Clinical TrialJun 1, 2026, 08:31 AM
Disc Medicine Launches Expanded Access Program for Bitopertin
AI Summary
Disc Medicine, Inc. announced the launch of an Expanded Access Program (EAP) for bitopertin, an investigational oral glycine transporter 1 (GlyT1) inhibitor. The program provides access to eligible patients aged 12 and above with erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) in the U.S. who lack satisfactory therapeutic alternatives. Bitopertin is currently being evaluated in the Phase 3 APOLLO clinical trial, with topline data expected in Q4 2026 and a potential FDA decision by mid-2027.
Key Highlights
- Disc Medicine launched an Expanded Access Program (EAP) for bitopertin for eligible patients with erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) in the U.S.
- Bitopertin is an oral glycine transporter 1 (GlyT1) inhibitor being evaluated in the Phase 3 APOLLO clinical trial.
- Topline data from the Phase 3 APOLLO study is anticipated in Q4 2026.
- A potential FDA decision for bitopertin is expected by mid-2027.
- The EAP is available for EPP patients aged 12 and above who lack satisfactory therapeutic alternatives and meet eligibility criteria.
Price Impact
More from IRON