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

Incyte to present skin disease data at EADV congress in Vienna (Streetinsider.com) - "Data on ruxolitinib cream, marketed as Opzelura, will feature across multiple atopic dermatitis sessions, including 24-week results from the TRuE-AD4 study examining long-term safety, pharmacokinetics, and patient-reported outcomes in adults with moderate atopic dermatitis. Additional posters will address comparative efficacy against systemic therapies and real-world data...Povorcitinib, an oral JAK1 selective inhibitor under regulatory review in both the U.S. and Europe as a potential treatment for moderate to severe hidradenitis suppurativa, will be the subject of pooled Phase 3 data from the STOP-HS1 and STOP-HS2 studies. A poster will also present data on its use in nonsegmental vitiligo....Presentations on prurigo nodularis will include epidemiological data on incidence, prevalence, and treatment patterns in the U.S. and Germany."

Clinical data • P3 data • Atopic Dermatitis • Hidradenitis Suppurativa • Immunology • Prurigo Nodularis • Vitiligo

From pathogenesis to emerging therapeutic targets (EADV 2026) - "The lecture will review the rapidly evolving landscape of Janus kinase (JAK) inhibitors, including ruxolitinib, upadacitinib, povorcitinib, baricitinib, and ritlecitinib, with discussion of available phase 2 and phase 3 clinical trial data, combination strategies with phototherapy, and practical considerations for daily clinical practice. - Review the current evidence and clinical development of targeted therapies, particularly JAK inhibitors and novel immune-modulating agents. - Explore the rationale and clinical potential of combination therapies, including JAK inhibitors with phototherapy."

Dermatology • Genetic Disorders • Immunology • Non-melanoma Skin Cancer • Skin Cancer • Solid Tumor • Vitiligo • CAT • CXCL10 • CXCL9 • IFNG • IL15 • NKG2D

On 17 September 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Povofortay, intended for the treatment of hidradenitis suppurativa. (European Medicines Agency) - "Povofortay will be available as 45 mg and 75 mg film-coated tablets."

CHMP • Hidradenitis Suppurativa • Immunology

HiSCR100 as the New Benchmark. A Critical Meta-Analysis of the Gap Between Statistical Significance and Complete Disease Resolution in Contemporary Hidradenitis Suppurativa Trials (Povorcitinib, Izokibep, Bimekizumab) (EADV 2026) - No abstract available

Retrospective data • Dermatology • Hidradenitis Suppurativa • Immunology

Application of Exposure-Response Modeling to Inform the Phase 3 Dose Selection of Povorcitinib in Nonsegmental Vitiligo (EADV 2026) - No abstract available

P3 data • Dermatology • Immunology • Vitiligo

Characterization of Acne in Pooled STOP-HS1/STOP-HS2 Phase 3 Studies of Povorcitinib in Patients With Moderate to Severe Hidradenitis Suppurativa (EADV 2026) - No abstract available

Clinical • P3 data • Acne Vulgaris • Dermatology • Hidradenitis Suppurativa • Immunology

Effect of Povorcitinib on Clinical, Patient-Reported, and Biomarker Outcomes in Patients With High Disease Burden: Results of Pooled STOP-HS1/STOP-HS2 Phase 3 Studies in Hidradenitis Suppurativa (EADV 2026) - No abstract available

Biomarker • Clinical • P3 data • Dermatology • Hidradenitis Suppurativa • Immunology

The Committee adopted the CHMP recommendation and scientific discussion, together with a list of questions for the applicant. (European Medicines Agency) - CHMP Final Minutes of the meeting on 23 - 26 Feb 2026: CHMP discussed the issues identified in the application for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults.

CHMP • Hidradenitis Suppurativa • Immunology

Prevalence and Clinical Characteristics of Vitiligo-Associated Hearing Loss Among Patients in a Phase 2 Clinical Trial of Povorcitinib. (PubMed, Dermatol Ther (Heidelb)) - P2 | "SNHL was common in this patient population, suggesting that audiologic evaluation may be appropriate for some patients with vitiligo to support early detection and management of hearing loss. Changes in hearing with povorcitinib treatment require confirmation in larger patient populations. Graphical abstract available for this article."

Journal • P2 data • Dermatology • Immunology • Otorhinolaryngology • Vitiligo

Emerging synthetic drugs for the management of Hidradenitis Suppurativa: a comprehensive update. (PubMed, Expert Opin Pharmacother) - "Currently, only three biologic agents - adalimumab, secukinumab, and bimekizumab - hold regulatory approval for moderate-to-severe HS...Mechanistic classes discussed include Janus kinase (JAK) inhibitors (povorcitinib, upadacitinib, ruxolitinib), TYK2 inhibitors (brepocitinib, ropsacitinib, deucravacitinib), PDE-4 inhibitors (apremilast, orismilast, roflumilast), BTK/SYK inhibitors (remibrutinib, fostamatinib), IRAK-4 inhibitors (zimlovisertib), and HSP-90 inhibitors (RGRN-305)...The emergence of topical JAK inhibitors (ruxolitinib cream) for milder HS and the progression of BTK inhibitors (remibrutinib) to Phase 3 trials signal a broadening treatment landscape. Personalized selection of synthetic drugs versus biologics - informed by patient comorbidities, disease phenotype, and biomarkers - will be involved in next-generation HS management."

Journal • Review • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • IRAK4 • JAK1 • SYK • TYK2

Povorcitinib for hidradenitis suppurativa: the randomized, double-blind, placebo-controlled STOP-HS1 and STOP-HS2 phase 3 trials. (PubMed, Nat Med) - P3 | "Oral povorcitinib demonstrated significant improvements in HiSCR50 versus placebo and a favorable safety profile in patients with moderate to severe HS. ClinicalTrials.gov registration: NCT05620823 and NCT05620836 ."

Clinical • Journal • P3 data • Acne Vulgaris • Dermatology • Hidradenitis Suppurativa • Immunology • Infectious Disease • Respiratory Diseases • JAK1

Post Hoc Subgroup and Body Region Analyses of VASI Outcomes Among Patients with Vitiligo in a Phase 2 Povorcitinib Trial. (PubMed, Adv Ther) - P2 | "In this exploratory post hoc analysis of adults with extensive NSV, oral povorcitinib produced clinically meaningful repigmentation (as measured by achievement of T-VASI50 and F-VASI75) across patient characteristic subgroups and body regions through 1 year of treatment. Response rates varied by body region, reinforcing the lengthy repigmentation process, especially in nonfacial areas, and highlighting the need to manage patient expectations and encourage adherence to long-term therapy."

Journal • P2 data • Retrospective data • Dermatology • Immunology • Vitiligo

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma (clinicaltrials.gov) - P2 | N=247 | Active, not recruiting | Sponsor: Incyte Corporation | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2027 ➔ Jul 2027 | Trial primary completion date: Jun 2026 ➔ Nov 2026

Enrollment closed • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

New Horizons in Vitiligo: Oral JAKs, Combination Strategies, and Consensus Updates (BAD 2026) - "Summary The recent (and anticipated) completion and topline results from phase 3 trials of three major oral JAK inhibitors—povorcitinib, ritlecitinib, and upadacitinib—provide the first comprehensive evidence for systemic treatment of vitiligo. This talk will discuss these results, highlighting novel combination strategies, including oral and topical JAKs (such as ruxolitinib cream) with phototherapy...This multistep, multidisciplinary consensus exercise included representatives of all continents and 20 different countries (including patients, healthcare professionals and academics) and provide a comprehensive stepwise approach on how to stratify patients and assist clinicians in guiding their therapeutic decisions. This timely content equips dermatologists with practical, evidence-based knowledge directly applicable to patient care."

Dermatology • Immunology • Vitiligo

Large-scale meta-analysis of infection risk with JAK-STAT inhibitors in 29,000 patients. (PubMed, J Eur Acad Dermatol Venereol) - "This meta-analysis provides a comprehensive assessment of the risk of infection associated with JAK-STAT inhibitors in IMIDs of the skin. Although overall safety is acceptable, clinicians should be aware of the higher infection risk of influenza and herpes zoster and should consider vaccination and preventive strategies for high-risk patients with atopic dermatitis. The main limitation is that the included studies involved highly selected populations with few comorbidities and short follow-up."

Journal • Retrospective data • Review • Alopecia • Atopic Dermatitis • Dermatitis • Dermatology • Herpes Zoster • Immunology • Infectious Disease • Inflammation • Influenza • Pulmonary Disease • Respiratory Diseases • Varicella Zoster • Vitiligo

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1) (clinicaltrials.gov) - P3 | N=349 | Active, not recruiting | Sponsor: Incyte Corporation | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Prurigo Nodularis

Discovery of the Orally Bioavailable Isoform Selective Janus Kinase 1 (JAK1) Compound Povorcitinib (INCB054707) for the Treatment of Inflammatory and Autoimmune Diseases. (PubMed, J Med Chem) - "Protein crystallography suggested that JAK1 selectivity was conferred by the amide's alkyl group accessing a small lipophilic groove formed by the P-loop conformation of JAK1 that was distinct from JAK2. In murine arthritis models, povorcitinib demonstrated dose-dependent efficacy and reduced inflammatory signaling, supporting its therapeutic potential in immunological disorders."

Journal • Hematological Disorders • Immunology • Myeloproliferative Neoplasm • Oncology • Rheumatology • JAK1

A Study to Evaluate Dermal Open-Flow Microperfusion and Plasma Pharmacokinetic Study of Multiple Doses of Oral Povorcitinib or Topical Ruxolitinib Cream in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Incyte Corporation

New P1 trial

Repigmentation outcomes with oral JAK inhibitors in vitiligo: A systematic review (SID 2026) - "Five oral JAK inhibitors were evaluated: tofacitinib (JAK1/3), baricitinib (JAK1/2), ritlecitinib (JAK3/TEC), upadacitinib (JAK1), and povorcitinib (JAK1). Four placebo-controlled trials demonstrated low overall risk of bias, while non-randomized studies showed serious bias due to confounding. Overall, these findings position oral JAKs as a rational escalation strategy for severe, recalcitrant, or topical non-responsive vitiligo, with evidence suggesting that broader pathway inhibition may be required to overcome persistent immune activity."

Review • Acne Vulgaris • Dermatology • Immunology • Infectious Disease • Respiratory Diseases • Vitiligo • JAK1 • JAK2 • JAK3

Targeting the Pathway or the Cytokine? First Network Meta-Analysis Incorporating Phase 3 Povorcitinib Data: Comparative Efficacy of JAK1 vs. IL-17 Inhibitors in Moderate-to-Severe Hidradenitis Suppurativa (EADV-Sp 2026) - "Two novel mechanistic classes have emerged as frontrunners: cytokine blockade targeting IL-17A and IL-17F (e.g., bimekizumab, secukinumab) and intracellular signaling inhibition via JAK1 (e.g., povorcitinib, upadacitinib)...The analysis integrated the most recent Phase 3 data for povorcitinib (STOP-HS1/2) [2] and bimekizumab (BE HEARD I/II) [3], alongside pivotal Phase 3 data for secukinumab (SUNSHINE/SUNRISE) [4] and adalimumab (PIONEER I/II) [5]...JAAD. 2022;87(1):52-61."

Late-breaking abstract • P3 data • Retrospective data • Dermatology • Hidradenitis Suppurativa • Immunology • IL17A • JAK1

Povorcitinib for Hidradenitis Suppurativa: a narrative review on clinical trial Data with expert commentary. (PubMed, Expert Opin Pharmacother) - "Overall, povorcitinib represents an important potential advancement in the HS treatment landscape, offering a potential oral option for patients with moderate-to-severe disease. Future research should elucidate its long-term safety, define predictive biomarkers of response, and determine its optimal role within a personalized, multimodal treatment framework."

Journal • Review • Dermatology • Gastrointestinal Disorder • Hidradenitis Suppurativa • Immunology • Inflammation • Oncology • IL17A • JAK1 • TNFA

Advanced povorcitinib development program… (Incyte Press Release) - "The New Drug Application (NDA) submission for povorcitinib as a treatment for patients with moderate to severe HS was accepted by the FDA in the first quarter of 2026. The Company anticipates potential approval and launches in late-2026 in the EU and the first quarter of 2027 in the U.S....Data from the Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib in patients with moderate to severe prurigo nodularis (PN) are anticipated in the fourth quarter of 2026; Topline data from the Phase 2 proof-of-concept trial for povorcitinib in asthma are anticipated in the second half of 2026."

FDA filing • Launch Europe • Launch US • P2 data • P3 data • Asthma • Hidradenitis Suppurativa • Immunology • Prurigo Nodularis

Today the Company announced positive results from the Phase 3 program evaluating povorcitinib (30mg) in adult patients with nonsegmental vitiligo. In both Phase 3 studies (STOP-V1 and STOP-V2), povorcitinib achieved the primary endpoint of >75% reduction in Facial Vitiligo Area Scoring Index (F-VASI75) from baseline at Week 52. (Incyte Press Release) - "In STOP-V1, 18.9% of povorcitinib-treated patients achieved a >75% reduction in F-VASI75 compared to 6.8% of placebo-treated patients at Week 52 (p75% reduction in F-VASI75 compared to 3.1% of placebo-treated patients at Week 52 (p<0.001). Across both studies, statistically significant and clinically meaningful differences were also observed in key secondary endpoint measures, including T-VASI50 at Week 52....We expect to share additional data from the Phase 3 program in the second half of 2026; The positive results from the Phase 3 STOP-V1 and STOP-V2 studies will support regulatory applications for povorcitinib in nonsegmental vitiligo planned for the first half of 2027."

Filing • P3 data • Immunology • Vitiligo

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2) (clinicaltrials.gov) - P3 | N=346 | Active, not recruiting | Sponsor: Incyte Corporation | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Prurigo Nodularis

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2) (clinicaltrials.gov) - P3 | N=330 | Recruiting | Sponsor: Incyte Corporation | Active, not recruiting ➔ Recruiting

Enrollment open • Immunology • Prurigo Nodularis