16 July 2025
Category: New Drug Approval I DermatologyI
Alopecia Areata Treatment
Written By: Pharmacally Medical News Desk
India’s Sun Pharmaceutical Industries Ltd., one of the world’s largest specialty generics pharmaceutical companies, has officially launched LEQSELVI™ (deuruxolitinib) 8 mg tablets in the United States for the treatment of severe alopecia areata. Leqselvi is a Janus kinase (JAK1/JAK2) inhibitor. is now available to U.S. adults through prescription, following an important patent litigation settlement with Incyte Corporation.
The launch marks Sun Pharma’s strategic entry into the U.S. dermatology specialty market with a much-needed treatment for an autoimmune condition that affects hair follicles and causes patchy or total hair loss.
What is LEQSELVI?
LEQSELVI (deuruxolitinib) is an oral small molecule that inhibits Janus kinase 1 and 2 (JAK1/JAK2), pathways known to be involved in the autoimmune destruction of hair follicles in alopecia areata. It is now the third FDA-approved JAK inhibitor for this condition in the U.S., joining competitors like Olumiant (baricitinib) and Litfulo (ritlecitinib).
Clinical Trial Highlights
LEQSELVI’s efficacy was demonstrated in two pivotal Phase 3 trials (THRIVE-AA1 and THRIVE-AA2) (NCT04518995 and NCT04797650) involving over 1,200 adults with ≥50% scalp hair loss. Key outcomes included:
33% of patients experienced near-complete hair regrowth by week 24.
38% and 33% of patients achieved a SALT score ≤20 with deuruxolitinib 12 mg BID and 8 mg BID, respectively, over 24 weeks of treatment
In the long-term extension study, nearly 49% of patients achieved a SALT score ≤20 (representing minimal hair loss) by week 68, with 76.6% achieving this when using observed data.
These findings underscore LEQSELVI’s potential to offer sustained, meaningful hair regrowth in patients suffering from moderate to severe alopecia areata.
Safety and Prescribing Considerations
While LEQSELVI offers hope, it comes with important safety considerations. Potential serious side effects include:
- Increased risk of serious infections, including TB, malignancy, blood clots, and cardiovascular events.
- Testing for latent TB before and during treatment is advisable.
- It should be avoided in patients who are CYP2C9 poor metabolizers or are on moderate to strong CYP2C9 inhibitors.
- Common side effects noted in trials include headache, acne, and nasopharyngitis.
Physicians are advised to conduct appropriate risk-benefit assessments before initiating therapy.
Legal & Commercial Strategy: Settlement with Incyte
The U.S. launch was made possible after Sun Pharma reached a settlement with Incyte Corporation, which had earlier filed a patent infringement lawsuit. As part of the agreement, Incyte granted Sun Pharma a non-exclusive license for non-oncology uses, including alopecia areata. Sun Pharma also agreed to pay upfront and milestone payments, along with royalties until expiration of the patents.
This resolution not only cleared the path for LEQSELVI’s commercial debut but also signaled a strategic win for Sun Pharma in the specialty drug space.
Market Impact & Access Program
Analysts estimate LEQSELVI’s market potential to reach $200–300 million over the next 3–5 years, with a peak potential of up to $900 million. Its launch boosts Sun Pharma’s growing U.S. dermatology and specialty care portfolio. Leqselvi’s US market entry builds on the 2023 acquisition of Concert Pharmaceuticals, the original developer of deuruxolitinib, for $576 million.
To support patient access, Sun Pharma introduced the LEQSELVI SUPPORT™ Program, offering:
- Medication for as low as $0 for up to two years for eligible patients.
- Dedicated Patient Access Liaisons to guide the treatment journey.
Key People’s Opinion
“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,” expressed Richard Ascroft, CEO, Sun Pharma North America.
Arash Mostaghimi, MD, MPA, MPH, FAAD, Vice Chair of Clinical Trials and Innovation and Associate Professor of Dermatology at Brigham and Women’s Hospital, said, “The clinical evidence for LEQSELVI is truly compelling, demonstrating consistent efficacy.”
Conclusion
The launch of LEQSELVI marks a major milestone in the treatment of severe alopecia areata, offering a new oral option with proven efficacy and sustained results. For Sun Pharma, it represents not just a product launch but a successful foray into high-value specialty markets in the U.S., backed by smart legal navigation and strong clinical data.
As awareness and diagnosis of alopecia areata grow, especially among younger adults, LEQSELVI could soon become a cornerstone therapy offering both hopes for patients and growth for Sun Pharma.
Reference
Sun Pharma Announces Launch of LEQSELVI™ (deuruxolitinib) in the United States for the Treatment of Severe Alopecia Areata, Sun Pharma, July 14 2025, https://sunpharma.com/wp-content/uploads/2025/07/AFD_LEQSELVI-Product-Launch-Press-Release_7.14.25.pdf
Leqselvi, https://www.leqselvi.com/
Sun Pharma launches alopecia drug Leqselvi in US after settling patent dispute, mint, https://www.livemint.com/companies/sun-pharma-alopecia-drug-leqselvi-us-patent-dispute-pharmaceutical-market-deuruxolitinib-clinical-trials-11752504343463.html
Sun Pharma launches key alopecia drug in US, experts estimate $200–300 million market potential, Financial Express, July 15 2025, https://www.financialexpress.com/business/industry-sun-pharma-launches-key-alopecia-drug-in-us-experts-estimate-200300-million-market-potential-3914871/
Sun Pharma Announces Launch of LEQSELVI™ (deuruxolitinib) in the United States for the Treatment of Severe Alopecia Areata, PR Newswire, July 14 2025, https://www.prnewswire.com/news-releases/sun-pharma-announces-launch-of-leqselvi-deuruxolitinib-in-the-united-states-for-the-treatment-of-severe-alopecia-areata-302504221.html
Results from thrive-aa2: a double blind, placebocontrolled phase 3 clinical trial of deuruxolitinib (ctp543), an oral jak inhibitor, in adult patients with moderate to severe alopecia areata, AAD Annual Meeting, New Orleans S042 Late Breaking Research Session Mar 18, 2023, https://www.biomedtracker.com/EventFiles/Concert%202023-03-18%20CTP-543%20Phase%20III%20Updated%20Results%20AAD%20Slides.pdf
King B, Senna MM, Mesinkovska NA, et al, Efficacy and safety of deuruxolitinib, an oral selective Janus kinase inhibitor, in adults with alopecia areata: Results from the Phase 3 randomized, controlled trial (THRIVE-AA1). J Am Acad Dermatol. 2024 Nov;91(5):880-888. doi: 10.1016/j.jaad.2024.06.097. Epub 2024 Jul 23. PMID: 39053611.
Long-Term Results Demonstrate Clinically Meaningful Improvements in Hair Regrowth Following Oral Deuruxolitinib, Dermatology Times, 26 Oct 2024, https://www.dermatologytimes.com/view/long-term-results-demonstrate-clinically-meaningful-improvements-in-hair-regrowth-following-oral-deuruxolitinib