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Bitopertin - Disc Medicine

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Drug Profile

Bitopertin - Disc Medicine

Alternative Names: DISC-1459; Heme synthesis modulator - Disc Medicine; R-1678; RG 6718; RG-6178; RG1678; RO-4917838

Latest Information Update: 23 Jun 2025

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At a glance

  • Originator Roche
  • Developer Chugai Pharmaceutical; Disc Medicine; Roche
  • Class Antianaemics; Antipsychotics; Behavioural disorder therapies; Piperazines; Pyridines; Skin disorder therapies; Small molecules
  • Mechanism of Action Glycine transporter 1 inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Erythropoietic protoporphyria
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Erythropoietic protoporphyria
  • Phase I/II Diamond-Blackfan syndrome
  • Preclinical Myelodysplastic syndromes
  • Discontinued Beta-thalassaemia; Obsessive-compulsive disorders; Schizophrenia

Most Recent Events

  • 12 Jun 2025 Efficacy and adverse events data from phase-II/III HELIOS trial in Erythropoietic protoporphyria released by Disc Medicine
  • 04 Apr 2025 Phase-III clinical trials in Erythropoietic protoporphyria (In adolescents, In the elderly, In adults) in USA (PO) (NCT06910358)
  • 21 Jan 2025 Disc Medicine announces intention to submit NDA to the US FDA for Erythropoietic protoporphyria under accelerated approval pathway in the second half of 2025

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