Ozmosi | IDRX-42 Drug Profile

Product Description

IDRX-42, an orally administered small molecule tyrosine kinase inhibitor, is a drug candidate from IDRx for the treatment of Metastatic and/or Unresectable Gastrointestinal Stromal Tumors. (Sourced from: https://clinicaltrials.gov/ct2/show/NCT05489237?term=IDRX-42&draw=2&rank=1)

Mechanisms of Action: TK Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: GSK
Company Location: Europe
Company Founding Year: 2000
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for IDRX-42

Countries in Clinic: Belgium, Brazil, Canada, China, France, Germany, Hungary, Italy, Japan, Korea, Netherlands, Norway, Poland, Romania, South Korea, Spain, Taiwan, United Kingdom, United States, Unknown Location

Active Clinical Trial Count: 6

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Gastrointestinal Cancer|Gastrointestinal Stromal Tumors

Phase 1: Digestive System Cancer|Intestinal Diseases

Trial ID	Trial	Phase	Trial Status	Disease	Primary Completion Date	Probability of Success	Latest Trial Update Date	Data Updated
NCT05489237	Study ID: StrateGIST 1	P1	Recruiting	Gastrointestinal Stromal Tumors\|Intestinal Diseases\|Gastrointestinal Cancer\|Digestive System Cancer	2027-11-03	12%	2025-11-18
jRCT2051240255	jRCT2051240255	P1	Not yet recruiting	Gastrointestinal Stromal Tumors	2027-10-31
CTR20230641	CTR20230641	P1	Recruiting	Gastrointestinal Stromal Tumors	None		2025-08-13	Patient Enrollment\|Treatments\|Trial Status
2025-522229-37-00	300383	P3	Not yet recruiting	Gastrointestinal Cancer	2030-10-30	38%
jRCT2031250371	jRCT2031250371	P3	Not yet recruiting	Gastrointestinal Stromal Tumors	2028-10-30
NCT07218926	StrateGIST 3	P3	Recruiting	Gastrointestinal Cancer\|Gastrointestinal Stromal Tumors	2028-05-30	38%	2025-12-24

Recent News Events

Date	Type	Title
10/23/2025	News Article	Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma
07/23/2025	News Article	Blenrep (belantamab mafodotin) combinations approved in Canada for the treatment of relapsed/refractory multiple myeloma
01/22/2025	News Article	Demand for Advanced Pancreatic Cancer Treatments at All Time High as Promising Options Come into Focus
01/13/2025	News Article	GSK Enters Agreement to Acquire IDRx, Inc.
03/01/2024	PubMed	KIT/PDGFRA inhibitors for the treatment of gastrointestinal stromal tumors: getting to the gist of the problem.
08/01/2023	PubMed	Antitumor Efficacy of the Novel KIT Inhibitor IDRX-42 (Formerly M4205) in Patient- and Cell Line-Derived Xenograft Models of Gastrointestinal Stromal Tumor (GIST).
02/23/2023	PubMed	Identification of M4205─A Highly Selective Inhibitor of KIT Mutations for Treatment of Unresectable Metastatic or Recurrent Gastrointestinal Stromal Tumors.

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IDRX-42

Alternative Names: IDRX-42, IDRX 42, IDRX42, GSK-6042981, GSK6042981, GSK 6042981 Clinical Status: Active Latest Update: 2026-02-10 Latest Update Note: Clinical Trial Update