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# FibroGen, FDA Agree on Roxadustat Phase 3 Elements
- URL: https://www.fdaweb.com/fibrogen-fda-agree-on-roxadustat-phase-3-elements/
- Published: 2025-08-07T12:00:00.000Z
- Updated: 2026-09-14T15:18:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159644

FibroGen and FDA have reached an agreement on important design elements for a pivotal Phase 3 trial of the company’s roxadustat to treat anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high red blood cell burden. A company statement says it will submit the Phase 3 protocol in the fourth quarter.

The planned trial will assess the safety and efficacy of roxadustat in some 200 patients with LR-MDS. The company says agreement was reached in a meeting with FDA on the patient population, dose regimen, and management of potential thrombotic risk through eligibility and dose modification and discontinuation criteria.

Roxadustat is described as the first in a new class of medicines that are HIF-PH inhibitors that promote red blood cell production through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. It is in clinical development for chemotherapy-induced anemia, FibroGen says.