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NCT04624659 · ClinicalTrials.gov record · last posted 2026-04-06

A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)

Study acronym: HIBISCUS
StatusActive, Not Recruiting
PhasePhase 3
Started2021-01-29
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from the ClinicalTrials.gov record
This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of etavopivat and test how well etavopivat works compared to placebo to improve the amount of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when the blood vessels become blocked and cause pain).

Amendment record 37 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 37 times since 2020-11-05; most recent amendment 2026-03-31. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-03-10
Status change Recruiting→Active, Not Recruitingv28
2021-01-06
Status change Not Yet Recruiting→Recruitingv4
Trial Details
NCT Number NCT04624659
Lead Sponsor Forma Therapeutics, Inc.
Collaborators: This study is currently undergoing a sponsor transition from Forma to Novo Nordisk. Sponsor field will be updated once the transition is complete.
Conditions Sickle Cell Disease
Enrollment 450 participants
Start Date 2021-01-29
Primary Completion 2026-02-06 (estimated)
Study Completion 2027-03-19 (estimated)
Updated on ClinicalTrials.gov 2026-04-06