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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: 18 Feb 2026

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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

  • 14 Feb 2026 Disc Medicine announces intention to file a response to the Complete Response Letter (CRL) and expect an updated FDA decision for Erythropoietic protoporphyria (In adolescents, In adults, In the elderly) by mid-2027
  • 13 Feb 2026 Disc Medicine announces intention to request a Type A meeting with the US FDA to review bitopertin Erythropoietic protoporphyria (In adolescents, In adults, In the elderly)
  • 13 Feb 2026 Disc Medicine receives complete response letter from the FDA for bitopertin in Erythropoietic protoporphyria (In adolescents, In adults, In the elderly)

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