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Tiny tablet, big hope: new PKU supplement put to the test

NCT ID NCT06694662

Disease control Sponsor: Galen Limited 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a new microtablet supplement called PKU EASY Microtabs Plus in 10 people with PKU aged 3 and older. The supplement is a slow-release protein substitute designed to help manage PKU. Over one week, researchers checked how well participants tolerated it (stomach issues), how much they actually took, and whether they liked the taste and texture. It's a small, early-stage study focused on acceptability, not on long-term disease control.

What this could mean

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

Active substance
PKU EASY Microtabs Plus (a slow-release, phenylalanine-free protein substitute with amino acids, vitamins, and minerals)
What this could lead to
If successful, this could provide a more convenient and tolerable dietary supplement option for people with PKU.
What could go wrong
This is a very small, short-term study (10 participants, 1 week) focused only on acceptability and tolerance, not on long-term health outcomes. Results may not apply to all PKU patients.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

10 people

The number who actually took part.

Started

Mar 2025

Finished

Aug 2025

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

3 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.

Inclusion Criteria: * Diagnosis of PKU requiring an appropriate protein substitute * Subjects who are already taking an appropriate protein substitute and are willing to try the study product for 7 days * Subjects aged 3 years and above * Written informed consent obtained from subject or parent/legal guardian, depending on subject age Exclusion Criteria: * Presence of serious concurrent illness * Lead Dietitian's uncertainty about the willingness or ability of the patient to comply with the protocol requirements * Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study, with the exception of sapropterin * Any subject having taken antibiotics over the previous 2 weeks leading up to the study * Subjects less than 3 years of age

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Conditions

The condition(s) this trial relates to.

phenylketonuria

As listed by the trial registrant

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

Phenylketonuria (PKU)

Contacts and locations

Locations

  • Birmingham Children's Hospital

    Birmingham, UK, B4 6NH, United Kingdom

More trials for these conditions

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