The Medicines and Healthcare products Regulatory Agency has authorised Jascayd (nerandomilast) for adults with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, marking the first new IPF treatment in over a decade.
The preferential PDE4B inhibitor offers antifibrotic, immunomodulatory and vascular effects and is the first therapy of its kind to be licensed for these conditions. At present, treatment options that slow disease progression remain limited, with IPF associated with a five‑year survival rate of just 45.6%.
Professor Philip Molyneaux, Consultant Respiratory Physician and Professor of Interstitial Lung Disease at Imperial College London, said: “A diagnosis of progressive pulmonary fibrosis means that life expectancy is reduced while day‑to‑day quality of life can often deteriorate, as breathlessness and fatigue worsen.”
He added: “With the authorisation of nerandomilast by the MHRA, clinicians have a new treatment option that can slow the decline in lung function, expanding the choices available for eligible patients.”
Pulmonary fibrosis is a chronic, fatal condition characterised by irreversible lung scarring and a continuous decline in lung function. Symptoms include worsening breathlessness, persistent dry cough and fatigue.
Antifibrotics have been the mainstay of treatment for the past decade, with no effective innovations licensed in that time. More than 5,000 people in the UK die each year from IPF, representing around 1 in 100 deaths nationwide.
The MHRA decision is based on the phase 3 Fibroneer‑IPF and Fibroneer‑ILD trials, which enrolled over 2,300 patients. Both met their primary endpoint, showing a smaller decline in forced vital capacity over 52 weeks compared with placebo.
Although the key secondary endpoint was not met, a numerical reduction in mortality was observed, reaching nominal significance in Fibroneer‑ILD. The most frequent adverse effects were diarrhoea and weight loss.
Dr Douglas Clark, Medical Director of Boehringer Ingelheim UK & Ireland, said: “Boehringer Ingelheim has an extensive heritage in pulmonary fibrosis and the MHRA authorisation of nerandomilast is a meaningful advancement in the management of this condition, where there is high mortality and a substantial impact on quality of life.”
He continued: “We are incredibly grateful to everyone involved in the extensive clinical research programmes, particularly the participating patients. We are now working closely with NICE, aiming to bring nerandomilast to eligible patients on the NHS as soon as possible.”
NICE is currently evaluating nerandomilast for adults with IPF or PPF, with guidance expected in September 2026.
Daniel Saxton, Chief Executive Officer of Action for Pulmonary Fibrosis, said: “Progress towards this new treatment option will be welcomed by people living with pulmonary fibrosis. For a condition where there have been very limited therapies for many years, developments like this represent an important step forward.”
He added: “Action for Pulmonary Fibrosis has worked to ensure the voices of people living with the condition are heard and we will continue to champion access to new and effective treatments for this debilitating illness.
“Early diagnosis and referral to specialist care will also remain essential so people have the best possible chance to benefit from treatments that can help slow disease progression.”
