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New pill tebapivat aims to ease anemia in sickle cell disease

NCT ID NCT06924970

Disease control Sponsor: Agios Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This Phase 2 trial tests whether tebapivat, an oral tablet, can improve anemia in people with sickle cell disease compared to a placebo. About 59 participants will take the drug or a dummy pill for several weeks. The main goal is to see if hemoglobin levels rise, which could mean fewer symptoms and complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tebapivat (oral tablet)
What this could lead to
If successful, tebapivat could offer a new oral treatment option to improve anemia and reduce complications in people with sickle cell disease.
What could go wrong
This is an early Phase 2 trial with only 59 participants, so results may not apply to everyone. The drug may not work better than placebo or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

59 people

The number who actually took part.

Started

May 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Documented diagnosis of SCD (HbSS, HbSC \[combined heterozygosity for hemoglobins S and C\], sickle hemoglobin \[HbS\]/β0-thalassemia, HbS/β+-thalassemia, or other sickle cell syndrome variants). * Hemoglobin ≥5.5 and ≤10.5 grams per decilitre (g/dL). Hemoglobin concentration must be based on an average of at least 2 Hb concentration measurements (separated by ≥7 days) collected during the screening period. * If taking hydroxyurea, the hydroxyurea dose must be stable for at least 90 days before randomization. Discontinuation of hydroxyurea requires a 90-day washout before providing informed consent. Key Exclusion Criteria: * Receiving regularly scheduled red blood cell (RBC) transfusion therapy (also termed chronic, prophylactic, or preventative transfusion); episodic transfusion in response to worsened anemia or vaso-occlusive crisis (VOC) is permitted. Additionally, a participant who requires episodic transfusion(s) may not have received a transfusion(s) within 60 days before providing informed consent or during the screening period. * \>10 sickle cell pain crisis (SCPCs) in the 12 months before providing informed consent. * Receiving anabolic steroids that have not been stopped for at least 4 weeks before randomization. Testosterone replacement therapy to treat hypogonadism is allowed; the testosterone dose and preparation must be stable for ≥10 weeks before randomization. * Hospitalized for an SCPC and/or other vaso-occlusive event within 14 days before providing informed consent or within 14 days before randomization. If an SCPC occurs during the screening period, the screening period may be extended with Medical Monitor approval. * Receiving treatment with voxelotor, crizanlizumab, or L-glutamine within 90 days before randomization. * Platelet count \<lower limit of normal (LLN) for the local laboratory or \<150×109/liter (L) (whichever is lower) during screening. Platelet transfusions received within 28 days before consent or during screening. * Receiving treatment with hematopoietic stimulating agents within 90 days before randomization. * Prior exposure to gene therapy or prior bone marrow or stem cell transplantation, including any conditioning regimen.

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Conditions

The condition(s) this trial relates to.

sickle cell disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sickle cell disease

Contacts and locations

Locations

  • Amsterdam Universitair Medisch Centrum, Locatie AMC

    Amsterdam, North Holland, 1105AZ, Netherlands

  • CHR de la Citadelle

    Liège, Wallonne, 4000, Belgium

  • CHU Hôpital Henri Mondor

    Créteil, Île-de-France Region, 94010, France

  • CHU Montreal

    Montreal, Quebec, H2X 3E4, Canada

  • Children's Hospital of Michigan

    Detroit, Michigan, 48304, United States

  • Emory-Children's Center/ Children's Healthcare of Atlanta: Arthur M. Blank Hospital

    Atlanta, Georgia, 30322, United States

  • Erasmus MC

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Fred Hutchinson Cancer Center, University of Washington

    Seattle, Washington, 98195, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hôpital Edouard Herriot, CHU de Lyon

    Lyon, Auvergne-Rhône-Alpes, 69003, France

  • Icahn School of Medicine at Mt. Sinai

    New York, New York, 10029, United States

  • Institut Universitaire du Cancer de Toulouse - Oncopole

    Toulouse, Midi Pyrenees, 31059, France

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Prisma Health Cancer Institute - Farris Road

    Greenville, South Carolina, 29605, United States

  • St. James Hospital

    Dublin, Leinster, D08 A978, Ireland

  • UConn Health

    Farmington, Connecticut, 06030-0001, United States

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX, Netherlands

  • University College London

    London, WC1E 6BT, United Kingdom

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas Health Science Center of Houston

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.