Deuruxolitinib in the Alopecia Areata Treatment Paradigm: Emma Guttman-Yassky, MD

Deuruxolitinib (Leqselvi; Sun Pharma) was found safe and effective in patients with moderate to severe alopecia areata in the THRIVE-AA1 (NCT04518995) and THRIVE-AA2 trials (NCT04797650), leading to its FDA approval in 2024.¹ The oral selective inhibitor of Janus kinases JAK1 and JAK2 launched in the US in July 2025.²

Emma Guttman-Yassky, MD, PhD, Waldman Professor of Dermatology and Immunology and health system chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai, discussed how deuruxolitinib fits into the alopecia areata treatment paradigm and how its efficacy and safety impact clinical practice.

This transcript has been lightly edited; captions are auto-generated.

Transcript

How does deuruxolitinib fit into the evolving treatment paradigm for severe alopecia areata?

The way it fits in the treatment paradigm is the data that was described in the clinical trials showed a very high percent of hair regrowth with the drug in both doses that it was studied—both the 8 and the 12 mg. The 12 mg was not approved by the FDA, but the 8 mg showed good safety and actually great efficacy. What was very meaningful with the drug was that it achieved very fast hair regrowth. Not only were the percentages of patients achieving hairy growth very high, but also it appeared to be faster than other drugs.

How might the relatively rapid efficacy influence treatment expectations or strategies in clinical practice?

Patients want to achieve 2 things. They want to achieve fast hair regrowth, and they want to maintain it over time. And also, they want to maintain it in a safe manner. The safety over time we need to still assess over time. We don't have enough data. But it is very meaningful for patients to get fast hair regrowth because many times, you have a wedding, you have something, you start school, some kids are bullied in college, or things like that. The quick efficacy, of course, is meaningful for our patients and for us as treating physicians.

How does the safety profile of deuruxolitinib compare with other JAK inhibitors? What are key adverse events providers should be aware of?

In the 12 mg, we saw several pulmonary emboli and a DVT [deep vein thrombosis]. In the 8 mg, I would say that the safety was on par with the other JAK inhibitors. And of course, I think we need to learn a lot from a clinical use that is starting now. One important thing that providers should know is that you cannot just prescribe [this drug] like the other 2 [JAK inhibitors]. You need to do a genetic test that we do here; LabCorp has it, and you need to be aware of that. The company, of course, is supporting it as well. That is important—it doesn't take too long. We just put some patients on it. You prescribe it, and the results come back in 1 week. But it is important to know that it's not the type of drug that you do [the bloodwork for] like with others and you can just prescribe it immediately. Here, you need to wait for an extra week, so just keep it in mind when you have the patient to adjust the expectations of the patient.

References

1. Santoro C. FDA approves deuruxolitinib for alopecia areata. AJMC^®. July 26, 2024. Accessed September 5, 2025. https://www.ajmc.com/view/fda-approves-deuruxolitinib-for-alopecia-areata

2. Sun Pharma announces launch of Leqselvi (deuruxolitinib) in the
United States for the treatment of severe alopecia areata. News release. Sun Pharma. July 14, 2025. Accessed September 5, 2025. https://sunpharma.com/wp-content/uploads/2025/07/AFD_LEQSELVI-Product-Launch-Press-Release_7.14.25.pdf