Olutasidenib is under clinical development by Rigel Pharmaceuticals and currently in Phase II for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia). According to GlobalData, Phase II drugs for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia) have a 25% 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), clonal cytopenia of undetermined significance, relapsed or refractory acute myeloid leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia. It is administered through the oral route. The drug candidate acts by targeting Isocitrate dehydrogenase.
It was also under development for chondrosarcoma, glioma, hepatobiliary cancer includes (hepatocellular carcinoma, bile duct carcinoma, intrahepatic cholangiocarcinoma or other hepatobiliary carcinomas).
Rigel Pharmaceuticals overview
Rigel Pharmaceuticals (Rigel) is a biotechnology company. It focuses on discovering, developing and providing novel therapies for the treatment of hematologic disorders and cancer. The company provides fostamatinib disodium hexahydrate tablets, an oral spleen tyrosine kinase inhibitor, to treat adult patients with chronic immune thrombocytopenia, olutasidenib capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and pralsetinib capsules for the treatment of adult patients with non-small cell lung cancer (NSCLC). The company also has partnered for clinical programs with BerGenBio, Daiichi Sankyo, and Eli Lilly. 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.
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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.
