Drugs / Povorcitinib
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | hidradenitis suppurativa | — | “The MAA for povorcitinib in HS was submitted to the EMA at the end of 2025” incyte.com ↗ |
| Filed | US (FDA) | — | hidradenitis suppurativa | — | “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.” incyte.com ↗ |
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT07588139 | May → Sep 2026 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT06505265 | Aug → Sep 2024 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT06441318 | Jul → Sep 2024 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT06416800 | Jun 2024 → Jan 2025 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT06380205 | May → Jun 2024 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT05624723 | Jan 2023 → Feb 2024 | impaired renal function disease | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT05624710 | Dec 2022 → Jun 2023 | impaired renal function disease | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT05068466 | Oct 2021 → Jan 2022 | — | Incyte Biosciences Japan GK | Completed | No outcome recorded |
| Phase 28 trials · 4 met primary | ||||||
| Phase 2 | NCT07213973 | Feb 2026 → Mar 2028 expected | hidradenitis suppurativa | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 2 | NCT05936567 | Jul 2023 → Feb 2025 | angioedema, chronic idiopathic urticaria | Incyte Corporation | Completed | Met primary |
| Phase 2 | NCT05851443 | Jul 2023 → Nov 2026 expected | asthma | Incyte Corporation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05061693 | Nov 2021 → Aug 2023 | prurigo nodularis | Incyte Corporation | Completed | Met primary |
| Phase 2 | NCT04818346 | May 2021 → May 2022 | vitiligo | Incyte Corporation | Completed | Met primary |
| Phase 2 | NCT04476043 | Aug 2020 → Dec 2021 | hidradenitis suppurativa | Incyte Corporation | Completed | Met primary |
| Phase 2 | NCT03607487 | Oct 2018 → Aug 2019 | hidradenitis suppurativa | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT03569371 | Jul 2018 → Apr 2019 | hidradenitis suppurativa | Incyte Corporation | Completed | No outcome recorded |
| Phase 39 trials · 4 met primary | ||||||
| Phase 3 | NCT07865312 | Nov 2026 → May 2028 expected | vitiligo | Dermavon Holdings Limited | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06855498 | Feb 2025 → Feb 2028 expected | hidradenitis suppurativa | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 3 | NCT06516952 | Oct 2024 → Oct 2026 expected | prurigo nodularis | Incyte Corporation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06516965 | Oct 2024 → Oct 2026 expected | prurigo nodularis | Incyte Corporation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06212999 | Jan 2024 → Dec 2026 expected | hidradenitis suppurativa | Incyte Corporation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06113445 | Nov 2023 → Feb 2026 overdue | vitiligo | Incyte Corporation | Active not recruiting | Met primary |
| Phase 3 | NCT06113471 | Nov 2023 → Mar 2026 overdue | vitiligo | Incyte Corporation | Active not recruiting | Met primary |
| Phase 3 | NCT05620836 | Feb 2023 → Jan 2025 | hidradenitis suppurativa | Incyte Corporation | Completed | Met primary |
| Phase 3 | NCT05620823 | Dec 2022 → Feb 2025 | hidradenitis suppurativa | Incyte Corporation | Completed | Met primary |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-03-28 | Incyte Corporation | Results Incyte Announces New Positive 54-Week Late-Breaking Data for Povorcitinib in Hidradenitis Suppurativa at the 2026 American Academy of Dermatology (AAD) Annual Meeting incyte.com ↗
Incyte (Nasdaq:INCY) today announced 54-week data evaluating the safety and efficacy of povorcitinib (INCB54707), an oral small-molecule highly-selective JAK1 inhibitor, from the pivotal Phase 3 STOP-HS clinical trial program in adult patients (≥18 years) with moderate to severe hidradenitis suppurativa (HS). |
| 2025-09-17 | Incyte Corporation | Results Incyte Announces New 24-Week Phase 3 Data from the STOP-HS Clinical Trial Program of Povorcitinib in Hidradenitis Suppurativa at EADV 2025 incyte.com ↗
Incyte (Nasdaq:INCY) today announced new 24-week interim data evaluating the safety and efficacy of povorcitinib (INCB54707), an oral small-molecule highly-selective JAK1 inhibitor, from the pivotal Phase 3 STOP-HS clinical trial program in adult patients (≥18 years) with moderate to severe hidradenitis suppurativa (HS). |
| 2025-04-29 | Incyte Corporation | Results Incyte Reports 2025 First Quarter Financial Results and Provides Updates on Key Clinical Programs incyte.com ↗
Positive Phase 2 topline results for povorcitinib in chronic spontaneous urticaria (CSU) demonstrates proof-of-concept in new indication |
| 2025-03-17 | Incyte Corporation | Results Incyte Announces Positive Topline Results From Two Phase 3 Clinical Trials of Povorcitinib in Patients With Hidradenitis Suppurativa incyte.com ↗
Both the STOP-HS1 and STOP-HS2 studies met their primary endpoint at both tested doses (45 mg and 75 mg). |
| 2024-03-10 | Incyte Corporation | Results Incyte Presents New Late-Breaking Data from Phase 2 Study Evaluating Povorcitinib in Patients with Prurigo Nodularis incyte.com ↗
Incyte (Nasdaq:INCY) today announced results from a Phase 2 study evaluating the efficacy and safety of povorcitinib (INCB54707), an oral JAK1 inhibitor, in adult patients with prurigo nodularis (PN). |
| 2023-10-11 | Incyte Corporation | Results Incyte Announces Positive 52-Week Data from Phase 2b Study Evaluating Povorcitinib (INCB54707) in Patients with Extensive Nonsegmental Vitiligo incyte.com ↗
Incyte (Nasdaq:INCY) today announced new 52-week data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib (INCB54707), an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo. |
| 2023-03-18 | Incyte Corporation | Results Incyte Announces Data from Phase 2b Study Evaluating Povorcitinib (INCB54707) in Patients with Extensive Nonsegmental Vitiligo incyte.com ↗
Incyte (Nasdaq:INCY) today announced new data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib (INCB54707), an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo. |
| 2023-02-10 | Incyte Corporation | Results Incyte Announces 52-Week Results from Phase 2 Study Evaluating Povorcitinib (INCB54707) in Patients with Hidradenitis Suppurativa incyte.com ↗
Incyte (Nasdaq:INCY) today announced new 52-week results from a Phase 2 study evaluating the efficacy and safety of povorcitinib (formerly INCB54707), an oral JAK1 inhibitor, in adult patients with hidradenitis suppurativa (HS). |
All press releases naming this drug 10 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Povorcitinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06212999 ↗ |
| Known as | INCB-054707 PHOSPHATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095079 ↗ |
| Known as | INCB054707 | “A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)” NCT05620836 ↗ |
| Known as | Povorcitinib phosphate | “Povorcitinib phosphate tablets, 30 mg orally once daily for 52 weeks.” NCT07865312 ↗ |
| Action | Inhibit | “Janus kinase 1 inhibitor INCB054707” PMID 34978076 ↗ Mar 2022 |
| Modality | Small molecule | — CHEMBL5095079 ↗ |
| Route | Oral | “INCB054707 administered once daily orally with water without regard to food for 8 weeks.” NCT03569371 ↗ |
| Target | JAK1 | “Janus kinase 1 inhibitor INCB054707” PMID 34978076 ↗ Mar 2022 |