Sun Pharmaceutical Industries has said that new long-term data for its therapy LEQSELVI (deuruxolitinib) showed sustained efficacy and a consistent safety profile in adults with severe alopecia areata -- sustained hair regrowth over two years, in a nutshell.

 

The data, drawn from a European open-label extension study, tracked patients for up to two years and found that the safety profile of LEQSELVI remained generally consistent with earlier clinical experience.

 

Most treatment-emergent adverse events were mild or moderate, while treatment discontinuations linked to adverse events were uncommon. No deaths, thrombosis or major adverse cardiovascular events were reported among patients receiving the FDA-approved 8 mg twice-daily dose.

 

The long-term efficacy findings also pointed to sustained scalp hair regrowth.

 

Among patients who had responded to treatment at the start of the open-label extension — defined as a Severity of Alopecia Tool (SALT) score of 20 or below — 93.9% maintained their response through Week 108.

 

The study also found that 76.6% of patients who were nonresponders at baseline, with a SALT score above 20, achieved a response by Week 52. Of those responders who continued in the study, 96.8% maintained their response through Week 108.

 

A SALT score of 100 represents complete scalp hair loss, while a score of 0 represents no scalp hair loss.

 

“Severe alopecia areata is a chronic autoimmune disease, making long-term treatment considerations particularly important for both patients and their clinicians,” said Arash Mostaghimi, Vice Chair of Clinical Trials and Innovation and Associate Professor of Dermatology at Brigham and Women's Hospital. 

 

“Collectively, these data show durable efficacy and maintenance of response for deuruxolitinib over time and reinforce the growing body of evidence supporting its use as a long-term treatment option for eligible adults.”

 

The EADV data add to the evidence on the use of LEQSELVI in a disease that can require long-term management. Additional analyses from the THRIVE-AA1 and THRIVE-AA2 studies reported consistent efficacy across several patient subgroups, including people with eyebrow, eyelash or nail involvement and those with shorter- or longer-duration disease.

 

“Our data at EADV 2026 expands our understanding of LEQSELVI beyond initial treatment response and provides important evidence for dermatologists and advance practice providers into long-term tolerability, durability of response, and maintenance of clinical benefit in adults with severe alopecia areata,” said Ahmad Naim, Senior Vice President, North America Chief Medical Officer, Sun Pharma. 

 

“We remain committed to advancing research that addresses the significant unmet needs of people living with this autoimmune disease impacting their daily lives.”

 

Sun Pharma said LEQSELVI data were among 22 presentations from the company covering its dermatology and immunology portfolio at the EADV Congress.

 

LEQSELVI (deuruxolitinib) 8 mg tablets is an oral selective inhibitor of Janus kinases JAK1 and JAK2 and is FDA-approved for adults with severe alopecia areata.

 

Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, causing partial or complete hair loss on the scalp and other parts of the body. The disease can occur at any age and affect both women and men.