MHRA approves deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults
The UK’s MHRA has licensed deuruxolitinib (Leqselvi) for adults with severe alopecia areata, offering a twice-daily 8 mg tablet under prescription.
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for deuruxolitinib (brand name Leqselvi) to treat adults with severe alopecia areata, a condition in which the immune system attacks hair follicles, causing patchy hair loss on the scalp, face or other areas. The medicine works by inhibiting enzymes JAK1, JAK2 and TYK2, reducing inflammation at the follicle and enabling regrowth. Deuruxolitinib will be available only by prescription and must be taken as an 8 mg tablet twice daily.
Approval follows two pivotal trials involving 1,209 adults who had lost at least 50% of their scalp hair for more than six months. Participants received either Leqselvi 8 mg, deuruxolitinib 12 mg or placebo for 24 weeks. After 24 weeks, patients on Leqselvi showed significantly higher scalp hair coverage than those on placebo, with around 30% achieving at least 80% regrowth and about 23% reaching at least 90% regrowth.
The most frequently reported side effects—affecting more than one in ten users—are headache and acne. Patients are advised to report suspected side effects to the MHRA’s Yellow Card scheme via the website or mobile app. The regulator notes that deuruxolitinib will be subject to additional monitoring to detect any new safety signals promptly.
Deuruxolitinib was licensed to Sun Pharma UK Limited on 10 March 2026 through the International Recognition Procedure. The MHRA, an executive agency of the Department of Health and Social Care, regulates medicines in the UK, ensuring benefits outweigh risks based on robust evidence. Patient and prescriber information will be published on the MHRA Products website within seven days.