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New pill aims to clean iron from organs in blood disorder patients

NCT ID NCT05693909

Disease control Sponsor: Pharmacosmos A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This trial tests an oral drug called SP-420 in about 90 adults with transfusion-dependent β-thalassemia or low-risk myelodysplastic syndromes (MDS). The goal is to see how well SP-420 removes excess iron from the liver and other organs, and whether it is safe. Participants take the drug three times a week and undergo MRI scans to measure iron levels.

What this could mean

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

Active substance
SP-420 (an oral iron chelator)
What this could lead to
If successful, SP-420 could offer a new oral option to safely reduce iron buildup from frequent blood transfusions, potentially lowering organ damage risk.
What could go wrong
This is an early Phase 2 trial with only 90 participants, so results may not apply broadly. The drug may cause side effects or fail to clear iron effectively.

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

About 90 people

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

Started

Sep 2023

Expected to finish

May 2028

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.

Thalassemia cohorts: Inclusion criteria: * Women and men aged 18 years or older * Transfusion-dependent β-thalassemia including HbE/β-thalassemia requiring iron chelation therapy (β-thalassemia with mutation and/or multiplication of α-globin is allowed) * On a stable dose of iron chelation for at least 4 weeks prior to screening * Weight ≥ 35kg at screening * Transfusion iron overload * Treated and followed for at least the past 6 months in a specialized centre Exclusion criteria: * β-thalassemia with the structural Hb variants HbS and HbC * Current MDS * Current biliary disorder * Historic or ongoing clinically significant kidney disease * Unable to undergo trial assessments including MRI e.g. due to claustrophobia in MRI scanner * Pregnant or nursing women * Men who do not agree to practice effective barrier contraception during the entire period Myelodysplastic Syndromes Cohorts: Inclusion criteria: * Women and men aged 18 years or older * Very low, low, or intermediate risk Myelodysplastic Syndrome according to IPSS-R * Weight ≥ 35kg at screening * Transfusion iron overload * Treated and followed for at least the past 6 months at medical facilities experienced with MDS Exclusion criteria: * Therapy-related MDS or MDS with a known bone marrow fibrosis * Diagnosis of decompensated liver cirrhosis * Clinically significant kidney disease, either historic or ongoing * Uncontrolled ischemic heart disease or uncontrolled arrythmia * Uncontrolled hypertension * Uncontrolled dyslipidaemia * Uncontrolled Diabetes * Major surgery within 8 weeks prior to screening * Pregnant or nursing women * Men who do not agree to practice effective barrier contraception during the entire period

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Conditions

The condition(s) this trial relates to.

beta-thalassemia major myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

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

Beta thalassemia major anemia Myelodysplastic syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Pharmacosmos Investigational Site

    RECRUITING

    Copenhagen, Denmark

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