povorcitinib (INCB54707) / Incyte, China Medical System - LARVOL DELTA

Incyte Announces New Positive 54-Week Late-Breaking Data for Povorcitinib in Hidradenitis Suppurativa at the 2026 American Academy of Dermatology (AAD) Annual Meeting (Businesswire) - "Through Week 54, clinically meaningful and durable responses were observed across all groups in both STOP-HS1 and STOP-HS2, with up to 71.4% of patients achieving HiSCR50...Full clearance of inflammatory lesions (ANdT=0) was achieved by 16.1-20.2% of patients at Week 54. Reductions in dT counts were observed with both doses (75 mg, up to −62.0%; 45 mg, up to −57.7%), as well as reduction in inflammatory nodule counts (75 mg, up to −63.2%; 45 mg, up to −57.0%) and abscess counts (75 mg, up to −63.7%; 45 mg, up to −62.9%)...The overall safety profile of povorcitinib over 54 weeks was consistent with previously reported 24-week data, and both doses were well tolerated."

Late-breaking abstract • P3 data • Hidradenitis Suppurativa • Immunology

Povorcitinib for Moderate-to-Severe Hidradenitis Suppurativa: Week 24 Interim Phase 3 Results in Anti-TNF-Experienced Patients (AAD 2026) - "Povorcitinib improved HS signs/symptoms through 24 weeks, including achievement of high-threshold HiSCR90 responses, in anti-TNF–experienced patients, a population likely to have greater disease burden and be more recalcitrant to treatment."

Clinical • P3 data • P3 data: top line • Dermatology • Hidradenitis Suppurativa • Immunology • JAK1

Povorcitinib in Patients With Moderate to Severe Hidradenitis Suppurativa: 54-Week Efficacy and Safety Results From the STOP-HS1 & STOP-HS2 Phase 3 Studies (AAD 2026) - No abstract available

Clinical • Late-breaking abstract • P3 data • Dermatology • Hidradenitis Suppurativa • Immunology

Povorcitinib Demonstrates Efficacy in Patients With Chronic Spontaneous Urticaria (CSU) Regardless of Baseline Immunoglobulin E (IgE) Levels or Prior Exposure to Anti-IgE Biologics (AAD 2026) - P2 | "Povorcitinib, especially the 75-mg dose, demonstrated superior efficacy versus placebo regardless of baseline IgE level or prior exposure to anti-IgE biologics. Given lower IgE levels and anti-IgE exposure have been associated with poor response to anti-IgE biologics and interleukin inhibitors, respectively, povorcitinib may be an early treatment option for these subsets of patients with CSU."

Clinical • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria • JAK1

Safety and Efficacy of Janus Kinase Inhibitors for Hidradenitis Suppurativa: A Systematic Review and Meta-Analysis (AAD 2026) - "Of 909 screened records, four RCTs met inclusion criteria. JAKi significantly increased the probability of achieving HiSCR compared to placebo (RR: 1.51; 95% CI: 1.14–2.00; p = 0.004), with consistent efficacy across seven arms of povorcitinib, especially at 15 mg (RR: 1.67). Significant reductions in abscess and nodule counts were observed."

Retrospective data • Review • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation

Incyte to Highlight Late-Breaking Hidradenitis Suppurativa Data at the 2026 American Academy of Dermatology (AAD) Annual Meeting (Businesswire) - "New, late-breaking 54-week data for povorcitinib in hidradenitis suppurativa (STOP-HS1 & STOP-HS2) to be highlighted; Featured abstracts for ruxolitinib cream (Opzelura) and povorcitinib include multiple ePosters in atopic dermatitis, hidradenitis suppurativa and vitiligo"

Clinical data • Atopic Dermatitis • Hidradenitis Suppurativa • Vitiligo

Povorcitinib Demonstrates Improvement in Patient-Reported Outcome Measures (PROMs) Evaluating Disease Control and Quality of Life (QOL) in Patients With Chronic Spontaneous Urticaria (CSU) (AAAAI 2026) - P2 | "All 3 povorcitinib doses were well tolerated with no safety signals observed. Conclusions PROMs assessing disease control and QOL improved as early as week 4 and were maintained through week 12 with povorcitinib versus placebo, further supporting the potential for povorcitinib as an effective and tolerable treatment option for patients with CSU refractory to SGAH."

Clinical • HEOR • Patient reported outcomes • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

New Clinical Data Highlight Povorcitinib’s Potential to Achieve High-Threshold Lesion Clearance in HS (AJMC) - "Post hoc interim analyses in 1227 patients with long-standing, high-burden HS included substantial Hurley stage III, ~35%–39% prior biologic failure, and ~20% prior excision surgery...At the Winter Clinical Miami 2026 meeting, researchers shared promising results from 2 posters detailing how an investigational oral therapy, povorcitinib, addressed both the physical lesions and the profound quality of life challenges associated with this chronic inflammatory condition....High-threshold responses for abscesses were also notable; 22% to 62% of those on the 75-mg dose achieved total clearance by week 12. These clinical benefits continued to grow through week 24, suggesting that longer treatment duration could lead to even greater clearance."

P3 data • Hidradenitis Suppurativa

INCB054707-801: Selective Treatment of Oral Povorcitinib Long-Term Rollover Study (STOP-LTR) (clinicaltrialsregister.eu) - P2/3 | N=845 | Recruiting | Sponsor: Incyte Corp.

New P2/3 trial • Dermatology • Hidradenitis Suppurativa • Immunology • Prurigo Nodularis • Vitiligo

Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Incyte Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Hidradenitis Suppurativa • Immunology

The MAA for povorcitinib in HS was submitted to the EMA at the end of 2025 and the Company anticipates a potential approval by the end of 2026. (Businesswire) - "The acceptance by the FDA of our New Drug Application (NDA) submission for povorcitinib in HS is anticipated in the first quarter of 2026, with potential approval by early 2027; Data from the Phase 3 studies evaluating povorcitinib in vitiligo and moderate to severe PN are anticipated in the middle of 2026 and fourth quarter of 2026, respectively; Topline data from the Phase 2 proof-of-concept trial for povorcitinib in asthma are anticipated in the second half of 2026."

Approval • Clinical data • FDA filing • Asthma • Hidradenitis Suppurativa • Immunology • Prurigo Nodularis • Vitiligo

STOP-HS LTE: A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P3 | N=617 | Active, not recruiting | Sponsor: Incyte Corporation | Recruiting ➔ Active, not recruiting | N=960 ➔ 617

Enrollment change • Enrollment closed • Dermatology • Hidradenitis Suppurativa • Immunology

Oral JΑΚ Inhibitors in Vitiligo Treatment. (PubMed, Dermatol Ther (Heidelb)) - "Oral JAK inhibitors could present an effective and safe option for patients with vitiligo; however. there is a need for further long-term studies and more data about treatment procedures."

Journal • Review • CNS Disorders • Depression • Dermatology • Immunology • Mood Disorders • Psychiatry • Vitiligo

Delphi consensus: First-line use of biologics and small molecules in hidradenitis suppurativa. (PubMed, J Eur Acad Dermatol Venereol) - "This consensus provides evidence-based criteria for upgrading HS patients to first-line biologic therapy, reflecting expert practices across Europe aimed at preventing irreversible disease progression. The results support a 'hit hard and early' approach to minimize scarring and tunnel formation, although prospective studies are still needed to validate these expert-driven recommendations."

Journal • Review • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hidradenitis Suppurativa • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics • Rheumatology

STOP-HS1: A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P3 | N=608 | Completed | Sponsor: Incyte Corporation | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Hidradenitis Suppurativa • Immunology

Povorcitinib: Data readout from P3 STOP-PN1 trial (NCT06516952) for prurigo nodularis in Q4 2026 (44th Annual J.P. Morgan Healthcare Conference, Incyte) - Data readout from P3 STOP-PN2 trial (NCT06516965) for prurigo nodularis in Q4 2026

P3 data • Immunology • Prurigo Nodularis

Povorcitinib: Data readout from P3 STOP-PN1 trial (NCT06516952) for prurigo nodularis in Q4 2026 (44th Annual J.P. Morgan Healthcare Conference, Incyte) - Data readout from P3 STOP-PN2 trial (NCT06516965) for prurigo nodularis in Q4 2026

P3 data • Immunology • Prurigo Nodularis

Povorcitinib: Regulatory approval for Hidradenitis suppurativa in late 2026 (44th Annual J.P. Morgan Healthcare Conference, Incyte) - Launch for Hidradenitis suppurativa in early 2027

Approval • Launch • Hidradenitis Suppurativa • Immunology

Povorcitinib: Regulatory approval for Hidradenitis suppurativa in late 2026 (44th Annual J.P. Morgan Healthcare Conference, Incyte) - Launch for Hidradenitis suppurativa in early 2027

Approval • Launch • Hidradenitis Suppurativa • Immunology

Povorcitinib: Data readout from P3 trial (NCT05851443) for asthma in H2 2026 (44th Annual J.P. Morgan Healthcare Conference, Incyte)

P2 data • Asthma • Immunology

Povorcitinib: Data readout from P3 trial (NCT05851443) for asthma in H2 2026 (44th Annual J.P. Morgan Healthcare Conference, Incyte)

P2 data • Asthma • Immunology

Povorcitinib: Data readout from P3 STOP-V1 trial (NCT06113445) for vitiligo in mid-2026 (Incyte, 44th Annual J.P. Morgan Healthcare Conference) - Data readout from P3 STOP-V2 trial (NCT06113471) for vitiligo in mid-2026

P3 data • Immunology • Vitiligo

Povorcitinib: Data readout from P3 STOP-V1 trial (NCT06113445) for vitiligo in mid-2026 (Incyte, 44th Annual J.P. Morgan Healthcare Conference) - Data readout from P3 STOP-V2 trial (NCT06113471) for vitiligo in mid-2026

P3 data • Immunology • Vitiligo

Development and validation of a bioanalytical method to quantify povorcitinib in human skin with clinical application. (PubMed, Bioanalysis) - P1 | "This study provides the first systemic evaluation of human skin homogenization parameters and a direct comparison of wet and dry approaches. The validated dry homogenization method enabled accurate and reproducible quantification of povorcitinib in skin biopsies from a phase I clinical study and offers a robust framework for quantifying a broad range of analytes in human skin tissues.Clinical trial registration: https://www.clinicaltrials.gov/study/NCT06505265 [clinicaltrials.gov] identifier is NCT06505265."

Journal

STOP-HS2: A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS) (clinicaltrials.gov) - P3 | N=619 | Completed | Sponsor: Incyte Corporation | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Hidradenitis Suppurativa • Immunology