Etavopivat Phase 3 results support potential approval in sickle cell disease

A global, late-stage clinical trial testing etavopivat in people with sickle cell disease (SCD) has hit its main goals, showing that the experimental oral therapy improved hemoglobin levels and reduced the risk of painful episodes compared with a placebo.

Based on these positive results from the Phase 3 portion of the Phase 2/3 HIBISCUS clinical trial (NCT04624659), Novo Nordisk — which acquired etavopivat in 2022 — is planning to begin regulatory submissions in the second half of 2026 seeking the therapy’s approval for SCD.