Fast-Acting Alopecia Treatment, Leqselvi, Hits U.S.
Adults gained nearly full scalp hair regrowth by week 24 after deuruxolitinib (Leqselvi) treatment.
By
Lana Pine
| Published on July 14, 2025
3 min read
Credit: Adobe Stock/Siam
Sun Pharma today announced the U.S. availability of deuruxolitinib (Leqselvi) 8 mg, a newly FDA-approved oral treatment for adults with severe alopecia areata — a condition where the immune system attacks hair follicles, affecting roughly 2.5% of individuals in their lifetime.
For people living with alopecia areata, the psychological impact can be immense — loss of confidence, social anxiety and significant emotional distress. A treatment that works quickly can offer not just visible hair — but a much-needed boost in well-being.
In phase 3 trials (THRIVE-AA1 and AA2) involving 1,223 adults, deuruxolitinib demonstrated impressive results: About one-third of participants nearly regrew all their hair by 24 weeks, while a smaller subset (3%) saw 80% regain by Week 8. Open-label extensions up to 68 weeks also showed sustained improvements, with many patients achieving over 80% scalp coverage.
“The clinical evidence for Leqselvi is truly compelling, demonstrating consistent efficacy,” said Arash Mostaghimi, M.D., M.P.A., M.P.H., vice chair of Clinical Trials and Innovation and associate professor of dermatology at Brigham and Women’s Hospital. “Leqselvi provides clinicians with an important new treatment that can deliver significant, rapid outcomes for patients with alopecia areata.”
Common side effects of deuruxolitinib noted in trials included headache (12%), acne (10%) and nasopharyngitis (8%), which were slightly higher than in placebo groups. It should be avoided in patients with specific genetic metabolic profiles or those on certain medications.
To improve access, Sun Pharma has rolled out the LEQSELVI SUPPORT Program, offering eligible adults the drug at no cost for up to two years. This includes a dedicated patient access liaison to guide treatment, help with insurance and offer ongoing support.
“The availability of Leqselvi offers hope to our community, delivering a new, effective treatment option for adults living with severe alopecia areata,” said Nicole Friedland, president and CEO of the National Alopecia Areata Foundation (NAAF). “NAAF is thrilled to see expanded choices and increased opportunities for individuals to find an FDA-approved treatment to address hair loss caused by this autoimmune disease.”
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