DISC-0974 is an investigational first-in-class monoclonal antibody targeting hemojuvelin to suppress hepcidin and improve iron availability for erythropoiesis in anemia of inflammation states. It has progressed through Phase 1 and into ongoing Phase 1b/2 clinical studies in anemia populations, including non-dialysis dependent CKD and myelofibrosis-associated anemia. The therapy is not approved in any jurisdiction.
Three comprehensive reports examine the monoclonal antibody landscape, covering CD47-targeted immunotherapy pipelines, competitive analysis of 180+ companies developing mAb therapeutics, and recombinant antibody market forecasts through 2033.
The FDA declined to approve Disc Medicine's bitopertin for erythropoietic protoporphyria on February 13, 2026, citing insufficient evidence linking biomarker reductions to clinical benefit. The company will pursue traditional approval using Phase 3 APOLLO trial data expected in Q4 2026.
Disc Medicine received a complete response letter from the FDA for bitopertin as a treatment for erythropoietic protoporphyria. The FDA acknowledged the drug lowers PPIX levels but requires evidence from the ongoing Phase 3 APOLLO study before approval.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07368972 |
Study of DISC-0974-201 in Participants With IBD and Anemia |
RECRUITING | PHASE2 |
| NCT05745883 |
Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants With CKD and Anemia |
COMPLETED | PHASE1 |
| NCT05320198 |
Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia |
RECRUITING | PHASE1/PHASE2 |
| NCT04999527 |
Study to Evaluate the Safety, Tolerability, PK and PD of DISC-0974 in Healthy Subjects |
COMPLETED | PHASE1 |
