Integrating Deuruxolitinib Into Clinical Practice for Severe Alopecia Areata

“I'm thrilled that for adult patients with alopecia areata, we now have 3 oral JAK inhibitors approved in the United States, those being baricitinib, ritlecitinib, and deuruxolitinib.... I always say we are currently in an era of discovery for alopecia areata, nothing like we've witnessed before. This really is the best time to be a patient with alopecia areata and the best time to be a dermatologist who treats alopecia areata,” said Vimal Prajapati, MD, FRCPC, DABD, in an interview with Dermatology Times.

Prajapati, a clinical associate professor at the University of Calgary and co-founder and co-director of the Skin Health & Wellness Centre, Dermphi Centre, Dermphi Shop, and Dermatology Research Institute, shared his perspective on deuruxolitinib (Leqselvi; Sun Pharma), the newest oral JAK1/2 inhibitor for severe alopecia areata (AA), focusing on trial design, clinical outcomes, and its positioning within the treatment landscape.

In a previous interview, Prajapati discussed the mechanism of action, clinical trial outcomes, monitoring considerations, and safety profile of deuruxolitinib.

Dosing in THRIVE-AA Trials

In the pivotal THRIVE-AA1 (NCT04518995) and THRIVE-AA2 (NCT04797650) studies, adult patients with severe AA were randomized to receive deuruxolitinib 8 mg twice a day, 12 mg twice a day, or placebo. THRIVE-AA1 used a 5:3:1 randomization (8 mg: 12 mg: placebo), while THRIVE-AA2 applied a 2:1:1 ratio. Both regimens demonstrated significant efficacy over placebo at 24 weeks. Based on trial findings and regulatory review, the currently approved US dose is 8 mg twice a day, taken with or without food.^1,2

Efficacy and Clinical Experience

At week 24, 31% of patients on the 8 mg twice a day dose achieved a Severity of Alopecia Tool (SALT) score ≤20, reflecting robust hair regrowth. Prajapati noted that both investigators and patients were highly satisfied with outcomes at his trial site, where more than 30 adults participated. Importantly, an ongoing trial is evaluating deuruxolitinib in adolescents with severe AA, which may expand its clinical utility across age groups.

Comparative Positioning

Prajapati noted that clinicians often ask how deuruxolitinib compares with baricitinib (Olumianr; Eli Lilly) and ritlecitinib (Litfulo; Pfizer), the other FDA-approved oral JAK inhibitors for AA. While no head-to-head studies exist, a recent network meta-analysis presented at the American Academy of Dermatology identified deuruxolitinib 8 mg twice a day as the most effective regimen across multiple efficacy endpoints, including SALT 20 at week 24 and SALT 10 at week 24. Baricitinib 4 mg daily and ritlecitinib 50 mg daily followed in ranking.³

Future Role and Clinical Takeaway

Given its efficacy, favorable safety profile, and regulatory approval, Prajapati anticipates deuruxolitinib will be integrated as a first-line option for adults with severe AA. He emphasizes the importance of clinicians gaining experience with the drug in both JAK inhibitor–naïve and –experienced patients, as real-world data will further define its optimal use.

Reflecting on the broader therapeutic landscape, Prajapati described this as a “new era of discovery” for AA, with 3 approved JAK inhibitors in the US and ongoing studies in younger populations—bringing hope to patients and new opportunities for clinicians.

References

1. 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 September 2, 2025. https://clinicaltrials.gov/study/NCT04518995

2. 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 September 2, 2025. https://clinicaltrials.gov/study/NCT04797650

3. Gupta AK, Bamimore MA, Mirmirani P, Piguet V, Talukder M. The relative efficacy and safety of monotherapies for alopecia areata: a network meta-analysis study. J Cosmet Dermatol. 2025;24(4):e70185. doi:10.1111/jocd.70185