report more significant microcirculatory changes. Microcirculatory changes and cardiac index only aligned in 39% of cases, highlighting a disconnect between global hemodynamics and microvascular perfusion. Several vasoactives, including norepinephrine, vasopressin, terlipressin, and levosimendan demonstrated context-dependent improvements in peripheral/sublingual microcirculation. Despite limitations in directly monitoring gastric microcirculation, dobutamine may enhance perfusion; however, further studies are needed to support dobutamine and other vasoactive agents’ impacts on clinical outcomes.

Conclusions::

Despite growing interest in perfusion-guided care, significant challenges remain in understanding how vasoactive agents affect the microcirculation. Clarifying these effects through standardized research and point-of-care perfusion monitoring remains a challenge in advancing outcome-driven resuscitation strategies.

20 Feb 2026·MEDICINE

Development and validation of a bedside nomogram for predicting 30-day mortality in patients with type 1 hepatorenal syndrome: A retrospective cohort study

Article

Author: Shen, Yining ; Hu, Yanqing ; Zhong, Yandan ; Fan, Fan ; Jiang, Chunling

Type 1 hepatorenal syndrome (T1HRS) is the most rapidly progressive form of functional renal failure in decompensated cirrhosis, with 30-day mortality exceeding 50%. We aimed to develop and internally validate a bedside nomogram to predict 30-day death in intensive care unit (ICU) patients with T1HRS. Using the Medical Information Mart for Intensive Care IV database, adults who met diagnostic criteria for T1HRS within 48 hours of ICU admission (2008–2019) were randomly split 7:3 into development (n = 340) and internal validation (n = 146) sets. Predictors collected within 24 hours of diagnosis were selected using least absolute shrinkage and selection operator-Cox; a multivariable Cox model was constructed and internally validated. Performance was assessed by area under the curve, calibration slope, and decision-curve analysis. Overall 30-day mortality was 47.1% (229/486). Seven variables were retained: model for end-stage liver disease-sodium, total bilirubin, international normalized ratio, serum creatinine, mean arterial pressure, urine Na + , and terlipressin use. The model achieved the area under the curves of 0.82 (development) and 0.81 (validation) at 30 days, with a calibration slope of 0.99. The findings were robust to competing-risk, terlipressin exclusion, and Child–Pugh substitution. A 7-variable nomogram provides accurate, well-calibrated, and clinically actionable prediction of 30-day mortality in ICU patients with T1HRS, ready for prospective evaluation and trial stratification.

163

News (Medical) associated with Terlipressin Acetate

17 Mar 2026

·endpoints.news

Pfizer's next-gen breast cancer data; Bristol Myers' PRMT5 candidate

Plus, news about Genentech, Mestag and BioVie: 📊 Pfizer says next-gen breast cancer drug succeeds in Phase 2: The company is developing a CDK4 inhibitor called atirmociclib as a successor to its breast cancer drug Ibrance, a CDK4/6 inhibitor. It said that atirmociclib plus the hormone therapy fulvestrant cut the risk of disease progression or death by 40% versus standard treatment options as part of a 264-patient trial. The study included patients with advanced HR-positive, HER2-negative breast cancer whose disease progressed after treatment with a CDK4/6 inhibitor. Pfizer did not share the median progression-free survival numbers from the Phase 2 study, noting detailed results will be reported at a future medical meeting. It did say that overall survival was not mature. Pfizer said that more than 90% of patients started on atirmociclib within three months of their last CDK4/6 inhibitor treatment. It is running a Phase 3 trial for atirmociclib as a first-line treatment for advanced HR-positive, HER2-negative breast cancer. That study is expected to bear results in 2029. — Lei Lei Wu 📊 Bristol Myers shares pancreatic cancer combo data on PRMT5 drug: Five of 11 pancreatic cancer patients saw their tumors shrink substantially following treatment with the experimental drug known as navlimetostat (previously BMS-986504) alongside chemotherapy, equating to an overall response rate of 46%. The median follow-up time was 6.6 months in the data cut shared at the ESMO Targeted Anticancer Therapies conference. Now, BMS is studying the regimen in a Phase 2/3 study for patients with previously untreated metastatic pancreatic cancer that bears a mutation called an MTAP deletion. The study is expected to be completed in 2029. — Lei Lei Wu 🛑 Genentech terminates Phase 2 trial in heart surgery-associated kidney injury: In an update to the trial’s webpage on the federal clinical trials database, the Roche-owned company said the Phase 2 is “unlikely to demonstrate a statistically significant clinical benefit.” Researchers were testing GDC-8264 in heart surgery patients who were susceptible to acute kidney injury within three months of the procedure. — Max Gelman 💰 Mestag closes $40M fundraise, announces C-suite additions: The cash will be used to fund Mestag’s first clinical trial, a Phase 1 study in cancer for MST-0312. Johnson & Johnson’s corporate venture arm participated in the round. The biotech also named Lindsey Rolfe as chief medical officer and Pascal Merchiers as its new chief development officer. — Max Gelman 💰 BioVie seeks up to $19.7M IPO for spinout: Option Therapeutics will move forward a reformulation of Mallinckrodt’s drug Terlivaz, approved in a kidney disorder, for a separate liver condition. The new company expects to receive $17 million in IPO funds but could net up to $19.7 million if all options are exercised, according to an SEC filing . — Max Gelman

Phase 2Phase 1IPOClinical ResultExecutive Change

17 Mar 2026

·www.fiercebiotech.com

BioVie plans $20M IPO for spinout tasked with developing liver disease drug

BioVie disclosed in 2024 that it was halting work on BIV201.\n BioVie is eyeing a $19.7 million IPO for a spinout focused on bringing a new formulation of an approved kidney failure drug to market as a potential treatment for liver disease.The plan is to offer 1.8 million shares of the spinout, called Option Therapeutics, priced between $10 and $12 apiece, according to a March 13 Securities and Exchange Commission (SEC) filing. Should the final price come in at the middle of this range, BioVie expects Option to rake in $17 million in net proceeds for the IPO—rising to $19.7 million if underwriters fully take up their option to buy an additional 272,727 shares at the same price.After the IPO—for which a date has yet to be set—BioVie will still own at least 60% of Option, meaning the company has the final say in electing Option’s directors.Option will be focused on taking forward an investigational infusion treatment called BIV201. The vasopressin V1 receptor agonist is made of terlipressin acetate, an injectable form of which is marketed by Mallinckrodt Pharmaceuticals under the name Terlivaz to improve kidney function for adults with hepatorenal syndrome. BioVie had previously been evaluating BIV201 for ascites, a common complication of liver cirrhosis. There are currently no approved treatments specifically for the condition.With about 190,000 patients hospitalized each year in the U.S. with cirrhosis and ascites, BioVie has estimated that the potential market for BIV201 could top $2.3 billion. But, despite having labeled BIV201 its “most de-risked program,” BioVie disclosed in 2024 that it was halting work on the asset, explaining that “unfortunately [it] is a program that will take two years to complete.”At the time, BioVie CEO Cuong Do said the biotech “look[ed] forward to partnering this program with a company interested in developing the first potential treatment for ascites and related complications potentially at an earlier stage of cirrhosis.” Now, it’s been decided that the vehicle to take BIV201 forward will be Option. In Friday’s SEC filing, BioVie reaffirmed that it had already received clearance from the FDA to begin a phase 3 study in adults with decompensated liver cirrhosis and ascites who have recently recovered from, or are recovering from, acute kidney injury. The only thing delaying Option is sourcing the necessary funds.After a lull of biotech IPOs in 2025, Option could soon be joining a growing list of drug developers voicing an interest in the public markets. CEOs of companies that already made the leap this year told Fierce they had detected a positive change in sentiment toward biotech IPOs in recent months.

IPOPhase 3

12 Mar 2026

·www.biospace.com

BioVie Announces Abstract Accepted for Presentation at AD/PD 2026

CARSON CITY, Nev., March 12, 2026 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for neurological and neurodegenerative diseases, today announced the acceptance of an abstract from its SUNRISE-PD study on lead candidate bezisterim (NE3107) in the treatment of patients with Parkinson’s Disease at the upcoming AD/PD 2026 Advances in Science & Therapy annual meeting, to be held March 17-21, 2026 in Copenhagen, Denmark. The abstract, titled Demographics and Baseline Characteristics of Participants in a Study of Bezisterim (NE3107) in Early Parkinson’s Disease (SUNRISE-PD) (J. Palumbo 1 , C Ahlem1, C.L. Reading 1 , S. O’Quinn 2 , J. Zhang 3 , M. Stacy 4 ), summarizes the initial data on patients enrolled in the SUNRISE-PD study, and will be presented as a poster. Topline results from the SUNRISE-PD study are expected in mid‑2026. The AD/PD™ Alzheimer’s Disease and Parkinson’s Disease Conference will present all the latest breakthroughs in treatment, translational R&D, early diagnosis, drug development, and clinical trials in Alzheimer’s, Parkinson’s, and other related neurological disorders. Affiliations: 1 BioVie, Inc, 2 Perissos, Inc., 3 Princeton Pharmatech, 4 Medical University of South Carolina About Bezisterim Bezisterim (NE3107) is an oral drug that crosses the blood-brain barrier and works to reduce inflammation and improve insulin sensitivity without suppressing the immune system and with a low risk of drug-drug interactions. By modulating key pathways involved in neuroinflammation (ERK, NFκB, TNF-α), bezisterim may have therapeutic potential in several disease indications, including Parkinson’s disease, Long COVID, and Alzheimer’s disease. In Parkinson’s disease, BioVie has already completed a Phase 2 study that showed patients with moderate-to severe Parkinson’s taking bezisterim with levodopa had better motor control and fewer morning symptoms compared to those taking levodopa alone. Few drug-related side effects were observed. The current SUNRISE-PD just completed enrolling 60 patients to evaluate whether bezisterim alone can help improve motor and non-motor symptoms for Parkinson’s patients who have not been treated with carbidopa/levodopa. Topline results are expected in mid‑2026. For Long COVID, the ADDRESS-LC trial is enrolling about 200 patient to evaluate if bezisterim can reduce brain fog, fatigue, and other lingering neurological symptoms associated with Long Covid, which are believed to be triggered by persistent circulation of spike protein fragments that trigger inflammation via NFκB activation (which bezisterim has been shown to modulate). Topline data is expected mid-2026. In Alzheimer’s disease, BioVie has conducted both Phase 2 and Phase 3 trials. Early results suggest improvements in cognition and biomarkers, supporting further trials to evaluate its potential as a therapy for the six million Americans living with Alzheimer’s. About BioVie Inc. BioVie Inc. (NASDAQ: BIVI) is a clinical-stage biopharmaceutical company focused on developing therapies for neurological disorders and advanced liver disease. Its lead candidate, bezisterim (NE3107), targets neuroinflammation and insulin resistance, which are believed to be key drivers of Alzheimer’s and Parkinson’s disease. Bezisterim is also being studied for long COVID, where persistent inflammation is thought to underlie symptoms such as brain fog and fatigue. In liver disease, BioVie is advancing BIV201, a continuous infusion of terlipressin treatment that has received FDA Orphan and Fast Track designations. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, and the Company plans to study BIV201 in a Phase 3 trial for the reduction of further decompensation in patients with cirrhosis and ascites. For more information, visit . For Investor Relations Inquiries: For Media Inquiries: Contact: Chuck Padala Managing Director, LifeSci Advisors, LLC chuck@lifesciadvisors.com Contact: Melyssa Weible Managing Partner, Elixir Health Public Relations mweible@elixirhealthpr.com

Phase 2Fast TrackOrphan DrugPhase 3

100 Deals associated with Terlipressin Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D08571	Terlipressin Acetate	H01BA04	DB02638

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bleeding esophageal varices	Australia	Ferring Pharmaceuticals Pty Ltd.	14 May 2012
Hepatorenal Syndrome	Australia	Ferring Pharmaceuticals Pty Ltd.	14 May 2012
Hemorrhage	China	Ferring GmbH	-

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Ascites	Phase 3	United States	BioVie, Inc.	19 Sep 2023
Decompensated cirrhosis of liver	Phase 2	United States	BioVie, Inc.	17 Jun 2021
Fibrosis	Phase 2	United States	BioVie, Inc.	15 Jul 2017
Hepatic ascites	Phase 2	United States	BioVie, Inc.	15 Jul 2017
Liver Cirrhosis	Phase 2	United States	BioVie, Inc.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01143246 \| NCT00089570 \| NCT02770716 (OT-0401, Pubmed \| Aliment Pharmacol Ther)	Phase 3	Hepatorenal Syndrome	598	Terlipressin	ajtntoqiye(rdwxdymazo) = oowzvkkrhj pfpzbohnoo (ndlenryote ) View more	Positive	01 Dec 2025
				Placebo	ajtntoqiye(rdwxdymazo) = lqspmipman pfpzbohnoo (ndlenryote ) View more
NCT01143246 \| NCT02770716 (REVERSE, PRNewswire) Manual	Phase 3	Hepatorenal Syndrome	-	TERLIVAZ	capzuzypwr(wopfmiamvv) = wdplssggab ovjflmvhno (elrmvddaut ) View more	Positive	26 Oct 2024
				Placebo	capzuzypwr(wopfmiamvv) = guwrnihukz ovjflmvhno (elrmvddaut ) View more
ASN2024	Not Applicable	Liver Diseases	110	Terlipressin	hyvbzviwzz(irpjnwpobb) = eotqnnfzys qlslzvodjk (sosgzjoxjw ) View more	Positive	26 Oct 2024
NCT04460560 (INFUSE, CTgov)	Phase 3	Myoclonic Epilepsies, Progressive \| Hepatorenal Syndrome	50	Terlipressin (Open-label Terlipressin)	xiuftkdswv = ifhiajnyng cjmwxszmlr (zdydhnosgo, owkyrbjkty - pzxbnrfewo) View more	-	09 Oct 2024
				Terlipressin (Open-Label Terlipressin)	otkejjzlaw(zxtczpixvy) = htjpbkyxqh bgjzzujyfh (pfrobksizf, nfuvqbrjry - pfzqgsysya) View more
EASL2024 Manual	Not Applicable	Hepatorenal Syndrome	-	terlipressin	udwxqguuog(bfjcaiwvap) = srdbtyndtu upriwtpndr (xmtpuwegeb ) View more	Positive	01 Jun 2024
EASL2024 Manual	Phase 3	Hepatitis, Alcoholic \| Hepatorenal Syndrome	141	Terlipressin	ujggrrbakm(cgrmtipupl) = jmhdxgtrcn hayswmwtij (gwwzvopuno ) View more	Positive	01 Jun 2024
				Placebo	ujggrrbakm(cgrmtipupl) = qtfjlaasqm hayswmwtij (gwwzvopuno ) View more
EASL2024 Manual	Phase 3	Hepatorenal Syndrome	83	Terlipressin (MAP <65 mm Hg)	tlneyfdijo(lxhzpbzgol) = wyqdbqfxkr cstzswqvqd (pivdvqrhha ) View more	Positive	01 Jun 2024
				Placebo (MAP <65 mm Hg)	tlneyfdijo(lxhzpbzgol) = yafwlmvvbn cstzswqvqd (pivdvqrhha ) View more
DDW 12024 \| DDW 22024 \| DDW 32024 \| DDW 42024	Not Applicable	-	-	Terlipressin	tzwuwsrabs(ozculedtre) = vdlljabvra vaosufjulu (cpznxkzwkh ) View more	-	18 May 2024
				Placebo	tzwuwsrabs(ozculedtre) = fnhryvmcmo vaosufjulu (cpznxkzwkh ) View more
DDW 12024 \| DDW 22024 \| DDW 32024 \| DDW 42024	Not Applicable	Acute Kidney Injury	-	Terlipressin	ckxwysdatz(rtpjspjwdt) = A dose interruption due to AEs was needed for 7% of pts in both treatment groups (terli: 14/200; pbo: 7/99) dkizjqiofv (qbpcirkaue ) View more	-	18 May 2024
				Placebo
NCT02770716 (CONFIRM, PRNewswire) Manual	Phase 3	Hepatorenal Syndrome	117	TERLIVAZ	byedlrtabm(dkfiicqynd) = jsytawfpeu pgrutombcv (zlaoavifxt ) View more	Positive	22 Jan 2024
				Placebo	byedlrtabm(dkfiicqynd) = onokjiekpo pgrutombcv (zlaoavifxt ) View more

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