Trial intelligence / Profile preview

HELIOS long-term open-label bitopertin extension in EPP/XLP

2025-523275-27-00Phase 3Authorised

Sponsor
Disc Medicine
Start
May 2026
Modality
Small Molecules
Countries
13
01

Overview

Phase 3, open-label, single-arm trial of bitopertin in erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), sponsored by Disc Medicine. Primary endpoint: Safety and tolerability of bitopertin. Planned start May 2026; status: authorised.

02

Drugs

bitopertin
03

Conditions

erythropoietic protoporphyria (EPP)X-linked protoporphyria (XLP)

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