Deuruxolitinib Launches in US for Treatment of Severe Alopecia Areata

Sun Pharmaceuticals announced today that deuruxolitinib (Leqselvi) has launched in the US for the treatment of severe alopecia areata (AA) in adults.¹ Deuruxolitinib is available in the form of 8-mg tablets to health care providers and patients aged 18 years and older with severe AA.

Clinical Backing and Efficacy

The US FDA approved the oral JAK1/2 inhibitor in this indication in July 2024.² The approval was based on positive clinical data from the THRIVE-AA1 (NCT04518995) and THRIVE-AA2 (NCT04797650) phase 3 trials, which showed that by week 24, approximately one-third of patients achieved greater than or equal to 80% scalp hair coverage, with some reaching 90%.^3-4 Patients began with an average of only 13% hair coverage, and treatment with deuruxolitinib demonstrated a progressive regrowth trajectory with no plateau at 24 weeks.

In the time since, further studies have demonstrated its efficacy on a long-term basis and as a monotherapy.

New long-term data presented at the 2024 Fall Clinical Dermatology Conference highlighted sustained efficacy of deuruxolitinib 8 mg twice daily in adults with severe AA.⁴ In pooled open-label extension studies of the THRIVE-AA1 and THRIVE-AA2 trials, 48.8% of patients achieved a Severity of Alopecia Tool score of less than or equal to 20 by week 68, with 76.6% reaching that threshold using observed data. In total, 99.6% of initial responders maintained their response, highlighting the durability of hair regrowth.

Expanding Access to Patients

With the launch of deuruxolitinib, Sun Pharmaceuticals has also shared its efforts to expand and improve access to treatment. The company has also launched the Leqselvi Support Program to improve access to treatment for eligible patients, offering the medication for as little as $0 for up to 2 years. The program also includes support from a patient access liaison to help guide patients through the process and provide personalized assistance.

Expert Insights

“The clinical evidence for Leqselvi is truly compelling, demonstrating consistent efficacy," Arash Mostaghimi, MD, MPA, MPH, FAAD, vice chair of clinical trials and innovation at Brigham and Women's Hospital and associate professor of dermatology at Harvard Medical School, said in a news release.¹ "Leqselvi provides clinicians with an important new treatment that can deliver significant, rapid outcomes for patients with alopecia areata.”

Nicole Friedland, president and CEO of the National Alopecia Areata Foundation (NAAF), highlighted the impact of deuruxolitinib's availability for patients with AA. “The availability of Leqselvi offers hope to our community, delivering a new, effective treatment option for adults living with severe alopecia areata,” Friedland said.¹ “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.”

References

1. Sun Pharma announces launch of Leqselvi (deuruxolitinib) in the United States for the treatment of severe alopecia areata. News release. Sun Pharmaceuticals Industries. July 14, 2025. Accessed July 14, 2025. https://sunpharma.com/wp-content/uploads/2025/07/AFD_LEQSELVI-Product-Launch-Press-Release_7.14.25.pdf
2. US FDA approves Leqselvi (deuruxolitinib), an oral JAK inhibitor for the treatment of severe alopecia areata. News release. Sun Pharmaceuticals Industries. July 26, 2024. Accessed July 14, 2025. https://www.prnewswire.com/news-releases/us-fda--approves-leqselvi-deuruxolitinib-an-oral-jak-inhibitor-for-the-treatment-of-severe-alopecia-areata-302207222.html?tc=eml_cleartime
3. Completed study to evaluate the efficacy and safety of CTP-543 in adults with moderate to severe alopecia areata (THRIVE-AA1). ClinicalTrials.gov. Updated May 3, 2023. Accessed July 14, 2025. https://clinicaltrials.gov/study/NCT04518995
4. Completed study to evaluate the efficacy and safety of CTP-543 in adults with moderate to severe alopecia areata (THRIVE-AA2). ClinicalTrials.gov. Updated July 3, 2023. Accessed July 14, 2025. https://clinicaltrials.gov/study/NCT04797650