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

Povorcitinib Demonstrates Rapid Improvement in Hives and Itch in Patients With Chronic Spontaneous Urticaria (CSU) (ACAAI 2025) - P2 | "All 3 povorcitinib doses were well tolerated with no safety signals observed. Conclusion Povorcitinib markedly and rapidly reduced hives and itch, demonstrating its potential as an early treatment option for CSU inadequately controlled by second-generation H 1 -antihistamines."

Clinical • Late-breaking abstract • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria: Phase 2 Results (ACAAI 2025) - P2 | "All povorcitinib doses were well tolerated with no safety signals observed. Conclusion Povorcitinib 75mg markedly and rapidly reduced hives and itch and had favorable safety and tolerability, suggesting it could be an early treatment option for CSU inadequately controlled by second-generation H 1 antihistamines."

Clinical • Late-breaking abstract • P2 data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria • JAK1

Data from the Phase 3 studies evaluating povorcitinib in prurigo nodularis (PN) and vitiligo, as well as data from the Phase 2 proof-of-concept trial in asthma, are anticipated in 2026. (Businesswire)

P2 data • P3 data • Asthma • Prurigo Nodularis • Vitiligo

Corporate and Business Development Updates (Businesswire) - "Based on ongoing pipeline prioritization efforts, the Company has paused further development of the INCA034460 (anti-CD122) and INCB57643 (BET inhibitor) programs, as well as the development of povorcitinib in chronic spontaneous urticaria (CSU)."

Discontinued • Chronic Spontaneous Urticaria • Myelodysplastic Syndrome • Myelofibrosis • Vitiligo

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

New P2 trial • Dermatology • Hidradenitis Suppurativa • Immunology

Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria (clinicaltrials.gov) - P2 | N=136 | Completed | Sponsor: Incyte Corporation | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Pruritus • Urticaria

Next-Generation Therapies for Hidradenitis Suppurativa: Recent FDA Approvals and a Look at Clinical Trial Landscape (EADV 2025) - "Over the past decade, numerous immunotherapies have been developed for a wide range of dermatologic conditions, including two recently FDA-approved treatments for HS within the last year (bimekizumab and secukinumab)2,3...Sonelokimab, another IL-17A/F inhibitor, is currently in a recruiting phase 3 trial...Other cytokine-targeting agents are lutikizumab (IL-1α/IL-1β inhibitor), spesolimab (anti-IL-36R), and anifrolumab (type I interferon receptor antagonist)...Agents targeting the JAK-STAT pathway include the JAK1 inhibitors povorcitinib, upadacitinib, and ruxolitinib, as well as deucravacitinib, a tyrosine kinase 2 inhibitor; all are currently under investigation for HS...Remibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, also showed promising results, with 72.7% of patients reaching the HiSCR endpoint at week 167. Brensocatib, a dipeptidyl-peptidase 1 inhibitor, is currently being evaluated in a recruiting phase 3 trial... The last decade has brought a wave..."

Clinical • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • IFNAR2 • IL17A • IL1B • TYK2

JAK Inhibitors for the Treatment of Vitiligo: Current Evidence and Emerging Therapeutic Potential. (PubMed, Drugs) - "Topical ruxolitinib, a JAK1/2 inhibitor, has demonstrated consistent and clinically meaningful repigmentation, particularly in facial lesions, and is already approved for use in both adolescents and adults. Among oral agents, ritlecitinib (a JAK3/tyrosine kinase expressed in hepatocellular carcinoma (TEC) inhibitor), upadacitinib and povorcitinib (JAK1 inhibitors) have shown the most promising efficacy, either as monotherapy or in combination with NB-UVB phototherapy...Other agents, including tofacitinib, baricitinib, abrocitinib, among others, are currently under investigation or being used off-label in clinical practice...Topical agents are generally well tolerated with minimal systemic absorption, whereas oral JAK inhibitors require monitoring owing to potential risks of infection, hematologic abnormalities, and cardiovascular events. In this article, we review the current evidence on the efficacy and safety of topical and oral JAK inhibitors for vitiligo and..."

Journal • Review • Cardiovascular • Dermatology • Hematological Disorders • Hepatocellular Cancer • Immunology • Infectious Disease • Oncology • Solid Tumor • Vitiligo • IFNG • IL15 • JAK3

Efficacy and Safety of Janus Kinase Inhibitors in Moderate to Severe Hidradenitis Suppurativa: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (EADV 2025) - "Treatments assessed were upadacitinib, INCB054707, and povorcitinib. In conclusion, JAK inhibitors appear to be a promising therapeutic option for patients with moderate-to-severe HS, demonstrating a favorable safety profile. Our findings suggest that a longer treatment duration may be necessary to achieve optimal clinical efficacy. Nevertheless, further large-scale, high-quality RCTs are warranted to confirm these results."

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

Reimagining care for patients with HS: how is the treatment landscape evolving? (EADV 2025) - "Sponsored by Incyte. Understand how povorcitinib could fit within the future HS treatment strategy as the first oral JAK inhibitor"

Clinical • Hidradenitis Suppurativa

Prevalence and Clinical Characteristics of Vitiligo-Associated Hearing Loss Among Patients Enrolled in a Phase 2 Clinical Trial of Povorcitinib (EADV 2025) - "SNHL was common in this patient population. Physicians treating vitiligo should consider conducting routine hearing assessments for early recognition and management of hearing loss. Changes in hearing with povorcitinib treatment need to be confirmed in larger patient populations."

Clinical • P2 data • Dermatology • Immunology • Otorhinolaryngology • Vitiligo

Povorcitinib for Moderate to Severe Hidradenitis Suppurativa: Week 24 Interim Phase 3 Results (EADV 2025) - "Conclusion Povorcitinib demonstrated clinically meaningful superiority over placebo in pts with HS within 12 wk, with continued improvements through Wk 24, including in high-threshold, stringent endpoints such as HiSCR90 and HiSCR100. Both doses were well tolerated, with a very low frequency of laboratory abnormalities."

Late-breaking abstract • P3 data • P3 data: top line • Dermatology • Hidradenitis Suppurativa • Immunology

Incyte Announces New 24-Week Phase 3 Data from the STOP-HS Clinical Trial Program of Povorcitinib in Hidradenitis Suppurativa at EADV 2025 (Yahoo Finance) - "At Week 24, nearly 60% of efficacy-evaluable patients among both povorcitinib treatment groups achieved HiSCR50; Additionally, patients treated with povorcitinib achieved HiSCR75 (31.0%-40.3%), HiSCR90 (13.8%-27.7%) and HiSCR100 (9.2%-21.3%) through Week 24....These data will support the planned regulatory submissions for povorcitinib in HS in Europe and the United States in 2025 and early 2026, respectively."

EMA filing • FDA filing • P3 data • Hidradenitis Suppurativa

A Systematic Review of Oral JAK Inhibitors for the Treatment of Vitiligo: Evidence from Phase II Clinical Trials (ESDR 2025) - P2, P2/3, P2b, P3 | "We identified three Phase II clinical trials, including upadacitinib (NCT04927975), ritlecitinib (NCT03715829), and povorcitinib (NCT04818346). While published data remain limited to Phase II trials, two ongoing studies, NCT06118411 (Phase III upadacitinib) and NCT06768840 (Phase II/III baricitinib), are expected to provide important insights on long-term safety and efficacy. Further research is needed to optimize therapies and establish the role of oral JAK inhibitors in clinical practice, as well as identify patient populations most likely to benefit."

Clinical • P2 data • Review • Acne Vulgaris • Dermatology • Fatigue • Herpes Zoster • Immunology • Infectious Disease • Varicella Zoster • Vitiligo • CXCL10 • IFNG

Incyte to Present New Data Highlighting Progress Across its Dermatology Pipeline at the European Association of Dermatology and Venerology 2025 Congress (Businesswire) - "Highlights include late-breaking, oral and poster presentations featuring data for povorcitinib (INCB054707), an oral small-molecule JAK1 inhibitor, and ruxolitinib cream (Opzelura), a topical JAK1/2 inhibitor."

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

Inflammation and Autoimmunity (IAI) – key highlights (Businesswire) - "Povorcitinib (INCB54707): Two Phase 3 studies (STOP-V1 and STOP-V2) evaluating povorcitinib versus placebo in patients with vitiligo are ongoing. The Phase 3 data are anticipated in 2026; Two Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib versus placebo in patients with PN are ongoing. The Phase 3 data are anticipated in 2026; A Phase 2 trial evaluating povorcitinib in asthma is ongoing. Data are anticipated in the second half of 2025."

P2 data • P3 data • Asthma • Immunology • Inflammation • Prurigo Nodularis • Vitiligo

Efficacy and Safety of Medical Interventions for Moderate to Severe Hidradenitis Suppurativa: A Living Systematic Review and Network Meta-Analysis. (PubMed, JAMA Dermatol) - "Compared with placebo, the following treatments were associated with significantly higher HiSCR-50 response rates: sonelokimab, 120 mg, every 4 weeks; lutikizumab, 300 mg, every 2 weeks; adalimumab, 40 mg, once per week; sonelokimab, 240 mg, every 2 weeks; bimekizumab, 320 mg, every 2 weeks; povorcitinib, 15 mg, once per day; bimekizumab, 320 mg, every 4 weeks; secukinumab, 300 mg, every 4 weeks; and secukinumab, 300 mg, every 2 weeks. The percentage of patients discontinuing treatment due to adverse events ranged from 0% to 10% in the placebo groups, 0% to 4% in the adalimumab (40 mg, once per week) groups, and 0% to 15% (ropsacitinib) in the other active treatment groups. This network meta-analysis provides evidence for the comparative efficacy and safety of currently approved and pipeline medications for moderate to severe HS in the absence of head-to-head trials."

Clinical • Journal • Retrospective data • Dermatology • Hidradenitis Suppurativa • Immunology

Maintenance of Povorcitinib Response in Patients With Hidradenitis Suppurativa: Efficacy During the Open-Label Extension Period of a Phase 2 Study (CDA 2025) - P2 | "Percentages of patients requiring local lesional rescue at each visit during OLE ranged from 0.0%–6.9% in placebo‎→75mg, 0.0%–14.7% in 15→75mg, 0.0%–10.0% in 45→75mg, and 0.0%–3.2% in 75mg group. Conclusions A high proportion of patients with HS treated with povorcitinib 75mg can maintain meaningful clinical responses during long-term treatment."

Clinical • P2 data • Dermatology • Hidradenitis Suppurativa • Immunology • JAK1

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Incyte Corporation | Trial completion date: May 2026 ➔ Jan 2027 | Trial primary completion date: Oct 2025 ➔ Jun 2026

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

Efficacy and Safety of the Oral Janus Kinase 1 Inhibitor Povorcitinib in Patients With Extensive Vitiligo in a Phase 2, Randomized, Double-Blinded, Dose-Ranging, Placebo-Controlled Study. (PubMed, J Am Acad Dermatol) - P2 | "Povorcitinib demonstrated substantial total body and facial repigmentation in adult patients with extensive nonsegmental vitiligo and was generally well tolerated through 52 weeks of treatment."

Clinical • Journal • P2 data • Dermatology • Immunology • Vitiligo

Potential future targeted therapies for the treatment of vitiligo: focus on phase 2 and 3. (PubMed, Expert Rev Clin Immunol) - "Novel approaches, including JAK inhibitors (e.g. povorcitinib, upadacitinib) and monoclonal antibodies (e.g. anifrolumab), are evaluated for their efficacy and safety based on phase II and III clinical trial data. targeted therapies that address immune mechanisms and oxidative stress represent promising advances in vitiligo management and may substantially improve patient outcomes in the near future."

Journal • P2 data • Review • Dermatology • Immunology • Vitiligo • CD8 • IFNG

Incyte Reports 2025 First Quarter Financial Results and Provides Updates on Key Clinical Programs (Businesswire) - "A Phase 2 trial evaluating povorcitinib in asthma is ongoing and enrolling. Data are anticipated in the second half of 2025."

P2 data • Asthma • Immunology

New and Emerging Biologics and Jak Inhibitors for the Treatment of Prurigo Nodularis: A Narrative Review. (PubMed, Medicina (Kaunas)) - "Among new treatment options, dupilumab, an IL-4 receptor antagonist, and nemolizumab, an IL-31 receptor inhibitor, demonstrated significant efficacy in reducing pruritus and lesion severity in PN patients. Other promising monoclonal antibodies include vixarelimab (OSMRβ inhibitor) and barzolvolimab (KIT inhibitor). Small molecules such as JAK inhibitors (upadacitinib, povorcitinib) also show potential by modulating inflammatory pathways...Emerging biologics and small molecules represent a transformative approach for PN management, offering targeted therapies that address underlying immunological and neurological mechanisms. Ongoing research and long-term studies are crucial to optimizing treatment strategies and improving patient outcomes."

Journal • Review • Dermatology • Immunology • Prurigo Nodularis • Pruritus • IL4

A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1) (clinicaltrials.gov) - P3 | N=467 | Active, not recruiting | Sponsor: Incyte Corporation | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Vitiligo

STOP-LTR: Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Incyte Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Hidradenitis Suppurativa • Immunology