Etavopivat

DRUG15 trials

Sponsors

Forma Therapeutics, Inc., Novo Nordisk A/S, Forma Therapeutics Inc, Novo Nordisk

Conditions

Haematological DisordersHaematological Disorders PaediatricsHealthy VolunteersHealthy Volunteers Sickle Cell Disease, ThalassemiaLiver DiseasesSickle Cell DiseaseThalassemiaVery Low Risk, Low Risk, or Intermediate Risk MDS Per IPSS-R

Phase 1

A Research Study on Etavopivat in Participants With and Without Liver Disease

CompletedNCT06336018

Novo Nordisk A/SLiver Diseases

Start: 2024-05-20End: 2025-08-01Updated: 2026-06-18

A Research Study of the Effect of Food on Etavopivat in Healthy Participants

CompletedNCT06433661

Novo Nordisk A/SHealthy Volunteers Sickle Cell Disease, Thalassemia

Start: 2024-05-28End: 2024-07-08Updated: 2025-10-10

A Research Study Looking at a Single Dose of Etavopivat in Healthy Chinese Participants

CompletedNCT06581627

Novo Nordisk A/SHealthy Volunteers, Sickle Cell Disease, Thalassemia

Start: 2024-08-26End: 2024-10-31Updated: 2025-12-29

A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants

CompletedNCT06813924

Novo Nordisk A/SHealthy Volunteers Sickle Cell Disease, Thalassemia

Start: 2025-02-06End: 2025-05-27Updated: 2025-09-25

A Study on the Effect of Etavopivat on Heart Rhythm in Healthy Participants

CompletedNCT07023029

Novo Nordisk A/SHealthy Volunteers, Sickle Cell Disease, Thalassemia

Start: 2025-06-09End: 2025-09-22Updated: 2026-01-02

Phase 2

A Single Arm, Open Label, Phase 1/2 Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients with Sickle Cell Disease

RecruitingPACTR202209604592389

Forma Therapeutics IncHaematological Disorders

Start: 2023-01-02Target: 95Updated: 2026-08-03

A Study of Etavopivat for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS)

TerminatedNCT05568225

Forma Therapeutics, Inc.Very Low Risk, Low Risk, or Intermediate Risk MDS Per IPSS-R

Start: 2022-11-15End: 2024-07-15Updated: 2026-09-03

A Phase 2 Open-label Study to Evaluate the Activity of Etavopivat on Transcranial Doppler Velocities in Pediatric Patients with Sickle Cell Disease who are at Increased Risk for Primary Stroke

RecruitingPACTR202301655446404

Forma Therapeutics IncHaematological Disorders

Start: 2023-09-04Target: 46Updated: 2026-09-14

Study of the Effect of Etavopivat on Cerebral Hemodynamic Response in Children With Sickle Cell Disease

CompletedNCT05725902

Novo Nordisk A/SSickle Cell Disease

Start: 2024-03-09End: 2026-03-09Updated: 2026-04-08

A Phase 2 Open-label Study to Evaluate the Activity of Etavopivat on Transcranial Doppler Velocities in Pediatric Patients With Sickle Cell Disease Who Are at Increased Risk for Primary Stroke

RecruitingNCT05953584

Forma Therapeutics, Inc.Sickle Cell Disease

Start: 2023-06-20End: 2028-06-28Target: 27Updated: 2026-09-10

A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease

RecruitingNCT06198712

Forma Therapeutics, Inc.Sickle Cell Disease

Start: 2023-01-12End: 2029-08-08Target: 95Updated: 2026-09-18

Phase 3

A research study to evaluate how well etavopivat works in people with sickle cell disease - Hibiscus 2

Active, not recruitingPACTR202406801520269

Novo NordiskHaematological Disorders

Start: 2024-11-30Target: 408Updated: 2026-09-14

FLORAL: A research study looking at long-term treatment with etavopivat in people with sickle cell disease or thalassaemia

Active, not recruitingPACTR202408476236496

Novo NordiskHaematological Disorders

Start: 2025-07-31Target: 325Updated: 2026-09-14

A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease

RecruitingNCT06612268

Novo Nordisk A/SSickle Cell Disease

Start: 2025-02-17End: 2029-08-12Target: 510Updated: 2026-09-17

A research study to evaluate how well etavopivat works in children with sickle cell disease

Active, not recruitingPACTR202603858736405

Novo NordiskHaematological Disorders Paediatrics

Start: 2026-11-30Target: 260Updated: 2026-09-14

Related Papers

Hibiscus 2 (Trial-in-Progress): A global, Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of etavopivat in adolescents and adults with sickle cell disease

Blood2025-11-03

Etavopivat in adolescents with sickle cell disease: Emerging safety and efficacy findings from the first cohort of the ongoing Phase 1/2 hibiscus kids study

Blood2025-11-03

FORTITUDE: A Phase 2 Open-Label Study in Progress to Evaluate Etavopivat for the Treatment of Anemia in Patients with Lower-Risk Myelodysplastic Syndromes

Blood2023-11-02

PB2524: TRIAL IN PROGRESS: THE HIBISCUS-KIDS STUDY, A SINGLE-ARM, OPEN-LABEL, PHASE 1/2 STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY OF ETAVOPIVAT IN PEDIATRIC PATIENTS WITH SICKLE CELL DISEASE

HemaSphere2023-08-011 citations