The Medicines and Healthcare products Regulatory Agency (MHRA) has approved deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults.

Alopecia areata is a disease where the body’s own immune system attacks hair follicles, causing inflammation that leads to hair loss on the scalp, face and/or other parts of the body.

Deuruxolitinib works by reducing the activity of enzymes called JAK1, JAK2 and TYK2 relative to JAK3 kinases, which are involved in inflammation at the hair follicle. This reduces the inflammation, leading to hair regrowth in patients with alopecia areata.

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

“This approval gives adults with alopecia areata another potential treatment option to help manage their condition.

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

“Deuruxolitinib can only be obtained with a prescription. The recommended dose is an 8 mg tablet to be taken twice a day.”

This medicine was evaluated in two pivotal clinical trials. The trials studied 1209 adult patients with alopecia areata that had lost at least 50% of their hair for more than 6 months. In both trials, subjects received twice daily either Leqselvi 8 mg, deuruxolitinib 12 mg or a placebo for 24 weeks.

After 24 weeks, the patients that received Leqselvi scored higher on a scale used to measure scalp hair than those that received the placebo.

Leqselvi was shown to improve hair growth in subjects with severe alopecia areata, with around 30% of subjects experiencing 80% or more scalp hair after 24 weeks of treatment, and around 23% of subjects experiencing 90% or more scalp hair after 24 weeks of treatment.

The most common side effects with deuruxolitinib (which may affect more than 1 in 10 people) are headache and acne. Anyone who suspects they are having a side effect from this medicine is encouraged to talk to their doctor, pharmacist or nurse and report it 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

• Deuruxolitinib was approved on 10 March 2026 to Sun Pharma UK Limited.
• This medicine was approved via the International Recognition Procedure  (IRP).
• This medicine is subject to additional monitoring to allow quick identification of new safety information. 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.
• The 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.

source: GOV