Systemic Mastocytosis Clinical Trial Pipeline Shows Potential with Active Contributions from 8+ Key Companies | DelveInsight

DelveInsight's, "Systemic Mastocytosis Pipeline Insight, 2025," report provides comprehensive insights about 8+ companies and 8+ pipeline drugs in Systemic Mastocytosis pipeline landscape. It covers the Systemic Mastocytosis pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Systemic Mastocytosis pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Systemic Mastocytosis Pipeline Report

* On December 08, 2025 - Cogent Biosciences, Inc. (NASDAQ: COGT) today announced positive top-line results from the registration-directed APEX Part 2 clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) demonstrating clinically meaningful results as measured by consensus criteria used to assess patient response. This is the third positive pivotal trial result for bezuclastinib in 2025, following positive announcements from the SUMMIT trial in NonAdvSM patients and the PEAK trial in GIST patients earlier this year. Based on these top-line data, Cogent expects to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in AdvSM during the first half of 2026. In addition, Cogent plans to present detailed data from the APEX trial at an upcoming scientific meeting in the first half of 2026.
* In November 2025, Blueprint Medicines Corporation conducted a study is to evaluate the long-term safety of avapritinib in participants who have completed a Blueprint Medicines sponsored study (parent study) and continued to benefit from avapritinib.
* DelveInsight's Systemic Mastocytosis Pipeline report depicts a robust space with 8+ active players working to develop 8+ pipeline therapies for Systemic Mastocytosis treatment.
* The leading Systemic Mastocytosis Companies such as AB Sciences, Blueprint Medicines, Patara Pharma, Seagen Inc., GT Biopharma, Deciphera Pharmaceuticals, Novartis Oncology and others.
* Promising Systemic Mastocytosis Pipeline Therapies such as PA101, Avapritinib, RAD001 (Everolimus), Elenestinib, Masitinib, Avapritinib, Brentuximab vedotin, TL-895 and others.

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Systemic Mastocytosis Overview

Systemic Mastocytosis (SM) is a rare disorder characterized by the abnormal growth and accumulation of mast cells-immune cells involved in allergic and inflammatory responses-within multiple organs of the body. Unlike cutaneous mastocytosis, which affects only the skin, systemic mastocytosis involves internal tissues such as the bone marrow, liver, spleen, gastrointestinal tract, and lymph nodes.

Systemic Mastocytosis Emerging Drugs Profile

* Avapritinib: Blueprint Medicines

Avapritinib is a potent and selective inhibitor of activated KIT and PDGFRA mutant kinases. In certain diseases, mutations in KIT and PDGFRA force protein kinases into an increasingly active state. Avapritinib is uniquely designed to bind and inhibit the active conformation of these proteins. Blueprint Medicines is developing AYVAKIT globally for the treatment of advanced and indolent SM. Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of AYVAKIT in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for AYVAKIT in the rest of the world. The FDA granted breakthrough therapy designation to AYVAKIT for the treatment of advanced SM, including the subtypes of aggressive SM, SM with an associated hematological neoplasm and mast cell leukemia, and for the treatment of moderate to severe indolent SM. The FDA has accepted a supplemental new drug application for avapritinib for the treatment of advanced SM. The European Medicines Agency has validated a Type II variation marketing authorization application for avapritinib for the treatment of advanced SM.

* Masitinib: AB Sciences

Masitinib's anti-mast cell properties appear particularly well-adapted to the treatment of indolent systemic mastocytosis. A reduction of mast cell activity is generated via its inhibitory action on wild-type c-Kit, Lyn and Fyn tyrosine kinases. In recognition of the critical need for new treatments, masitinib received orphan drug designation for mastocytosis from both the European Medicine Agency (EMA) and the U.S. Food and Drug Administration (FDA). AB Science initiated a confirmatory phase 3 study, with design optimized based on findings from the first phase 3 study.

The Systemic Mastocytosis Pipeline Report Provides Insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Systemic Mastocytosis with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Systemic Mastocytosis Treatment.
* Systemic Mastocytosis Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Systemic Mastocytosis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Systemic Mastocytosis market

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Systemic Mastocytosis Companies

AB Sciences, Blueprint Medicines, Patara Pharma, Seagen Inc., GT Biopharma, Deciphera Pharmaceuticals, Novartis Oncology and others.

Systemic Mastocytosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

* Oral
* Parenteral
* Intravenous
* Subcutaneous
* Topical
* Molecule Type

Systemic Mastocytosis Products have been categorized under various Molecule types such as

* Monoclonal Antibody
* Peptides
* Polymer
* Small molecule
* Gene therapy
* Product Type

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Scope of the Systemic Mastocytosis Pipeline Report

* Coverage- Global
* Systemic Mastocytosis Companies- AB Sciences, Blueprint Medicines, Patara Pharma, Seagen Inc., GT Biopharma, Deciphera Pharmaceuticals, Novartis Oncology and others.
* Systemic Mastocytosis Pipeline Therapies- PA101, Avapritinib, RAD001 (Everolimus), Elenestinib, Masitinib, Avapritinib, Brentuximab vedotin, TL-895 and others.
* Systemic Mastocytosis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Systemic Mastocytosis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content

* Introduction
* Executive Summary
* Systemic Mastocytosis: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Systemic Mastocytosis - DelveInsight's Analytical Perspective
* In-depth Commercial Assessment
* Systemic Mastocytosis Collaboration Deals
* Late Stage Products (Preregistration)
* Avapritinib: Blueprint Medicines
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* PA101: Patara Pharma
* Drug profiles in the detailed report.....
* Early stage products (Phase I)
* DCC-2618: Deciphera Pharmaceuticals
* Drug profiles in the detailed report.....
* Inactive Products
* Systemic Mastocytosis Key Companies
* Systemic Mastocytosis Key Products
* Systemic Mastocytosis- Unmet Needs
* Systemic Mastocytosis- Market Drivers and Barriers
* Systemic Mastocytosis- Future Perspectives and Conclusion
* Systemic Mastocytosis Analyst Views
* Systemic Mastocytosis Key Companies
* Appendix

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