Bitopertin - Roche
Alternative Names: DISC-1459; Heme synthesis modulator - Disc Medicine; R-1678; RG 6718; RG-6178; RG1678; RO-4917838Latest Information Update: 28 May 2026
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
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Orphan Drug Status
Yes - Erythropoietic protoporphyria
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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
- 22 May 2026 Disc Medicine plans an expanded access trial for Erythropoietic protoporphyria ( In adolescents, In adults) in unknown location (PO) (NCT07603401)
- 05 May 2026 Disc Medicine schedules a Type A meeting with the US FDA to review approach for resubmission of NDA in Q2 2026
- 27 Mar 2026 Disc Medicine announces intention to file a response to the Complete Response Letter (CRL) and expects an updated FDA decision for Erythropoietic protoporphyria (In adolescents, In adults, In the elderly), by mid-2027