Incyte Reports Positive Vitiligo Phase 3 Data Supporting JAK Therapies

Key Takeaways

• Ruxolitinib cream (Opzelura) continues to expand across inflammatory dermatoses, with EU regulatory review in atopic dermatitis and Phase 3 HS data pending.
• Povorcitinib met primary endpoints in Phase 3 vitiligo trials, with statistically significant F-VASI75 responses at Week 52.
• Broad late-stage development for povorcitinib spans HS, prurigo nodularis, and asthma, with multiple readouts expected through 2027.

Incyte provided updated data on two therapies in its dermatology pipeline during its recent earnings call, according to a statement from the company. 

Ruxolitinib Update

Ruxolitinib cream 1.5% (Opzelura) remains under regulatory review in the European Union for adults with moderate atopic dermatitis (AD), following submission of a Type II variation, with a decision anticipated in the second half of 2026. Additionally, phase 3 trials (TRuE-HS1 and TRuE-HS2) evaluating ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) are ongoing. Topline data expected in late 2026.

Positive Povorcitinib Data

For selective oral JAK1 inhibitor povorcitinib, phase 3 data from STOP-V1 and STOP-V2 trials in nonsegmental vitiligo met the primary endpoint, with 18.9% of treated patients achieving F-VASI75 at week 52 vs 6.8% and 3.1% with placebo, respectively (P < 0.001 for both). Secondary endpoints, including T-VASI50, also demonstrated statistically significant improvements. Safety findings through 52 weeks were consistent with prior studies.

In HS, 54-week data from STOP-HS1 and STOP-HS2 showed about 71% of patients achieved HiSCR50, with responses extending to HiSCR75 (57%) and HiSCR100 (29%), along with improvements in pain and quality of life. Regulatory submissions for HS are underway, with potential approvals projected in late 2026 (EU) and early 2027 (US), according to Incyte. Additional phase 3 data in prurigo nodularis and phase 2 asthma data are expected in 2026.