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Compound · clinical trials

Maralixibat clinical trials

Also listed in trial records as TAK-625, Livmarli
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 3 trials in our Germany, France, Spain, Italy, UK, USA, Poland, Canada, Brazil, Netherlands, Belgium, Portugal and Japan registers that name Maralixibat as an intervention. Synced 26 Sep 2026
3Current trials
2Recruiting now
2Lead sponsors
13Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Maralixibat is named as an intervention in 3 current clinical trials in our Germany, France, Spain, Italy, UK, USA, Poland, Canada, Brazil, Netherlands, Belgium, Portugal and Japan registers. 2 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Mirum Pharmaceuticals, Inc (2). The most-studied condition is Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC).

Trials by status

  • Recruiting267%
  • Active, closed133%

Trials by phase

  • Phase 3133%
  • Phase 4133%
  • Observational133%
01

Clinical trials of Maralixibat

3 trials
StudyPhaseStatusLead sponsorRegisters
Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArliยฎ in Patients With Alagille Syndrome or Progressive Familial Intrahepatic Cholestasis in the European Union (LEAP-EU)
NCT07290257 · ClinicalTrials.gov ↗ · Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Phase 4 Recruiting Mirum Pharmaceuticals, Inc Germany, France, Spain, Italy, Netherlands, Belgium, Portugal
A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)
NCT07293897 · ClinicalTrials.gov ↗ · Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC)
Observational Recruiting Takeda Japan
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)
NCT06553768 · Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
Phase 3 Active, closed Mirum Pharmaceuticals, Inc UK, USA, Germany, France, Spain, Italy, Poland, Canada, Brazil

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Maralixibat across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

6 single-substance products containing Maralixibat on the HPRA medicines list.

All 6 Irish products →

Supply shortages

No entry for Maralixibat in the EMA, FDA or German BfArM shortage lists we track.

03

Conditions studied with Maralixibat

5 conditions
Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)1Alagille Syndrome1Progressive Familial Intrahepatic Cholestasis1Alagille Syndrome (ALGS)1Progressive Familial Intrahepatic Cholestasis (PFIC)1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
Mirum Pharmaceuticals, Inc2
Takeda1
05

By country register

RegisterTrialsRecruiting
Clinical trials in Germany21
Clinical trials in France21
Clinical trials in Spain21
Clinical trials in Italy21
Clinical trials in UK10
Clinical trials in USA10
Clinical trials in Poland10
Clinical trials in Canada10
Clinical trials in Brazil10
Clinical trials in Netherlands11
Clinical trials in Belgium11
Clinical trials in Portugal11
Clinical trials in Japan11

A trial with sites in more than one country appears in each of those registers.

06

Questions about Maralixibat trials

How many clinical trials are testing Maralixibat?

3 current trials in our Germany, France, Spain, Italy, UK, USA, Poland, Canada, Brazil, Netherlands, Belgium, Portugal and Japan registers name Maralixibat (also registered as TAK-625) as a drug or biological intervention, as of the registry sync on 26 September 2026. Completed and withdrawn studies are not counted.

Are Maralixibat trials recruiting patients?

Yes. 2 of the 3 trials are recruiting: 1 with sites in Germany, 1 with sites in France, 1 with sites in Spain, 1 with sites in Italy, 1 with sites in Netherlands, 1 with sites in Belgium, 1 with sites in Portugal and 1 with sites in Japan. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Maralixibat clinical trials?

Mirum Pharmaceuticals, Inc (2) and Takeda (1). The number in brackets is how many trials each organisation leads.

Is Maralixibat licensed in Ireland?

Yes. The HPRA medicines list includes 6 single-substance products containing Maralixibat, for example Livmarli 10 mg tablets (Mirum Pharmaceuticals International B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Maralixibat shortage?

Not in the lists we track: Maralixibat has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Maralixibat works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Maralixibat works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Maralixibat (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 26 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.