Clinical Trial

HELIOS: Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP or XLP

Enrolling by Invitation Phase 2/3
View on ClinicalTrials.gov →
Summary
This is an open-label, long-term extension study to investigate the safety, tolerability and efficacy of DISC-1459 in participants with EPP.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2023-05-22; most recent amendment 2026-07-22.
Status change: Not Yet Recruiting → Enrolling by Invitation 2024-02-21
Trial Details
NCT Number NCT05883748
Lead Sponsor Disc Medicine, Inc
Conditions Erythropoietic Protoporphyria
Enrollment 230 participants
Start Date 2023-08-31
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-12