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# Promising Insmed Data in Pulmonary Arterial Hypertension
- URL: https://www.fdaweb.com/promising-insmed-data-in-pulmonary-arterial-hypertension/
- Published: 2025-06-10T12:00:00.000Z
- Updated: 2026-09-14T15:13:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159334

Insmed is reporting positive results from a Phase 2b clinical trial of its once-daily inhaled therapy treprostinil palmitil inhalation powder (TPIP) and its use in treating pulmonary arterial hypertension (PAH). According to the company, the placebo-controlled trial met its primary and all secondary efficacy endpoints. The therapy showed a 35% reduction in pulmonary vascular resistance, a key measure of the disease's impact on blood vessels in the lungs, compared to placebo. TPIP also led to a 35.5 meter improvement in six-minute walk distance, and a 60% reduction in NT-proBNP, a biomarker of cardiac stress, compared to placebo, it says.

The company says TPIP was generally well tolerated, though treatment-emergent adverse events were more common in the TPIP group (88.4%) than in the placebo group (75.8%). Common side effects included cough, headache and fatigue. No deaths were reported.

Insmed plans to begin a Phase 3 study in patients with pulmonary hypertension associated with interstitial lung disease by the end of 2025 and another Phase 3 study in PAH patients in early 2026.