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Bitopertin - Roche

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Drug Profile

Bitopertin - Roche

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

Latest Information Update: 31 Oct 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

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

Most Recent Events

  • 20 Oct 2025 Disc Medicine announced its plan to launch bitopertin for Erythropoietic protoporphyria in late 2025 or early 2026
  • 16 Oct 2025 US FDA grants Commissioner’s National Priority Voucher (CNPV) to Bitopertin for Erythropoietic protoporphyria
  • 30 Sep 2025 Preregistration for Erythropoietic protoporphyria (In adults, In adolescents, In the elderly) in USA (PO)

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