Olutasidenib

Last updated

Olutasidenib
Olutasidenib.svg
Clinical data
Trade names Rezlidhia
Other namesFT-2102
License data
Routes of
administration 		By mouth
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
PDB ligand
Chemical and physical data
Formula C18H15ClN4O2
Molar mass 354.79 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]

Contents

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.PD-icon.svg 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 JM, Baer MR, Yang J, Prebet T, Lee S, Schiller GJ, et al. (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. 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

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