May 19, 2025
The full results of the FIBRONEER-IPFTM and FIBRONEER-ILDTM clinical trials that were published in the New England Journal of Medicine and presented at the American Thoracic Society Congress in San Francisco, USA.
The studies tested a new oral medication called nerandomilast and results show it slowed the decline in lung function over one year in people living with IPF and other forms of pumonary fibrosis — both chronic lung diseases with limited treatment options.
This development could mark the first new treatment for over a decade, potentially transforming care for thousands of people across the UK and globally.
The two current treatments, nintedanib and pirfenidone, were introduced more than 10 years ago and, while helpful in slowing disease progression, can cause significant side effects and are not suitable for everyone. Whilst the new drug doesn’t stop progression of disease, it offers hope as an additional treatment option that may be tolerated by more people.
Peter O'Brien, who is living with pulmonary fibrosis, said:
When you’re living with pulmonary fibrosis, you hold on to hope quietly. Progress takes time, and a lot of work happens behind the scenes — but this feels like a breakthrough we can actually see. A treatment that more people might tolerate could make a real difference to how we live and what comes next.
More than 2,200 people in over 40 countries took part in the trials for IPF and PPF. Participants who received nerandomilast experienced a significantly smaller decline in lung function compared to those who received a placebo. Importantly, the drug showed effectiveness both as a standalone therapy and when used alongside existing treatments.
While participants experienced some degree of lung function decline, reinforcing the need for ongoing research, the slowed progression seen in those taking nerandomilast is a substantial and encouraging step forward.
Daniel Saxton, CEO of Action for Pulmonary Fibrosis, said:
This milestone marks another step forward in the effort to overcome pulmonary fibrosis. Nerandomilast could be the first new approved treatment for the disease in over 10 years, and it’s one that may be better tolerated and suitable for more people. We are committed to advocating that regulators prioritise the review and approval of this medicine so people in the UK can access it as soon as possible.
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