Drugs / Olutasidenib
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed relapsed/refractory diffuse large B-cell lymphoma 1 milestone | |||||
| Filed | US (FDA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2022-08-02 | “The U.S. Food and Drug Administration (FDA) has accepted Forma's New Drug Application (NDA) for olutasidenib.” rigel.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | US (FDA) | REZLIDHIA | — | 2022-12-01 | fda.gov ↗ |
| Filed | Japan (PMDA) | — | — | — | “Rigel's partner Kissei Pharmaceutical Co., Ltd. (Kissei) submitted a new drug application for manufacturing and marketing approval in Japan for olutasidenib in May.” rigel.com ↗ |
Trials 19
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2025-11-17 | Rigel Pharmaceuticals | Results Rigel Announces Publication of Final 5-year Data on REZLIDHIA® (olutasidenib) in Patients with R/R mIDH1 AML in the Journal of Hematology & Oncology rigel.com ↗
The publication reports the final follow-up analysis of the registrational Phase 2 trial, with an additional two years of efficacy and safety data. |
| 2025-11-03 | Rigel Pharmaceuticals | Results Rigel Announces One Oral and Four Poster Presentations at the 67th American Society of Hematology Annual Meeting and Exposition rigel.com ↗
Patients with SD after 2 cycles of olutasidenib may experience meaningful clinical benefit with continued treatment, as one-third of these patients subsequently achieved a late response, resulting in a lower risk of death compared to patients with no later response. |
| 2025-05-22 | Rigel Pharmaceuticals | Results Rigel Announces Poster Presentations at the 2025 ASCO Annual Meeting and EHA2025 Congress rigel.com ↗
In the final five-year analysis of the registrational trial, mutational analysis showed durable responses across IDH1 -R132 mutation types, particularly in the absence of RTK pathway co-mutations. |
| 2024-06-14 | Rigel Pharmaceuticals | Results Rigel Announces Five Presentations at the EHA2024 Hybrid Congress rigel.com ↗
New data shows clinically meaningful effect of olutasidenib in patients with mIDH1 AML secondary to MPN and as bridge-to-transplant treatment in patients with R/R mIDH1 AML |
| 2024-06-03 | Rigel Pharmaceuticals | Results Rigel Highlights New Data in Three Poster Presentations at the 2024 ASCO Annual Meeting rigel.com ↗
Data from a subgroup analyses of elderly R/R mIDH1 AML patients treated with olutasidenib shows consistent CR/CRh results |
| 2024-05-23 | Rigel Pharmaceuticals | Results Rigel Announces Presentations at the Upcoming 2024 ASCO Annual Meeting and EHA2024 Hybrid Congress rigel.com ↗
The five-year data from the registrational Phase 2 trial continue to demonstrate that REZLIDHIA induces rapid and durable responses. |
| 2024-04-04 | Rigel Pharmaceuticals | Results Rigel Announces Publication of Data on REZLIDHIA® (Olutasidenib) in Post-Venetoclax Patients with Mutant IDH1 AML in Leukemia & Lymphoma rigel.com ↗
Olutasidenib induced durable composite complete remission in 43.8% of patients relapsed or refractory to prior venetoclax-based regimens |
| 2023-06-07 | Rigel Pharmaceuticals | Results Rigel Announces Presentation of Data from Analysis of REZLIDHIA® (Olutasidenib) in Post-Venetoclax Patients with Mutant IDH1 AML rigel.com ↗
Olutasidenib induced durable remissions in patients with mIDH1 R/R AML, including those failing prior treatment with a venetoclax-based regimen |
| 2023-02-02 | Rigel Pharmaceuticals | Results Rigel Announces Publication of REZLIDHIA™ (olutasidenib) Phase 2 Clinical Results in Blood Advances rigel.com ↗
The published data demonstrate that REZLIDHIA induced durable remissions and transfusion independence with a well-characterized safety profile. |
| 2022-12-01 | Rigel Pharmaceuticals | Regulatory Rigel Announces U.S. FDA Approval of REZLIDHIA™ (olutasidenib) for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with a Susceptible IDH1 Mutation rigel.com ↗ |
| 2022-11-10 | Rigel Pharmaceuticals | Results Rigel Announces Publication of Early Clinical Data of Olutasidenib in The Lancet Haematology rigel.com ↗
The published data suggest that olutasidenib, with or without azacitidine, was well-tolerated and was associated with improvements in clinical efficacy endpoints in patients with mIDH1 AML. |
| 2022-11-03 | Rigel Pharmaceuticals | Results Rigel Announces Five Poster Presentations at the Upcoming 64th American Society of Hematology Annual Meeting and Exposition rigel.com ↗
Updated interim analysis from Phase 2 registrational study highlights 35% of mIDH1 R/R AML patients who received olutasidenib achieved CR+CRh with a median duration of 25.9 months |
All press releases naming this drug 20 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | olutasidenib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07130695 ↗ |
| 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 |
| 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 |