Primary completion· ClinicalTrials.gov
A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease
Etavopivat History and Updates
40 events · 2020 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
0
FDA Approvals
0
Label Revisions
40
Trial Milestones
0
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-11Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Etavopivat since 2020, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (2)
2026
- Primary completionEtavopivat Phase 3 Trial for Sickle Cell Disease Reaches Primary Completion· Feb 6, 2026
2025
- Results postedEtavopivat Phase 2 for MDS Anemia: 50% HI-E Response in Low Transfusion Burden· Oct 22, 2025
Upcoming & expected milestones
Primary completion· ClinicalTrials.gov
A Phase 2 Open-label Study to Evaluate the Activity of Etavopivat on Transcranial Doppler Velocities in Pediatric Patients With Sickle Cell
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease
Primary completion· ClinicalTrials.gov
A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia
Past events
2026
Primary completion· ClinicalTrials.gov
Study of the Effect of Etavopivat on Cerebral Hemodynamic Response in Children With Sickle Cell Disease
Primary completion· ClinicalTrials.gov
A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)
2025
Results posted· ClinicalTrials.gov
A Study of Etavopivat for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS)
Primary completion· ClinicalTrials.gov
A Study on the Effect of Etavopivat on Heart Rhythm in Healthy Participants
Primary completion· ClinicalTrials.gov
A Study of Etavopivat in Patients With Thalassemia or Sickle Cell Disease
Primary completion· ClinicalTrials.gov
A Research Study on Etavopivat in Participants With and Without Liver Disease
Trial registered· ClinicalTrials.gov
A Study on the Effect of Etavopivat on Heart Rhythm in Healthy Participants
Trial started· ClinicalTrials.gov
A Study on the Effect of Etavopivat on Heart Rhythm in Healthy Participants
Primary completion· ClinicalTrials.gov
A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants
Trial started· ClinicalTrials.gov
A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease
Trial registered· ClinicalTrials.gov
A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants
Trial started· ClinicalTrials.gov
A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants
Trial started· ClinicalTrials.gov
A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia
2024
Primary completion· ClinicalTrials.gov
A Research Study Looking at a Single Dose of Etavopivat in Healthy Chinese Participants
Trial registered· ClinicalTrials.gov
A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease
Trial registered· ClinicalTrials.gov
A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia
Trial registered· ClinicalTrials.gov
A Research Study Looking at a Single Dose of Etavopivat in Healthy Chinese Participants
Trial started· ClinicalTrials.gov
A Research Study Looking at a Single Dose of Etavopivat in Healthy Chinese Participants
Primary completion· ClinicalTrials.gov
A Study of Etavopivat for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS)
Primary completion· ClinicalTrials.gov
A Research Study of the Effect of Food on Etavopivat in Healthy Participants
Trial registered· ClinicalTrials.gov
A Research Study of the Effect of Food on Etavopivat in Healthy Participants
Trial started· ClinicalTrials.gov
A Research Study of the Effect of Food on Etavopivat in Healthy Participants
Trial started· ClinicalTrials.gov
A Research Study on Etavopivat in Participants With and Without Liver Disease
Trial registered· ClinicalTrials.gov
A Research Study on Etavopivat in Participants With and Without Liver Disease
Trial started· ClinicalTrials.gov
Study of the Effect of Etavopivat on Cerebral Hemodynamic Response in Children With Sickle Cell Disease
Trial registered· ClinicalTrials.gov
A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease
2023
Trial registered· ClinicalTrials.gov
A Phase 2 Open-label Study to Evaluate the Activity of Etavopivat on Transcranial Doppler Velocities in Pediatric Patients With Sickle Cell
Trial started· ClinicalTrials.gov
A Phase 2 Open-label Study to Evaluate the Activity of Etavopivat on Transcranial Doppler Velocities in Pediatric Patients With Sickle Cell
Trial registered· ClinicalTrials.gov
Study of the Effect of Etavopivat on Cerebral Hemodynamic Response in Children With Sickle Cell Disease
Trial started· ClinicalTrials.gov
A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease
2022
Trial started· ClinicalTrials.gov
A Study of Etavopivat for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS)
Trial registered· ClinicalTrials.gov
A Study of Etavopivat for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS)
Trial started· ClinicalTrials.gov
A Study of Etavopivat in Patients With Thalassemia or Sickle Cell Disease
2021
Trial registered· ClinicalTrials.gov
A Study of Etavopivat in Patients With Thalassemia or Sickle Cell Disease
Trial started· ClinicalTrials.gov
A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)
2020
Trial registered· ClinicalTrials.gov
A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.