Phase 2b results confirm the efficacy of treprostinil palmitil inhalation powder in pulmonary arterial hypertension

Treprostinil palmitil inhalation powder (TPIP) versus placebo improved pulmonary vascular resistance and 6-minute walk distance, while being associated with more frequent cough events, in patients with pulmonary arterial hypertension (PAH).

TPIP-202 (NCT05147805) was a phase 2b, randomised, placebo-controlled, 16-week trial in patients with WHO Group 1 PAH who were receiving up to 2 other background therapies. Following screening, participants were randomised 2:1 to either TPIP capsules once daily (80-640 µg, with a 3-week up-titration) or a matching placebo. The primary endpoint was the change from baseline in pulmonary vascular resistance at Week 16. In total, 102 patients were randomised.

Prof. Ekkehard Grünig (University of Heidelberg, Germany) presented the results. The study met its primary endpoint, with a least-squares mean ratio of pulmonary vascular resistance of 0.63 at Week 16 for TPIP versus 0.97 for placebo (adjusted ratio 0.65; 95% CI 0.54-0.79; P<0.001). Additionally, TPIP demonstrated a 35.5 m improvement in the 6-minute walk distance compared to the placebo after 16 weeks of treatment (95% CI 11.23-60.73; P=0.003). In total, 5.8% of patients discontinued TPIP, but none discontinued placebo. Adverse events were more common with TPIP, including cough (40.6% vs 21.2%, mostly mild events), headache (31.9% vs 15.2%), and fatigue (10.1% vs 3.0%) [1].

“The study showed a positive effect on the primary endpoint, with a 35% reduction in pulmonary vascular resistance alongside improvement in 6-minute walk distance”, concluded Prof. Grünig. “The drug was well-tolerated, and this success supports initiation of a phase 3 program, planned for next year.”

1. Grünig E, et al. A randomized, double-blind, placebo-controlled study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH). ERS Congress, 27 September–1 October 2025, Amsterdam, the Netherlands.

Medical writing support was provided by Mihai Surducan, PhD.

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Posted on 3 October 20253 November 2025