Is IPF the Next Big Market Opportunity for United Therapeutics?

United Therapeutics UTHR remains poised to expand Tyvaso’s label in the respiratory disease space. It recently unveiled results from the late-stage TETON-2 study, which showed clinical benefit in idiopathic pulmonary fibrosis (IPF) patients after a year-long treatment with nebulized Tyvaso (treprostinil).

The study met its primary endpoint, with Tyvaso-treated patients showing a 95.6 mL improvement in absolute forced vital capacity (FVC) over placebo. FVC measures the maximum amount of air a person can forcibly exhale after taking a deep breath. The treatment benefits were also consistent across patient subgroups — regardless of background therapy, smoking status, or oxygen use — while the safety profile aligned with prior Tyvaso studies.

The TETON 2 study is one of the two late-stage registrational studies initiated by United Therapeutics for Tyvaso in IPF. The company is also conducting the phase III TETON-1 study of nebulized Tyvaso in IPF patients. Though both studies are parallel in design, the only difference is that the TETON-1 study is being conducted at sites in the United States and Canada, while the TETON-2 study was conducted at locations outside these two countries. A data readout from the TETON-1 study is expected in the first half of 2026.

UTHR plans to meet with the FDA before this year’s end to potentially expedite the regulatory review process once the TETON-1 results are available.

Why IPF Results Matter to UTHR?

IPF is a chronic, scarring disease characterized by progressive loss of the lungs’ ability to transfer oxygen into the blood, ultimately leading to respiratory failure and death. With the TETON-2 study results, United Therapeutics succeeded in an indication where many companies, including Gilead Sciences and Fibrogen, have failed over the years.

While currently marketed therapies, such as Roche’s Esbriet and Boehringer Ingelheim’s Ofev, are designed to slow disease progression, the TETON-2 study results showed that Tyvaso takes the extra mile. The United Therapeutics drug demonstrated the potential to improve lung function and quality of life in IPF patients, even in those who were also taking Esbriet and Ofev. This is likely to reshape the current treatment landscape.

United Therapeutics currently markets two versions of Tyvaso — a dry powder inhalation (DPI) formulation and a nebulized version. Both products are approved for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) indications.The timing of the TETON-2 results is also crucial for UTHR, as it recently lost exclusivity for Tyvaso in both PAH and PH-ILD indications.

United Therapeutics estimates that around 100,000 IPF patients are living in the United States, representing a substantial untapped market with blockbuster potential. The company had previously pointed out that if Tyvaso were approved in the IPF indication, sales from this indication could surpass those from PAH.

Peers Who Could Capitalize on UTHR’s IPF Results

United Therapeutics’ progress with Tyvaso in IPF also puts focus on other smaller biotechs like Insmed INSM and Liquidia Corporation LQDA, which are either developing or already market treprostinil.

Insmed is developing treprostinil palmitil inhalation powder (TPIP), which is a prodrug of UTHR’s treprostinil, the active ingredient in the Tyvaso products. A prodrug is an inactive compound that becomes active once inside the body, allowing Insmed’s TPIP to release treprostinil more gradually. This extended-release design enables once-daily dosing, compared to Tyvaso, which requires multiple daily doses using either a nebulizer or a DPI.

Insmed has previously reported encouraging results from separate mid-stage studies on TPIP for PAH and PH-ILD indications, demonstrating the potential to prolong the duration of effect and reduce dose frequency compared to Tyvaso products. INSM could likely explore the potential of TPIP in the IPF indication.

Liquidia recently made headlines when it secured the FDA approval for an inhaled treprostinil product called Yutrepia after Tyvaso lost exclusivity in May. Yutrepia marked the first inhaled competitor for both PAH and PH-ILD indications. Like Insmed, Liquidia could also explore its treprostinil drug’s potential in the IPF space.

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