RegulationOrphan Drug (US), Conditional marketing approval (CN), Accelerated Approval (US), Priority Review (CN), Fast Track (US), Orphan Drug (EU), Orphan Drug (JP)

Structure

Molecular FormulaC13H11N3O4

InChIKeyUVSMNLNDYGZFPF-UHFFFAOYSA-N

CAS Registry19171-19-8

294

Clinical Trials associated with Pomalidomide

NCT06615479 / Not yet recruitingPhase 3

A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of BMS-986393, a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma

The purpose of this study is to compare the efficacy and safety of BMS-986393 versus standard regimens in adult participants with Relapsed or Refractory and Lanalidomide-refractory Multiple Myeloma.

Start Date15 Feb 2025

Sponsor / Collaborator

Juno Therapeutics, Inc.

[+1]

NCT06660498 / Not yet recruitingPhase 1/2IIT

Pomalidomide As an Immune-enhancing Agent for the Control of HIV (PEACH): an Investigator-initiated Phase I/IIb Clinical Trial in People Living with HIV on ART and During Analytical Treatment Interruption

This study is designed to evaluate the safety and efficacy of pomalidomide in HIV-1-infected individuals on ART and to determine the impact of pomalidomide on virological control in people living with HIV during an analytical treatment interruption.

Start Date20 Nov 2024

Sponsor / Collaborator

University of Aarhus

NCT06058689 / Not yet recruitingPhase 1

A Pilot, Open-label, Randomized, Two-Way Crossover, Single-Dose Bioequivalence Study of Pomalidomide Under Fasting Condition in Indian Healthy Volunteers

Pilot bioequivalence trial of two pomalidomide formulations consisting in 4 mg oral capsules.

Start Date15 Sep 2024

Sponsor / Collaborator

Mega Labs SA

100 Clinical Results associated with Pomalidomide

100 Translational Medicine associated with Pomalidomide

100 Patents (Medical) associated with Pomalidomide

1,114

Literatures (Medical) associated with Pomalidomide

01 Dec 2024·BIOORGANIC CHEMISTRY

Pomalidomide sensitizes lung cancer cells to TRAIL/CDDP-induced apoptosis via directly targeting electron transfer flavoprotein alpha subunit

Article

Author: Zeng, Shulan ; Wang, Hui ; Li, Liangping ; Huang, Yuying ; Ma, Xuesong ; Du, Wenqing ; Li, Yongkun ; Zhang, Guohai ; Peng, Yan ; Li, Pingping ; Zhao, Yufei ; Huang, Zetian

Immunomodulatory drugs (IMiDs) represented by thalidomide exhibit benefits when combined with other chemotherapeutic drugs for patients with lung cancer, which inspired the exploration of combining pomalidomide with another agent to treat lung cancer as it is more potent than thalidomide. However, the drugs that can be combined with pomalidomide to benefit patients and related mechanisms remain unclear. Here, we performed a proteomic analysis based on the streptavidin pull-down to identify the potential target of pomalidomide in non-small cell lung cancer (NSCLC). In this work, electron transfer flavoprotein alpha subunit (ETFA), an important enzyme involved in electron transport in the respiratory chains was identified as a crucial cellular target of pomalidomide in NCI-H460 cells. Using apoptosis model and combination analyses, we found that pomalidomide directly targeted ETFA, and increased ATP generation, thereby significantly promoting tumor necrosis factor-related apoptosis-inducing ligand (TRAIL)-induced apoptosis. Specific knockdown of ETFA could effectively eliminate the promoting effect of pomalidomide on energy production. Furthermore, respiratory chain inhibitors can effectively block cell apoptosis induced by TRAIL and pomalidomide. These results suggested that pomalidomide may promote apoptosis by facilitating energy production by targeting ETFA and thus enhanced the anticancer effects of chemotherapeutic drugs. It is noteworthy that pomalidomide noticeably increased the anticancer efficacy of cisplatin (CDDP) in NCI-H460 xenograft model with the main mechanisms by inducing apoptosis. Collectively, our data not only provide new insights into the anticancer mechanisms of pomalidomide but also reflect translational prospects of combining pomalidomide with CDDP for NSCLC treatment.

01 Nov 2024·Clinical Lymphoma Myeloma & Leukemia

Cereblon E3 Ligase Modulators Mezigdomide and Iberdomide in Multiple Myeloma

Review

Author: van Rhee, Frits ; Patel, Tanvi H ; Al Hadidi, Samer

Multiple Myeloma (MM) remains a challenging hematological malignancy despite significant advancements made during the past 2 decades. Outcomes have improved by incorporating immunomodulatory drugs, proteasome inhibitors, and anti-CD38 monoclonal antibodies into treatment algorithms that include high dose chemotherapy and autologous hematopoietic stem cell transplantation. However, many patients may eventually relapse despite these innovations. Newer therapies targeting B-Cell Maturation Antigen (BCMA) offer promise for patients with relapsed or refractory disease. BCMA-targeted therapies carry notable side effects, necessitating vigilant monitoring and proactive infection prevention measures. They can also induce considerable immunosuppression, attributed to lower levels of immunoglobulins and increased susceptibility to infections. There is still a need for alternative treatment options with different mechanisms of action that can be easily administered and have a better safety profile. In addition, pomalidomide only overcomes lenalidomide refractoriness in a subset of patients. This review aims to explore 2 next-generation cereblon E3 ligase modulators (CELMoDs), Mezigdomide (CC92480), and Iberdomide (CC-220). We will discuss the biological aspects of these agents, including their mechanisms of action, efficacy, and toxicity profile, and provide a comprehensive review of current literature. Special attention will be paid to ongoing and future clinical trials that provide insights into the potential of these novel therapies in the management of MM.

01 Nov 2024·BIOMEDICINE & PHARMACOTHERAPY

Cereblon mediates macrophage differentiation and microglial phagocytosis by regulating calpain protease activity

Article

Author: Cao, Dan ; Zhou, Liang ; Sun, Qing

Autoimmune diseases encompass over 80 distinct types, affecting approximately 7.6-9.4 % of the population globally. The intricate interplay between genetic predispositions and environmental triggers complicates early diagnosis and intervention. Abnormal macrophage differentiation and proliferation have been identified as key contributors to the pathogenesis of these conditions, though the precise molecular pathways remain poorly understood. Recent studies suggest that cereblon (CRBN), a target for immunomodulatory drugs like thalidomide, lenalidomide, and pomalidomide, may offer therapeutic potential for autoimmune diseases such as systemic lupus erythematosus. In this study, quantitative proteomics revealed that CRBN downregulated the calpain regulatory subunit, calpain small subunit 1 (CAPNS1), in macrophages. Subsequent biochemical assays demonstrated that CRBN modulated calpain activity, impacting autophagy processes during macrophage differentiation and microglial phagocytosis. Histological evaluation of CRBN-deficient mice indicated a marked increase in microglial populations in the brain. These findings highlight potential therapeutic targets and present new avenues for the treatment of autoimmune diseases.

277

News (Medical) associated with Pomalidomide

14 Nov 2024

·www.globenewswire.com

Press Release: Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma

Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma Recommendation based on IMROZ phase 3 study demonstrating Sarclisa in combination with VRd significantly improved progression-free survival, compared to standard-of-care VRd aloneIf approved, Sarclisa would be the first anti-CD38 therapy in the EU available for use in combination with VRd for adult patients with transplant-ineligible NDMM Paris, November 14, 2024. The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). A final decision is expected in the coming months. Dietmar Berger, M.D., Ph.D.Chief Medical Officer, Global Head of Development at Sanofi“The positive CHMP opinion is an important step forward for people with transplant-ineligible newly diagnosed multiple myeloma for whom effective front-line therapy may improve long-term outcomes. If approved, this Sarclisa-based combination could establish a new standard-of-care treatment approach for patients in the EU, helping to address a critical care gap in multiple myeloma treatment, and reinforcing Sarclisa’s potential as the anti-CD38 therapy of choice.” In September 2024, the US Food and Drug Administration (FDA) approved Sarclisa in combination with VRd for the treatment of adult patients with NDMM who are not eligible for ASCT, representing the first global approval for Sarclisa in the first line setting. In addition, the FDA granted orphan drug exclusivity for Sarclisa in the approved indication. Sarclisa is currently approved in two indications for the treatment of certain adult patients with relapsed or refractory MM in more than 50 countries, including the US and EU. First positive global phase 3 study combining anti-CD38 therapy with VRd to significantly improve PFS versus VRd alone in transplant-ineligible NDMM supports CHMP decisionThe positive CHMP opinion is based on data from the IMROZ phase 3 study, which was presented at the American Society of Clinical Oncology 2024 annual meeting, European Hematology Association 2024 meeting, and published in The New England Journal of Medicine. IMROZ is the first global phase 3 study of a CD38 monoclonal antibody in combination with standard-of-care VRd to significantly improve progression-free survival (PFS) versus VRd alone. The safety and tolerability of Sarclisa observed was consistent with the established safety profile of Sarclisa and VRd with no new safety signals. About SarclisaSarclisa (isatuximab) is a CD38 monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a target for antibody-based therapeutics such as Sarclisa. In the US, the non-proprietary name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with nonproprietary naming of biological products guidance for industry issued by the US FDA. Currently Sarclisa is approved in more than 50 countries, including the US and EU, across two indications; Sarclisa is approved under an additional indication in the US. In Europe, based on the ICARIA-MM phase 3 study, Sarclisa is approved in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed refractory MM (RRMM) who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor and who progressed on last therapy. Based on the IKEMA phase 3 study, Sarclisa is also approved in 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with RRMM who have received 1–3 prior lines of therapy and in the European Union for patients with MM who have received at least 1 prior therapy. In the US, Sarclisa is also approved in combination with VRd as a first line treatment option for adult patients with NDMM who are not eligible for ASCT, based on the IMROZ phase 3 study. Sanofi continues to advance Sarclisa as part of a patient-centric clinical development program, which includes several phase 2 and phase 3 studies across the MM treatment continuum spanning six potential indications. In addition, the company is evaluating a subcutaneous administration method for Sarclisa in clinical studies. The safety and efficacy of Sarclisa has not been evaluated by any regulatory authority outside of its approved indications and methods of delivery. In striving to become the number one immunoscience company globally, Sanofi remains committed to advancing oncology innovation. Through focused strategic decisions the company has reshaped and prioritized its pipeline, leveraging its expertise in immunoscience to drive progress. Efforts are centered on difficult-to-treat cancers such as select hematologic malignancies and solid tumors with critical unmet needs, including multiple myeloma, acute myeloid leukemia, certain types of lymphomas, as well as gastrointestinal and lung cancers. For more information on Sarclisa clinical studies, please visit www.clinicaltrials.gov. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comNicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.comVictor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.comTimothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com Investor RelationsThomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.comAlizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.comArnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comKeita Browne | + 1 781 249 1766 | keita.browne@sanofi.comNathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.comTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.comThibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group. Attachment Press Release

Phase 3Drug ApprovalASCOClinical ResultImmunotherapy

14 Nov 2024

·endpts.com

GSK makes case for Blenrep's return with new blood cancer survival data

GSK continues to stack up wins to support Blenrep’s comeback, as the company teased new survival data from a late-stage multiple myeloma trial on Thursday. In people with second-line or later relapsed or refractory disease, Blenrep combined with bortezomib and dexamethasone met the overall survival secondary endpoint in the DREAMM-7 trial versus standard of care daratumumab plus bortezomib and dexamethasone, according to a Thursday release . The UK drugmaker is gearing up to relaunch Blenrep in the US in the second half of 2025 after it pulled the drug from the market several years ago in the wake of a failed confirmatory trial in later lines of multiple myeloma. The company has filed data from both the DREAMM-7 and the DREAMM-8 trial of Blenrep combined with pomalidomide plus dexamethasone this year. According to DREAMM-7 topline results in February, the Blenrep regimen slashed the risk of disease progression or death by 59%. At the time, the company only said it had a “meaningful trend” in survival. The new DREAMM-7 data “underscore the potential for this Blenrep combination to extend the lives of patients,” GSK’s head of oncology R&D Hesham Abdullah said in the release. But details of the survival data will have to wait as the company will present them at the American Society of Hematology annual meeting in December. The drugmaker believes Blenrep could reach more than $3 billion in peak sales, mostly driven by the second-line patient population. It is looking to displace Johnson & Johnson’s anti-CD38 monoclonal antibody Darzalex as the second-line standard of care. Meanwhile, GSK plans to start Phase 3 studies comparing Blenrep with Darzalex in first-line multiple myeloma next year. So far this year, GSK has filed Blenrep in the US, Europe, Japan, the UK, Canada and Switzerland. In China, the combination of Blenrep plus bortezomib and dexamethasone has been granted breakthrough therapy designation.

Phase 3Clinical ResultBreakthrough TherapyASHPriority Review

14 Nov 2024

·firstwordpharma.com

Blenrep's resurrection bid gains momentum as GSK confirms new survival data

GSK on Thursday said that the BCMA-targeted antibody-drug conjugate Blenrep (belantamab mafodotin) significantly improved overall survival (OS) versus Johnson & Johnson's Darzalex (daratumumab) as a second-line or later treatment for relapsed or refractory multiple myeloma, marking the latest development in the drug's turnaround story."This is a statistically significant and clinically meaningful advancement for patients and potentially transformative for treatment," remarked Hesham Abdullah, global head for oncology R&D at GSK. "We look forward to sharing these data with health authorities and presenting the full results at next month’s American Society of Hematology (ASH) annual meeting."Back in February, GSK detailed results from the primary endpoint of the Phase III DREAMM-7 study, with Blenrep in combination with bortezomib and dexamethasone reducing the risk of disease progression or death by 59% compared to Darzalex plus bortezomib and dexamethasone, with median progression-free survival (PFS) in the two groups of 36.6 months and 13.4 months, respectively. At the time, the company also noted that a clinically meaningful OS trend had been observed, with Blenrep cutting the risk of death by 43%, although the data were not mature. On Thursday, GSK indicated that the the key secondary OS endpoint of the trial has now been met, with Blenrep significantly reducing the risk of death versus standard of care with Darzalex.Based on the earlier results from DREAMM-7, as well as those from the Phase III DREAMM-8 study, the pharma has submitted filings for Blenrep in a number of markets, including the US, EU and Japan.Blenrep was yanked from the US market in 2022 after it failed to show superiority over the combination of Bristol Myers Squibb's Pomalyst (pomalidomide) and low-dose dexamethasone in a confirmatory study of patients with relapsed or refractory multiple myeloma, with the drug meeting a similar fate in Europe.

Phase 3Clinical ResultASH

100 Deals associated with Pomalidomide

External Link

KEGG	Wiki	ATC	Drug Bank
D08976	Pomalidomide	L04AX06	DB08910

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Kaposi Sarcoma	US	Bristol Myers Squibb Co.	14 May 2020
Multiple Myeloma	US	Bristol Myers Squibb Co.	08 Feb 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Relapse multiple myeloma	NDA/BLA	EU	Viatris Ltd. (New Zealand)	14 Dec 2023
Plasma cell myeloma refractory	Phase 3	AU	Celgene Corp.	01 Mar 2011
Plasma cell myeloma refractory	Phase 3	BE	Celgene Corp.	01 Mar 2011
Plasma cell myeloma refractory	Phase 3	CA	Celgene Corp.	01 Mar 2011
Plasma cell myeloma refractory	Phase 3	CZ	Celgene Corp.	01 Mar 2011
Plasma cell myeloma refractory	Phase 3	DK	Celgene Corp.	01 Mar 2011
Plasma cell myeloma refractory	Phase 3	FR	Celgene Corp.	01 Mar 2011
Plasma cell myeloma refractory	Phase 3	DE	Celgene Corp.	01 Mar 2011
Plasma cell myeloma refractory	Phase 3	GR	Celgene Corp.	01 Mar 2011
Plasma cell myeloma refractory	Phase 3	IT	Celgene Corp.	01 Mar 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2024	Not Applicable	Multiple Myeloma	-	Pomalidomide, Bortezomib, Dexamethasone	ymetvcagzf(nrlnxgjirg) = yycjbeoyrn zbkslscpiw (jnjisqqava ) View more	-	09 Dec 2024
ASH2024	Not Applicable	Immunoglobulin Light-Chain Amyloidosis	-	Isatuximab	qcwhsqkrtb(jhdexyzxxx) = 5 GI tract adverse events reported yhbujgpexa (detuowybkm ) View more	-	09 Dec 2024
ASH2024	Not Applicable	Multiple Myeloma	-	Selinexor 60 mg QW	qoezzsqdlr(zhciqiscdv) = Entire cohort: 54.3%/33.3%, SPd60: 65.0%/25.0%, SPd40: 31.3%/18.8% jxfjfyknpd (fznxbpnaqy ) View more	-	07 Dec 2024
				Selinexor 40 mg QW
1965 (ASH2024)	Not Applicable	Relapse multiple myeloma	399	Daratumumab, Pomalidomide and Dexamethasone (DPd)	pcaqvbdbpq(wxhkhavvno) = nrsdgobqrb sbkmkmzmmx (okouetivxo ) View more	Positive	07 Dec 2024
				Daratumumab, Carfilzomib and Dexamethasone (DKd)	pcaqvbdbpq(wxhkhavvno) = exnmflpewz sbkmkmzmmx (okouetivxo ) View more
NCT03910244 (PATH-HHT, CTgov)	Phase 2	Hemorrhage \| Telangiectasia, Hereditary Hemorrhagic	145	Placebo oral capsule (Placebo)	wisraanaug(sbvkbsrcwj) = pkdycyjmer ireatyggwg (xiipsmbptz, vejhebdeve - ektmoxlxrn) View more	-	23 Oct 2024
				Pomalidomide Oral Product (Pomalidomide)	wisraanaug(sbvkbsrcwj) = gjvaephluj ireatyggwg (xiipsmbptz, vmryfkzsxr - dbcshcenos) View more
NCT02004275 (Alliance A061202, Pubmed \| Blood Adv) Manual	Phase 2	Relapse multiple myeloma	30	Ixazomib, Pomalidomide, Dexamethasone	bgocagqinb(usmhksudas) = More hematologic toxicities were seen with the triplet therapy hxfrtgufyv (mvuyzshznl ) View more	Positive	08 Oct 2024
				Pomalidomide, Dexamethasone
NCT03910244 (PATH-HHT, Pubmed \| N Engl J Med)	Phase 2	Telangiectasia, Hereditary Hemorrhagic	144	Pomalidomide 4 mg	goaylvazti(elovraoufm) = fumqqofszp tpvwolqdoa (vhtgwbdyze, -1.57 to -0.31)	Positive	19 Sep 2024
NCT04484623 (DREAMM-8, Pubmed)	Phase 3	Multiple Myeloma lenalidomide-refractory disease	302	Belantamab mafodotin, pomalidomide, and dexamethasone (BPd)	xyfgfkhzum(ouqvftljnm) = Ocular events were common but were controllable by belantamab mafodotin dose modification lfsqffyodo (ulgmjyqvgp ) View more	Positive	02 Jun 2024
				Pomalidomide, bortezomib, and dexamethasone (PVd)
ATS2024	Not Applicable	Carrington Syndrome	-	Pomalidomide	lzpotssrmt(megfcbnecq) = a rare and not well described side effect of the medication pkhuqemzhd (nueyeivrjs ) View more	-	19 May 2024
NCT04802161 (EHA2024) Manual	Phase 2	Acute myeloid leukemia with multilineage dysplasia First line	9	CPX-351 + Pomalidomide (4 mg for 10 d)	yaftdqcaiu(dflefrorqw) = rskrnycgyh gttkoegcbn (sqbncjykwm ) View more	Positive	14 May 2024
				CPX-351 + Pomalidomide (4 mg for 14 d)	yaftdqcaiu(dflefrorqw) = xrzuhsocmb gttkoegcbn (sqbncjykwm )

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