Drugs / RANOSIDENIB
last change Jul 2025 re-read 9 days ago

RANOSIDENIB

also known as HMPL-306

Small molecule targets IDH1 via inhibition

Developed for
acute myeloid leukemia · glioma
Investigated by
Hutchmed · Hutchison Medipharma Limited

Trials 6

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT07025018 Jul 2025 → Dec 2026 expected glioma Hutchmed Recruiting No outcome recorded
Phase 1 NCT06671873 Nov 2024 → Feb 2025 — Hutchmed Completed No outcome recorded
Phase 1 NCT04764474 Apr 2021 → Jan 2025 — Hutchmed Terminated No outcome recorded Stop: Business
Phase 1 NCT04762602 Feb 2021 → Feb 2025 — Hutchmed Terminated No outcome recorded Stop: Business
Phase 1 NCT04272957 May 2020 → Jun 2021 acute myeloid leukemia Hutchison Medipharma Limited Unknown No outcome recorded
Phase 31 trial
Phase 3 NCT06387069 Apr 2024 → Dec 2028 expected acute myeloid leukemia Hutchmed Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2023-06-09 Hutchison Medipharma Limited Results HUTCHMED Highlights Presentations for Hematological Malignancy Programs at the 2023 EHA and ICML Meetings hutch-med.com ↗
Based on PD, pharmaco­kinetic (“PK”), and preliminary clinical findings, a recommended Phase II dose was nominated for the dose expansion phase of the study.

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as RANOSIDENIB ChEMBL registry synonym — accepted as the source's own label CHEMBL6068069 ↗
Known as HMPL-306 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06387069 ↗
5

NCT06671873 ↗

NCT04764474 ↗

NCT04762602 ↗

NCT07025018 ↗

NCT04272957 ↗

Action Inhibit “HMPL-306 has equally high inhibitory activity against mutated isocitrate dehydrogenases 1 and 2 (mIDH1/2).” PMID 39892383 ↗ Jan 2025
Modality Small molecule “IDH small molecule inhibitor” NCT07025018 ↗
Route Oral “HMPL-306 administered continuously as a single agent orally every day” NCT04272957 ↗
Target IDH1 “HMPL-306 has equally high inhibitory activity against mutated isocitrate dehydrogenases 1 and 2 (mIDH1/2).” PMID 39892383 ↗ Jan 2025