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(AURORA) a Randomized, Double-blind, Placebo-Controlled Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and Protoporphyrin IX (PPIX) Concentrations in Participants with Erythropoietic Protoporphyria (EPP)

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Trial Profile

(AURORA) a Randomized, Double-blind, Placebo-Controlled Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and Protoporphyrin IX (PPIX) Concentrations in Participants with Erythropoietic Protoporphyria (EPP)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 02 Mar 2026

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At a glance

  • Drugs Bitopertin (Primary)
  • Indications Erythropoietic protoporphyria
  • Focus Therapeutic Use
  • Acronyms AURORA
  • Sponsors Disc Medicine

Most Recent Events

  • 13 Feb 2026 According to Disc Medicine media release, based on review of AURORA and BEACON, the U.S. Food and Drug Administration concluded that the trials did not demonstrate an association between percent change in PPIX and sunlight exposure endpoints, and therefore the data do not currently support accelerated approval despite the biological rationale for the biomarker in protoporphyria.
  • 21 Jan 2026 Last checked against ClinicalTrials.gov record.
  • 20 Oct 2025 According to the Disc Medicine media release, the company has accelerated activities to support a potential U.S. approval and launch in late 2025 or early 2026, based on the expedited review timeline enabled by the receipt of the CNPV, which is intended to shorten the NDA review process to 1-2 months.

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