After years of limited progress, new treatments for idiopathic pulmonary fibrosis (IPF) are moving closer to approval. Boehringer Ingelheim’s nerandomilast has shown strong Phase III results and could secure approval later in 2025, while United Therapeutics’ inhaled treprostinil advances in late-stage trials, signaling a potential breakthrough for patients facing this debilitating lung disease, says GlobalData, a leading data and analytics company.

The pharmaceutical industry currently focuses on developing the next generation of IPF therapies, with several companies currently standing out. Such companies include Boehringer Ingelheim, already known for its anti-fibrotic drug Ofev (nintedanib), and now leading the pipeline with nerandomilast, which has recently concluded a successful Phase III clinical trial (FIBRONEER-ILD), demonstrating significant slowing of lung function decline in IPF patients compared to placebo.

The drug’s favorable safety and ease of use as an oral therapy administered twice daily, have made it a potential candidate for regulatory approval, with a PDUFA date expected in the fourth quarter of 2025, as mentioned by Boehringer Ingelheim.

Bristol Myers Squibb is another company that desires to enter the IPF treatment landscape, with its LPA1 receptor agonist admilparant, which is currently being investigated in Phase III clinical trials, and is expected to be completed by October 2026.

United Therapeutics has also entered Phase III clinical trials with Tyvaso (inhaled treprostinil), which is now being investigated in the Phase III TETON trials for IPF patients, following its approval in patients with pulmonary arterial hypertension (PAH) in May 2022 by the FDA in the US.

Filippos Maniatis, Healthcare Analyst at GlobalData, comments: “With the recent positive TETON-2 results demonstrating superiority over placebo for the change in absolute forced vital capacity (FVC) by 95.6mL from baseline to Week 52 in patients with IPF, United Therapeutics may be able to further expand its indication to IPF patients, competing with Boehringer Ingelheim’s nerandomilast for approval.”

Emerging therapies such as nerandomilast, admilparant, and inhaled treprostinil highlight the need for improved measures in clinical trials, focusing on tolerability and long-term anti-fibrotic efficacy. As Boehringer Ingelheim may be expected to pursue regulatory approval for nerandomilast, it may bring the first significant new first-line agent to the IPF market in years, competing with Ofev (nintedanib), Esbriet (pirfenidone) and its generics. Nevertheless, with the recent positive TETON-2 results, Tyvaso is one step closer to approval, which increases the competition in the space.

Maniatis concludes: “Although the landscape of IPF is currently dynamic, the recent failures such as Fibrogen’s pamrevlumab (Phase III) and Pliant Therapeutics’ bexotegrast (Phase IIb/III) highlight the urgent need for better trial endpoints and an improved understanding of the therapeutic impact of treatments on lung function. 2025 may mark a turning point for IPF. New drugs potentially reaching approval in 2025 may bring hope to IPF patients.”