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NCE-1 Intelligence & Market Opportunity

Rezlidhia

Olutasidenib
Anticancer
Oral Capsule

IDH1 mutations occur in a small share of acute myeloid leukemia and block normal blood cell maturation. Rezlidhia (olutasidenib) added a second targeted option for these patients.

Olutasidenib inhibits the mutant IDH1 enzyme, lowering the oncometabolite 2-hydroxyglutarate so immature leukemia cells can resume normal differentiation. The twice-daily capsule treats adults with relapsed or refractory acute myeloid leukemia carrying a susceptible IDH1 mutation detected by an approved test.

Rezlidhia carries a boxed warning for differentiation syndrome, an on-target effect of restored maturation that requires prompt recognition. It holds orphan designation and competes directly with ivosidenib, making tolerability and hepatic safety the practical differentiators.

Approval Date
01-Dec-22
NCE-1 Date
01-Dec-26
NCE Date
01-Dec-27
Commercial snapshot

Market performance & projections

Revenue ($M)
31
CAGR (%)
22.14%
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
37
2027
49
2028
60
2029
69
2030
78
2031
89
2032
101
Molecule profile

Details & specifications

Molecule
Olutasidenib
Innovator
RIGEL PHARMACEUTICALS, INC.
Dosage Form
Oral Capsule
Strength
150 mg
Therapeutic Category
Anticancer
Usage
To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation
Good to know

Frequently asked questions

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