Drugs / ENVUCITINIB
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06952634 | Apr 2025 → Mar 2026 | — | Alumis Inc | Completed | No outcome recorded |
| Phase 1 | NCT06962774 | Apr → Aug 2025 | impaired renal function disease | Alumis Inc | Completed | No outcome recorded |
| Phase 1 | NCT07378579 | Jun → Aug 2024 | — | Alumis Inc | Completed | No outcome recorded |
| Phase 1 | NCT05431634 | May → Dec 2022 | — | Alumis Inc | Completed | No outcome recorded |
| Phase 1 | NCT05330858 | Mar → Jun 2022 | — | Alumis Inc | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT05966480 | Jun 2023 → Jul 2026 overdue | systemic lupus erythematosus | Alumis Inc | Active not recruiting | Missed primary |
| Phase 2 | NCT05953688 | Jun 2023 → Aug 2024 | intermediate uveitis, panuveitis, posterior uveitis | Alumis Inc | Terminated | No outcome recorded |
| Phase 2 | NCT05739435 | Jan 2023 → Dec 2026 expected | psoriasis | Alumis Inc | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05600036 | Sep 2022 → Jun 2023 | psoriasis | Alumis Inc | Completed | Met primary |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT06846541 | Jan 2025 → Nov 2028 expected | psoriasis | Alumis Inc | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06588738 | Aug 2024 → Sep 2025 | psoriasis | Alumis Inc | Completed | Met primary |
| Phase 3 | NCT06586112 | Jul 2024 → Sep 2025 | psoriasis | Alumis Inc | Completed | Met primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-10-09 | Alumis Inc | Results Alumis Announces New Phase 3 Data Demonstrating Envudeucitinib Rapidly and Durably Improved Psoriasis Burden Across Scalp, Itch, and Quality of Life Measures alumis.com ↗
The data demonstrated early and durable improvements across scalp disease severity (a high-impact, difficult-to-treat area), itch resolution, and quality of life measures. |
| 2026-09-01 | Alumis Inc | Results Alumis Announces Topline Results from Envudeucitinib Phase 2b Trial in Systemic Lupus Erythematosus (SLE) alumis.com ↗
Robust responses in the prespecified subgroup of patients with high interferon gene signature (IFNGS-high) support moving forward with Phase 3 development in SLE |
| 2026-08-10 | Alumis Inc | Results Envudeucitinib Long-term Data Positioned to Set a New Standard for Plaque Psoriasis Treatment, Delivering Highest Reported PASI 100 Skin Clearance Among Oral Therapies alumis.com ↗
Data confirm envudeucitinib delivered leading skin clearance and the highest reported Psoriasis Area and Severity Index (PASI) 100 response rates among existing and investigational oral therapies. |
| 2026-03-28 | Alumis Inc | Results Alumis’ Envudeucitinib Delivers Early and Robust Improvements in Skin Clearance, Quality of Life and Psoriasis Symptoms in Two Phase 3 Trials, Underscoring Its Potential as a Leading Oral Therapy for Plaque Psoriasis alumis.com ↗
Envudeucitinib demonstrated robust skin clearance, achieving high thresholds of clinical response at Week 16 that continued to deepen through Week 24 in both trials. |
| 2026-01-06 | Alumis Inc | Results Alumis’ Envudeucitinib Delivers Leading Skin Clearance Among Next-Generation Oral Plaque Psoriasis Therapies in Phase 3 Program alumis.com ↗
Envudeucitinib met all primary and secondary endpoints with high statistical significance in ONWARD1 and ONWARD2. |
| 2024-09-27 | Alumis Inc | Results Late-Breaking Data at EADV of ESK-001, an Oral TYK2 Inhibitor for the Treatment of Psoriasis, Demonstrate Significant Responses with Sustained Increases Over 28 Weeks in Phase 2 OLE Study alumis.com ↗
28-week data show ESK-001 was generally well tolerated and most patients treated with the top dose of 40 mg twice daily achieved PASI 75 |
All press releases naming this drug 13 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ENVUCITINIB | ChEMBL registry synonym — accepted as the source's own label CHEMBL5499275 ↗ |
| Known as | envudeucitinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05739435 ↗ |
| Known as | ESK-001 | “Patients will enter the long-term extension study following completion of one of the parent studies (ESK-001-016 or ESK-001-017) and will receive open-label ESK-001 twice daily...” NCT06846541 ↗7“Envudeucitinib (ESK-001), a highly selective, oral tyrosine kinase 2 inhibitor” PMID 41061968 ↗ Oct 2025 |
| Action | Inhibit | “Highly selective, allosteric inhibition of TYK2 with oral ESK-001” PMID 40659116 ↗ Jul 2025 |
| Modality | Small molecule | — CHEMBL5499275 ↗ |
| Route | Oral | “ESK-001 administered as an oral liquid” NCT05330858 ↗ |
| Target | TYK2 | “Highly selective, allosteric inhibition of TYK2 with oral ESK-001” PMID 40659116 ↗ Jul 2025 |