Sun Pharmaceutical Industries has announced the US launch of its specialty drug, LEQSELVI (deuruxolitinib) 8 mg tablets, for the treatment of severe alopecia areata, an autoimmune condition, which causes sudden and often severe hair loss.

LEQSELVI has been approved by the US FDA, following strong results from clinical trials and is now available to adults suffering from this disorder. Experts estimate that it could become a $ 200–300 million (Rs 1,600–2,500 crore) market opportunity for Sun Pharma over the next three to five years.

New treatment addressing a critical need

LEQSELVI has demonstrated rapid results in the clinical trials. Nearly one-third of patients treated with the drug achieved almost complete hair regrowth within 24 weeks, while some saw over 80 per cent scalp coverage in as little as 8 weeks.

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The drug was tested in two pivotal trials—THRIVE-AA1 and THRIVE-AA2—conducted across the US, Canada, and Europe, involving more than 1,200 adults with severe alopecia areata. At the start of the trials, participants had an average of 86 to 88 per cent scalp hair loss. After 24 weeks of treatment, a significant number experienced notable hair regrowth.

$200–300 million market potential: Elara Capital

The US FDA approval makes LEQSELVI a significant addition to Sun Pharma’s specialty portfolio. Industry experts estimate that the drug could generate a $200–300 million (Rs 1,600–2,500 crore) opportunity over the next three to five years.

Originally developed by Concert Pharmaceuticals, LEQSELVI became part of Sun Pharma’s pipeline following its $576 million acquisition of the company in January 2023. The deal also includes up to USD 252 million in milestone payments.

The drug was involved in a patent dispute with Incyte Pharma, which has now been resolved through a settlement agreement. As part of the deal, Sun Pharma will make an upfront payment to Incyte and pay ongoing royalties; however, the specific terms remain confidential.

According to Elara capital, “LEQSELVI could become the second-largest product for Sun Pharma after Ilumya.” The stock is currently trading at 35.9 times its FY26 estimated core earnings. 

However, brokerage firm Elara has warned that adverse US trade tariffs could pose a near-term risk to the company’s performance.

Eligible patients can access LEQSELVI for as little as $0

To enhance accessibility, Sun Pharma has launched the LEQSELVI SUPPORT Program in the US. Under this initiative, eligible patients can obtain the drug for as little as $0 for up to two years. The program also includes the support of a Patient Access Liaison to help guide patients through their treatment journey.

What is alopecia areata?

Alopecia areata is an autoimmune disorder in which the immune system mistakenly attacks hair follicles, leading to hair loss on the scalp and other areas of the body. According to Elara Capital the disease affects around 70,000 people in the US each year. It can lead to severe psychological effects, including anxiety, depression, and loss of self-esteem.

About LEQSELVI and safety profile

LEQSELVI is an oral Janus kinase (JAK1 and JAK2) inhibitor. While clinically effective, it carries potential risks, including serious infections, malignancies, blood clots, and cardiovascular issues. Common side effects observed during clinical trials included headache, acne, and nasopharyngitis.

Share price of Sun Pharma

The share price of Sun Pharma gained nearly 2.27 per cent as of 12:00 PM on July 15, following the announcement made on July 14.

Sun Pharma, India’s largest drug manufacturer and one of the world’s top specialty generics companies, has a strong presence in the US, with a specialty business focused on dermatology, ophthalmology, and oncology, which accounts for over 18 per cent of its total sales. The company operates across six continents and serves customers in more than 100 countries.