A Phase Ia, Randomized, Investigator- and Subject-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single-Ascending Doses of RO7490677 in Healthy Volunteers

Start Date07 Jul 2022

Sponsor / Collaborator-

ISRCTN59409907

/ CompletedPhase 1

A phase 1 double-blind, randomized, two-arm, two-way crossover, sequential two-stage study to assess the pharmacokinetic comparability of first and second generation RO7490677 (recombinant human pentraxin-2; rhPTX-2) drug products in healthy subjects

Start Date30 Jun 2022

Sponsor / Collaborator-

NCT04594707

/ TerminatedPhase 3

A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).

Start Date30 Aug 2021

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

100 Clinical Results associated with Zinpentraxin alfa

100 Translational Medicine associated with Zinpentraxin alfa

100 Patents (Medical) associated with Zinpentraxin alfa

Literatures (Medical) associated with Zinpentraxin alfa

01 Apr 2025·Breathe

“Regression to the truth”: lessons learned from negative IPF trials

Article

Author: Petrarulo, Simone ; Trachalaki, Athina ; Margaritopoulos, George A ; Lindahl, Anna L

Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease with limited treatment options. Despite the approval of pirfenidone and nintedanib that slow disease progression, IPF remains a disease with poor survival. Promising therapeutic candidates were tested as potential treatments for IPF and while some drugs were successful in phase II clinical trials, their successful transition to positive phase III was unfortunately disappointing. This highlights the “regression to the truth” concept in drug development, whereby positive phase II trial results may simply be a statistical anomaly rather than the result of true efficacy.We examine three pivotal trials of novel IPF therapies, zinpentraxin alfa, ziritaxestat and pamrevlumab, that failed in late-stage clinical development. These failures underscore common pitfalls in IPF drug development, including inadequate phase II sample sizes, reliance on surrogate endpoints like forced vital capacity, and challenges integrating background antifibrotic therapies.Moving forward, innovative approaches like adaptive trial designs, Bayesian statistics and composite endpoints could improve trial robustness. Moreover, platform trials may accelerate drug development by testing multiple therapies simultaneously. Negative trials are not failures but opportunities for learning. By recognising and addressing these challenges, while also embracing novel trial methodologies, we can enhance drug development and improve IPF outcomes.

01 Jun 2024·Clinical pharmacology in drug development

Comparative Pharmacokinetics and Safety Assessment of 1st‐ and 2nd‐Generation Zinpentraxin Alfa Drug Products in Healthy Volunteers: A Randomized Crossover Study

Article

Author: Pan, Lin ; Arjomandi, Audrey ; Zhao, Rui ; Yadav, Rajbharan ; Meier, Monika M ; Jung, Christine ; Donaldson, Francis ; Mai, Tu H ; Hsu, Joy C ; Ding, Han-Ting ; Kamath, Nikhil

Abstract:

Zinpentraxin alfa is a recombinant form of the human pentraxin‐2 that was studied in idiopathic pulmonary fibrosis (IPF). To improve the purity and yield of the drug material, a 2nd‐generation drug product was developed. To characterize and compare the pharmacokinetic (PK) properties of the 1st‐ and 2nd‐generation zinpentraxin alfa, PK studies were conducted in healthy volunteers (HVs). In a phase 1 randomized, double‐blind, 2‐sequence crossover, sequential 2‐stage study (ISRCTN59409907), single intravenous (IV) doses of 1st‐ and 2nd‐generation zinpentraxin alfa at 10 mg/kg were studied with a blinded interim analysis (IA) at the end of stage 1. Bioequivalence (BE) was achieved for the maximum observed plasma concentration (Cmax), but the overall exposure was higher for the 2nd‐ compared to the 1st‐generation zinpentraxin alfa. The study was stopped after stage 1 as the gating criteria were met based on the result of the blinded IA. Safety profiles were similar for the 1st‐ and 2nd‐generation drug products, and antidrug antibody (ADA) was not observed in this study.

01 May 2024·American journal of respiratory and critical care medicine

Zinpentraxin Alfa for Idiopathic Pulmonary Fibrosis: The Randomized Phase III STARSCAPE Trial

Article

Author: Inoue, Yoshikazu ; Walsh, Simon L. F. ; Jayia, Parminderjit K. ; Jenkins, R. Gisli ; Nathan, Steven D. ; Behr, Jürgen ; Cottin, Vincent ; Raghu, Ganesh ; Corte, Tamera J. ; Richeldi, Luca ; Kamath, Nikhil ; Schiffman, Courtney ; Martinez, Fernando J.

Abstract:

Rationale:

A phase II trial reported clinical benefit over 28 weeks in patients with idiopathic pulmonary fibrosis (IPF) who received zinpentraxin alfa.

Objectives:

To investigate the efficacy and safety of zinpentraxin alfa in patients with IPF in a phase III trial.

Methods:

This 52-week phase III, double-blind, placebo-controlled, pivotal trial was conducted at 275 sites in 29 countries. Patients with IPF were randomized 1:1 to intravenous placebo or zinpentraxin alfa 10 mg/kg every 4 weeks. The primary endpoint was absolute change from baseline to Week 52 in FVC. Secondary endpoints included absolute change from baseline to Week 52 in percent predicted FVC and 6-minute walk distance. Safety was monitored via adverse events. Post hoc analysis of the phase II and phase III data explored changes in FVC and their impact on the efficacy results.

Measurements and Main Results:

Of 664 randomized patients, 333 were assigned to placebo and 331 to zinpentraxin alfa. Four of the 664 randomized patients were never administered study drug. The trial was terminated early after a prespecified futility analysis that demonstrated no treatment benefit of zinpentraxin alfa over placebo. In the final analysis, absolute change from baseline to Week 52 in FVC was similar between placebo and zinpentraxin alfa (−214.89 ml and −235.72 ml; P = 0.5420); there were no apparent treatment effects on secondary endpoints. Overall, 72.3% and 74.6% of patients receiving placebo and zinpentraxin alfa, respectively, experienced one or more adverse events. Post hoc analysis revealed that extreme FVC decline in two placebo-treated patients resulted in the clinical benefit of zinpentraxin alfa reported by phase II.

Conclusions:

Zinpentraxin alfa treatment did not benefit patients with IPF over placebo. Learnings from this program may help improve decision making around trials in IPF.Clinical trial registered with www.clinicaltrials.gov (NCT04552899).

News (Medical) associated with Zinpentraxin alfa

18 Mar 2026

·www.biospace.com

Vesicor Therapeutics Appoints Michael Tolentino, M.D. Chief Executive Officer

Blackhawk, Calif., March 17, 2026 – Vesicor Therapeutics, Inc., a San Gabriel, California-based early development stage biotechnology corporation focused on the development of p53-based cancer therapeutics delivered via precision-engineered microvesicles and a proposed de-SPAC acquisition target for Black Hawk Acquisition Corporation (Nasdaq: BKHA, BKHAU, BKHAR) today announced that its Board of Directors has appointed Michael Tolentino, M.D., an accomplished biotech leader with deep industry experience, as Chief Executive Officer, effective March 17. He succeeds Founder and CEO Luo Feng, Ph.D., who has been appointed Chief Scientific Officer “Dr. Tolentino is an exceptional leader whose biotech industry expertise, deep relationships across the CRO and pharma ecosystems, and proven track record of creating shareholder value is exactly what Vesicor needs in its next CEO,” stated Warren Hosseinion, M.D., Chairman of the Board of Vesicor Therapeutics. “We are honored to have Dr. Tolentino as our new CEO as we work to complete our de-SPAC with Blackhawk Acquisition Corporation and accelerate our IND-enabling studies and IND-submission to the FDA.” “I am delighted to join Vesicor as CEO. I have tremendous respect and admiration for the company, its science and its Founder and am eager to build upon the technology and work the team has been doing to position itself for an IND submission in 2027. I see significant opportunities to develop potent therapeutics against cancer and create value for our shareholders,” stated Michael Tolentino, M.D. Dr. Tolentino is a serial entrepreneur and longtime biotechnology leader and widely respected executive with more than 20 years of experience and deep relationships across the drug discovery, pre-clinical development, clinical development, and pharmaceutical industry. In the laboratory of Dr. Judah Folkman, he discovered the importance of the VEGF pathway in retinal disease and cancer. While at Harvard, he helped invent and pre-clinically develop Avastin with Genentech, the drug that launched both the retinal and oncologic anti-VEGF industry. He subsequently invented and was the pre-clinical and clinical developer of Bevasiranib, the first RNA interference and siRNA drug taken to clinic for diabetic retinopathy and macular degeneration. He was the Founder and served as CEO, CSO and CMO of Acuity Pharmaceuticals, which merged to form OPKO Health (NASDAQ: OPK) in 2007. In 2008, he was the scientific founder and consultant for Promedior, Inc., a privately held biotech company that advanced the anti-fibrotic PRM-151 for idiopathic pulmonary fibrosis and myelofibrosis. Promedior was sold to Roche in 2018 for $390 million in cash and contingent payments up to $1 billion. He Co-founded and was a Board member of Panther Pharmaceuticals from 2018-2023. Concurrently, he was the Co-founding physician and partner of Vision Integrated Partners, a PE-funded ophthalmic roll-up where he founded, directed and incorporated a clinical trial site management organization called Blue Ocean Clinical Research that ran clinical trials with Dr. Tolentino as the principal investigator. Dr. Tolentino Co-founded Aviceda Therapeutics, invented AVD-104 and served as CSO from 2018-2021 and CTO/CIO from 2018 until 2025, when Aviceda secured $207.5 million Series C financing. He also served on the board of the company from 2018-2024 and helped design and manage the Phase 2-3 clinical trial. Dr. Tolentino is the Co-founder, CEO and Chairman of Avdarna Therapeutics since 2021. Avdarna is a pre-clinical to clinical developer of novel AI-generated proprietary protein/peptide therapeutics that mimic and enhance the efficacy of current blockbuster drugs like GLP-1, GIP-1, glucagon agonists, checkpoint inhibitors, targeted nucleotide therapeutic gene delivery, cancer-targeted antibodies, nanobodies and ADCs. Avdarna is the pre-clinical to clinical developer for assets generated by Aikium. He is also the Co-founder and Chief Development Officer of Aikium, Inc. Aikium is revolutionizing therapeutics discovery and development with Yotta-ML², the world’s first proprietary 10^24 protein/peptide sequence structured data-set trained, drug discovery AI platform. The Yotta platform is taught to identify therapeutic agonists or antagonists that bind clinically validated targets such as GLP-1, GIP-1, Glucagon, and checkpoint receptors, as well as previously undruggable targets such as GPCRs, cancer associated antigens, and intracellular proteins. Aikium with Avdarna is rapidly developing novel therapeutics replacing drugs going off patent with more efficacious, longer acting, less toxic, multi-specific and oral drugs. Aikium has also identified protein binders to be developed for novel targets leading to the next-generation peptide/protein therapeutics, antibody drug conjugates, gene therapies and beyond. Cancer antigen targeted peptides discovered by Aikium can be conjugated to microvesicles and be used to specifically target cancer cells for p53 gene delivery and other cancer killing agents such as topoisomerase inhibitors, alkylating agents and microtubule inhibitors. Dr. Tolentino holds a BA in both Computer Science and Organizational Behavior and Management from Brown University, a M.D. from the University of Massachusetts Chan School of Medicine, completed his Research Fellowships and Residency in Ophthalmology from Harvard Medical School and a Retinal Surgical Clinical Fellowship from the University of Pennsylvania. He served on the Faculty of Cellular, Molecular Biology and Gene Therapy, was a Scientist at the FM Kirby Center for Molecular Ophthalmology, and Clinical Faculty at the Scheie Eye Institute, all organizations at the University of Pennsylvania.

Executive ChangeAcquisition

26 Apr 2023

·www.fiercebiotech.com

Roche, seeing MAGE magic wane, makes pair of solid tumor bispecifics disappear

Roche used an update to reveal the disappearance of a geographic atrophy program from its pipeline. Roche no longer sees the magic in MAGE-A4. The Swiss drugmaker signaled a retreat from the TCR T-cell target in its first quarter results by putting a pair of phase 1 solid tumor programs out to pasture along with hopes of recouping the $490 million paid out for the assets. Genentech, a subsidiary of Roche, put down $100 million in upfront and near-term milestone payments to co-develop one of the candidates with Immunocore in 2018. The drug candidate, a bispecific T-cell engager targeting MAGE-A4, entered the clinic the following year, but both developers have walked away from the program since the release of phase 1 ovarian cancer data late last year. In February, Immunocore stopped funding the program, apart from the cost of winding down the phase 1 trial. The action left Roche’s Genentech with an exclusive worldwide license to the MAGE-A4 HLA-A02 soluble TCR bispecific therapeutic candidate compounds. It seems Roche doesn’t want the compounds, either. The Swiss drugmaker disclosed the axing of RG6290, a drug candidate based on Immunocore’s ImmTAC technology that is also known as IMC-C103C, alongside news of the removal of another MAGE-A4 asset from its pipeline. Roche took the other candidate, HLA-A2-MAGE-A4xCD3 bispecific antibody RG6129, into the clinic months after Immunocore began a phase 1 trial of IMC-C103C. Early this year, Roche said it had stopped enrolling patients in the study of RG6129, pulling the targeted completion date of the trial forward by more than two years in the process. The removal of the asset from the pipeline recasts the cessation of enrollment as the start of Roche’s retreat from the candidate. Roche invested in the programs in the belief a molecule that simultaneously binds to CD3 on cytotoxic T-lymphocytes and HLA-A2 MAGE-A4 on tumor cells could orchestrate an anti-cancer immune attack. As MAGE-A4 is overexpressed by a variety of cancer cell types, the mechanism is potentially applicable to a range of tumors. The attributes of MAGE-A4 have made it a popular target for TCR T-cell biotechs, with Immunocore and its sibling Adaptimmune among the companies to go after the protein. Adaptimmune is closing in (PDF) on a filing for FDA approval of its first-generation MAGE-A4 candidate. Roche disclosed the MAGE-A4 news as part of a pipeline update that saw it punt two other programs. The list of castoffs includes zinpentraxin alfa, also known as PRM-151 and RG6354. Roche previously stopped a phase 3 trial of the candidate in idiopathic pulmonary fibrosis early because the study looked on course to fail. Now, the drugmaker has stopped work on myelofibrosis, too. Roche acquired the drug candidate in the 2019 takeover of Promedior, which cost it $390 million upfront. Removing the myelofibrosis program from the midphase pipeline leaves Roche without active clinical programs involving zinpentraxin alfa. Finally, Roche also used the update to disclose the removal of a geographic atrophy program RG6312 from its phase 1 pipeline. Since RG6312 entered the clinic in 2020, the Big Pharma has suffered setbacks in its pursuit of the eye indication, failing a phase 3 trial in 2017 and dropping galegenimab last year. But it still has two shots on goal, including a Lineage Cell Therapeutics candidate that recently entered phase 2.

Phase 1License out/inPhase 3AcquisitionPhase 2

02 Feb 2023

·endpts.com

Roche ditches final PhIII for cancer hopeful, reports setback for key drug in $1.4B buyout

Over the past few years, Roche has released news about its AKT inhibitor ipatasertib in drips — most of them negative. The drug yielded mixed data in a key prostate cancer trial, Phase III flops in triple-negative breast cancer forced the pharma giant to pull the plug there, and in mid-2022 Roche trimmed two more early-stage indications in prostate cancer after completing the trials. Now, the last piece of the program is gone. Roche is officially scrapping the combination of ipatasertib and abiraterone, which was in a Phase III trial for first-line castration-resistant prostate cancer. It’s one of several late-stage programs Roche is sweeping out of the pipeline in its Q4 housecleaning exercise, alongside a trio of Tecentriq combos, the failed Alzheimer’s candidate gantenerumab and a drug for idiopathic pulmonary fibrosis. Separately, the company is dropping a Phase I compound for acute graft-versus-host disease. A Roche spokesperson confirmed to Endpoints News that “we don’t have any further projects ongoing with ipatasertib.” Although the Phase III IPATential150 study met its co-primary endpoint of radiographic progression-free survival in June 2020, it missed the key endpoint of overall survival at the second interim analysis. The spokesperson added that the safety profile of the ipatasertib/abiraterone combo was consistent with that observed at the primary analysis. Designed to block the PI3K/AKT pathway, ipatasertib arose from a partnership that Roche’s Genentech struck with Array BioPharma before Pfizer bought them out, and once inspired high hopes as a targeted approach. In the same presentation, Roche disclosed that it slammed the brakes on a Phase III study in idiopathic pulmonary fibrosis after a recent futility analysis suggested it’s unlikely to meet the primary endpoint. RG6354, which is also dubbed PRM-151 or zinpentraxin alfa, was the lead drug from Roche’s 2019 buyout of Promedior , for which it paid $390 million in cash upfront. Despite the setback, Roche still lists that program as a potential drug for myelofibrosis, with a filing expected in 2025 or later. Then there are three Phase III trials for the PD-L1 inhibitor Tecentriq being cut, in frontline metastatic urothelial carcinoma (Tecentriq + chemo), second-line non-small cell lung cancer (Tecentriq + Cabometyx) and second-line HER2-positive, PD-L1-positive metastatic breast cancer (Tecentriq + Kadcyla), respectively. Also exiting the pipeline are trials for gantenerumab, an anti-amyloid antibody, in preclinical Alzheimer’s and prodromal to mild Alzheimer’s — a reflection of Roche’s previously disclosed decision to stop all studies in the wake of a Phase III failure . Finally, Roche said it’s shutting down an IL-22 fusion protein, known as RG7880 or efmarodocokin alfa, that was being tested for the prevention of acute graft-versus-host disease in patients undergoing bone marrow transplant. The spokesperson cited “strategic reasons” for discontinuing the development, noting that “safety did not play any part in this decision.” Data from the Phase Ib study will be published.

Phase 3Phase 1Phase 2Clinical Trial TerminationClinical Trial Failure

100 Deals associated with Zinpentraxin alfa

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic lung disease	Phase 3	Sweden	-	01 Dec 2020
Idiopathic Pulmonary Fibrosis	Phase 3	Sweden	-	01 Dec 2020
Polycythemia Vera	Phase 2	United States	Hoffmann-La Roche, Inc.	01 Oct 2013
Polycythemia Vera	Phase 2	Canada	Hoffmann-La Roche, Inc.	01 Oct 2013
Polycythemia Vera	Phase 2	France	Hoffmann-La Roche, Inc.	01 Oct 2013
Polycythemia Vera	Phase 2	Germany	Hoffmann-La Roche, Inc.	01 Oct 2013
Polycythemia Vera	Phase 2	Israel	Hoffmann-La Roche, Inc.	01 Oct 2013
Polycythemia Vera	Phase 2	Italy	Hoffmann-La Roche, Inc.	01 Oct 2013
Polycythemia Vera	Phase 2	Netherlands	Hoffmann-La Roche, Inc.	01 Oct 2013
Polycythemia Vera	Phase 2	United Kingdom	Hoffmann-La Roche, Inc.	01 Oct 2013

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04552899 (STARSCAPE, ATS2024) Manual	Phase 3	Idiopathic Pulmonary Fibrosis	664	Zinpentraxin alfa (10 mg/kg)	usjvngvhdc(fvcjivvsdy) = icgbtutvyd eurlckroba (lfevdodagz ) View more	Negative	21 May 2024
				Placebo	usjvngvhdc(fvcjivvsdy) = fvakpxkdfy eurlckroba (lfevdodagz ) View more
NCT04552899 (STARSCAPE, CTgov)	Phase 3	Idiopathic Pulmonary Fibrosis	665	PRM-151 (Zinpentraxin Alfa) (Zinpentraxin Alfa)	vpxobtotdd(twqgyyuwxu) = numjpbcnol wbmlmizoxf (dhfoztzsor, tfbabgcfrw - pjjrebydcz) View more	-	18 Apr 2024
				Placebo (Placebo)	vpxobtotdd(twqgyyuwxu) = tqxkyetchh wbmlmizoxf (dhfoztzsor, abtwgcchfa - wlxpmipouu) View more
NCT01981850 (ASH2023)	Phase 2	Myeloproliferative Disorders \| Primary Myelofibrosis	8	Zinpentraxin alfa	cbcfpseqrd(nxwolejpzm) = arrblorqcc oatrcsjdjz (sdwbbtzldl )	-	09 Dec 2023
				Ruxolitinib	cbcfpseqrd(nxwolejpzm) = rzkoafxsng oatrcsjdjz (sdwbbtzldl )
NCT01981850 (Pubmed)	Phase 2	Myelofibrosis	27	Zinpentraxin alfa monotherapy	cobobzflpc(gjpxckqjmh) = ercctgmdkg tolazozvbp (iccixnntjv )	-	11 May 2023
				Zinpentraxin alfa + Ruxolitinib	cobobzflpc(gjpxckqjmh) = ranacaxgtc tolazozvbp (iccixnntjv )
NCT02550873 (Pubmed \| Respir Res) Manual	Phase 2	Idiopathic Pulmonary Fibrosis	111	rhPTX-2 (started rhPTX-2)	dlkvnrhjej(anurvygbar) = qsqifxusqi jsajxhcdul (dtfywiqlxy, -7.7 to -4.6) View more	Positive	21 May 2022
				rhPTX-2 (continued rhPTX-2)	dlkvnrhjej(anurvygbar) = jjjdwzorss jsajxhcdul (dtfywiqlxy, -8.0 to -3.3) View more
EHA2019	Phase 2	Myelofibrosis	98	PRM-151 0.3 mg/kg	clijzdwtvs(mqakclpbov) = hgrqrgtwta zbgmfuqraj (cupclkjdds ) View more	-	15 Jun 2019
				PRM-151 3 mg/kg	clijzdwtvs(mqakclpbov) = njkjavhrro zbgmfuqraj (cupclkjdds ) View more
NCT02550873 (CTgov)	Phase 2	Idiopathic Pulmonary Fibrosis	117	placebo	jbyteviaqj(uphrcxfsyi) = mzibhnbbmm bkvzcnckbm (ewofoqlpkw, yiktleeqik - oskbybblyt) View more	-	14 Dec 2018
NCT02550873 (Pubmed) Manual	Phase 2	Idiopathic Pulmonary Fibrosis	116	Recombinant Human Pentraxin 2	vxxdraygll(qvetoauuvq) = prtccuaslo cvyfophsfn (irkdesubuu ) View more	Positive	12 Jun 2018
				Placebo	vxxdraygll(qvetoauuvq) = hnlphlaxch cvyfophsfn (irkdesubuu ) View more
SOHO2015	Not Applicable	Myelofibrosis	-	PRM-151 10 mg/kg IV QW	dazjaortjs(huyfbqgryo) = Most AEs were Grade 1 or 2 chjvdpypep (dvhijxnqgt ) View more	-	01 Sep 2015
				PRM-151 10 mg/kg IV Q4W
NCT01254409 (PRM151F-12GL, CTgov)	Phase 1	Idiopathic Pulmonary Fibrosis	21	Placebo	mfxotqhckv = cuihdvyzzd zbegpgfrhf (jemilgivgt, gnuswuvgze - ykhkdmsgam) View more	-	02 Nov 2014

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