VEGF-C inhibitors(Vascular endothelial growth factor C inhibitors), VEGF-D inhibitors(Vascular endothelial growth factor D inhibitors), VEGFR3 modulators(Vascular endothelial growth factor receptor 3 modulators)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Polypoidal choroidal vasculopathy

Inactive Indication

Diabetic macular oedemaNeovascularization, PathologicWet age-related macular degeneration+ [1]

Originator Organization

Orphan Europe SARL

Active Organization

Opthea Ltd.

Inactive Organization-

License Organization

Opthea Ltd.

Launch Therapeutics, Inc.

Drug Highest PhasePhase 2

First Approval Date-

RegulationFast Track (United States)

Structure/Sequence

Sequence Code 9733459

Source: *****

Clinical Trials associated with Sozinibercept

CTRI/2021/10/037451

/ RecruitingPhase 3

A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Ranibizumab, Compared with Ranibizumab Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD) - ShORe

Start Date30 Oct 2021

Sponsor / Collaborator

Opthea Ltd.

[+1]

NCT04757610

/ TerminatedPhase 3

A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With nAMD

A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

Start Date12 Mar 2021

Sponsor / Collaborator

Opthea Ltd.

NCT04757636

/ TerminatedPhase 3

A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Aflibercept, Compared With Aflibercept Alone, in Participants With nAMD

A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

Start Date12 Mar 2021

Sponsor / Collaborator

Opthea Ltd.

100 Clinical Results associated with Sozinibercept

100 Translational Medicine associated with Sozinibercept

100 Patents (Medical) associated with Sozinibercept

Literatures (Medical) associated with Sozinibercept

01 May 2025·Ophthalmic Surgery Lasers & Imaging Retina

Sozinibercept Combination Therapy for Neovascular Age-related Macular Degeneration: Phase 2b Study Subgroup Analysis by Lesion Type

Article

Author: Wykoff, Charles C. ; Slakter, Jason ; Jackson, Timothy L. ; Price, Clare F. ; Leitch, Ian M. ; Baldwin, Megan E.

Background and Objective:

The purpose of this study was to evaluate the angiographic predictors of response to the anti-vascular endothelial growth factor-C/-D agent, sozinibercept.

Patients and Methods:

Prespecified and post hoc subgroup analyses of a phase 2b, randomized, double-masked, sham-controlled trial of 240 participants with treatment-naïve neovascular age-related macular degeneration, comparing monthly intravitreal sozinibercept 0.5 mg or 2 mg, plus ranibizumab 0.5 mg, versus monthly ranibizumab monotherapy.

Results:

Visual acuity benefits at week 24 were greatest in participants with occult lesions receiving 2 mg sozinibercept combination therapy (+15.65 [ n = 53] letters versus +9.62 [ n = 51] with ranibizumab monotherapy; least squares mean difference +6.03; P = 0.0009). A composite analysis of occult and minimally classic lesions excluding retinal angiomatous proliferation ( n = 175/240) also favored sozinibercept over control (+16.08 versus +10.34 letters; +5.74; P = 0.0002). Structural outcomes mirrored sozinibercept visual acuity benefits, with less leakage and smaller lesions on multimodal imaging.

Conclusion:

Angiographic lesion characteristics were found to predict the response to sozinibercept combination therapy. [ Ophthalmic Surg Lasers Imaging Retina 2025;56:287–296.]

01 Jan 2025·EYE

Exploring new horizons in neovascular age-related macular degeneration: novel mechanisms of action and future therapeutic avenues

Review

Author: Shirian, Jonathan D ; Shirian, Jonathan D. ; Shukla, Priya ; Singh, Rishi P. ; Singh, Rishi P

Abstract:

Neovascular age-related macular degeneration (nAMD) can lead to significant vision impairment through the growth of abnormal neovascular membranes in the choroid. Despite advancements with current anti-vascular endothelial growth factor (VEGF) therapies, challenges such as frequent injections, inadequate response, and patient-related concerns persist. Emerging therapeutics aim to reduce vision-loss through a variety of mechanisms. Gene therapies, including RGX-314 and Ixo-vec, express an anti-VEGF protein, and 4D-150, expresses an anti-VEGF protein and a VEGF-C inhibitory miRNA. Anti-VEGF associated therapeutics include OPT-302, targeting VEGF-C and VEGF-D, BI 836880, which inhibits VEGF-A and Ang-2 activity, and Tarcocimab tedromer, inhibiting all VEGF-A isoforms. Agents with novel mechanisms of action include UBX1325, which inhibits an anti-apoptotic protein, Restoret (EYE103), a Wnt agonist, and the tyrosine kinase inhibitors, EYP-1901, OTX-TKI, CLS-AX, and KHK4951.

19 Dec 2024·Translational Vision Science & Technology

Phase 1b Dose Escalation Study of Sozinibercept Inhibition of Vascular Endothelial Growth Factors C and D With Aflibercept for Diabetic Macular Edema

Article

Author: Baldwin, Megan E. ; Boyer, David S. ; Gupta, Sunil ; Crawford, Courtney ; Stone, Cameron M. ; Leitch, Ian M. ; Dugel, Pravin U. ; Steinle, Nathan C. ; Pearlman, Joel A.

Purpose:

Sozinibercept inhibits vascular endothelial growth factors (VEGFs) C and D. This study evaluated outcomes following switching from anti-VEGF-A monotherapy to intravitreal injections of three dose levels of sozinibercept in combination with aflibercept in patients with diabetic macular edema (DME).

Methods:

A phase 1b, open-label, multicenter dose-escalation study with a 24-week follow-up. Patients received 3 loading doses of aflibercept (2 mg) in combination with sozinibercept (0.3, 1, or 2 mg) once every 4 weeks and were followed through week 24. The primary endpoint was safety, and secondary endpoints included mean change from baseline in best-corrected visual acuity (BCVA) and anatomic changes on imaging.

Results:

Nine patients received sozinibercept in combination with aflibercept after a mean (SD) of 6.3 (2.4) injections of previous anti-VEGF-A. Sozinibercept combination therapy was well tolerated with no dose-limiting toxicities. Mean change in BCVA at week 12 was +7.7 letters (95% confidence interval [CI], 2-13.3) from baseline (65 letters [SD 5.5]) with a dose response for increasing doses of sozinibercept. At week 12, central subfield thickness (CST) was decreased by -71 µm (95% CI, -117 to -26) from baseline (434 µm [SD 58]), and 6 of 9 (67%) patients had a ≥50% reduction in excess foveal thickness.

Conclusions:

In prior-treated patients with center-involved DME, switching to sozinibercept in combination with aflibercept was well tolerated with improved visual and anatomic outcomes.

Translational Relevance:

This first-in-human study builds upon basic research by providing safety and preliminary efficacy of sozinibercept (anti-VEGF-C/-D) in combination with aflibercept for DME.

News (Medical) associated with Sozinibercept

31 Mar 2025

·ir.opthea.com

Opthea Announces Decision to Discontinue Wet AMD Trials

ShORe Phase 3 topline results accelerated; trial did not meet primary endpoint of mean change in BCVA from baseline to week 52 Opthea and DFA Investors agreed to terminate both COAST and ShORe trials Opthea continues to consider impact of negative trial results under its Development Funding Agreement (DFA) and on the Company as a going concern MELBOURNE, Australia and PRINCETON, N.J. , March 31, 2025 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT, “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced updates on its Phase 3 clinical program, including the termination of COAST (Combination of OPT-302 with Aflibercept Study) and accelerated topline results from its second Phase 3 trial ShORe (Study of OPT-302 in combination with Ranibizumab) in patients with wet AMD. ShORe Topline Results Following the negative results of the COAST Phase 3 trial announced on 24 March 2025 , Opthea determined that the most appropriate course of action for wet AMD patients, shareholders, and other stakeholders was to accelerate the ShORe trial topline data readout, including in consultation with its Development Funding Agreement investors (“ DFA Investors ”). The global ShORe Phase 3 trial evaluated the efficacy and safety of intravitreally administered 2 mg sozinibercept every four or eight weeks in combination with 0.5 mg ranibizumab every four weeks, as per label, versus 0.5 mg ranibizumab monotherapy. The trial did not meet its primary endpoint of mean change in best corrected visual acuity (BCVA) from baseline to week 52. In wet AMD patients with minimally classic and occult lesions, participants receiving sozinibercept combination therapy with a dosing regimen of every four weeks (n=301) or every eight weeks (n=301) achieved a mean change in BCVA of 13.3 or 12.9 letters from baseline to week 52, respectively, versus 14.2 letters with ranibizumab monotherapy (n=299, p-values of 0.35 and 0.19 respectively). In the overall population, participants receiving sozinibercept combination therapy with a dosing regimen of every four weeks (n=328) or every eight weeks (n=326) achieved a mean change in BCVA of 13.3 and 12.6 letters from baseline to week 52, respectively, versus 14.3 letters with ranibizumab monotherapy (n=331 p-values of 0.32 and 0.09 respectively). Sozinibercept combination therapy was well tolerated. “We are disappointed that COAST and ShORe did not demonstrate the improvements in vision with sozinibercept combination therapy compared to standard of care that we had hoped for,” said Frederic Guerard , PharmD, Chief Executive Officer of Opthea . “We are grateful to all patients, clinical investigators and their staff around the world who participated in the sozinibercept Phase 3 clinical program, and for their contributions in investigating new treatments for wet AMD.” “As previously disclosed, the Company has certain obligations under the DFA. In light of the Phase 3 clinical trial results, the Company and the DFA Investors will continue to discuss this matter in good faith, and we will provide updates on this matter in the future,” Dr. Guerard concluded. Corporate Updates Following the negative results of the COAST and ShORe trials, Opthea and the DFA Investors agreed to discontinue the development of sozinibercept in wet AMD with immediate effect, and that this decision did not constitute a termination event under the DFA resulting in any amount payable by Opthea . It remains possible that under the DFA, in certain circumstances upon or following termination of the DFA, Opthea could become required to pay a multiple of the amount funded by the DFA Investors that would have a material adverse impact on the solvency of the Company. As previously disclosed, termination can be triggered by a range of events, including, among other things, Opthea’s insolvency, in which case Opthea will be obligated to pay a multiple of the amounts funded by the DFA Investors . Opthea continues active discussions with the DFA Investors , pursuant to and as required under the DFA, to explore possible options to deliver the best outcome for the Company and its shareholders. A copy of the DFA is included as Exhibit 4.19 to Opthea’s Annual Report on Form 20-F filed with the US Securities and Exchange Commission on August 30, 2024 . Opthea estimates it will have unaudited cash and cash equivalents of US$100M at the end of March 2025 . In light of these matters, there remains material uncertainty as to Opthea's ability to continue as a going concern.1 As noted above, discussions with the DFA Investors are ongoing and Opthea cannot be certain as to the outcome of those discussions or when that outcome may become known. Opthea is currently relying on the "safe harbour" provisions in section 588GA of the Corporations Act 2001 (Cth). Trading in Opthea’s listed securities will be suspended by ASX under ASX Listing Rule 17.3 until Opthea is in a position to provide an announcement to the market providing more clarity on these issues and the impact on Opthea’s financial position. Authorized for release to ASX by The Board of Directors. Forward-Looking Statements This ASX announcement contains certain forward-looking statements, including within the meaning of the US Private Securities Litigation Reform Act of 1995. The words “expect”, “believe”, “should”, “could”, “may”, “will”, “plan” and other similar expressions are intended to identify forward-looking statements. Forward-looking statements in this ASX announcement include statements regarding possible outcomes in connection with the DFA and Opthea’s ability to continue as a going concern. Forward-looking statements, opinions and estimates provided in this ASX announcement are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current conditions. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. They involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Opthea and its directors and management and may involve significant elements of subjective judgment and assumptions as to future events that may or may not be correct. These statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to future capital requirements, the development, testing, production, marketing and sale of drug treatments, regulatory risk and potential loss of regulatory approvals, clinical research organization and labor costs, intellectual property protections, and other factors that are of a general nature which may affect the future operating and financial performance of the Company including risk factors set forth in Opthea’s Annual Report on Form 20-F filed with the US Securities and Exchange Commission (the “SEC”) on August 30, 2024 , and other future filings with the SEC . Actual results, performance or achievements may vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. Subject to any continuing obligations under applicable law or any relevant ASX listing rules, Opthea disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this ASX announcement to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based, except as otherwise required by applicable law. Investor Inquiries PJ Kelleher LifeSci Advisors , LLC Email: pkelleher@lifesciadvisors.comPhone: 617-430-7579 Join our email database to receive program updates: Email: info@opthea.com Web: www.opthea.com Source: Opthea Limited [1] Investors should refer also to the 'going concern' statements contained in Note 2 to Opthea's Condensed Consolidated Financial Statements for the half year ended 31 December 2024 released on 28 February 2025 . Source: Opthea Limited

Phase 3Clinical Result

25 Mar 2025

·www.biospace.com

Opthea, UNITY Fail to Unseat Regeneron’s Eylea in Vision Disorders

iStock, White Bear Studio The Eylea franchise was in need of a win after an appellate court last week denied the pharma’s bid to block Amgen’s biosimilar from the U.S. Two investigational eye therapies, from Opthea Limited and UNITY Biotechnology, were unable to unseat Regeneron ’s blockbuster anti-VEGF therapy Eylea on Monday as the standard of care in two different ophthalmic indications. The news comes as Regeneron last week lost its court appeal to prevent Amgen’s biosimilar Pavblu from entering the U.S. market. In a March 15 note to investors, BMO Capital Markets analysts said the failed appeal “reads as a modest negative to Regeneron” and compounds the existing risk to its Eylea franchise. Presenting topline data from the Phase III COAST study, Australian biotech Opthea revealed that its investigational VEGF blocker sozinibercept failed to significantly outperform Eylea at improving vision in patients with wet age-related macular degeneration (AMD). At 52 weeks, best-corrected visual acuity (BCVA) in those treated with sozinibercept improved by 12.8 letters on average from baseline, while mean improvement in Eylea counterparts was 13.7 letters. Like Eylea, sozinibercept is designed to be injected into the eye and also works by binding VEGF, a protein involved in the formation of new blood vessels. Uniquely, however, sozinibercept targets the VEGF-C and VEGF-D subtypes (Eylea binds to VEGF-A and placental growth factor), which according to Opthea is highly expressed in patients receiving the standard VEGF-A therapies, in turn leading to leaky blood vessels that could ultimately also harm vision. Sozinibercept is Opthea’s only clinical candidate , and wet AMD is its most advanced indication. Monday’s Phase III stumble thus presents a financial problem for the biotech, which in its news release revealed that it “has been assessing its rights and obligations” to investors. Opthea could be on the hook for certain payments that “would have a material adverse impact on the solvency of the company,” it wrote. The biotech is in “active discussions” with its investors, trying to determine “whether there is a pathway that represents the best outcome for the company and its shareholders,” according to Monday’s release. Opthea has yet to reach a decision but is mulling over terminating the COAST trial or unmasking a separate wet AMD trial. Also on Monday, California-based UNITY Biotechnology announced that its investigational eye injection UBX1325 likewise fell to Eylea in patients with diabetic macular edema. Topline data from the Phase IIb ASPIRE study showed that UBX1325 improved visual acuity by more than five letters at 24 and 36 weeks versus baseline. These gains, according to UNITY, were “non-inferior” to Eylea at almost all time points through 36 weeks except at the average of weeks 20 and 24. At this time point, UBX1325 showed non-inferiority at an 88% confidence interval—just shy of the 90% prespecified threshold for the study’s primary endpoint. Despite missing its target, UNITY CEO Anirvan Ghosh sang an optimistic tune in a statement on Monday, noting that UBX1325 “showed robust vision improvements in a difficult to treat patient population.” The biotech will continue to advance the candidate into late-stage studies.

Clinical ResultPhase 3Phase 2

24 Mar 2025

·endpts.com

Two biotechs fail to beat or match Regeneron's Eylea in key trials

Opthea and Unity Biotechnology, which are both developing new drugs for eye diseases, were unable to beat or match aflibercept, the standard-of-care treatment that Regeneron markets as Eylea, in two different conditions. Opthea said Monday that its VEGF drug sozinibercept in combination with Eylea failed a Phase 3 study in wet age-related macular degeneration, an eye disease that causes blurry central vision. The Phase 3 COAST study enrolled nearly 1,000 patients who received either a four-week or eight-week regimen of sozinibercept on top of Eylea or Eylea alone. At one year, the average change measured on a vision chart was 13.5 and 12.8 letters with each sozinibercept combination, respectively, compared to 13.7 for those on Eylea alone. That equates to p-values of 0.86 and 0.42, respectively — meaning the combination treatments did not significantly improve vision compared to just Eylea. Sozinibercept is Opthea’s only pipeline candidate, and the failed study puts the biotech in financial precarity. Opthea has asked Nasdaq and the Australian Securities Exchange to temporarily pause trading of its stock. The biotech also said Monday it could have to pay certain investors up to $680 million if those investors terminate a financing contract with the company. It would be a bill much larger than the $113.8 million in cash the biotech had as of the end of February. Opthea said it is currently discussing options with investors and is also considering whether to “discontinue activities for the COAST trial” or unmask a second Phase 3 study in wet AMD ahead of schedule. Regeneron’s Eylea franchise brought in $5.9 billion in revenue last year. The drug is approved for a range of conditions including wet AMD and diabetic macular edema. The first biosimilar for Eylea entered the market last year. Meanwhile, Unity’s experimental drug just missed the primary endpoint in a Phase 2b study for diabetic macular edema, a complication of diabetes that causes fluid to build up in a part of the eye and leads to vision problems. The biotech’s goal was to match Eylea with UBX1325, its BCL-xL inhibitor, in patients who had poor vision despite treatment with a VEGF inhibitor like Eylea. The Phase 2b study enrolled 52 people who received either UBX1325 or Eylea. In order to succeed, the study had to show with over 90% confidence that UBX1325 did not lead to less vision improvements compared to Eylea at the average of 20 weeks and 24 weeks. However, it only reached the 88% confidence interval, according to Unity. It appears that Unity still plans to move forward with its drug in diabetic macular edema. “We look forward to advancing UBX1325 to late-stage studies against aflibercept in DME patients with inadequate response to anti-VEGF therapies,” Unity CEO Anirvan Ghosh said in a statement. Unity’s shares were down 33% Monday morning.

Phase 3Phase 2Clinical ResultDrug Approval

100 Deals associated with Sozinibercept

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Wet age-related macular degeneration	Phase 3	United States	Opthea Ltd.	12 Mar 2021
Wet age-related macular degeneration	Phase 3	Argentina	Opthea Ltd.	12 Mar 2021
Wet age-related macular degeneration	Phase 3	Australia	Opthea Ltd.	12 Mar 2021
Wet age-related macular degeneration	Phase 3	Austria	Opthea Ltd.	12 Mar 2021
Wet age-related macular degeneration	Phase 3	Brazil	Opthea Ltd.	12 Mar 2021
Wet age-related macular degeneration	Phase 3	Bulgaria	Opthea Ltd.	12 Mar 2021
Wet age-related macular degeneration	Phase 3	Canada	Opthea Ltd.	12 Mar 2021
Wet age-related macular degeneration	Phase 3	Colombia	Opthea Ltd.	12 Mar 2021
Wet age-related macular degeneration	Phase 3	Croatia	Opthea Ltd.	12 Mar 2021
Wet age-related macular degeneration	Phase 3	Czechia	Opthea Ltd.	12 Mar 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04757636 (COAST, Company_Website) Manual	Phase 3	Wet age-related macular degeneration	-	Sozinibercept 2 mg every four weeks + aflibercept	dysiscixtk(xwsripvsyw) = femhxdjvli aldxzxzhvm (pvvdugobus ) Not Met	Negative	24 Mar 2025
				Sozinibercept 2 mg every eight weeks + aflibercept	dysiscixtk(xwsripvsyw) = trcnrzwgqr aldxzxzhvm (pvvdugobus ) Not Met
NCT03345082 (Literature) Manual	Phase 2	Wet age-related macular degeneration First line	240	sozinibercept 2 mg,+ranibizumab 0.5 mg	eizwbwvtmt(nywzgitcuz) = sznxmmmyvh amjqhgkjdk (owmtuqfcxl )	Positive	01 Feb 2025
				ranibizumab 0.5 mg	eizwbwvtmt(nywzgitcuz) = lcypzccddp amjqhgkjdk (owmtuqfcxl )
NCT03345082 (EURETINA2024) Manual	Phase 2	Polypoidal choroidal vasculopathy	66	Ranibizumab 0.5 mg	nxynmcdjoo(qjvsntogpz) = tqckjjmypw lzzgbrggjb (dhlueyncba ) View more	Positive	19 Sep 2024
				Sozinibercept 0.5 mgRanibizumab	nxynmcdjoo(qjvsntogpz) = mcjyaoxwsn lzzgbrggjb (dhlueyncba )
NCT03397264 (CTgov)	Phase 1/2	Diabetic macular oedema	153	OPT-302+Aflibercept (Ph 1b: 2.0 mg Aflibercept With 0.3 mg OPT-302)	qhyqvtgjvc = swuxdfnnoh kwjdclhhcx (xajsdcuhgl, swyggboqcu - ncjmbpgatn) View more	-	22 Jun 2022
				OPT-302+Aflibercept (Ph 1b: 2.0 mg Aflibercept With 1.0 mg OPT-302)	qhyqvtgjvc = tpligcxece kwjdclhhcx (xajsdcuhgl, gbxgbquulb - fwlsostfzy) View more
NCT03397264 (GlobeNewswire) Manual	Phase 2	Diabetic macular oedema	115	Aflibercept+OPT-302	ewgzvgvynb(fmnesliylp) = gfydlgyuuy yhkizrtmws (wxjjlprtgc ) View more	Positive	09 Jun 2020
				Aflibercept+Sham Procedure	ewgzvgvynb(fmnesliylp) = fuhgvkvocj yhkizrtmws (wxjjlprtgc ) View more
NCT02543229 (Pubmed) Manual	Phase 1	Wet age-related macular degeneration	51	OPT-302	mqsibqwkci(zojzhsdouv) = shavzfergw rrfraolnxg (iwabgveubn )	Positive	01 Mar 2020
				ranibizumab+OPT-302	mqsibqwkci(uhognhamzb) = smzmnxxutn wxwmhqzqeh (kgermyjetr, 3 - 7) View more

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