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New hope for PAH patients: Extended-Release tacrolimus enters phase 3 trial

NCT ID NCT07612657

Disease control Sponsor: VIVUS LLC 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 study tests VI-0106, an extended-release form of tacrolimus, in 300 people with pulmonary arterial hypertension (PAH) who still have trouble with daily activities despite taking standard PAH medications. Participants will receive either the drug or a placebo for 24 weeks to see if it improves their walking distance and delays disease worsening. The trial is not yet recruiting.

What this could mean

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

Active substance
VI-0106 (extended-release tacrolimus)
What this could lead to
If successful, this could provide a new treatment option to improve exercise capacity and delay disease worsening for people with PAH who still have symptoms on current therapies.
What could go wrong
This is a Phase 3 trial, but PAH is a complex disease and previous tacrolimus studies have shown mixed results. The drug may cause side effects like kidney problems or infections, and it requires lifelong use alongside other PAH medications.

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 300 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

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 to 75 years

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: * WHO Group 1 PH: Pulmonary Arterial Hypertension; * WHO functional class II - IV despite optimized treatment with one or more modalities. Treatments for PAH must be stable for at least 3 months at the time of screening; * Right heart catheterization (RHC) at screening (or within 3 months prior to screening); * Screening 6MWD \>75 meters to ≤450 meters. Exclusion Criteria: * PAH due to pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis * Chronic thromboembolic or portopulmonary hypertension * Total Lung Capacity (TLC) \<60% predicted; * FEV1/FVC \<70% predicted or FEV1 \<60% predicted; * Evidence of left-sided heart disease; * Inability to safely attempt completion of the 6MWD; * Life expectancy \<6 months; * eGFR \<30 mL/min/1.73 m2 (CKD-EPI equation); * Moderate to severe hepatic dysfunction (Child-Pugh score \>10); * Serum potassium \>5.1 mEq/L; * Use of experimental PAH treatments within the past 3 months; * Active infection requiring antibiotic, antifungal, or antiviral therapies; * Current systemic treatment with cyclosporine; * Known allergy or hypersensitivity to tacrolimus; * Significant psychiatric, addictive, or other disorder that compromises the subject's ability to provide informed consent, follow study protocol, or adhere to study treatment

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

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

Pulmonary arterial hypertension Pulmonary arterial hypertension (PAH) Pulmonary arterial hypertension (PAH) (who group 1 PH) Pulmonary arterial hypertension who group I

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.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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