Olutasidenib
Clinical data
Trade namesRezlidhia
Other namesFT-2102
License data
Routes of
administration		By mouth
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
PDB ligand
Chemical and physical data
FormulaC18H15ClN4O2
Molar mass354.79 g·mol−1
3D model (JSmol)
  • C[C@H](NC1=CC=C(C#N)N(C)C1=O)C1=CC2=C(NC1=O)C=CC(Cl)=C2
  • InChI=InChI=1S/C18H15ClN4O2/c1-10(21-16-6-4-13(9-20)23(2)18(16)25)14-8-11-7-12(19)3-5-15(11)22-17(14)24/h3-8,10,21H,1-2H3,(H,22,24)/t10-/m0/s1
  • Key:NEQYWYXGTJDAKR-JTQLQIEISA-N

Olutasidenib, sold under the brand name Rezlidhia, is an anticancer medication used to treat relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation.[2][3] Olutasidenib is an isocitrate dehydrogenase-1 (IDH1) inhibitor.[2] It is taken by mouth.[2]

The most common adverse reactions include nausea, fatigue/malaise, arthralgia, constipation, leukocytosis, dyspnea, fever, rash, mucositis, diarrhea, and transaminitis.[4]

Olutasidenib was approved for medical use in the United States in December 2022,[2][3][4][5][6][7] based on the phase 1 results of a phase 1/2 trial.[8]

Medical uses

Olutasidenib is indicated for the treatment of adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.[2][3][4]

Society and culture

Names

Olutasidenib is the international nonproprietary name.[9]

References

  1. ↑ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
  2. 1 2 3 4 5 6 "Rezlidhia- olutasidenib capsule". DailyMed. U.S. National Library of Medicine. 13 December 2022. Retrieved 21 January 2023.
  3. 1 2 3 4 Theoret MR (December 2022). "REZLIDHIA (olutasidenib) capsules" (PDF). Approval Letter. U.S. Food and Drug Administration. Public Domain This article incorporates text from this source, which is in the public domain.
  4. 1 2 3 "FDA approves olutasidenib for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation". U.S. Food and Drug Administration (FDA). 1 December 2022. Retrieved 20 December 2022.
  5. ↑ "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 Pharmaceuticals, Inc. (Press release). 1 December 2022. Retrieved 2 December 2022.
  6. ↑ "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" (Press release). Rigel Pharmaceuticals. 1 December 2022. Retrieved 2 December 2022 – via PR Newswire.
  7. ↑ Kang C (March 2023). "Olutasidenib: First Approval". Drugs. 83 (4): 341–346. doi:10.1007/s40265-023-01844-1. PMID 36848032. S2CID 257218495.
  8. ↑ Watts, Justin M; Baer, Maria R; Yang, Jay; Prebet, Thomas; Lee, Sangmin; Schiller, Gary J; Dinner, Shira N; Pigneux, Arnaud; Montesinos, Pau; Wang, Eunice S; Seiter, Karen P; Wei, Andrew H; De Botton, Stephane; Arnan, Montserrat; Donnellan, Will (January 2023). "Olutasidenib alone or with azacitidine in IDH1-mutated acute myeloid leukaemia and myelodysplastic syndrome: phase 1 results of a phase 1/2 trial". The Lancet Haematology. 10 (1): e46–e58. doi:10.1016/s2352-3026(22)00292-7. ISSN 2352-3026. PMID 36370742. S2CID 253471380.
  9. ↑ World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information. 33 (3). hdl:10665/330879.

Further reading

  • "Olutasidenib". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT02719574 for "Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation" at ClinicalTrials.gov


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