Pulmonary Arterial HypertensionPhase 3TRANSCENDNCT07612657
A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations
A Phase 3 study testing VI-0106 in people with Pulmonary Arterial Hypertension and Pulmonary Arterial Hypertension (PAH), run by VIVUS LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension (PAH), Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
- What is being tested?
- VI-0106
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 29 May 2026to 30 Nov 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Safety and Efficacy Study of VI-0106 (Extended-release Tacrolimus) in Subjects With PAH and Functional Limitations Despite Optimized Treatment With Available PAH Medications
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 PAH, Pulmonary Arterial Hypertension WHO Group I
- Being tested
- VI-0106, Placebo
- Keywords
- PAH, Pulmonary Arterial Hypertension
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VI-0106Drug
Also called Tacrolimus
Tacrolimus Extended-Release Capsules
PlaceboDrug
Inactive oral capsule
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: VI-0106 |
| Placebo | Placebo comparator | Placebo oral capsule; once daily; Week 0-52 during double-blind treatment period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in 6MWD (6 Minute Walk Distance) at Week 24
Measured: Baseline to Week 24
Secondary outcomes (4)
Percentage of subjects with a ≥1 category improvement vs baseline in WHO functional class at Week 24
Measured: Baseline to Week 24
Time to clinical worsening defined as a composite of the following events:
- All-cause death;
- In-patient hospitalization for PAH or right-sided heart failure;
- Worsening-related placement on a recipient list for heart-lung or lung transplantation;
- Diminished functional capacity (decrease from baseline 6MWD of ≥15% with an absolute value of at least 22 meters and a ≥1 category worsening of WHO functional class);
- Worsening-related need to initiate rescue therapy with an approved PAH therapy, or the need to increase the dose of an IV prostacyclin infusion by 10% or more.
Measured: 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
Measured: Baseline to Week 52
Change from baseline in 6MWD at Week 28
Measured: Baseline to Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start29 May 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VIVUS LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612657
- Sponsor's protocol ID
- PH-201
- Acronym
- TRANSCEND
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Safety and Efficacy Study of VI-0106 (Extended-release Tacrolimus) in Subjects With PAH and Functional Limitations Despite Optimized Treatment With Available PAH Medications
- ClinicalTrials.gov ID
- NCT07612657
- Acronym / sponsor ID
- TRANSCEND / PH-201
- Conditions
- Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension (PAH), Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), Pulmonary Arterial Hypertension PAH, Pulmonary Arterial Hypertension WHO Group I
- Keywords
- PAH, Pulmonary Arterial Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- VIVUS LLCIndustry (pharma, biotech, devices)
- Study start
- 29 May 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VI-0106 | Experimental | Drug: VI-0106Extended-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. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oral capsule; once daily; Week 0-52 during double-blind treatment period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VI-0106Also: TacrolimusTacrolimus Extended-Release Capsules | Drug | VI-0106 |
| PlaceboInactive oral capsule | Drug | Placebo |
Primary outcome
Change from baseline in 6MWD (6 Minute Walk Distance) at Week 24
Time frame: Baseline to Week 24
4 secondary outcomes
Percentage of subjects with a ≥1 category improvement vs baseline in WHO functional class at Week 24
Time frame: Baseline to Week 24
Time to clinical worsening defined as a composite of the following events:
Time frame: 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
Time frame: Baseline to Week 52
Change from baseline in 6MWD at Week 28
Time frame: Baseline to Week 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VI-0106 in people with Pulmonary Arterial Hypertension and Pulmonary Arterial Hypertension (PAH), run by VIVUS LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VIVUS Clinical (650-934-5200, clinical@vivus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in 6MWD (6 Minute Walk Distance) at Week 24 (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.