Olutasidenib is under clinical development by Rigel Pharmaceuticals and currently in Phase II for Myelodysplastic Syndrome. According to GlobalData, Phase II drugs for Myelodysplastic Syndrome have a 30% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Olutasidenib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Olutasidenib overview

Olutasidenib (Rezlidhia) is an isocitrate dehydrogenase-1 (IDH1) inhibitor. It is formulated as hard gelatin capsules for oral route of administration. Rezlidhia is indicated in the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation.

Olutasidenib (FT-2102) is under development for the treatment of high-grade glioma (HGG), relapsed or refractory acute myeloid leukemia, myelodysplastic syndrome, glioma, hepatobiliary cancer includes (hepatocellular carcinoma, bile duct carcinoma, intrahepatic cholangiocarcinoma or other hepatobiliary carcinomas). It is administered through the oral route. The drug candidate acts by targeting Isocitrate dehydrogenase.

It was also under development for chondrosarcoma.

Rigel Pharmaceuticals overview

Rigel Pharmaceuticals (Rigel) is a biotechnology company that discovers and develops innovative small-molecule drugs for patients with immune disorders, hematological disorders, cancer, and rare diseases. Its research activities focus on signaling pathways that are critical to disease mechanisms. The company’s lead product, the US FDA approved Tavalisse (fostamatinib disodium hexahydrate), is an oral spleen tyrosine kinase inhibitor to treat adult patients with chronic immune thrombocytopenia; and Rezlidhia (olutasidenib) for the treatment of adult patients with R/R AML with a susceptible IDH1 mutation. Rigel is also evaluating Fostamatinib for autoimmune hemolytic anemia and IgA nephropathy in Phase II trials. The company has partnered clinical programs with Aclaris, BerGenBio, Daiichi, AstraZeneca, Kissei, Grifols, Merck and Novartis. Rigel is headquartered in South San Francisco, California, the US.

For a complete picture of Olutasidenib’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.