A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations

NCT07612657 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: PH-201
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the effects of VI-0106 (an extended-release formulation of tacrolimus) in participants with pulmonary arterial hypertension (PAH) who continue to have functional limitations despite being on optimized background PAH therapy. Participants will be randomly assigned with equal chance to receive either VI-0106 or placebo in a double-blind fashion to assess whether VI-0106 improves outcomes in this population.

Conditions

Pulmonary Arterial Hypertension; Pulmonary Arterial Hypertension PAH; Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH); Pulmonary Arterial Hypertension WHO Group I

Keywords

PAH; Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in 6MWD (6 Minute Walk Distance) at Week 24

  Baseline to Week 24

Secondary Outcomes (4)

• Percentage of subjects with a ≥1 category improvement vs baseline in WHO functional class at Week 24

  Baseline to Week 24

• Time to clinical worsening defined as a composite of the following events:

  Baseline to Week 52

• Time to clinical worsening by a restricted definition comprised of all-cause death and in-patient hospitalization for PAH or right-sided heart failure

  Baseline to Week 52

• Change from baseline in 6MWD at Week 28

  Baseline to Week 28

Study Arms (2)

VI-0106

EXPERIMENTAL

Extended-release tacrolimus dosages of 1.25 mg or 0.625 mg oral capsules; once daily; Week 0-24, Week 28-52 during double-blind treatment period; Week 52-104 during open-label treatment period.

Drug: VI-0106

Placebo

PLACEBO COMPARATOR

Placebo oral capsule; once daily; Week 0-52 during double-blind treatment period.

Drug: Placebo

Interventions

VI-0106 DRUG

Tacrolimus Extended-Release Capsules

Also known as: Tacrolimus

VI-0106

Placebo DRUG

Inactive oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VIVUS LLC: lead

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Central Study Contacts

VIVUS Clinical

CONTACT

650-934-5200; clinical@vivus.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 29, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): November 30, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share