A new Janus kinase inhibitor medication, deuruxolitinib (Leqselvi, Sun Pharma UK Limited), has been approved in the UK for the treatment of severe alopecia areata in adult patients. The Medicines and Healthcare products Regulatory Agency's (MHRA's) decision expands treatment options for patients with this immune-mediated hair loss disorder that affects the scalp and other body areas.

The approval was granted through the International Recognition Procedure.

Alopecia UK's CEO Sue Schilling said the approval marked further progress in expanding treatment options for people with alopecia areata and expressed hope that Leqselvi would now secure a positive assessment by the National Institute for Health and Care Excellence (NICE), allowing eventual NHS access. She added that access to effective treatments should not depend on a patient’s ability to pay for private care.

Mechanism and Clinical Evidence

Deuruxolitinib works by reducing activity of Janus kinase enzymes JAK1, JAK2, and TYK2 relative to JAK3 kinases, which participate in inflammation at hair follicles. This mechanism decreases inflammatory responses, enabling hair regrowth in patients with alopecia areata.

The approval relied on evidence from two phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2. 

In these studies, oral deuruxolitinib was evaluated in 1223 adults aged 18-65 years with severe alopecia areata (defined as ≥ 50% scalp hair loss). Patients were randomized to receive deuruxolitinib 8 mg twice daily, deuruxolitinib 12 mg twice daily, or placebo for 24 weeks. The primary endpoint in both studies was the proportion of patients achieving a Severity of Alopecia Tool score ≤ 20 at week 24. 

In THRIVE-AA1, the primary endpoint was achieved by 29.6% of patients treated with deuruxolitinib 8 mg twice daily and 41.5% treated with deuruxolitinib 12 mg twice daily, compared with 0.8% in the placebo group. In THRIVE-AA2, the corresponding rates were 33.0% and 38.3% with deuruxolitinib 8 mg and 12 mg twice daily, respectively, vs 0.8% with placebo.

Across both trials, treatment with deuruxolitinib resulted in substantially greater scalp hair regrowth than placebo by week 24.

Dosing and Safety Profile

The recommended dose is an 8-mg tablet taken twice daily, available only by prescription. The most common side effects affecting more than 1 in 10 people include headache and acne. The medication is subject to additional monitoring to enable quick identification of new safety information.

Currently, ritlecitinib is the only NICE-approved treatment for adults with severe alopecia areata. Deuruxolitinib differs from ritlecitinib by primarily reducing JAK1, JAK2, and TYK2 protein activity, whereas ritlecitinib primarily targets JAK3. The four JAK proteins are important for relaying signals between immune cells and hair follicles, and reducing their activity can decrease inflammation and immune cell attacks on hair follicles.

Next Steps and Access

The Summary of Product Characteristics and Patient Information leaflets will be published on the MHRA Products website within 7 days of approval.

Although MHRA approval marks an important step, deuruxolitinib must still be assessed by NICE before it can become available through the NHS. NICE’s appraisal for is currently in progress, with publication expected in October 2026. Alopecia UK is participating as a stakeholder in this process.