Idiopathic pulmonary fibrosis (IPF) remains one of the most challenging lung diseases to treat, with progressive scarring, limited treatment options and poor prognosis. However, in 2025, the scientific and medical communities are witnessing major advances in drug development with the rise of promising new therapies.
The pharmaceutical industry is currently focused on developing the next generation of IPF therapies, with several companies standing out. These 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 favourable safety and ease of use have made it a potential candidate for regulatory approval, with a Prescription Drug User Fee Act date expected in the fourth quarter of 2025. Bristol Myers Squibb is another player intending to enter the IPF treatment landscape, with its LPA1 receptor agonist admilparant under investigation in Phase III clinical trials, expected to be completed by October 2026.
Go deeper with GlobalData
Access deeper industry intelligence
Experience unmatched clarity with a single platform that combines unique data, AI, and human expertise.
In the race for approval, 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 without pulmonary hypertension, following its approval in IPF patients with pulmonary arterial hypertension (PAH) in May 2022 by the US Food and Drug Administration. With the recent positive TETON-2 results demonstrating superiority over placebo for the change in absolute forced vital capacity 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 nintedanib and pirfenidone. Nevertheless, with the recent positive TETON-2 results, Tyvaso is one step closer to approval, which increases the competition in the space. Although the landscape of IPF is currently dynamic, 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 idiopathic pulmonary fibrosis. New drugs potentially reaching approval may bring hope to multiple patients currently suffering from IPF. While challenges persist, collaborations between manufacturers and clinical trial innovation across the globe may provide a more positive treatment future.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData
