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Clinical trials
catalyst calendar across sponsors →Studies where IRON is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
10 interventional · 1 expanded access · 1 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| HELIOS: Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP or XLPNCT05883748Incidence of treatment-emergent adverse eventsRandomized · Open-label · Treatment | Phase 2/3 | Enrolling by invitation | Drug: DISC-1459, DISC-1459 | Erythropoietic Protoporphyria | 230 | Jun 2028 | ≤ 681 d | 2026-08-12 |
| A Phase 1b, Open-Label Study of DISC-3405 in Participants With Sickle Cell Disease (SCD)NCT07187973Safety and tolerability of DISC-3405 administration in participants with SCDOpen-label · Treatment | Phase 1 | Recruiting | Drug: DISC-3405 | Sickle Cell Disease | 24 | Jun 2027 | ≤ 315 d | 2026-08-19 |
| Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and AnemiaNCT05320198Safety and Tolerability of DISC-0974 (Phase 1b only)Randomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: DISC-0974 | Myelofibrosis; Anemia, Anemia, Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera, Primary Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Myelodysplastic Syndromes | 150 | May 2027 | ≤ 285 d | 2026-08-12 |
| A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)NCT06985147Number of participants with treatment-related adverse events as assessed by CTCAEOpen-label · Treatment | Phase 2 | Active, not recruiting | Drug: DISC-3405 | Polycythemia Vera (PV) | 60 | Feb 2027 | ≤ 193 d | 2026-07-31 |
| Study of DISC-0974-201 in Participants With IBD and AnemiaNCT07368972Maximal change from baseline in Hgb through Day 85Randomized · Quadruple-masked · Treatment | Phase 2 | Recruiting | Drug: DISC-0974, Placebo | Inflammatory Bowel Disease (IBD), Anemia, Inflammatory Bowel Disease (IBD); Anemia | 21 | Oct 2026 | ≤ 73 d | 2026-08-03 |
| Study of Bitopertin in Participants With EPP or XLP (APOLLO)NCT06910358Average monthly total time in sunlight on days without pain from a phototoxic reaction between 10:00 to 18:00 (10:00 AM to 6:00 PM) after 6 months (24 weeks) of treatmentRandomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Placebo, DISC-1459 | Erythropoietic Protoporphyria (EPP), X-Linked Protoporphyria (XLP) | 183 | Sep 2026 | ≤ 42 d | 2026-08-12 |
| Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants With CKD and AnemiaNCT05745883Incidence of treatment-emergent adverse eventsRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: DISC-0974, Placebo | Chronic Kidney Diseases, Anemia of Chronic Kidney Disease | 55 | 2025-10-09actual | — | 2026-04-22 |
| A Study of DISC-3405 in Healthy VolunteersNCT06050915Incidence of adverse eventsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: DISC-3405, DISC-3405, Placebo, Placebo | Healthy Volunteer | 64 | 2024-07-09actual | — | 2024-12-18 |
| Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPPNCT05308472results2026-01-08Percent Change From Baseline in Whole Blood Metal-free PPIX LevelsRandomized · Triple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: DISC-1459, DISC-1459, Placebo | Erythropoietic Protoporphyria | 75 | 2024-02-20actual | — | 2026-01-08 |
| Study to Evaluate the Safety, Tolerability, PK and PD of DISC-0974 in Healthy SubjectsNCT04999527Incidence of adverse eventsRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: DISC-0974, Placebo | Healthy Volunteer | 42 | 2022-06-30actual | — | 2022-07-19 |
| Expanded Access Program of Bitopertin For Participants With EPP or XLPNCT07603401expanded access | — | Available | Drug: DISC-1459 | Erythropoietic Protoporphyria (EPP), X-Linked Protoporphyria (XLP) | — | — | — | 2026-08-03 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19