Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors of the gastrointestinal (GI) tract. As per Sneh Sonaiya et al., 2025, the disease accounts for an annual global incidence of 7-20 cases per million adults and a prevalence of 129 per million adults. GIST accounts for a significant portion of GI malignancies and continues to attract research attention due to its complex molecular profile. According to the gastrointestinal stromal tumors (GIST) pipeline analysis by Expert Market Research, the market for GIST therapeutic products is expected to grow steadily, driven by the development of targeted therapies and increasing diagnosis rates.
Major companies involved in the gastrointestinal stromal tumors (GIST) pipeline analysis include Novartis Pharmaceuticals, Cogent Biosciences, Inc., and others.
Leading drugs currently in the pipeline include DCC-3009, UCB4594, IDRX-42, and others.
The gastrointestinal stromal tumors (GIST) drug pipeline is expanding due to advancements in tyrosine kinase inhibitors, increased clinical trials for rare mutations, and rising investments in targeted therapies
The Gastrointestinal Stromal Tumors (GIST) Pipeline Analysis Report by Expert Market Research gives comprehensive insights into gastrointestinal stromal tumors (GIST) therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for gastrointestinal stromal tumors (GIST). The gastrointestinal stromal tumors (GIST) report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The gastrointestinal stromal tumors (GIST) pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with gastrointestinal stromal tumors (GIST) treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to gastrointestinal stromal tumors (GIST).
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Gastrointestinal stromal tumors (GIST) are rare tumors that originate in the ICC (interstitial cells of Cajal within the gastrointestinal tract), most commonly in the stomach or small intestine. They occur due to mutations, typically in the KIT or PDGFRA genes, which lead to uncontrolled cell growth. GIST is considered the most prevalent type of soft tissue sarcoma in the digestive system.
Gastrointestinal stromal tumors (GIST) are primarily treated with tyrosine kinase inhibitors such as imatinib. Advanced cases may require surgery, targeted therapies, or second-line drugs following resistance to initial treatment. In August 2024, Kura Oncology received FDA clearance for an Investigational New Drug (IND) application to evaluate ziftomenib in combination with imatinib for advanced GIST. This novel menin inhibitor aims to resensitize resistant patients to imatinib, showing promise for deeper, sustained responses.
According to Sneh Sonaiya et al., 2025, the global incidence of gastrointestinal stromal tumors (GISTs) ranges from 7 to 20 cases per million adults, with a prevalence of 129 per million. As per the National Organization for Rare Disorders, approximately 5,000-6,000 new cases occur annually in the United States. According to Dinesh Abhijeeth Shanker et al., 2024, the annual incidence in the United Kingdom is estimated at 1.32 to 1.50 per 100,000 individuals. These data highlight the need for continued research and targeted drug development.
This section of the report covers the analysis of gastrointestinal stromal tumors (GIST) drug candidates based on several segmentations, including:
By Phase
By Drug Class
By Route of Administration
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II accounts for 64%, covering a major share of the total gastrointestinal stromal tumors (GIST) clinical trials. It reflects a strong focus on therapeutic development and clinical validation. Phase I holds 24%, while phase III contributes 11%. The robust pipeline across these phases indicates promising advancements that can significantly enhance treatment options and accelerate market growth.
The drug molecule categories covered under the gastrointestinal stromal tumors (GIST) pipeline analysis include small molecules, monoclonal antibodies, gene therapies, peptides, and polymers. The gastrointestinal stromal tumors (GIST) report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for gastrointestinal stromal tumors (GIST). Antibody-drug conjugates are gaining attention in the treatment landscape of gastrointestinal stromal tumors. For instance, NN3201, a c-Kit-targeting monoclonal antibody-drug conjugate linked to monomethyl auristatin E, is under Phase 1 investigation. It is designed to selectively bind c-Kit–expressing tumor cells, induce internalization, and deliver cytotoxic payloads, showing promise in overcoming imatinib resistance in GIST patients.
The EMR report for the gastrointestinal stromal tumors (GIST) pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed gastrointestinal stromal tumors (GIST) therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in gastrointestinal stromal tumors (GIST) clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for gastrointestinal stromal tumors (GIST). It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of gastrointestinal stromal tumors (GIST) drug candidates.
DCC-3009 is being evaluated by Deciphera Pharmaceuticals, LLC in a Phase 1/2 master protocol study for gastrointestinal stromal tumor (GIST). This next-generation KIT inhibitor is targeting primary KIT mutations in exons 9 and 11, as well as resistant mutations in exons 13, 14, 17, and 18. The study is examining its safety, tolerability, and effectiveness, with treatment continuing in 28-day cycles over an estimated two-year duration.
UCB4594, sponsored by Cancer Research UK, is currently undergoing a Phase I/II clinical trial in participants with advanced cancers. This monoclonal antibody targets HLA-G, a protein found on certain cancer cells, potentially helping the immune system attack them. The trial is assessing safety, tolerability, pharmacokinetics, and early anti-tumor activity. Researchers are determining the optimal dose and monitoring how UCB4594 behaves and performs in the human body.
IDRX-42 is an investigational oral small molecule tyrosine kinase inhibitor. It is being developed by IDRx for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST). The ongoing Phase 1/1b study is evaluating its safety, tolerability, pharmacokinetics, and preliminary antitumor activity. IDRX-42 is specifically designed to target primary KIT mutations (exons 9 and 11) and resistance mutations (exons 13 and 17), aiming to overcome limitations of current therapies like imatinib and sunitinib.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The Gastrointestinal Stromal Tumors (GIST) Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for gastrointestinal stromal tumors (GIST). It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into gastrointestinal stromal tumors (GIST) collaborations, regulatory environments, and potential growth opportunities.
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