MHRA Grants Approval for Deuruxolitinib (Leqselvi) as a Treatment for Severe Alopecia Areata in Adults

Approval of Deuruxolitinib for Alopecia Areata

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for deuruxolitinib, marketed as Leqselvi, for the treatment of severe alopecia areata in adults. This condition is characterised by the immune system mistakenly attacking hair follicles, resulting in hair loss from the scalp, face, and other areas of the body.

Mechanism of Action and Benefits

Deuruxolitinib functions by inhibiting the activity of specific enzymes known as JAK1, JAK2, and TYK2, relative to JAK3 kinases, which play a significant role in the inflammatory processes affecting hair follicles. By mitigating this inflammation, the medication promotes hair regrowth in those suffering from alopecia areata.

Julian Beach, Executive Director for Healthcare Quality and Access at the MHRA, remarked on the significance of this approval: “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.” He also noted that the medication is available only through prescription, with the recommended dosage being an 8 mg tablet taken twice daily.

Clinical Trials and Efficacy

The efficacy of Leqselvi was examined in two pivotal clinical trials involving 1,209 adult patients who had lost at least 50% of their hair for a minimum of six months. Participants received either 8 mg of Leqselvi, 12 mg of deuruxolitinib, or a placebo, administered twice daily over a period of 24 weeks.

Results indicated that patients receiving Leqselvi demonstrated significantly improved scores on a scale measuring scalp hair compared to those on the placebo. Approximately 30% of participants experienced an 80% or greater regrowth of scalp hair, while around 23% achieved a 90% or more regrowth rate after the 24-week treatment period.

Potential Side Effects and Monitoring

Common side effects associated with deuruxolitinib, which may affect more than one in ten users, include headaches and acne. Individuals experiencing adverse effects are advised to consult their doctor, pharmacist, or nurse. They can also report any concerns through the Yellow Card scheme, accessible via the dedicated website or by searching for the MHRA Yellow Card app on mobile platforms.

Regulatory Background and Further Information

Deuruxolitinib received its approval on 10 March 2026 from Sun Pharma UK Limited through the International Recognition Procedure (IRP). The medication is subject to additional monitoring, facilitating the swift identification of new safety information. Comprehensive details will be made available in the Summary of Product Characteristics and Patient Information leaflets, which are expected to be published on the MHRA Products website within seven days of the approval.

The MHRA is tasked with regulating all medicines and medical devices in the UK, ensuring their efficacy and safety through rigorous and evidence-based assessments. As an executive agency of the Department of Health and Social Care, it plays a crucial role in protecting public health.

For media enquiries, please reach out via email at newscentre@mhra.gov.uk, or contact the agency by phone at 020 3080 7651.