Rigel Pharmaceuticals Launches New Phase 2 Trial of Olutasidenib in IDH1-Mutated Myeloid Malignancies

Reuters
2025.11.17 13:05
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Rigel Pharmaceuticals has initiated a new Phase 2 clinical trial of olutasidenib for IDH1-mutated myeloid malignancies, under its alliance with MD Anderson. The trial aims to assess safety and remission rates. Additionally, a Phase 2 study for high-grade glioma in adolescents and young adults has begun. Final data from a previous trial showed durable efficacy and safety. This information was published by Rigel via PR Newswire.

Rigel Pharmaceuticals Inc. has announced the initiation of new clinical studies evaluating olutasidenib. The company activated a fifth study under its strategic alliance with MD Anderson, enrolling patients in a Phase 2 multi-arm, open-label clinical trial (NCT07032727) to assess olutasidenib in combination with co-targeted therapies for relapsed or refractory IDH1-mutated myeloid malignancies. The study’s primary objectives are safety and composite complete remission rate. Additionally, the first patient was enrolled in the CONNECT Phase 2 TarGeT-D study (NCT06161974), which is investigating olutasidenib in combination with temozolomide, followed by olutasidenib monotherapy as maintenance, in newly-diagnosed adolescent and young adult patients with high-grade glioma harboring an IDH1 mutation. Rigel also announced the publication of final five-year data from the pivotal Phase 2 registrational trial of REZLIDHIA® (olutasidenib) for relapsed or refractory mutant isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia in the Journal of Hematology & Oncology. The results indicate durable efficacy and a manageable safety profile, with no new safety signals identified compared to previous analyses. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Rigel Pharmaceuticals Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: SF25350) on November 17, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)