Drugs / IDRX-42
last change Aug 2026 re-read 9 days ago

IDRX-42

also known as Velzatinib · GSK6042981 · M-4205

Small molecule

Developed for
digestive system neoplasm · gastrointestinal stromal tumor · metastatic malignant neoplasm
Investigated by
GlaxoSmithKline · GSK

Trials 8

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT07859735 Nov 2026 → Apr 2028 expected digestive system neoplasm GlaxoSmithKline Not yet recruiting No outcome recorded
Phase 1 NCT07867171 Oct 2026 → Sep 2027 expected digestive system neoplasm GlaxoSmithKline Not yet recruiting No outcome recorded
Phase 1 NCT07862114 Oct 2026 → Jan 2027 expected digestive system neoplasm GlaxoSmithKline Not yet recruiting No outcome recorded
Phase 1 NCT05489237 Aug 2022 → Mar 2027 expected gastrointestinal stromal tumor, metastatic malignant neoplasm GSK Active not recruiting No outcome recorded
Phase 22 trials
Phase 2 NCT07843641 Oct 2026 → Jan 2031 expected digestive system neoplasm GlaxoSmithKline Not yet recruiting No outcome recorded
Phase 2 NCT07689201 Aug 2026 → Nov 2027 expected gastrointestinal stromal tumor GlaxoSmithKline Recruiting No outcome recorded
Phase 32 trials
Phase 3 NCT07585266 Jul 2026 → Aug 2032 expected gastrointestinal stromal tumor GlaxoSmithKline Recruiting No outcome recorded
Phase 3 NCT07218926 Dec 2025 → May 2028 expected gastrointestinal stromal tumor GlaxoSmithKline Recruiting No outcome recorded
Comparator or background therapy1 trial
— NCT07825701 Background — gastrointestinal stromal tumor GlaxoSmithKline Available No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2026-05-26 GlaxoSmithKline Results GSK to showcase long-term outcomes and pipeline expansion with latest oncology research at ASCO and EHA gsk.com ↗
First results for velzatinib in first-line (1L) advanced gastrointestinal stromal tumours (GIST) will show promising activity and tolerability across KIT mutations.

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 10 sources stand behind the page.

FieldValueCited text
Known as IDRX-42 “The goal of this study is to evaluate the study drug velzatinib (GSK6042981 / IDRX-42) to see whether velzatinib can shrink or control tumors and is safe and tolerated in Japan...” NCT07689201 ↗
2

NCT07218926 ↗

NCT05489237 ↗

Known as GSK6042981 “Individual Patient Expanded Access for Velzatinib (GSK6042981) in Patients With Gastrointestinal Stromal Tumours With KIT Mutations” NCT07825701 ↗
1

“A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy” NCT07218926 ↗

Known as M-4205 ChEMBL registry synonym — accepted as the source's own label CHEMBL5314917 ↗
Known as Velzatinib ClinicalTrials.gov intervention name — accepted as the source's own label NCT07859735 ↗
6

NCT07843641 ↗

NCT07689201 ↗

NCT07867171 ↗

NCT07825701 ↗

NCT07585266 ↗

NCT07862114 ↗

Action Inhibit “tyrosine kinase inhibitor” NCT05489237 ↗
Modality Small molecule “small molecule” NCT05489237 ↗
1

CHEMBL5314917 ↗

Route Oral “orally administered” NCT05489237 ↗