VI-0106

VI-0106 is an investigational proprietary soft capsule formulation of the calcineurin inhibitor tacrolimus being developed by Vivus for the treatment of pulmonary arterial hypertension (PAH). It leverages tacrolimus’s ability to increase signaling through the bone morphogenetic protein receptor type II (BMPR2) pathway, which is downregulated in PAH and implicated in disease progression, while maintaining low systemic tacrolimus concentrations suitable for chronic use.[1][3][9] As an oral, once‑daily soft gel designed under the FDA 505(b)(2) pathway, VI-0106 aims to provide a first‑in‑class disease‑modifying therapy that complements existing PAH treatments that primarily address symptoms rather than the underlying vascular pathology.[1][3][4][5][9][10]