Drugs / DISC-3405
last change 24 days ago re-read 3 minutes ago

DISC-3405

Developed for
acquired polycythemia vera · sickle cell disease
Investigated by
Disc Medicine, Inc

Trials 3

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT07187973 Jan 2026 → Jun 2027 expected sickle cell disease Disc Medicine, Inc Recruiting No outcome recorded
Phase 1 NCT06050915 Oct 2023 → Jul 2024 — Disc Medicine, Inc Completed No outcome recorded
Phase 21 trial
Phase 2 NCT06985147 Aug 2025 → Feb 2027 expected acquired polycythemia vera Disc Medicine, Inc Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2026-09-09 Disc Medicine, Inc Results Disc Medicine Presents Initial Results from RESTORE-PV Phase 2 Trial in Patients with Polycythemia Vera (PV) at the 14th Society of Hematologic Oncology (SOHO) Annual Meeting discmedicine.com ↗
Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today presented positive initial results from the RESTORE-PV Phase 2 trial of DISC-3405 in patients with polycythemia vera (PV).
2024-06-14 Disc Medicine, Inc Results Disc Medicine Presents Positive Clinical Data Across Portfolio at the European Hematology Association (EHA) 2024 Congress discmedicine.com ↗
Disc also shared initial SAD data from a Phase 1 healthy volunteer trial of DISC-3405 that provided proof of mechanism, showing that the drug has the potential to provide deep and sustained increases in hepcidin and reductions in iron.
2024-02-09 Disc Medicine, Inc Regulatory Disc Medicine Receives FDA Orphan Drug Designation for DISC-3405 for the Treatment of Polycythemia Vera discmedicine.com ↗
today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to DISC-3405 for the treatment of patients with polycythemia vera (PV).
2023-09-20 Disc Medicine, Inc Regulatory Disc Medicine Receives FDA Fast Track Designation for MWTX-003 for the Treatment of Polycythemia Vera discmedicine.com ↗

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 3 sources stand behind the page.

FieldValueCited text
Known as DISC-3405 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06985147 ↗
2

NCT07187973 ↗

NCT06050915 ↗

Route Intravenous “IV infusion” NCT06050915 ↗