Olutasidenib

Olutasidenib
Clinical data
Trade names	Rezlidhia
Other names	FT-2102
License data	US DailyMed: Olutasidenib;
Routes of; administration	By mouth
ATC code	None;
Legal status
Legal status	US: WARNINGRx-only;
Identifiers
CAS Number	1887014-12-1;
PubChem CID	118955396;
IUPHAR/BPS	10319;
DrugBank	DB16267;
ChemSpider	72380144;
UNII	0T4IMT8S5Z;
KEGG	D12483;
ChEMBL	ChEMBL4297610;
PDB ligand	PWV (PDBe, RCSB PDB);
Chemical and physical data
Formula	C18H15ClN4O2
Molar mass	354.79 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES C[C@H](NC1=CC=C(C#N)N(C)C1=O)C1=CC2=C(NC1=O)C=CC(Cl)=C2;
	InChI 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[edit]

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[edit]

Names[edit]

Olutasidenib is the international nonproprietary name.^[9]

References[edit]

^ "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.
^ ^a ^b ^c ^d ^e ^f "Rezlidhia- olutasidenib capsule". DailyMed. U.S. National Library of Medicine. 13 December 2022. Retrieved 21 January 2023.
^ ^a ^b ^c ^d Theoret MR (December 2022). "REZLIDHIA (olutasidenib) capsules" (PDF). Approval Letter. U.S. Food and Drug Administration. This article incorporates text from this source, which is in the public domain.
^ ^a ^b ^c "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.
^ "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.
^ "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.
^ Kang C (March 2023). "Olutasidenib: First Approval". Drugs. 83 (4): 341–346. doi:10.1007/s40265-023-01844-1. PMID 36848032. S2CID 257218495.
^ 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.
^ World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information. 33 (3). hdl:10665/330879.

External links[edit]

"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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[FDA-AllBoxedWarnings-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.

[Rezlidhia_FDA_label-2] ^ ^a ^b ^c ^d ^e ^f "Rezlidhia- olutasidenib capsule". DailyMed. U.S. National Library of Medicine. 13 December 2022. Retrieved 21 January 2023.

[FDA_approval_letter-3] Theoret MR (December 2022). "REZLIDHIA (olutasidenib) capsules" (PDF). Approval Letter. U.S. Food and Drug Administration. This article incorporates text from this source, which is in the public domain.

[FDA_Rezlidhia-4] "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.

[pmid36848032-7] 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.

[WHORecList82-9] World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information. 33 (3). hdl:10665/330879.

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