FDA Accepted Treprostinil Application for Pulmonary Fibrosis

The FDA accepted a supplemental application on September 2, 2026, for an inhaled treatment for pulmonary fibrosis.

Updated on Sept. 30, 2026 in Asthma

FDA Accepted Treprostinil Application for Pulmonary Fibrosis

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On September 2, 2026, the FDA accepted a supplemental new drug application from United Therapeutics for inhaled treprostinil to treat idiopathic pulmonary fibrosis. The submission is based on findings from the TETON-1 and TETON-2 phase 3 clinical trials.

Why it matters

If approved, inhaled treprostinil could become the first inhaled antifibrotic treatment for idiopathic pulmonary fibrosis. This option aims to offer a new therapeutic path for patients alongside existing treatments like nintedanib and pirfenidone.

Clinical trial participants treated with nebulized treprostinil showed a 111.8 mL improvement in forced vital capacity over placebo during a 52-week study. Regulatory review of this application is expected to conclude in late April 2027.

The players

United Therapeutics

This biotechnology company focuses on the development of novel pharmaceutical therapies for chronic and life-threatening conditions.

FDA

This federal agency is responsible for protecting public health by ensuring the safety and efficacy of human drugs and medical devices.

The details

The application relies on data from the TETON-1 and TETON-2 phase 3 trials which measured the change in lung function from baseline. Inhaled treprostinil is administered using durable medical equipment, expanding on its current use for pulmonary arterial hypertension.

September 2, 2026: The FDA officially accepted the supplemental new drug application.
May 2026: Combined clinical trial results were presented at the American Thoracic Society conference.
Late April 2027: The FDA is expected to complete its review of the application.

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Health Landscape

This story follows a pattern set by the TETON-1 and TETON-2 phase 3 clinical trials, which established the efficacy benchmarks for this specific drug candidate. The potential approval would mark a notable evolution in treatment options for the approximately 100,000 Americans with idiopathic pulmonary fibrosis.

Patients may eventually gain access to an inhaled antifibrotic therapy that requires administration via durable medical equipment. This potential treatment joins other available therapies like nintedanib and pirfenidone in the current landscape of chronic lung care.

The takeaway

The FDA's acceptance of this application initiates a formal review process that could expand the available treatments for pulmonary fibrosis by mid-2027. Patients and healthcare providers should monitor the upcoming regulatory decision for potential shifts in the standard of care.