Trial intelligence / Profile preview

VI-0106 extended-release tacrolimus in pulmonary arterial hypertension

2025-524596-24-00Phase 3Authorised

Sponsor
VIVUS
Start
Oct 2026
Modality
RNA-Targeting Small Molecules → Nucleic Acid-Directed Small Molecules → Small Molecules
Countries
14
01

Overview

Phase 3, randomised, double-blind trial in pulmonary arterial hypertension (PAH) comparing VI-0106 plus optimized background PAH therapy with Placebo plus optimized background PAH therapy (2 arms). Primary endpoint: Change from baseline in 6-minute walk distance at Week 24. Planned start Oct 2026; status: authorised.

02

Drugs

tacrolimus
03

Conditions

pulmonary arterial hypertension (PAH)

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