Drugs / Olutasidenib

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) REZLIDHIA 2022-12-01 fda.gov

Trials 19 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT07411586 Aug 2026 → Jan 2027 expected acute myeloid leukemia M.D. Anderson Cancer Center Not yet recruiting No outcome recorded
Phase 1 NCT07130695 Feb 2026 → Oct 2028 expected acute myeloid leukemia Virginia Commonwealth University Recruiting No outcome recorded
Phase 1 NCT06543381 Jan 2025 → Feb 2027 expected acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome City of Hope Medical Center Recruiting No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT06445959 Aug 2024 → Jun 2027 expected M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 1/2 NCT04013880 Aug 2019 → Mar 2021 acute myeloid leukemia, myelodysplastic syndrome Vanderbilt-Ingram Cancer Center Withdrawn No outcome recorded
Phase 1/2 NCT03684811 Nov 2018 → May 2021 chondrosarcoma, intrahepatic cholangiocarcinoma, malignant glioma Forma Therapeutics, Inc. Completed No outcome recorded
Phase 1/2 NCT02719574 Apr 2016 → Dec 2023 acute myeloid leukemia, myelodysplastic syndrome Forma Therapeutics, Inc. Completed No outcome recorded
Phase 211 trials
Phase 2 NCT07471841 Jul 2026 → Jun 2028 expected acute myeloid leukemia Timothy Pardee Recruiting No outcome recorded
Phase 2 NCT07604064 Jun 2026 → Sep 2030 expected acute myeloid leukemia Kissei Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 2 NCT07153497 May 2026 → Apr 2030 expected acute myeloid leukemia, myelodysplastic syndrome National Cancer Institute (NCI) Not yet recruiting No outcome recorded
Phase 2 NCT06782542 Mar 2026 → Mar 2029 expected acute myeloid leukemia Justin Watts, MD Recruiting No outcome recorded
Phase 2 NCT07304011 Dec 2025 → Dec 2027 expected acute myeloid leukemia University of California, Davis Recruiting No outcome recorded
Phase 2 NCT07032727 Sep 2025 → Jun 2027 expected M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT06161974 Feb 2025 → Jun 2029 expected astrocytoma, IDH-mutant, grade 4, diffuse midline glioma, H3 K27M-mutant, grade III glioma, metastatic malignant neoplasm in the brain +3 Rigel Pharmaceuticals Recruiting No outcome recorded
Phase 2 NCT06597734 Jan 2025 → Jun 2026 chronic myelomonocytic leukemia, myelodysplastic syndrome M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 2 NCT06668584 Dec 2024 → Dec 2027 expected myeloid neoplasm M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT06566742 Dec 2024 → Aug 2027 expected chronic myelomonocytic leukemia, clonal hematopoiesis of indeterminate potential, myelodysplastic syndrome M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 41 trial
Phase 4 NCT07486713 Feb 2026 → Apr 2027 expected acute myeloid leukemia, cholangiocarcinoma, glioma Rigel Pharmaceuticals Recruiting No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 22 sources stand behind the page.

FieldValueCited text
Known as Olutasidenib ClinicalTrials.gov intervention name — accepted as the source's own label NCT06543381
16

NCT07471841

NCT02719574

NCT06668584

NCT07411586

NCT07304011

NCT06445959

NCT07130695

NCT06782542

NCT07153497

NCT07604064

NCT05564390

NCT07032727

NCT06566742

NCT06597734

NCT06161974

NCT07486713

Known as FT-2102 “Olutasidenib (FT-2102) is a potent, selective, oral, small-molecule inhibitor of mutant isocitrate dehydrogenase 1 (IDH1).” PMID 36370742 Nov 2022
2

NCT03684811

NCT04013880

Known as Rezlidhia ChEMBL registry synonym — accepted as the source's own label CHEMBL4297610
Action Inhibit inhibitor of mutant isocitrate dehydrogenase 1 (IDH1)” PMID 36370742 Nov 2022
Modality Small molecule “Olutasidenib (FT-2102) is a potent, selective, oral, small-molecule inhibitor” PMID 36724515 Jul 2023
Route Oral “Olutasidenib was administered orally in doses of 150 mg once daily, 150 mg twice per day, and 300 mg once daily.” PMID 36370742 Nov 2022
Target IDH1 “inhibitor of mutant isocitrate dehydrogenase 1 (IDH1)” PMID 36370742 Nov 2022