MHRA approves prescription tablet Leqselvi for adults with severe alopecia areata
The Medicines and Healthcare products Regulatory Agency (MHRA) approved deuruxolitinib, sold under the brand name Leqselvi, on 10 March 2026. The prescription medicine is authorised for adult patients living with severe alopecia areata, an autoimmune condition where the body attacks its own hair follicles. Manufactured by Sun Pharma UK Limited, the drug is taken as an 8 mg tablet twice daily. It works by blocking specific enzymes, called JAK1, JAK2 and TYK2, that drive inflammation around the hair follicles. Approval followed two clinical trials involving 1,209 adults who had lost at least half of their scalp hair for longer than six months. After 24 weeks of taking Leqselvi, about 30% of trial participants regained 80% or more of their scalp hair, while around 23% regained 90% or more. Common side effects include headaches and acne, affecting more than 1 in 10 people.
What was announced
The Medicines and Healthcare products Regulatory Agency granted regulatory approval for deuruxolitinib, brand named Leqselvi, on 10 March 2026. The approval was granted to Sun Pharma UK Limited through the International Recognition Procedure.
This prescription medicine is for adult patients with severe alopecia areata. The condition occurs when the immune system mistakenly attacks hair follicles, leading to hair loss on the scalp, face or body. Patients take an 8 mg tablet twice daily. The drug targets specific enzymes, namely JAK1, JAK2 and TYK2 relative to JAK3 kinases, reducing inflammation near hair follicles to help hair regrow.
Two clinical trials involving 1,209 adult patients provided evidence for the decision. Participants had experienced at least 50% scalp hair loss for more than six months. In these 24-week trials, subjects received either Leqselvi 8 mg, deuruxolitinib 12 mg or a placebo. Patients receiving Leqselvi scored higher on scalp hair measures than those on placebo. Around 30% of participants achieved 80% or greater scalp hair coverage, while roughly 23% reached 90% or greater coverage after 24 weeks.
What it means
Adults in the UK dealing with severe hair loss from alopecia areata have a new licensed prescription choice. Julian Beach, Executive Director of Healthcare Quality and Access at the agency, stated that the decision gives patients another potential treatment option to help manage their condition.
The MHRA will keep the safety and effectiveness of the medicine under review. Patients or healthcare professionals can report suspected side effects, such as headaches or acne, through the Yellow Card portal or mobile app.
What the announcement does not tell us
The announcement leaves several practical details unstated. It does not clarify when Leqselvi will become available in pharmacies or how much it will cost.
It does not indicate whether NHS funding bodies will cover the treatment. The source also does not explain long-term outcomes beyond the 24-week trial period, nor does it detail side effect rates for the 12 mg trial dose mentioned in the release.
How this was written
This analysis was written with AI from the official announcement below, using only facts that announcement states. The quoted wording is gov.uk: Medicines and Healthcare products Regulatory Agency’s own. Always check the original before acting on anything here.
As with any medicine, the MHRA will keep the safety and effectiveness of deuruxolitinib under close review.
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