Gastrointestinal Stromal Tumors Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Gastrointestinal Stromal Tumors Pipeline Insight" report provides comprehensive insights about 25+ companies and 28+ pipeline drugs in Gastrointestinal Stromal Tumors pipeline landscape. It covers the Gastrointestinal Stromal Tumors pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Gastrointestinal Stromal Tumors 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 Gastrointestinal Stromal Tumors Pipeline Report

* In March 2025, Deciphera Pharmaceuticals, LLC conducted a two-arm, randomized, open-label, international, multicenter study to compare the efficacy of ripretinib versus sunitinib in patients with gastrointestinal stromal tumors (GIST) who have progressed on or were intolerant to first-line treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to receive either ripretinib (150 mg once daily, continuous dosing in 6-week cycles) or sunitinib (50 mg once daily in 6-week cycles, with 4 weeks on and 2 weeks off).
* In March 2025, Zai Lab (Shanghai) Co., Ltd. conducted a trial with the primary objective of evaluating progression-free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed after prior anticancer therapies, based on independent radiologic review.
* DelveInsight's Gastrointestinal Stromal Tumors Pipeline analysis depicts a robust space with 25+ active players working to develop 28+ pipeline treatment therapies.
* The leading Gastrointestinal Stromal Tumors Companies such as Jiangsu Hengrui Medicine, Daiichi Sankyo Company, Cogent Biosciences, Advenchen Laboratories, Chia Tai Tianqing Pharmaceutical Group, AB Science, Immunicum AB, Novartis, Bristol-Myers Squibb, Hanmi Pharmaceutical Company Limited, GlaxoSmithKline, Ascentage Pharma, Takeda, Array BioPharma, Plexxikon, Arog Pharmaceuticals, Xencor, Inc., DNAtrix, Inc., Onyx Pharmaceuticals, Exelixis, Allarity Therapeutics, Theseus Pharmaceuticals, IDRx, Inc., Allarity Therapeutics , and others.
* Promising Gastrointestinal Stromal Tumors Therapies such as Belzutifan, Sunitinib, CGT9486, DCC-3116, Ripretinib, UCB4594, and others.

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Gastrointestinal Stromal Tumors (GIST) Emerging Drugs

* Famitinib: Jiangsu Hengrui Medicine

Famitinib, an orally active, small molecule, is a tyrosine kinase inhibitor against multiple targets, including vascular endothelial growth factor receptor 2/3, platelet-derived growth factor receptor, and stem cell factor receptor (c-kit). Jiangsu Hengrui Medicine Co is developing famitinib against a wide variety of advanced-stage solid cancers. The drug is currently in phase 3 of clinical development for the treatment of Gastrointestinal Stromal Tumors (GIST).

* Nilotinib: Novartis

Tasigna (nilotinib hydrochloride monohydrate) is an orally available signal transduction inhibitor of the Bcr-Abl kinase, c-kit and Platelet Derived Growth Factor (PDGF), all of which play a role in cell proliferation, cell migration, and angiogenesis. Tasigna is specifically indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The drug is currently being investigated in Phase II clinical trial to evaluate its potential for the treatment of gastrointestinal stromal tumors.

* THE-630: Theseus Pharmaceuticals

THE-630 is a pan-variant inhibitor of the receptor tyrosine kinase KIT. It is designed for patients with advanced GIST whose cancer has developed resistance to earlier lines of therapy by accruing mutations that render those therapies ineffective. In GIST, these mutations occur most often in the KIT protein, where a patient can have multiple KIT mutations simultaneously, leading to complex disease heterogeneity. In preclinical studies, THE-630 demonstrated potent in vitro and in vivo activity against all major classes of KIT activating and resistance mutations in GIST. Moreover, THE-630 achieved predicted pan-variant KIT inhibitory blood concentrations at tolerable doses and was associated with significant anti-tumor activity. Theseus Pharmaceuticals is currently conducting Phase I/II study to evaluate lead candidate, THE-630, in patients with advanced gastrointestinal stromal tumors (GIST).

* DS 6157: Daiichi Sankyo Company

DS-6157 is a potential first-in-class GPR20 targeting ADC and the fifth DXd ADC in the oncology pipeline of Daiichi Sankyo to enter clinical development. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed utilizing Daiichi Sankyo's proprietary DXd ADC technology, DS-6157 is comprised of a humanized anti-GPR20 monoclonal antibody, which is attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. The drug is currently in Phase I stage of clinical trial evaluation to treat Gastrointestinal Stromal Tumors.

The Gastrointestinal Stromal Tumors pipeline report provides insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Gastrointestinal Stromal Tumors 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 Gastrointestinal Stromal Tumors Treatment.
* Gastrointestinal Stromal Tumors Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Gastrointestinal Stromal Tumors 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 Gastrointestinal Stromal Tumors market.

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Gastrointestinal Stromal Tumors Companies

Jiangsu Hengrui Medicine, Daiichi Sankyo Company, Cogent Biosciences, Advenchen Laboratories, Chia Tai Tianqing Pharmaceutical Group, AB Science, Immunicum AB, Novartis, Bristol-Myers Squibb, Hanmi Pharmaceutical Company Limited, GlaxoSmithKline, Ascentage Pharma, Takeda, Array BioPharma, Plexxikon, Arog Pharmaceuticals, Xencor, Inc., DNAtrix, Inc., Onyx Pharmaceuticals, Exelixis, Allarity Therapeutics, Theseus Pharmaceuticals, IDRx, Inc., Allarity Therapeutics, and others.

Gastrointestinal Stromal Tumors pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration

* Oral
* Parenteral
* Intravenous
* Subcutaneous
* Topical

Gastrointestinal Stromal Tumors Products have been categorized under various Molecule types such as

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

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Scope of the Gastrointestinal Stromal Tumors Pipeline Report

* Coverage- Global
* Gastrointestinal Stromal Tumors Companies- Jiangsu Hengrui Medicine, Daiichi Sankyo Company, Cogent Biosciences, Advenchen Laboratories, Chia Tai Tianqing Pharmaceutical Group, AB Science, Immunicum AB, Novartis, Bristol-Myers Squibb, Hanmi Pharmaceutical Company Limited, GlaxoSmithKline, Ascentage Pharma, Takeda, Array BioPharma, Plexxikon, Arog Pharmaceuticals, Xencor, Inc., DNAtrix, Inc., Onyx Pharmaceuticals, Exelixis, Allarity Therapeutics, Theseus Pharmaceuticals, IDRx, Inc., Allarity Therapeutics, and others.
* Gastrointestinal Stromal Tumors Therapies- Belzutifan, Sunitinib, CGT9486, DCC-3116, Ripretinib, UCB4594, and others.
* Gastrointestinal Stromal Tumors Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Gastrointestinal Stromal Tumors Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Get the latest on Gastrointestinal Stromal Tumors Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Gastrointestinal Stromal Tumors Companies, Key Products and Unmet Needs [https://www.delveinsight.com/sample-request/gastrointestinal-stromal-tumor-gist-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Table of Content

* Introduction
* Executive Summary
* Gastrointestinal Stromal Tumors: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Gastrointestinal Stromal Tumors - DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Famitinib: Jiangsu Hengrui Medicine
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* Nilotinib: Novartis
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* DS 6157: Daiichi Sankyo Company
* Drug profiles in the detailed report.....
* Inactive Products
* Gastrointestinal Stromal Tumors Key Companies
* Gastrointestinal Stromal Tumors Key Products
* Gastrointestinal Stromal Tumors- Unmet Needs
* Gastrointestinal Stromal Tumors- Market Drivers and Barriers
* Gastrointestinal Stromal Tumors- Future Perspectives and Conclusion
* Gastrointestinal Stromal Tumors Analyst Views
* Gastrointestinal Stromal Tumors Key Companies
* Appendix

About Us

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