LEQSELVI™ Launches in U.S. as Oral Treatment for Severe Alopecia Areata

Key Takeaways

• LEQSELVI™ (deuruxolitinib) is now available in the U.S. for adults with severe alopecia areata.

• TClinical trials showed rapid and meaningful regrowth, with one-third of patients achieving near-complete scalp hair coverage by 24 weeks.

Sun Pharmaceutical Industries Ltd. announced the U.S. commercial availability of LEQSELVI™ (deuruxolitinib), an oral Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata, according to a press release from the manufacturer. 

LEQSELVI was evaluated in clinical trials, showing rapid and substantial regrowth in patients with severe scalp hair loss. One-third of participants achieved near-complete regrowth by week 24, with a subset (3%) experiencing ≥80% scalp coverage within 8 weeks. Sun said the development marks a milestone for Sun Pharma’s dermatology division and the broader alopecia areata community, which has had limited FDA-approved treatment options to date. 

“The launch of LEQSELVI in the U.S. brings an effective, new treatment option for severe alopecia areata to eligible patients and the healthcare providers who treat them,” said Richard Ascroft, CEO, Sun Pharma North America, in the press release.

Prescribers were advised to remain vigilant for its known risks. Potential adverse effects include serious infections, thrombosis, malignancies, gastrointestinal perforations, and laboratory abnormalities. The drug should not be used in CYP2C9 poor metabolizers or with CYP2C9 inhibitors. Common adverse events include headache (12.4%), acne (10%), and nasopharyngitis (8.1%) vs. placebo, according to the press release. 

Sun Pharma has launched the LEQSELVI SUPPORT™ Program, offering financial assistance and patient navigation services. Eligible patients may receive therapy for as little as $0 for up to two years.

Source: Press release, July 14, 2025.