Date: 01 October 2026

Product Description

LEQSELVI® (deuruxolitinib) 8 mg tablets is an oral selective inhibitor of Janus kinases JAK1 and JAK2 FDA-approved for the treatment of adults with severe alopecia areata. Alopecia areata is an autoimmune disease where the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body, affecting up to 2.5% of the United States and global population during their lifetime.

Clinical Data Presentation

Sun Pharma announced that LEQSELVI will be featured in seven presentations at the 2026 European Academy of Dermatology and Venereology (EADV) Congress 2026, including a featured oral presentation reporting long-term safety results from a European open-label extension (OLE) study evaluating up to two years of treatment in adults with severe alopecia areata.

Efficacy Results

Long-term efficacy analyses showed durable scalp hair regrowth through Week 108:

  • Of OLE baseline treatment responders (SALT score ≤20) maintaining response at Week 52 and continuing in the study, 93.9% maintained response at Week 108
  • 76.6% of baseline nonresponders (SALT score >20) achieved response by Week 52
  • Of Week 52 responders who continued, 96.8% maintained that response at Week 108
  • A Severity of Alopecia Tool (SALT) score of 100 represents total scalp hair loss, while a score of 0 represents no scalp hair loss

Safety Profile

The safety profile remained generally consistent with previous clinical experience through up to two years of open-label treatment:

  • Most treatment-emergent adverse events were mild or moderate in severity
  • Treatment discontinuations due to adverse events were uncommon
  • No deaths, thrombosis or major adverse cardiovascular events were reported among patients receiving the FDA-approved dose of 8 mg twice-daily

Additional Analyses

Pooled post hoc analyses of THRIVE-AA1 and THRIVE-AA2 showed consistent efficacy across clinically relevant patient subgroups, including patients with baseline eyebrow, eyelash or nail involvement, and those with both shorter- and longer-duration disease episodes.

Safety Information

LEQSELVI can lower the ability to fight infections and is not for CYP2C9 poor metabolizers or anyone taking a CYP2C9 inhibitor. Serious infections, blood clots, cancers including lymphoma, stomach or intestinal tears have occurred. People 50+ taking a JAK inhibitor with risk for heart disease may have greater chance of heart attack, stroke, or death.

Most common side effects include: acne, headache, nasopharyngitis, increased blood creatine phosphokinase, increased blood cholesterol, weight gain, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, herpes simplex including cold sores, and tiredness.

Company Context

Sun Pharma is the world's leading specialty generics company with Innovative Medicines accounting for about 20% of company sales. The LEQSELVI data presentation is one of 22 presentations from Sun Pharma across its dermatology and immunology portfolio.

Management Commentary

Dr. Arash Mostaghimi stated: "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."

Dr. Ahmad Naim commented: "We remain committed to advancing research that addresses the significant unmet needs of people living with this autoimmune disease impacting their daily lives."