DISC-1459

DRUG4 trials

Sponsors

Disc Medicine, Inc

Conditions

Erythropoietic ProtoporphyriaErythropoietic Protoporphyria (EPP)X-Linked Protoporphyria (XLP)

Phase 2

Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPP

CompletedNCT05308472

Disc Medicine, IncErythropoietic Protoporphyria

Start: 2022-10-31End: 2024-08-23Updated: 2026-01-08

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 invitationNCT05883748

Disc Medicine, IncErythropoietic Protoporphyria

Start: 2023-08-31End: 2028-06-01Target: 230Updated: 2026-09-10

Phase 3

Study of Bitopertin in Participants With EPP or XLP (APOLLO)

Active, not recruitingNCT06910358

Disc Medicine, IncErythropoietic Protoporphyria (EPP), X-Linked Protoporphyria (XLP)

Start: 2025-04-04End: 2026-10-01Updated: 2026-09-02

Unknown Phase

Expanded Access Program of Bitopertin For Participants With EPP or XLP

Disc Medicine, IncErythropoietic Protoporphyria (EPP), X-Linked Protoporphyria (XLP)

Updated: 2026-08-03

Related Papers

Results from the Aurora Study: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Bitopertin in Erythropoietic Protoporphyria

Blood2024-11-053 citations

PB2562: STUDY DESIGN OF THE AURORA TRIAL: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF BITOPERTIN IN ERYTHROPOIETIC PROTOPORPHYRIA

HemaSphere2023-08-011 citations