MHRA Approves Nerandomilast for Pulmonary Fibrosis

The MHRA has approved nerandomilast for adults with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, expanding treatment options in the UK.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved nerandomilast (Jascayd) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), providing a new therapeutic option for patients living with these chronic, progressive lung diseases.

The approval marks the first UK authorisation for nerandomilast and follows evidence demonstrating its ability to slow the progression of pulmonary fibrosis. IPF and PPF are characterised by progressive scarring of the lung tissue, leading to declining lung function, worsening breathlessness, and reduced quality of life. Despite existing antifibrotic therapies, many patients continue to experience disease progression, highlighting the need for additional treatment options.

New Option for Progressive Fibrotic Lung Disease

Nerandomilast works by regulating immune pathways involved in the development of fibrosis, helping to reduce excessive scar tissue formation within the lungs.

The medicine has been approved for adults with both idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, broadening treatment options for patients across a range of fibrotic interstitial lung diseases.

According to the MHRA, nerandomilast is available only on prescription and should be taken as an 18 mg oral tablet twice daily, in accordance with healthcare professional guidance.

MHRA Highlights Patient Access

Commenting on the approval, Julian Beach, Executive Director of Healthcare Quality and Access at the MHRA, said the decision reflects the agency’s commitment to ensuring patients have timely access to safe and effective medicines where there is an unmet clinical need.

He noted that nerandomilast provides an additional treatment option for adults with IPF and PPF, while emphasising that the MHRA will continue to monitor the medicine’s safety and effectiveness through routine pharmacovigilance following its introduction into clinical practice.

Safety Monitoring to Continue

As with all newly authorised medicines, the MHRA will keep nerandomilast under close review as further real-world safety data become available.

The most commonly reported adverse effects are diarrhoea and weight loss, each affecting more than one in ten patients.

Healthcare professionals are encouraged to advise patients to report suspected adverse reactions through the MHRA Yellow Card Scheme, which supports ongoing monitoring of medicine safety across the UK.

Expanding the Treatment Landscape

The marketing authorisation for nerandomilast was granted to Boehringer Ingelheim Limited International GmbH on 8 July 2026.

The approval represents another advance in the management of fibrotic lung disease, an area where treatment options have historically been limited. By expanding the therapeutic arsenal for IPF and PPF, the decision may offer clinicians greater flexibility in managing progressive disease while providing patients with an additional option to help slow the progression of lung scarring.

As nerandomilast enters routine clinical use, longer-term real-world data will help further define its safety profile and effectiveness across broader patient populations.

Reference

GOV.UK. Nerandomilast (Jascayd) approved to treat adult patients with Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis. 2026. Available at: https://www.gov.uk/government/news/nerandomilast-jascayd-approved-to-treat-adult-patients-with-idiopathic-pulmonary-fibrosis-and-progressive-pulmonary-fibrosis.