Bitopertin is under clinical development by Disc Medicine and currently in Phase III for Porphyria (Erythropoietic Protoporphyri). According to GlobalData, Phase III drugs for Porphyria (Erythropoietic Protoporphyri) have a 67% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Bitopertin’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.

Bitopertin overview

Bitopertin is under development for the treatment of erythropoietic porphyrias (EP) including erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) and diamond-blackfan anemia (DBA). The drug candidate is administered through oral route. It is a first-in-class glycine reuptake inhibitor (glycine transporter type 1).

It was under development for the treatment of beta thalassemia and sub-optimally controlled positive symptoms of schizophrenia and obsessive-compulsive disorder

Disc Medicine overview

Disc Medicine, formerly Gemini Therapeutics Inc, is a clinical-stage biopharmaceutical company that specialises in the discovery, development and commercialization of novel treatments for patients with severe hematologic disorders. The company pipeline includes bitopertin for the treatment of erythropoietic porphyrias, including erythropoietic protoporphyria and X-linked protoporphyria and Diamond-Blackfan Anaemia, or DBA; DISC-0974 for the treatment of anaemia of myelofibrosis and anaemia of chronic kidney disease, or CKD; and MWTX-003 for the treatment of polycythemia vera, or PV, and other hematologic disorders. The company’s preclinical programmes consist of DISC-0998, which is used to treat anaemia brought on by inflammatory disorders. Disc Medicine is headquartered in Cambridge, Massachusetts, the US.

For a complete picture of Bitopertin’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.