Trial Profile

Phase 2 randomized, open-label, multiple dose clinical trial of bitopertin in patients with Erythropoietic Protoporphyria or X-linked Protoporphyria

Status: Active, no longer recruiting

Phase of Trial: Phase II

Latest Information Update: 14 May 2025

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At a glance

21 Jan 2025 According to a Disc Medicine Media Release, company planning to submit NDA under accelerated approval pathway in H2 2025 based on existing clinical data, including results from BEACON and AURORA Phase 2 trials.Scheduled pre-NDA meeting to align with the FDA on format and content of the NDA package.
09 Dec 2024 According to a Disc Medicine Media Release, data from the study were presented at the ASH 2024 annual meeting in San Diego, CA.
09 Dec 2024 Results presented in the Disc Medicine Media Release.

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