Product Description
Bitopertin is a selective inhibitor of glycine transport. (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5492956/)
Mechanisms of Action: GlyT1 Inhibitor
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Orphan Drug - Protoporphyria, Erythropoietic|Porphyria, Erythropoietic *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Hoffmann-La Roche
Company Location: BASEL SWITZERLAND V8
Company CEO: Severin Schwan
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Bulgaria, China, Czech Republic, Italy, Japan, Russia, United States
Active Clinical Trial Count: 6
Recent & Upcoming Milestones
- Clinical Outcomes Expected - Disc Medicine announced they will present P2 Protoporphyria, Erythropoietic results on 2025-06-14 for Bitopertin
- Clinical Outcomes Reported - Disc Medicine presented P2 Protoporphyria, Erythropoietic results on 2024-12-09 for Bitopertin
- Clinical Outcomes Reported - Disc Medicine presented P2 Protoporphyria, Erythropoietic results on 2024-12-07 for Bitopertin
Highest Development Phases
Phase 3: Genetic Diseases, X-Linked|Protoporphyria, Erythropoietic|Schizophrenia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| APOLLO | P3 |
Recruiting |
Protoporphyria, Erythropoietic|Genetic Diseases, X-Linked |
2026-10-01 |
44% |
2025-04-09 |
Primary Endpoints|Treatments|Trial Status |
| DISC-1459-501 | P3 |
Enrolling by invitation |
Protoporphyria, Erythropoietic |
2028-06-01 |
25% |
2024-02-23 |
Primary Endpoints|Start Date|Treatments|Trial Status |
| DISC-1459-201 | P2 |
Completed |
Protoporphyria, Erythropoietic |
2024-02-20 |
21% |
2024-09-24 |
Primary Endpoints |
| ACTRN12622000799752 | P2 |
Completed |
Protoporphyria, Erythropoietic |
2023-11-16 |
2025-01-27 |
Treatments |
|
| CTR20131493 | P3 |
Active, not recruiting |
Schizophrenia |
None |
2025-04-29 |
Patient Enrollment|Treatments |
|
| CTR20131504 | P3 |
Active, not recruiting |
Schizophrenia |
None |
2025-04-29 |