gastrointestinal stromal tumor gist pipeline insight

DelveInsight’s, “Gastrointestinal stromal tumor Pipeline Insight, 2026” report provides comprehensive insights about 22+ companies and 25+ pipeline drugs in Gastrointestinal stromal tumor pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Gastrointestinal stromal tumor Understanding

Gastrointestinal stromal tumor Overview

Gastrointestinal stromal tumor (GIST) is a rare malignancy arising in the gastrointestinal tract or adjacent intra-abdominal structures. Classified as a soft tissue sarcoma, it originates from the interstitial cells of Cajal (ICCs), which regulate gut motility, or from precursor cells capable of differentiating into ICCs. The disease is primarily driven by mutually exclusive activating mutations, most commonly in the KIT gene and less frequently in PDGFRA, with additional rare alterations contributing to its molecular heterogeneity.

At the molecular level, these mutations lead to constitutive, ligand-independent activation of tyrosine kinase receptors, triggering downstream signaling pathways such as MAPK and PI3K/AKT that promote uncontrolled cell proliferation and survival. Most GISTs harbor KIT exon 11 or PDGFRA exon 18 mutations, while approximately 10–15% are wild-type and may involve alternative drivers such as NF1 or BRAF mutations, or succinate dehydrogenase (SDH) deficiency often associated with metabolic and epigenetic dysregulation. Histologically, GISTs commonly exhibit spindle cell morphology and are characterized by positive immunohistochemical staining for CD117 (KIT) and DOG1.
Clinically, GISTs often present with nonspecific symptoms, including abdominal discomfort, early satiety, nausea, and weight loss, depending on tumor size and location. Gastrointestinal bleeding is frequent and may manifest as hematemesis, melena, or anemia-related fatigue. Larger tumors can cause obstruction, and rarely, perforation, while esophageal involvement may result in dysphagia. Notably, many cases remain asymptomatic and are incidentally identified during imaging performed for unrelated indications.

Diagnosis requires a multimodal approach integrating imaging, endoscopic techniques, and tissue-based analyses. Contrast-enhanced CT is the primary imaging modality, supplemented by MRI or PET scans to evaluate disease extent and metastasis. Endoscopic ultrasound (EUS)-guided fine-needle aspiration or core biopsy is the gold standard for tissue acquisition. Definitive diagnosis is established through histopathological assessment, immunohistochemistry (CD117, DOG1), and molecular testing for KIT and PDGFRA mutations, as imaging alone is insufficient.

Management is guided by disease stage, mutational profile, and patient-specific considerations, with surgery and tyrosine kinase inhibitors (TKIs) forming the cornerstone of treatment. Complete (R0) surgical resection is standard for localized disease, while lymph node dissection is generally unnecessary. Imatinib remains the first-line TKI for high-risk, metastatic, or recurrent GIST, with dosing tailored to mutation status. In cases of resistance or progression, alternative TKIs such as sunitinib, regorafenib, ripretinib, or avapritinib are employed, supported by ongoing surveillance and a multidisciplinary, mutation-informed treatment approach.

"Gastrointestinal stromal tumor Pipeline Insight, 2026" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Gastrointestinal stromal tumor pipeline landscape is provided which includes the disease overview and Gastrointestinal stromal tumor treatment guidelines. The assessment part of the report embraces, in depth Gastrointestinal stromal tumor commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Gastrointestinal stromal tumor collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Gastrointestinal stromal tumor Pipeline Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Gastrointestinal stromal tumor R&D. The therapies under development are focused on novel approaches to treat/improve Gastrointestinal stromal tumor.

Gastrointestinal stromal tumor Emerging Drugs Analysis

This segment of the Gastrointestinal stromal tumor report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Gastrointestinal stromal tumor Emerging Drugs

GSK6042981: GSK

GSK6042981 is an investigational, orally administered small-molecule KIT inhibitor being developed by GSK for the treatment of solid tumors. It is designed to target key oncogenic signaling pathways involved in tumor growth and survival, with a focus on genetically defined patient populations. In gastrointestinal stromal tumor, the agent aims to overcome resistance mechanisms associated with existing kinase inhibitors and improve disease control. GSK6042981 is currently in Phase III stage of its development for the treatment of Gastrointestinal stromal tumor.

DCC-3009: Ono Pharmaceuticals

DCC-3009 is an investigational, orally administered pan-KIT inhibitor being developed by Ono Pharmaceuticals. It is designed to broadly inhibit KIT signaling, a primary oncogenic driver in gastrointestinal stromal tumor, including resistant KIT mutations. By targeting multiple KIT variants, the drug aims to overcome limitations of earlier-generation tyrosine kinase inhibitors. Currently in Phase II stage of its clinical development, DCC-3009 is being evaluated for its safety, pharmacokinetics, and potential antitumor activity in GIST patients.

Ziftomenib: Kura Oncology

Ziftomenib is an investigational, once-daily oral menin inhibitor being developed to treat genetically defined cancers, including gastrointestinal stromal tumor. It is designed to selectively target key molecular drivers of disease progression, particularly in patients with limited therapeutic options. By inhibiting menin, the drug seeks to disrupt critical oncogenic signaling pathways in high-risk GIST populations. Ziftomenib is currently being evaluated in a Phase I clinical trial for the treatment of Gastrointestinal stromal tumor.

Further product details are provided in the report……..

Gastrointestinal stromal tumor Drug Therapeutic Assessment

This segment of the report provides insights about the different Gastrointestinal stromal tumor drugs segregated based on following parameters that define the scope of the report, such as:

Major Gastrointestinal stromal tumor Players in Gastrointestinal stromal tumor

There are approx. 22+ key companies which are developing the therapies for Gastrointestinal stromal tumor. The companies which have their Gastrointestinal stromal tumor drug candidates in the most advanced stage, i.e. Phase III include, GSK.

Gastrointestinal stromal tumor Clinical Trial Phases

DelveInsight’s report covers around 25+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of 
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Gastrointestinal stromal tumor Drug 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

• Oral
• Intravenous
• Subcutaneous
• Parenteral 
• Topical

Gastrointestinal stromal tumor Product Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer 
• Gene therapy

Gastrointestinal stromal tumor Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Gastrointestinal stromal tumor Clinical Trial Activities

The Gastrointestinal stromal tumor Pipeline report provides insights into different Gastrointestinal stromal tumor Clinical Trial within Phase III, II, I, preclinical and discovery stage. It also analyses Gastrointestinal stromal tumor therapeutic drugs key players involved in developing key drugs. 

Gastrointestinal stromal tumor Pipeline Development Activities

The Gastrointestinal stromal tumor Clinical Analysis report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Gastrointestinal stromal tumor drugs.

Gastrointestinal stromal tumor Pipeline Report Insights

• Gastrointestinal stromal tumor Pipeline Analysis
• Gastrointestinal stromal tumor Therapeutic Assessment
• Gastrointestinal stromal tumor Unmet Needs
• Impact of Gastrointestinal stromal tumor Drugs

Gastrointestinal stromal tumor Pipeline Report Assessment

• Gastrointestinal stromal tumor Pipeline Product Profiles
• Gastrointestinal stromal tumor Therapeutic Assessment
• Gastrointestinal stromal tumor Pipeline Assessment
• Gastrointestinal stromal tumor Inactive drugs assessment
• Gastrointestinal stromal tumor Market Unmet Needs

Key Questions Answered in the Gastrointestinal stromal tumor Pipeline Report

• Current Treatment Scenario and Emerging Therapies:
• How many companies are developing Gastrointestinal stromal tumor drugs?
• How many Gastrointestinal stromal tumor drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Gastrointestinal stromal tumor?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Gastrointestinal stromal tumor therapeutics? 
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? 
• What are the clinical studies going on for Gastrointestinal stromal tumor and their status?
• What are the key designations that have been granted to the emerging drugs?

Gastrointestinal stromal tumor Key Players

• GSK
• Kura Oncology
• Novelty Nobility, Inc
• Hoth Therapeutics, Inc.
• Ono Pharmaceuticals
• Merck
• Biodexa Pharmaceuticals
• Newbay Technology Development Co., Ltd
• Kumquat Biosciences
• Ascentage Pharma
• Cogent Biosciences

Gastrointestinal stromal tumor Key Products

• GSK6042981
• Ziftomenib
• NN3201
• HT-KIT
• DCC 3009
• MK 6482
• MTX 240
• NB003
• KQB198
• HQP1351
• Bezuclastinib