Etavopivat

Generic Name: Etavopivat

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₃N_₃O_₆S

CAS Number: 2245053-57-8

Unique Ingredient Identifier: V4E0A9M44Q

Background: Etavopivat is a small molecule activator of erythrocyte pyruvate kinase (PKR) under investigation for the treatment of sickle cell disease.

Clinical Trials

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

Phase 1

Recruiting

Conditions: Healthy Volunteers Sickle Cell Disease, Thalassemia

Interventions: Drug: Digoxin
Drug: Midazolam
Drug: Etavopivat
Drug: Pitavastatin
Drug: Rosuvastatin
Drug: Metformin

First Posted Date: 2025-02-07

Last Posted Date: 2025-03-21

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 29

Registration Number: NCT06813924

Locations: 🇺🇸
ICON-Salt Lake City, Salt Lake City, Utah, United States

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

Phase 3

Recruiting

Conditions: Sickle Cell Disease

Interventions: Drug: Etavopivat
Drug: Placebo

First Posted Date: 2024-09-25

Last Posted Date: 2025-05-20

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 408

Registration Number: NCT06612268

Locations: 🇫🇷
Ap-Hp-Hopital Henri Mondor, Créteil, France
🇳🇱
UMC Utrecht, Van Creveldkliniek, Utrecht, Netherlands
🇺🇸
Uni of Alabama at Birmingham, Birmingham, Alabama, United States

and more 152 locations

A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia

Phase 3

Recruiting

Conditions: Sickle Cell Disease, Thalassemia

Interventions: Drug: Etavopivat A
Drug: Etavopivat B

First Posted Date: 2024-09-24

Last Posted Date: 2025-05-20

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 325

Registration Number: NCT06609226

Locations: 🇺🇸
Univ of Alabama Birmingham, Birmingham, Alabama, United States
🇺🇸
Phoenix Children's Hsptl, Phoenix, Arizona, United States
🇺🇸
Children's Hospital Los Angeles - Endocrinology, Los Angeles, California, United States

and more 90 locations

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

Phase 1

Completed

Conditions: Healthy Volunteers
Sickle Cell Disease
Thalassemia

Interventions: Drug: Etavopivat

First Posted Date: 2024-09-03

Last Posted Date: 2024-12-16

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 24

Registration Number: NCT06581627

Locations: 🇨🇳
Beijing Hospital, Beijing, Beijing, China

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

Phase 1

Completed

Conditions: Healthy Volunteers Sickle Cell Disease, Thalassemia

Interventions: Drug: Etavopivat

First Posted Date: 2024-05-30

Last Posted Date: 2024-10-17

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 16

Registration Number: NCT06433661

Locations: 🇺🇸
ICON-Salt Lake City, Salt Lake City, Utah, United States

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

Phase 1

Recruiting

Conditions: Liver Diseases

Interventions: Drug: Etavopivat

First Posted Date: 2024-03-28

Last Posted Date: 2024-06-12

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 48

Registration Number: NCT06336018

Locations: 🇺🇸
Amer. Rrsch Corp-TX Liver Inst, San Antonio, Texas, United States
🇺🇸
Orlando Clinical Research Center, Orlando, Florida, United States

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

Phase 2

Recruiting

Conditions: Sickle Cell Disease

Interventions: Drug: Etavopivat

First Posted Date: 2024-01-10

Last Posted Date: 2025-01-16

Lead Sponsor: Forma Therapeutics, Inc.

Target Recruit Count: 50

Registration Number: NCT06198712

Locations: 🇨🇦
The Hospital for Sick Children, Toronto, Ontario, Canada
🇰🇪
Kombewa Clinical Research Centre, Kisumu, Kenya
🇰🇪
KEMRI-Walter-Reed Kericho, Kericho, Kenya

and more 12 locations

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

Phase 2

Recruiting

Conditions: Sickle Cell Disease

Interventions: Drug: Etavopivat
Drug: Hydroxyurea

First Posted Date: 2023-07-20

Last Posted Date: 2024-10-29

Lead Sponsor: Forma Therapeutics, Inc.

Target Recruit Count: 46

Registration Number: NCT05953584

Locations: 🇮🇳
All India Institute of Medical Sciences (AIIMS), Raipur, Raipur, Chhattisgarh, India
🇮🇳
All India Institute of Medical Sciences-Delhi, Delhi, India
🇮🇳
Nirmal Hospital Pvt. Ltd., Gujarat, India

and more 6 locations

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

Phase 2

Recruiting

Conditions: Sickle Cell Disease

Interventions: Drug: Etavopivat

First Posted Date: 2023-02-13

Last Posted Date: 2024-06-26

Lead Sponsor: Forma Therapeutics, Inc.

Target Recruit Count: 12

Registration Number: NCT05725902

Locations: 🇺🇸
Emory University Children's Healthcare of Atlanta, Atlanta, Georgia, United States

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

Phase 2

Terminated

Conditions: Very Low Risk, Low Risk, or Intermediate Risk MDS Per IPSS-R

Interventions: Drug: Etavopivat

First Posted Date: 2022-10-05

Last Posted Date: 2024-12-17

Lead Sponsor: Forma Therapeutics, Inc.

Target Recruit Count: 45

Registration Number: NCT05568225

Locations: 🇺🇸
Cedars-Sinai Medical Center, Plainsboro, New Jersey, United States
🇺🇸
Northwell Health, Plainsboro, New Jersey, United States
🇺🇸
Northwestern Memorial Hospital, Plainsboro, New Jersey, United States

and more 15 locations

Drug Development Updates

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