MHRA Licenses Brensocatib for Non-Cystic Fibrosis Bronchiectasis

MHRA Guidance & Safety

Published February 23rd, 2026

Detected February 23rd, 2026

Summary

The MHRA has granted a marketing authorisation for brensocatib (Brinsupri), the first medicine specifically designed to treat non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 years and older. This marks a significant advancement in treatment options for NCFB patients in the UK.

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What changed

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a marketing authorisation for brensocatib (Brinsupri), a new treatment for non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 and above who experience recurrent flare-ups. This authorisation, granted to Insmed Netherlands B.V. on February 20, 2026, signifies the first medicine specifically targeting this chronic lung condition in the UK. Brensocatib works by inhibiting the DPP1 protein to reduce lung inflammation.

This development means that healthcare providers can now prescribe brensocatib to eligible NCFB patients. The MHRA will continue to monitor the safety and effectiveness of the drug. Patients and healthcare professionals are encouraged to report any suspected side effects through the Yellow Card scheme. The Summary of Product Characteristics and Patient Information Leaflets will be available on the MHRA website within seven days of approval, providing detailed information on usage, side effects, and contraindications.

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Press release

Brensocatib licensed as the first medicine specifically designed to treat non-cystic fibrosis bronchiectasis in patients 12 years and older

As with any medicine, the MHRA will keep the safety and effectiveness of brensocatib under close review.

From: Medicines and Healthcare products Regulatory Agency Published 23 February 2026

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for the medicine brensocatib (Brinsupri) to treat patients 12 years and older with non-cystic fibrosis bronchiectasis (NCFB) who have experienced two or more flare-ups or worsening of symptoms in the past 12 months.

NCFB is a chronic, long-term condition where the airways of the lungs are damaged, causing a cough with mucus production. It can affect anybody but is more common in older adults.

Brensocatib works by targeting a protein called dipeptidyl peptidase 1 (DPP1), which is involved in the process that causes inflammation in the lungs. By blocking the activity of this protein, the medicine prevents flare-ups in the lungs and may improve some symptoms of NCFB.

Julian Beach, MHRA Executive Director, Healthcare Quality and Access, said:

“This is the first medicine licensed in the UK that specifically treats patients living with non-cystic fibrosis bronchiectasis.

“As with any medicine, the MHRA will keep the safety and effectiveness of brensocatib under close review.”

Brensocatib is available as a tablet to be taken by mouth once a day.

The most common side effects associated with this medicine include nose and throat infection, diarrhoea and vomiting, headache, problems affecting the gums, small areas of skin thickening (hyperkeratosis), rash, dryness and inflammation of the skin (dermatitis), and hair loss (alopecia)

A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), which will be published on the MHRA website within 7 days of approval.

Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.

Notes to editors

The new marketing authorisation was granted on 20 February 2026 to Insmed Netherlands B.V.
More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
For more information about bronchiectasis, visit: Bronchiectasis - NHS
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.  All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
The MHRA is an executive agency of the Department of Health and Social Care.
For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.