“Gastrointestinal Stromal Tumor Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Gastrointestinal Stromal Tumor Market.
The Gastrointestinal Stromal Tumor Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.
Some of the key takeaways from the Gastrointestinal Stromal Tumor Pipeline Report:
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Companies across the globe are diligently working toward developing novel Gastrointestinal Stromal Tumor treatment therapies with a considerable amount of success over the years.
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Gastrointestinal Stromal Tumor companies working in the treatment market are Deciphera, Blueprint Medicines, Bayer, Cogent Biosciences, GSK, Sartar Therapeutics, IDRx, Inc, Theseus Pharmaceuticals, Novartis, Arog Pharmaceuticals, Inc., Jiangsu HengRui Medicine Co., Ltd., Cogent Biosciences, Inc., Cogent Biosciences, Ascentage Pharma Group, Daiichi Sankyo Company, and others, are developing therapies for the Gastrointestinal Stromal Tumor treatment
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Emerging Gastrointestinal Stromal Tumor therapies in the different phases of clinical trials are- QINLOCK (ripretinib), AYVAKIT (avapritinib), VITRAKVI (larotrectinib), Bezuclastinib, GSK6042981, SAR003, IDRX-42, THE-630, PDR001, Crenolanib, Famitinib, CGT9486, PLX9486, Nilotinib, HQP1351, DS 6157, and others are expected to have a significant impact on the Gastrointestinal Stromal Tumor market in the coming years.
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In August 2025, In patients with advanced gastrointestinal stromal tumors (GIST) who had not received prior treatment, the combination of Gleevec (imatinib) and Mektovi (binimetinib) demonstrated strong and lasting clinical benefits in terms of disease progression and overall survival. Findings from a ten-year follow-up of this regimen, conducted in a single-center, single-arm Phase 2 study, were presented at the 2025 American Society of Clinical Oncology Annual Meeting and published in the Journal of Clinical Oncology.
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In August 2025, With a median follow-up of over 18 years, imatinib (Gleevec) was shown to achieve 20-year survival in more than 10% of patients with advanced gastrointestinal stromal tumors (GIST). Higher long-term survival rates were observed in women, patients with smaller primary tumors, and those with KIT exon 11 mutations, according to results from the Phase 3 BFR14 trial (NCT00367861). Published in Annals of Oncology, the study reported a median overall survival (OS) of 75.3 months (95% CI, 63.9–86.6) for all 424 patients, with a median GIST-specific survival of 83 months (95% CI, 70.2–97.7).
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In April 2025, Kura Oncology enrolled the first participants in the open-label Phase Ia/Ib KOMET-015 trial, investigating the oral menin inhibitor ziftomenib for advanced gastrointestinal stromal tumors (GIST) after imatinib failure. This dose-escalation study is designed to evaluate the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib in adults with GIST. The primary objectives are to determine tolerability, assess safety, and establish the recommended Phase II dose. Following dose escalation, expansion cohorts will further examine ziftomenib’s safety, clinical activity, and overall tolerability.
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In January 2025, The combination of bezuclastinib (CGT9486) and sunitinib (Sutent) demonstrated promising efficacy and long-term tolerability in patients with previously treated gastrointestinal stromal tumors (GIST), outperforming historical data. These results come from part 1 of the Phase 3 Peak study (NCT05208047) and were presented at the 2025 Gastrointestinal Cancers Symposium.
Gastrointestinal Stromal Tumor Overview
Gastrointestinal stromal tumor (GIST) is a rare type of cancer that develops in the digestive tract, most commonly in the stomach or small intestine. It originates from specialized cells in the gastrointestinal tract called interstitial cells of Cajal, which help regulate gut motility. GISTs can be benign or malignant and often grow silently, sometimes causing symptoms like abdominal pain, bloating, or gastrointestinal bleeding. Diagnosis typically involves imaging studies and biopsy, and treatment may include surgery, targeted therapies (such as tyrosine kinase inhibitors), and close monitoring to manage tumor growth and reduce recurrence risk.
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Emerging Gastrointestinal Stromal Tumor Drugs Under Different Phases of Clinical Development Include:
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QINLOCK (ripretinib): Deciphera
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AYVAKIT (avapritinib): Blueprint Medicines
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VITRAKVI (larotrectinib): Bayer
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Bezuclastinib: Cogent Biosciences
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GSK6042981: GSK
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SAR003: Sartar Therapeutics
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IDRX-42: IDRx, Inc
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THE-630: Theseus Pharmaceuticals
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PDR001: Novartis
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Crenolanib: Arog Pharmaceuticals, Inc.
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Famitinib: Jiangsu HengRui Medicine Co., Ltd.
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CGT9486: Cogent Biosciences, Inc.
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PLX9486: Cogent Biosciences
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Nilotinib: Novartis
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HQP1351: Ascentage Pharma Group
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DS 6157: Daiichi Sankyo Company
Gastrointestinal Stromal Tumor Emerging Therapies Assessment:
QINLOCK (ripretinib): Deciphera
QINLOCK (ripretinib) is an oral switch-control kinase inhibitor designed to treat GIST, targeting a broad range of KIT and PDGFRA mutations, including initiating and resistance mutations in exons 9, 11, 13, 14, 17, and 18. Beyond its approved use, it is also under Phase III investigation as a second-line therapy, underscoring its potential to expand treatment options and address resistance challenges in GIST.
AYVAKIT (avapritinib): Blueprint Medicines
AYVAKIT (avapritinib) is a selective kinase inhibitor approved for adults with unresectable or metastatic GIST harboring PDGFRA exon 18 mutations, including D842V, and Advanced Systemic Mastocytosis (AdvSM).
VITRAKVI (larotrectinib): Bayer
VITRAKVI (larotrectinib) is a kinase inhibitor approved for adults and children with solid tumors harboring an NTRK gene fusion without resistance mutations. It is indicated for metastatic or inoperable GIST with no satisfactory treatments or progression post-therapy.
Bezuclastinib: Cogent Biosciences
Bezuclastinib is a highly selective Type I inhibitor of the KIT receptor tyrosine kinase, targeting oncogenic KIT mutations in the activation loop encoded by exons 17 and 18, including KIT D816V, a key driver mutation in most cases of systemic mastocytosis.
GSK6042981: GSK
GSK6042981 also known as IDRX-42, an oral KIT tyrosine kinase inhibitor, is under clinical development for GIST, the most common soft tissue sarcoma in the gastrointestinal tract.
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Designed to target key KIT mutations driving tumor growth and resistance, GSK6042981 aims to address significant unmet needs in GIST treatment. Currently being evaluated in the Phase I/Ib StrateGIST 1 trial, IDRX-42 has shown promising anti-tumor activity, including a 53% objective response rate in second-line patients.
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Plans are underway for StrateGIST 3, a Phase III trial for second-line GIST therapy. The US FDA has granted IDRX-42 FTD and ODD.
SAR003: Sartar Therapeutics
SAR003, developed by Sartar Therapeutics, is a first in-class molecular glue in preclinical development for GIST and PDE3A-expressing sarcomas. By binding PDE3A to Schlafen12, it induces selective cancer cell death, including in TKI-resistant tumors. Backed by ODD in the US and EU and strong IP protection, SAR003 is being advanced for both monotherapy and combination approaches, positioning it as a promising precision therapy to address key unmet needs in advanced GIST.
Gastrointestinal Stromal Tumor Route of Administration
Gastrointestinal Stromal Tumor pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as
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Oral
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Parenteral
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Intravenous
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Subcutaneous
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Topical
Gastrointestinal Stromal Tumor Molecule Type
Gastrointestinal Stromal Tumor Products have been categorized under various Molecule types, such as
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Monoclonal Antibody
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Peptides
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Polymer
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Small molecule
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Gene therapy
Gastrointestinal Stromal Tumor Pipeline Therapeutics Assessment
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Gastrointestinal Stromal Tumor Assessment by Product Type
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Gastrointestinal Stromal Tumor By Stage and Product Type
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Gastrointestinal Stromal Tumor Assessment by Route of Administration
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Gastrointestinal Stromal Tumor By Stage and Route of Administration
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Gastrointestinal Stromal Tumor Assessment by Molecule Type
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Gastrointestinal Stromal Tumor by Stage and Molecule Type
DelveInsight's Gastrointestinal Stromal Tumor Report covers around 28+ products under different phases of clinical development like
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Late-stage products (Phase III)
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Mid-stage products (Phase II)
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Early-stage product (Phase I)
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Pre-clinical and Discovery stage candidates
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Discontinued & Inactive candidates
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Route of Administration
Further Gastrointestinal Stromal Tumor product details are provided in the report. Download the Gastrointestinal Stromal Tumor pipeline report to learn more about the emerging Gastrointestinal Stromal Tumor therapies
Some of the key companies in the Gastrointestinal Stromal Tumor Therapeutics Market include:
Key companies developing therapies for Gastrointestinal Stromal Tumor are - Novartis, Bayer, Pfizer, Deciphera Pharmaceuticals, Blueprint Medicines Corporation, Loxo Oncology, Roche, Arog Pharmaceuticals, Taiho Pharmaceutical, Turning Point Therapeutics, Inc., Cogent Biosciences, Inc., Plexxikon Inc., Theseus Pharmaceuticals, Exelixis, Inc., Ipsen, Bristol-Myers Squibb, Takeda, and others.
Gastrointestinal Stromal Tumor Pipeline Analysis:
The Gastrointestinal Stromal Tumor pipeline report provides insights into
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The report provides detailed insights about companies that are developing therapies for the treatment of Gastrointestinal Stromal Tumor with aggregate therapies developed by each company for the same.
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It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Gastrointestinal Stromal Tumor Treatment.
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Gastrointestinal Stromal Tumor key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
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Gastrointestinal Stromal Tumor 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.
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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Gastrointestinal Stromal Tumor market.
The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.
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Gastrointestinal Stromal Tumor Pipeline Market Drivers
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Increasing prevalence of digestive disorders, increasing investment of biotechnology and pharmaceutical industries in research and development, availability of funds is likely to drive the growth of the Gastrointestinal Stromal Tumor are some of the important factors that are fueling the Gastrointestinal Stromal Tumor Market.
Gastrointestinal Stromal Tumor Pipeline Market Barriers
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However, higher cost associated with the treatment procedure and hence, this is a major fact that might be responsible for slowing the market growth, reimbursement Policies and other factors are creating obstacles in the Gastrointestinal Stromal Tumor Market growth.
Scope of Gastrointestinal Stromal Tumor Pipeline Drug Insight
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Coverage: Global
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Key Gastrointestinal Stromal Tumor Companies: Deciphera, Blueprint Medicines, Bayer, Cogent Biosciences, GSK, Sartar Therapeutics, IDRx, Inc, Theseus Pharmaceuticals, Novartis, Arog Pharmaceuticals, Inc., Jiangsu HengRui Medicine Co., Ltd., Cogent Biosciences, Inc., Cogent Biosciences, Ascentage Pharma Group, Daiichi Sankyo Company, and others
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Key Gastrointestinal Stromal Tumor Therapies: QINLOCK (ripretinib), AYVAKIT (avapritinib), VITRAKVI (larotrectinib), Bezuclastinib, GSK6042981, SAR003, IDRX-42, THE-630, PDR001, Crenolanib, Famitinib, CGT9486, PLX9486, Nilotinib, HQP1351, DS 6157, and others
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Gastrointestinal Stromal Tumor Therapeutic Assessment: Gastrointestinal Stromal Tumor current marketed and Gastrointestinal Stromal Tumor emerging therapies
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Gastrointestinal Stromal Tumor Market Dynamics: Gastrointestinal Stromal Tumor market drivers and Gastrointestinal Stromal Tumor market barriers
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Table of Contents
1. Gastrointestinal Stromal Tumor Report Introduction
2. Gastrointestinal Stromal Tumor Executive Summary
3. Gastrointestinal Stromal Tumor Overview
4. Gastrointestinal Stromal Tumor- Analytical Perspective In-depth Commercial Assessment
5. Gastrointestinal Stromal Tumor Pipeline Therapeutics
6. Gastrointestinal Stromal Tumor Late Stage Products (Phase II/III)
7. Gastrointestinal Stromal Tumor Mid Stage Products (Phase II)
8. Gastrointestinal Stromal Tumor Early Stage Products (Phase I)
9. Gastrointestinal Stromal Tumor Preclinical Stage Products
10. Gastrointestinal Stromal Tumor Therapeutics Assessment
11. Gastrointestinal Stromal Tumor Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Gastrointestinal Stromal Tumor Key Companies
14. Gastrointestinal Stromal Tumor Key Products
15. Gastrointestinal Stromal Tumor Unmet Needs
16 . Gastrointestinal Stromal Tumor Market Drivers and Barriers
17. Gastrointestinal Stromal Tumor Future Perspectives and Conclusion
18. Gastrointestinal Stromal Tumor Analyst Views
19. Appendix
20. About DelveInsight
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.
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