Drug research
DISC-1459
Open a linked trial to see its study details and recorded changes, or check the regulatory events below and follow their sources.
Drug identity checked against registry records
Also recorded as Bitopertin; RO4917838
A drug appearing in a clinical trial does not mean it is FDA-approved. Check the original regulatory source for any approval claim.
Included trials
| Trial | Sponsor | Phase | Status | Primary completion |
|---|---|---|---|---|
| Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPPNCT05308472 | IRON | Phase 2 | Completed | 2024-02-20Actual |
| HELIOS: Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP or XLPNCT05883748 | IRON | Phase 2, Phase 3 | Enrolling by invitation | 2028-06Estimated |
| Study of Bitopertin in Participants With EPP or XLP (APOLLO)NCT06910358 | IRON | Phase 3 | Active not recruiting | 2026-09Estimated |
Regulatory dates and decisions
| Date as reported | Drug / company | Event | Condition | Evidence |
|---|---|---|---|---|
| 2026-02-13Day | DISC-1459Disc Medicine, Inc · IRON | FDA complete response letter | Not specified | Open original sourceRead source excerpt{"application_number": ["NDA 220707"], "letter_date": "02/13/2026", "letter_type": "COMPLETE RESPONSE", "company_name": "Disc Medicine, Inc.", "file_name": "CRL_NDA220707_20260213.pdf"} First seen: 26 Sep 2026 · Evidence last checked: 26 Sep 2026 |