A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Povorcitinib Phosphate Tablets in Chinese Adult Participants With Nonsegmental Vitiligo

This Phase 3 study will evaluate the efficacy and safety of oral povorcitinib phosphate compared with placebo in Chinese adults with nonsegmental vitiligo who are considered suitable for systemic therapy. Approximately 174 participants will be randomized 1:1 to povorcitinib phosphate 30 mg once daily or matching placebo for 52 weeks, followed by a 4-week safety follow-up. The primary efficacy assessment is proportion of participants achieving ≥75% improvement from baseline in face vitiligo area scoring index at Week 52.

Start Date01 Nov 2026

Sponsor / Collaborator-

NCT07588139

/ CompletedPhase 1

An Open-Label, Dermal Open-Flow Microperfusion and Plasma Pharmacokinetic Study of Multiple Doses of Oral Povorcitinib or Topical Ruxolitinib Cream in Healthy Adult Participants

The purpose of this study is to evaluate the interstitial concentrations using the open-flow microperfusion device and plasma pharmacokinetics following multiple doses of povorcitinib or topical ruxolitinib cream in healthy adult participants.

Start Date18 May 2026

Sponsor / Collaborator

Incyte Corp.

NCT07213973

/ RecruitingPhase 2

A Phase 2, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Povorcitinib in Adolescents With Moderate to Severe Hidradenitis Suppurativa

The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of povorcitinib in adolescent participants with moderate to severe hidradenitis suppurativa over a 54-week open-label treatment period.

Start Date02 Feb 2026

Sponsor / Collaborator

Incyte Corp.

100 Clinical Results associated with Povorcitinib

100 Translational Medicine associated with Povorcitinib

100 Patents (Medical) associated with Povorcitinib

Literatures (Medical) associated with Povorcitinib

01 Oct 2026·ADVANCES IN THERAPY

Post Hoc Subgroup and Body Region Analyses of VASI Outcomes Among Patients with Vitiligo in a Phase 2 Povorcitinib Trial

Article

Author: Passeron, Thierry ; Xue, Zhenyi ; Pandya, Amit G ; Ezzedine, Khaled ; Santos, Leandro L ; Erskine, Lois ; van Geel, Nanja ; Blauvelt, Andrew

INTRODUCTION:

A phase 2 trial (NCT04818346) of the oral Janus kinase 1 inhibitor povorcitinib demonstrated substantial total body and facial repigmentation over 52 weeks in adults with extensive nonsegmental vitiligo (NSV). Here, post hoc analyses evaluated povorcitinib efficacy in patients based on demographic and clinical characteristic subgroups, as well as affected body regions.

METHODS:

Data were pooled for 103 patients in the extension-evaluable population who received povorcitinib (15, 45, or 75 mg once daily) throughout the 52-week study. Efficacy among subgroups was evaluated using achievement of ≥ 50% reduction from baseline in total Vitiligo Area Scoring Index (T-VASI50) and ≥ 50%/≥ 75% reduction from baseline in facial VASI (F-VASI50/F-VASI75). Efficacy in the affected body regions was evaluated using VASI50 responses. Data were analyzed using descriptive statistics, and missing values were imputed as nonresponders.

RESULTS:

At Week 52, 34.0% (35/103) of patients achieved T-VASI50, 61.2% (63/103) achieved F-VASI50, and 45.6% (47/103) achieved F-VASI75. Repigmentation occurred across subgroups regardless of patient age, sex, race, Fitzpatrick skin type, affected body surface area, other autoimmune comorbidities, disease duration, or prior NSV treatment. In addition, VASI50 response rates increased consistently and, in most cases, without plateauing for each body region, ranging from 25.8% for the feet to 57.3% for the head and neck (excluding the face). Decreased rates of disease activity were also evident across body regions.

CONCLUSION:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier, NCT04818346.

01 Aug 2026·Dermatology and Therapy

Prevalence and Clinical Characteristics of Vitiligo-Associated Hearing Loss Among Patients in a Phase 2 Clinical Trial of Povorcitinib

Article

Author: Xue, Zhenyi ; Santos, Leandro L ; Brant, Jason A ; Brown, Kurt ; DePietro, Michael

INTRODUCTION:

Patients with vitiligo reportedly have an increased risk of sensorineural hearing loss (SNHL), driven by the loss of extracutaneous melanocytes in the inner ear. In a phase 2 dose-ranging study, the oral, selective Janus kinase 1 inhibitor povorcitinib demonstrated substantial repigmentation in patients with extensive nonsegmental vitiligo through 52 weeks of treatment. This exploratory post hoc analysis of the phase 2 study evaluated the prevalence of hearing loss among enrolled patients and examined their associated demographic and clinical characteristics, as well as their audiometric response to povorcitinib.

METHODS:

SNHL was defined as a bone-conduction threshold of ≥ 25 dB in either ear and was assessed using all-frequencies average (AFA: 250, 500, 1000, 2000, 3000, 4000, 6000, 8000 Hz), pure-tone average (PTA: 500, 1000, 2000, 4000 Hz), and high-frequencies average (HFA: 2000, 3000, 4000, 6000, 8000 Hz).

RESULTS:

Of 162 patients assessed for hearing loss, SNHL prevalence at baseline was 10.5% (AFA), 11.7% (PTA), and 14.2% (HFA). Patients with versus without SNHL were significantly older and had significantly greater facial involvement. Following up to 52 weeks of povorcitinib treatment, bone-conduction hearing thresholds improved across all frequency ranges, although no definitive conclusions can be drawn. At week 52, mean percentage change from baseline in the left and right ears was as follows: AFA, - 18.7% (P = 0.08) and - 16.1% (P = 0.10); PTA, - 13.9% (P = 0.18) and - 7.2% (P = 0.25); and HFA, - 11.0% (P = 0.21) and - 12.6% (P = 0.18), respectively.

CONCLUSION:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier, NCT04818346.

01 Aug 2026·NATURE MEDICINE

Povorcitinib for hidradenitis suppurativa: the randomized, double-blind, placebo-controlled STOP-HS1 and STOP-HS2 phase 3 trials

Article

Author: Marzano, Angelo V ; Brown, Kurt ; Hayama, Koremasa ; Kelley, Jennifer ; Tian, Chenwei ; Reguiaï, Ziad ; Goldfarb, Noah ; van der Zee, Hessel H ; Kirby, Joslyn S ; Zouboulis, Christos C ; Zhen, Huiling ; Sayed, Christopher J ; Santos, Leandro L ; Martorell, Antonio ; Hsiao, Jennifer L ; Lev-Tov, Hadar ; Ehst, Benjamin D ; Frew, John W ; Bechara, Falk G ; Gooderham, Melinda J ; Porter, Martina L ; Del Marmol, Veronique ; Ackerman, Lindsay S

Abstract:

Although therapeutic options for hidradenitis suppurativa (HS) continue to expand, unmet needs remain substantial. We evaluated the efficacy and safety of povorcitinib (an oral, highly selective Janus kinase 1 (JAK1) inhibitor) in patients with moderate to severe HS in two randomized trials. STOP-HS1 and STOP-HS2 were identically designed, randomized, double-blind, placebo-controlled phase 3 trials. Adults with moderate to severe HS were randomized 2:2:1:1 to once-daily treatment through week 54: povorcitinib 45 mg; povorcitinib 75 mg; placebo with crossover at week 12 to povorcitinib 45 mg; or placebo with crossover at week 12 to povorcitinib 75 mg. The primary endpoint was HiSCR50 (≥50% decrease in total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count) at week 12. STOP-HS1/STOP-HS2 enrolled 608/619 patients, respectively. In both studies, both povorcitinib doses met the primary endpoint; in STOP-HS1, 82/204 (40%) patients in the povorcitinib 45-mg group and 82/202 (41%) in the 75-mg group versus 60/202 (30%) in the placebo group achieved HiSCR50 (OR (95% CI) 45 mg: 1.6 (1.1−2.5), P = 0.0240; 75 mg: 1.6 (1.1−2.4), P = 0.0214); corresponding values for STOP-HS2 were 88/208 (42%) and 88/208 (42%) versus 58/203 (29%; OR (95% CI) 45 mg: 1.8 (1.2−2.8), P = 0.0035; 75 mg: 1.9 (1.2−2.8); P = 0.0033). Through week 12, across STOP-HS1/STOP-HS2, serious treatment-emergent adverse events (AEs) occurred in 1−2% of patients across povorcitinib doses and in 2−3% with placebo; through week 54, serious AEs occurred in 5%/6% of patients receiving 45-mg/75-mg povorcitinib, respectively. The most frequent AEs among patients treated with 45-mg/75-mg povorcitinib were acne (17%/20%), nasopharyngitis (10%/12%) and upper respiratory tract infection (11%/10%). One death of undetermined etiology was reported and deemed unrelated to treatment. No new or unexpected safety findings were identified. 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 .

News (Medical) associated with Povorcitinib

30 Sep 2026

·www.fiercebiotech.com

Merck’s anti-TL1A secures a ph. 2 hidradenitis suppurativa win

Merck & Co. has touted a win for its anti-TL1A antibody in a phase 2b trial in patients with moderate to severe hidradenitis suppurativa (HS). The study met its primary and secondary endpoints at week 16, informing phase 3 development for tulisokibart in HS, according to the company . The win was first announced in August during its second-quarter earnings update. “We are excited to expand the clinical data for tulisokibart beyond inflammatory bowel disease with these positive phase 2b results,” Aileen Pangan, M.D., vice president and therapeutic area head, immunology clinical research, Merck Research Laboratories, said in the release. “We look forward to advancing tulisokibart to phase 3 for patients living with HS.” Merck inherited tulisokibart in the $10.8 billion acquisition of Prometheus Biosciences in 2023. Since then, tulisokibart has been hit-or-miss. In June, Merck reported a phase 3 victory for tulisokibart in ulcerative colitis, followed by a phase 2 fail in systemic sclerosis associated with interstitial lung disease in August. Tulisokibart is designed to block TL1A signaling and downregulate key T cells (Th1, Th2, Th17), a core pathway in immuno-fibrosis. This process is a destructive loop driven by inflammation and fibroblast activation, leading to tissue damage, draining tunnel tracts and scarring seen in autoimmune diseases, such as HS. The phase 2b study was a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of tulisokibart in participants with moderate to severe HS. A total of 149 patients were stratified to receive either a high dose (480 mg every four weeks), medium dose (480 mg every two weeks), low dose (240 mg every four weeks) or placebo. By week 16, 72% of patients in the high-dose group, 64% in the medium-dose group and 52% in the low-dose group achieved HS clinical response 50 (HiSCR50), defined by at least a 50% reduction in total abscesses and inflammatory nodules with no increase in abscess count. Secondary endpoints showed that an HiSCR75 was achieved by 41% of high dose, 40% of medium dose, and 29% of low-dose patients, compared to 15% in the placebo group. In the high and medium-dose groups, patients’ quality of life with the skin condition, measured by the dermatology life quality index (DLQI), showed a 3.16-point and a 1.02-point improvement over placebo, respectively. Adverse events occurred in 42.9% of the high dose, 47.6% of the medium dose, and 52.4% of the low-dose group compared to 40.9% in the placebo-treated group. Serious adverse events occurred in 2.4% of both the high and medium-dose groups, 4.8% in the low-dose group and 2.3% in the placebo group. The HS space is densely populated with both FDA-approved drugs and candidates in mid-stage development. Avalo Therapeutics recently reported a phase 2 win with its anti-IL-1β antibody abdakibart in HS. In March 2025, Incyte delivered a pair of phase 3 wins in HS for its JAK1 inhibitor, povorcitinib, which could offer an oral alternative to biologics in multiple indications. UCB’s Bimzelx , Novartis’ biologic Cosentyx, and AbbVie’s off-patent Humira are all approved in the indication.

Clinical ResultPhase 2Phase 3AcquisitionDrug Approval

22 Sep 2026

·www.biospace.com

Incyte Data at the European Academy of Dermatology and Venereology (EADV) Congress Underscore the Breadth of Incyte’s Inflammation and Autoimmunity Portfolio

WILMINGTON, Del.--(BUSINESS WIRE)-- $INCY --Incyte (Nasdaq:INCY) today announced that data from across its Inflammation and Autoimmunity (IAI) portfolio will be presented at the European Academy of Dermatology and Venereology (EADV) 2026, held September 30 - October 3, 2026, in Vienna, Austria. "The breadth of research being presented at EADV 2026 highlights the strength of our Inflammation and Autoimmunity portfolio," said Pablo J. Cagnoni, M.D., President, Incyte and Global Head of Research and Development. "Data presentations in hidradenitis suppurativa, atopic dermatitis and prurigo nodularis demonstrate our commitment to advancing innovation across immune-mediated skin diseases and deepening our understanding of the patient experience." Details on key Incyte data presentations at EADV include: Oral Presentations Atopic Dermatitis Atopic Dermatitis and Life Course Disruption: Evidence From a Multidimensional International Survey (TOPiQAL) (Session: Free Communication 1: Atopic dermatitis/Eczema. Thursday, October 1, 2:50-3:00 a.m. ET [8:50-9:00 a.m. CEST]. Abstract #FC01.1C) Poster Presentations Atopic Dermatitis Comparative Efficacy of 1.5% Ruxolitinib Cream Versus Systemic Therapies in Moderate Atopic Dermatitis (Session: Atopic dermatitis/Eczema - Part II. Wednesday, September 30, 1:00 a.m. ET [7:00 a.m. CEST]. Abstract #P0196.) Long-Term Safety and Pharmacokinetics of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis Eligible for Systemic Therapy: 24-Week Results From the TRuE-AD4 Study (Session: Atopic dermatitis/Eczema - Part III. Wednesday, September 30, 1:00 a.m. ET [7:00 a.m. CEST]. Abstract #P1544.) Patient Pro Multidimensional Burden of Atopic Dermatitis: Results From an International Survey (TOPiQAL) (Session: Atopic dermatitis/Eczema - Part III. Wednesday, September 30, 1:00 a.m. ET [7:00 a.m. CEST]. Abstract #P1543.) Patient Treatment Preferences in Atopic Dermatitis: Best–Worst Scaling Results From an International Study (TOPiQAL) (Session: Atopic dermatitis/Eczema - Part III. Wednesday, September 30, 1:00 a.m. ET [7:00 a.m. CEST]. Abstract #P1615.) Ruxolitinib Cream in Moderate Atopic Dermatitis Across Disease Severity Thresholds: Insights From Randomized Trials and Real-World Data (Session: Atopic dermatitis/Eczema Part - III. Wednesday, September 30, 1:00 a.m. ET [7:00 a.m. CEST]. Abstract #P1617.) Ruxolitinib Cream Maintains Improvements in Patient-Reported Symptom and Quality of Life Outcomes When Used As Needed in Adults With Moderate Atopic Dermatitis Eligible for Systemic Therapy: Long-Term Results From the TRuE-AD4 Study (Session: Atopic dermatitis/Eczema - Part III. Wednesday, September 30, 1:00 a.m. ET [7:00 a.m. CEST]. Abstract #P1618.) Ruxolitinib Cream Reduced High Symptom and Quality-of-Life Burden in Adults With Moderate Atopic Dermatitis After Failure of Topical Corticosteroids and Topical Calcineurin Inhibitors: Item-Level Patient-Reported Outcome Results From TRuE-AD4 (Session: Atopic dermatitis/Eczema - Part III. Wednesday, September 30, 1:00 a.m. ET [7:00 a.m. CEST]. Abstract #P1547.) Ruxolitinib Cream Use to Delay or Prevent Treatment Escalation in Adults With Moderate Atopic Dermatitis Eligible for Systemic Therapy: Results From the TRuE-AD4 Study (Session: Atopic dermatitis/Eczema - Part III. Wednesday, September 30, 1:00 a.m. ET [7:00 a.m. CEST]. Abstract #P1614.) Hidradenitis Suppurativa Characterization of Acne in Pooled STOP-HS1/STOP-HS2 Phase 3 Studies of Povorcitinib in Patients With Moderate to Severe Hidradenitis Suppurativa (Session: Acne and related disorders, hidradenitis suppurativa - Part II. Wednesday, September 30, 1:00 a.m. ET [7:00 a.m. CEST]. Abstract #P1374.) 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 (Session: Acne and related disorders, hidradenitis suppurativa - Part II. Wednesday, September 30, 1:00 a.m. ET [7:00 a.m. CEST]. Abstract #P1343.) Real-World Treatment Challenges and Unmet Needs in Biologic-Experienced European Patients With Hidradenitis Suppurativa: Insights From the HERALD Survey (Session: Acne and related disorders, hidradenitis suppurativa - Part II. Wednesday, September 30, 1:00 a.m. ET [7:00 a.m. CEST]. Abstract #P1394.) Prurigo Nodularis A Real-World, Claims-Based Algorithm for Identifying Moderate to Severe Prurigo Nodularis (Session: Inflammatory skin diseases - Part II. Wednesday, September 30, 1:00 a.m. ET [7:00 a.m. CEST]. Abstract #P2314.) Incidence, Prevalence, Treatment Patterns, and Healthcare Resource Utilization of Prurigo Nodularis in the US and Germany (Session: Inflammatory skin diseases - Part II. Wednesday, September 30, 1:00 a.m. ET [7:00 a.m. CEST]. Abstract #P2279.) Vitiligo Application of Exposure-Response Modeling to Inform the Phase 3 Dose Selection of Povorcitinib in Nonsegmental Vitiligo (Session: Biologics, immunotherapy, targeted therapy. Wednesday, September 30, 1:00 a.m. ET [7:00 a.m. CEST]. Abstract #P1780.) Development of a Prospective, Regulatory-Grade Disease Registry to Characterize Real-World Nonsegmental Vitiligo Care (Session: Pigmentary disorders. Wednesday, September 30, 1:00 a.m. ET [7:00 a.m. CEST]. Abstract #P2463.) Quality-of-Life Impairment and Impact of Treatment in an Open-Label, Phase 2 Study of Ruxolitinib Cream in Patients With Genital Vitiligo (Session: Pigmentary disorders. Wednesday, September 30, 1:00 a.m. ET [7:00 a.m. CEST]. Abstract #P2467.) General Integrated Mixed-Effects Analysis of Pharmacokinetics of Ruxolitinib Cream and Implications on Safety Pro Patients With Inflammatory Skin Diseases (Session: Inflammatory skin diseases - Part II. Wednesday, September 30, 1:00 a.m. ET [7:00 a.m. CEST]. Abstract #P2288.) More information regarding the EADV Congress 2026 can be found at: About Opzelura ® (ruxolitinib) Cream Opzelura ® (ruxolitinib) cream, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. FDA for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. In Europe, Opzelura ® (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age and in adult patients with moderate atopic dermatitis (AD) for whom topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) are inadequate or inappropriate. Incyte has worldwide rights for the development and commercialization of Opzelura. To date, more than one million patients globally have been treated with Opzelura. Opzelura is a registered trademark of Incyte. About Povorcitinib Povorcitinib (INCB54707) is an oral small-molecule JAK1 selective inhibitor currently being investigated in Phase 3 clinical trials for moderate to severe HS (STOP-HS1, STOP-HS2, STOP- HS LTE), nonsegmental vitiligo (STOP-V1, STOP-V2) and prurigo nodularis (PN; STOP-PN1, STOP-PN2), as well as a Phase 2 trial for moderate to severe asthma. The New Drug Application (NDA) and Marketing Authorization Application (MAA) for povorcitinib as a potential treatment for patients with moderate to severe HS are under review by the U.S. Food and Drug Administration and European Medicines Agency, respectively. About Vitiligo Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin that results from the loss of pigment-producing cells known as melanocytes. Overactivity of the JAK signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of vitiligo. In the United States, more than 1.5 million people are diagnosed with vitiligo. 1 The overall prevalence of the condition is estimated to be approximately 2-3 million, 2 with the majority of patients (approximately 85%) suffering from nonsegmental vitiligo. 3 Vitiligo can occur at any age, although many patients with vitiligo will experience initial onset before the age of 30. 4 About Atopic Dermatitis AD – the most common type of eczema – is a chronic, recurring, inflammatory and highly pruritic skin condition that affects up to 25% of children and up to 12% of adults worldwide, with an estimated prevalence of 4.4% - 7.1% of adults in Europe. 5,6 Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust. 7 About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by painful nodules and abscesses that can lead to irreversible tissue destruction and scarring. 8,9 Over-activity of the JAK/STAT signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of HS. 10 More than 150,000 patients in the U.S. are estimated to have moderate to severe HS. 10 Given the debilitating nature of the condition, it can have a profoundly negative effect on patients’ quality of life. 11 About Prurigo Nodularis Prurigo nodularis (PN) is a chronic inflammatory skin disease characterized by an intense itch and thickened red bumps on the arms, legs and trunk. 12 There are approximately 200,000 individuals in the U.S. living with PN. 13 It can affect people of any age, though is most common among those 40-69 years old. 14,15,16,17 Due to the result of persistent, intense scratching and rubbing of the skin, PN results in itchy bumps on the skin called "nodules," these often have a substantial impact on a patient's sleep and overall quality of life. 12,18 About Incyte ® Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation and Autoimmunity. To learn more, visit Incyte.com and Investor.Incyte.com . Follow us on social media: LinkedIn , X and Instagram . Incyte Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the data to be presented by Incyte at the EADV Congress 2026 and Incyte’s expectations regarding the significance of such data, the strength of Incyte’s Inflammation and Autoimmunity portfolio, the potential presented by Incyte’s investigational and approved therapies such as povorcitinib and ruxolitinib cream and Incyte’s aspirations and goals as set forth under the heading “About Incyte”. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including Incyte’s ability to demonstrate the efficacy and safety of its products and product candidates; the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Incyte’s ability to achieve commercial success for its marketed products and product candidates, if approved; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended June 30, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements. 1 Bergqvist C, Ezzedine K. Vitiligo: A Review. Dermatology . 2020;236:571-592. 2 Gandhi K, et al. Prevalence of vitiligo among adults in the United States. J Am Acad Dermatol . 2022;158(1):43-50. 3 Ezzedine K, et al. Seminar: Vitiligo. Lancet . 2015;386:74–84. 4 Frisoli M, et al. Vitiligo: mechanisms of pathogenesis and treatment. Annu. Rev. Immunol . 2020;38(1):621-648. 5 Global Atopic Dermatitis Atlas. Global report on atopic dermatitis 2022. Available at: . Accessed April 2026 6 Eckert L, Gupta S, Gadkari A, et al. Burden of illness in adults with atopic dermatitis: Analysis of national health and wellness survey data from France, Germany, Italy, Spain, and the United Kingdom. J Am Acad Dermatol. 7 Boguniewicz M, Fonacier L, Guttman-Yassky E, et al. Atopic dermatitis yardstick: practical recommendations for an evolving therapeutic landscape. Ann Allergy Asthma Immunol. 2018;120(1):10-22.e2. Link to source ( ) 8 McCarthy, S. (2025) Hidradenitis suppurativa. Annu Rev Med. 76(1):69-80. Link to source ( ) 9 Kirby J.S., et al. (2024) Efficacy and safety of the oral Janus kinase 1 inhibitor povorcitinib (INCB054707) in patients with hidradenitis suppurativa in a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study. J Am Acad Dermatol . 90(3):521-529. Link to source ( ) 10 Maronese C.A., et al. (2024) Biologics for Hidradenitis suppurativa: evolution of the treatment paradigm. Expert Rev Clin Immunol. 20(5), 525-545. Link to source ( ) 11 McMillan K. (2014) Hidradenitis suppurativa: number of diagnosed patients, demographic characteristics, and treatment patterns in the United States. J Am Acad Dermatol . 179(12):1477-83. Link to source ( ) 12 National Organization for Rare Disorders. Prurigo Nodularis. . Accessed on January 28, 2025. 13 Huang AH, et al. JID . 2020;140:480-483 14 Huang AH, et al. J Am Acad Dermatol . 2020;83:1559-1565 15 Wongvibulsin S, et al. J Invest Dermatol . 2021;141:2530-2533 16 Boozalis E, et al. J Am Acad Dermatol . 2018;79:714-719 17 Whang KA, et al. Medicines (Basel) . 2019;6:88 18 Yale Medicine. Prurigo Nodularis. . Accessed January 28, 2025. Contacts Media media@incyte.com Investors ir@incyte.com

Phase 3Phase 2Clinical ResultDrug Approval

21 Sep 2026

·firstwordpharma.com

Novo's Frehemgo, Incyte's Povofortay among key CHMP nods in September

The EMA's drug advisory panel backed a dozen new medicines for approval at its September meeting, including Novo's Frehemgo (denecimig) for haemophilia A, Incyte's Povofortay (povorcitinib) in severe hidradenitis suppurativa (HS) and two therapies for ovarian cancer.Among the more closely watched decisions announced Friday, the agency's Committee for Medicinal Products for Human Use (CHMP) recommended Frehemgo for the routine prophylaxis of bleeding episodes in patients with haemophilia A, regardless of inhibitor status. The decision was supported by findings from the FRONTIER programme, in which Frehemgo significantly reduced the annualised bleeding rate compared to prior clotting factor prophylaxis and on-demand treatment. The next-generation factor VIIIa mimetic bispecific antibody, previously known as Mim8, has also shown comparable effectiveness in children.The drug's dosing flexibility – it can be given once-monthly, once every two weeks, or once-weekly via single-use pre-filled pens – could be a possible key differentiator (see — KOL Views Q&A: Novo Nordisk’s denecimig may struggle to displace entrenched Hemlibra in haemophilia A). A similar application for Frehemgo is under review in the US.On Friday, Novo also received a positive CHMP opinion to expand use of Sogroya (somapacitan) to include children living with idiopathic short stature with persistent growth disturbance. The once-weekly, long-acting human growth hormone analogue is already authorised in the EU for the treatment of growth hormone deficiency in adults and in children ages 3 years and older.Povofortay nears first OKMeanwhile, the positive opinion for Povofortay moves Incyte's oral JAK1 inhibitor one step closer to securing its first approval. CHMP's decision covers the treatment of active moderate-to-severe HS in adults who have responded inadequately to, or who are intolerant or contraindicated to an anti-TNF therapy.The submission is supported by findings from the Phase III STOP-HS1 and STOP-HS2 studies, which both met their primary endpoints by demonstrating significant reductions in abscess and nodule count. Longer-term results presented at this year's American Academy of Dermatology (AAD) meeting showed that up to 57% of HS patients taking Povofortay achieved ≥75% reduction in inflammatory lesions after one year in the trials.A filing in this indication is also under review in the US, while Incyte is planning applications in vitiligo based on data released earlier this year. Pair of ovarian cancer drugsIn ovarian cancer, CHMP backed the approval of drugs with two different mechanisms of action: Corcept Therapeutics' selective glucocorticoid receptor modulator Lifyorli (relacorilant) and IMPACT Therapeutics' oral PARP1/2 inhibitor Sepalna (senaparib).Lifyorli's positive opinion is for use in combination with nab-paclitaxel to treat platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. The drug, which was approved earlier this year in the US, is seen as an advancement in ovarian cancer treatment. Deanna Gerber, an assistant professor of obstetrics and gynaecology at Weill Cornell Medicine, previously told FirstWord that Lifyorli is "going to be the next big thing" in the field (see – KOL Views Q&A: Relacorilant set for early uptake in platinum-resistant ovarian cancer).The recommendation was based on clinical data including from the Phase III ROSELLA trial, in which patients given Lifyorli plus nab-paclitaxel achieved improved progression-free and overall survival compared to nab-paclitaxel alone, without an increase in adverse events.The EMA panel also endorsed Sepalna as a maintenance treatment for advanced epithelial ovarian, fallopian tube and primary peritoneal cancer. The decision was supported by findings from the Phase III FLAMES study, in which Sepalna reduced the risk of disease progression of death by 57% compared to placebo when used as first-line maintenance monotherapy in a broad patient population with advanced ovarian cancer.Sepalna is already approved in China in the ovarian cancer maintenance setting, while IMPACT recently out-licensed certain rights to the drug to Pharmanovia, including in the EU.Other new drugs recommended for approval at CHMP's latest meeting include Xcovery's Gevalka (ensartinib) for adults with ALK-positive advanced non–small-cell lung cancer, AstraZeneca's Klygefa (gefurulimab) for generalised myasthenia gravis, Sanofi's rabies vaccine VaxRabeo, and Zealand Pharma's Zeydovio (glepaglutide) for the treatment of short bowel syndrome.

Clinical ResultPhase 3Drug Approval

100 Deals associated with Povorcitinib

External Link

KEGG	Wiki	ATC	Drug Bank
D12575 D12576	-	-	-

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Autoimmune Diseases	NDA/BLA	Canada	Incyte Corp.	01 Jul 2026
Hidradenitis Suppurativa	NDA/BLA	United States	Incyte Corp.	-
Hidradenitis Suppurativa	NDA/BLA	European Union	Incyte Corp.	-
prurigo nodularis	Phase 3	United States	Incyte Corp.	10 Oct 2024
prurigo nodularis	Phase 3	Japan	Incyte Corp.	10 Oct 2024
prurigo nodularis	Phase 3	Argentina	Incyte Corp.	10 Oct 2024
prurigo nodularis	Phase 3	Australia	Incyte Corp.	10 Oct 2024
prurigo nodularis	Phase 3	Austria	Incyte Corp.	10 Oct 2024
prurigo nodularis	Phase 3	Belgium	Incyte Corp.	10 Oct 2024
prurigo nodularis	Phase 3	Bulgaria	Incyte Corp.	10 Oct 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04818346 (Pubmed \| Adv Ther)	Phase 2	Vitiligo	103	Povorcitinib 15 mg	urgfribbuk(exedxigodk) = nqfooaoowu ehenlxejkx (sonjyljfzq ) View more	Positive	01 Oct 2026
NCT04818346 (Pubmed \| Dermatol Ther (Heidelb))	Phase 2	-	162	Povorcitinib	xveiufngyk(arxjzhdpyx) = uzdmymumvt krbsqxyirl (kyeakrdpmx ) View more	Positive	01 Aug 2026
NCT05936567 (AAD2026)	Phase 2	Chronic Urticaria	136	Povorcitinib 15mg	znqeltpvtj(jmgbmnztcx) = ukxlkjzhtd qyxyysyquh (tnyqohkqmq, 2.94)	Positive	27 Mar 2026
				Povorcitinib 45mg	znqeltpvtj(jmgbmnztcx) = pflimyniyk qyxyysyquh (tnyqohkqmq, 2.78)
AAD2026	Not Applicable	Hidradenitis Suppurativa	177	povorcitinib	ainavlmmyk(cptirdtyqz) = mziktephrz nnedmtplwy (zzszezbldi )	Positive	27 Mar 2026
				Placebo	ainavlmmyk(cptirdtyqz) = iykacbeiqy nnedmtplwy (zzszezbldi )
NCT05936567 (CTgov)	Phase 2	Pruritus \| Chronic Urticaria \| Angioedema	136	placebo (Placebo)	gjmecyytcn(lqvfrkueoh) = kufhflhlxi rlaandebwf (rkvocwsfrj, 2.21) View more	-	12 Mar 2026
				Povorcitinib (Povorcitinib 15 mg QD)	gjmecyytcn(lqvfrkueoh) = jgsdclmazn rlaandebwf (rkvocwsfrj, 2.09) View more
NCT06505265 (Pubmed \| Bioanalysis)	Phase 1	-	18	Povorcitinib	rkwxfrmmnf(oxtzpyynvx) = mdsayxyspc wdajhwqecx (exjchbqiao )	Positive	08 Jan 2026
NCT04818346 (Pubmed \| J Am Acad Dermatol)	Phase 2	Vitiligo	171	Povorcitinib 15 mg	crokztmlfy(cccoexjcvo) = myngrscaid jxcllvugrz (lqumhxpqkl )	Positive	01 Oct 2025
				Povorcitinib 45 mg	crokztmlfy(cccoexjcvo) = ikzmuzeabk jxcllvugrz (lqumhxpqkl )
NCT05620836 \| NCT05620823 (STOP-HS2, Company_Website) Manual	Phase 3	Hidradenitis Suppurativa	-	Povorcitinib 45 mg (STOP-HS1)	pfswymdowx(cfxeixcddt) = gnmqrnnarf cdkqylbbcs (zmwyxvvbyz ) Met View more	Positive	17 Mar 2025
				Povorcitinib 75 mg (STOP-HS1)	pfswymdowx(cfxeixcddt) = edsbnbhvpj cdkqylbbcs (zmwyxvvbyz ) Met View more
NCT04818346 (AAD2024) Manual	Phase 2	Vitiligo	171	Povorcitinib (age≤40 years)	ktaxpcsmgx(tcfqmxamba) = wncavnqhfl cbzkbyoxgr (awfqcnafxb )	Positive	10 Mar 2024
				Povorcitinib (age>40 years)	ktaxpcsmgx(tcfqmxamba) = ehbflrdoud cbzkbyoxgr (awfqcnafxb )
NCT05061693 (Corporate Publications) Manual	Phase 2	prurigo nodularis	146	Povorcitinib 15 mg	jjufzdwksa(yxpgagpfvv) = vwofgmkbmk nrymdzrihq (zpmoozolya ) Met View more	Positive	10 Mar 2024
				Povorcitinib 45 mg	jjufzdwksa(yxpgagpfvv) = dwqfghgzlg nrymdzrihq (zpmoozolya ) Met View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis