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A pill that mimics the body's oxygen sensor may free MDS patients from frequent blood transfusions

NCT ID NCT07722988

Disease control Sponsor: Kyntra Bio Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether roxadustat, an oral drug that stimulates red blood cell production, can help people with myelodysplastic syndromes (MDS) who need frequent blood transfusions. Participants with very low, low, or intermediate risk MDS and a high transfusion burden will receive either roxadustat or a placebo. The main goal is to see if the drug allows them to go without transfusions for at least 56 consecutive days.

What this could mean

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

Active substance
roxadustat (FG-4592), an oral drug that stimulates red blood cell production
What this could lead to
If successful, roxadustat could offer a new treatment option to reduce or eliminate the need for frequent blood transfusions in people with MDS-related anemia.
What could go wrong
This is an early-phase 3 trial, and the drug may not prove effective or safe in this specific patient group. Potential risks include side effects common to drugs that boost red blood cell production, such as blood clots or high blood pressure.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 201 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2027

An estimate. Start dates often move.

Expected to finish

Dec 2032

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

18 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: * Diagnosis of MDS according to World Health Organization (WHO) criteria confirmed by bone marrow aspirate and biopsy within 12 weeks before randomization. * Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate risk MDS * HTB: Participants requiring ≥ 4 units of packed red blood cell (pRBC) in two consecutive 8-week periods prior to randomization * Refractory to, intolerant to, or ineligible for prior erythropoiesis-stimulating agents (ESAs). * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 Key Exclusion Criteria: * Pregnant or breastfeeding females * Participant has any significant medical illness or is considered vulnerable by local regulations * Prior allogeneic or autologous stem cell transplant * Major surgery within 8 weeks prior to randomization. Note: Other protocol-defined inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

anemia myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

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

Myelodysplastic syndromes

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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