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New study aims to find gentler iron treatment for anemic women

NCT ID NCT07308769

Disease control Sponsor: Pharmanutra S.p.a. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests two oral iron supplements, Sucrosomial® Iron and Ferric Maltol, in 146 women with mild to moderate iron deficiency anemia. The goal is to see if Sucrosomial® Iron works as well as Ferric Maltol at raising hemoglobin levels after 12 weeks, while causing fewer stomach issues. Participants are randomly assigned to one treatment and monitored for side effects.

Why investors are watching

PharmaNutra is running a Phase 4 trial comparing its Sucrosomial Iron against a rival oral iron treatment in 146 women with mild to moderate iron deficiency anemia. For a small-cap company, this head-to-head result matters because it tests whether its product works as well as an established alternative, which could support marketing claims and adoption. The readout is consequential because a positive outcome would give the company a direct comparison point to use with doctors and patients.

If it works: A positive result could show that Sucrosomial Iron matches Ferric Maltol in raising hemoglobin levels, giving PharmaNutra a stronger sales story. That could help the company grow its share of the oral iron market.

If it fails: A negative or unclear result could weaken confidence in Sucrosomial Iron's effectiveness compared with a competitor. Trials often fail to show what sponsors hope, and a small company has fewer products to absorb that setback.

AI-written from the trial record. Speculative, and not investment advice.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 146 people

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

Started

Dec 2025

Expected to finish

Oct 2026

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

Female participants only

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.

Inclusion Criteria: * Female participants ≥ 18 years * Mild anemia (11.0 ≤ Hb \< 12 g/dL) or moderate anemia (8.0 \< Hb \< 11 g/dL) * Signed informed consent Exclusion Criteria: * Use of iron-containing drugs or supplements within 1 month prior to screening * Psychiatric disorders interfering with consent or compliance * Active cancer (except fibroids and polyps) * Pregnant or breastfeeding women * Participation in another interventional study * History of poor adherence or inability to comply * Use of erythropoietin within 3 months prior to screening * Need for blood transfusion or IV iron (per investigator judgment) * Severe active IBD (HBI \> 16 for Crohn; CAI \> 12 for ulcerative colitis) * Previous bariatric surgery * Alcohol abuse * Hemochromatosis or iron overload syndromes * Hereditary anemias (including thalassemia) * Known hypersensitivity to study product ingredients

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Conditions

The condition(s) this trial relates to.

anemia Iron Deficiencies iron deficiency anemia

As listed by the trial registrant

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

Anemia Iron deficiency anemia (IDA)

How to take part

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

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Hospital Quironsalud Barcelona

    RECRUITING

    Barcelona, 08023, Spain

  • Hospital Quironsalud Malaga

    RECRUITING

    Málaga, 29004, Spain

  • Hospital Quironsalud Malága

    RECRUITING

    Málaga, 29004, Spain

  • Hospital Quironsalud Zaragoza

    RECRUITING

    Zaragoza, 50006, Spain

  • Hospital Universitari Dexeus Grupo Quironsalud

    RECRUITING

    Barcelona, 08028, Spain

  • Hospital Universitari General De Catalunya

    RECRUITING

    Sant Cugat del Vallès, 08195, Spain

  • Hospital Universitari Sagrat Cor

    RECRUITING

    Barcelona, 08029, Spain

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