New research adds to a growing body of evidence supporting the safety and efficacy of deuruxolitinib (Leqselvi, Sun Pharma) in alopecia areata (AA).
Taken together, the studies, which were presented at the 2025 Fall Clinical Dermatology Conference in Las Vegas, NV, show early efficacy that is sustained and also holds across subgroups.
“Deuruxolitinib represents a true leap forward in the treatment of severe alopecia areata. Taken twice daily, it delivers rapid and remarkable results—over 80% scalp regrowth in some patients as early as eight weeks—and marks the beginning of a new era in personalized care,” Natasha Atanaskova Mesinkovska, MD, PhD, Vice Chair, Dermatology Clinical Research at the University of California-Irvine, tells TDD. “By integrating genetic testing, deuruxolitinib stands as both a breakthrough in efficacy and a cornerstone in the evolution of individualized therapy for alopecia areata.”
Physicians must order a CYP2C9 genotyping test before prescribing deuruxolitinib as it is not recommended for individuals who are poor metabolizers of CYP2C9.
In a pooled post hoc analysis of two Phase 3 trials (THRIVE-AA1 and THRIVE-AA2), patients aged 18 to 65 with AA and ≥50% scalp hair loss received deuruxolitinib 8mg or 12mg twice daily (BID), or placebo. Scalp hair loss was assessed at baseline and at Weeks 8, 12, 16, 20, and 24 using Severity of Alopecia Tool (SALT) scores. Patients achieving SALT scores ≤20 (SALT20) or ≤10 (SALT10) were evaluated.
Patients receiving deuruxolitinib 8mg or 12mg twice daily (BID), or placebo had mean baseline SALT scores of 86.8, 85.9, and 88.6, respectively. At Week 8, a significantly greater percentage of patients receiving deuruxolitinib achieved SALT20 than those receiving placebo. By Week 12, 4.6% and 10.6% of patients receiving deuruxolitinib 8mg and 12mg BID, respectively, achieved SALT10, vs. 0 receiving placebo. At Week 24, the proportion of patients achieving SALT20 or SALT10 with deuruxolitinib increased ≥threefold from W8 (SALT20) and Week 12 vs. placebo.
Another analysis of the same trials showed that deuruxolitinib resulted in significant hair regrowth starting at Week 8, continually improving through Week 24.
Patients receiving deuruxolitinib 8mg or 12 mg, or placebo had mean baseline SALT scores of 86.8, 85.9, and 88.6, respectively. At Week 8, 4.5%, 10.8%, and 17.9% of patients receiving deuruxolitinib 8mg achieved SALT30, SALT40, and SALT50, respectively, vs. 1.9%, 3.4%, and 6.5% of placebo-treated patients. At Week 24, the proportions of patients achieving SALT30, SALT40, and SALT50 receiving deuruxolitinib 8mg or 12mg were significantly higher vs. placebo-treated patients. A greater percentage of patients receiving deuruxolitinib 8mg and 12 mg achieved improvements from baseline in SALT scores over time compared with their counterparts taking placebo.
Efficacy Holds Across Subgroups
In related research, deuruxolitinib 8mg and 12mg twice daily (BID) showed significant efficacy vs. placebo across subgroups, including age (<40, ≥40, <50, ≥50 years), sex, ethnicity (Hispanic, not Hispanic), race (White and Asian), study geographic regions (North America, Europe), baseline body weight (<75 kg, ≥75 kg), and baseline hair loss. In Black patients, deuruxolitinib 8mg and 12mg BID did not differ significantly vs. placebo, the study showed.
The Bigger Picture
The message is clear. Oral Janus kinase inhibitors (JAKi) are changing the way that alopecia is treated. In a cross-sectional survey, approximately 90% of respondents had prescribed an oral JAKi for AA.
The survey included 150 dermatologists, 50 advanced practice providers, and 25 primary care physicians. More than half reported that patients are somewhat/very aware of JAKi treatment options. In a treatment goal ranking, clinicians prioritized nearly complete hair regrowth as quickly as possible and regrowth in 6 to 12 months, the survey showed.
More than 80% of patients with moderate-to-severe AA reported satisfaction with their oral JAKi. Clinicians rated the impact of AA on quality of life and financial stress higher in patients with severe vs. moderate disease. The average Shared Decision-Making Questionnaire (SDM-Q-9 Doc) score was 80.8, indicating high engagement in shared decision-making.
Clinicians prioritize rapid and nearly complete hair regrowth in AA treatment and report high patient satisfaction with oral JAKis. “Despite this, only half believe their patients are aware of JAKi options. Our findings highlight an opportunity for improved patient education and shared decision-making,” conclude researchers who were led by Dr. Mesinkovska.
