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- envudeucitinib (ESK-001) / Alumis
Envudeucitinib, an allosteric TYK2 inhibitor, inhibits SLE-relevant type I IFN biomarkers in skin using spatial transcriptomics () - Sep 7, 2026 - Abstract #ACRConvergence2026ACR_Convergence_3169;
- envudeucitinib (ESK-001) / Alumis
Envudeucitinib (ESK-001) in moderate-to-severe plaque psoriasis: 24-week results from the randomized, double-blind, active comparator- and placebo-controlled, Phase 3 ONWARD1 and 2 studies () - Sep 7, 2026 - Abstract #ACRConvergence2026ACR_Convergence_2446;
- envudeucitinib (ESK-001) / Alumis
Envudeucitinib (ESK-001) in moderate-to-severe plaque psoriasis: 24-week results from the randomized, double-blind, active comparator- and placebo-controlled, Phase 3 ONWARD1 and 2 studies (ePoster Area) - Aug 6, 2026 - Abstract #EADV2026EADV_4089;
- envudeucitinib (ESK-001) / Alumis
Envudeucitinib, an oral allosteric TYK2 inhibitor, suppresses inflammatory supraspinous keratinocyte states in psoriasis skin (ePoster Area) - Aug 6, 2026 - Abstract #EADV2026EADV_4088;
- || envudeucitinib (ESK-001) / Alumis
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage (clinicaltrials.gov) - May 12, 2026
P1, N=32, Completed, Sponsor: Alumis Inc
Recruiting --> Completed | N=48 --> 32 | Trial completion date: Dec 2025 --> Mar 2026 | Trial primary completion date: Dec 2025 --> Mar 2026
- ||||||| envudeucitinib (ESK-001) / Alumis
Trial completion: ONWARD 2: A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (clinicaltrials.gov) - Apr 14, 2026
P3, N=862, Completed, Sponsor: Alumis Inc
Recruiting --> Completed | N=48 --> 32 | Trial completion date: Dec 2025 --> Mar 2026 | Trial primary completion date: Dec 2025 --> Mar 2026 Active, not recruiting --> Completed
- ||||||| envudeucitinib (ESK-001) / Alumis
Trial completion: ONWARD 1: A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - Apr 14, 2026
P3, N=912, Completed, Sponsor: Alumis Inc
Active, not recruiting --> Completed Active, not recruiting --> Completed
- Shifting Role of Oral Therapies in Psoriasis: Unmet Needs and Perspectives on Current and Emerging Therapies, and Evolving Treatment Sequencing Among Dermatologists. () - Mar 12, 2026 - Abstract #AAD2026AAD_3471;
Dermatologists report an expanding role for oral therapies in PsO. Broader availability of effective oral agents is expected to further delay biologic initiation, representing a paradigm shift in PsO management.
- envudeucitinib (ESK-001) / Alumis
Envudeucitinib (ESK-001) in moderate-to-severe plaque psoriasis: 24-week results from the randomized, double-blind, active comparator- and placebo-controlled, Phase 3 ONWARD 1 and 2 studies (Bellco Theatre) - Mar 11, 2026 - Abstract #AAD2026AAD_3134;
- envudeucitinib (ESK-001) / Alumis
Envudeucitinib Attenuates Inflammatory Biomarkers in Plaque Psoriasis at Both a Proteomic and Transcriptomic Level: A Subgroup Analysis of Tape Strip Biomarkers from the STRIDE Phase 2 Clinical Trial () - Mar 2, 2026 - Abstract #AAD2026AAD_2715;
Conclusion In moderate-to-severe psoriasis, envudeucitinib achieved robust suppression of pathogenic IL-23 and interferon-related pathways at transcriptomic and proteomic levels, underscoring its potential as an effective therapeutic strategy. Non-invasive tape-strip biomarker collection demonstrated concordance with biopsies, supporting its use for monitoring in clinical settings.
- ||||| envudeucitinib (ESK-001) / Alumis
Enrollment closed: ONWARD3: Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - Feb 25, 2026
P3, N=1680, Active, not recruiting, Sponsor: Alumis Inc
Non-invasive tape-strip biomarker collection demonstrated concordance with biopsies, supporting its use for monitoring in clinical settings. Recruiting --> Active, not recruiting
- ||| envudeucitinib (ESK-001) / Alumis
New P1 trial: An Investigational Study to Evaluate the Cardiac Safety Assessment (TQTc Study) of ESK-001 (clinicaltrials.gov) - Feb 1, 2026
P1, N=52, Completed, Sponsor: Alumis Inc
- || envudeucitinib (ESK-001) / Alumis
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: An Investigational Study of ESK-001 in Participants With Normal Renal Function and Participants With Mild, Moderate, and Severe Impaired Renal Function (clinicaltrials.gov) - Dec 10, 2025
P1, N=16, Completed, Sponsor: Alumis Inc
Recruiting --> Active, not recruiting Recruiting --> Completed | N=48 --> 16 | Trial completion date: Dec 2025 --> Aug 2025 | Trial primary completion date: Dec 2025 --> Aug 2025
- envudeucitinib (ESK-001) / Alumis
Transcriptomic and Proteomic Modulation in Psoriatic Skin Following Envudeucitinib Treatment: Subgroup Analysis of a Phase 2 Randomized Trial () - Nov 28, 2025 - Abstract #ISDS2025ISDS_232;
P2
In moderate-to-severe psoriasis, envudeucitinib at 40mg QD and 40mg BID produced robust suppression of pathogenic Th1, Th17, and interferon-related pathways at transcriptomic and proteomic levels. These findings present further evidence of TYK2 inhibition as an effective treatment for moderate-to-severe plaque psoriasis.
- envudeucitinib (ESK-001) / Alumis
Treat-to-Target Outcomes With ESK-001 in Moderate-to-Severe Plaque Psoriasis: Results From the Phase 2 STRIDE & Open-Label Extension Studies (Gorilla 1) - Aug 28, 2025 - Abstract #ESDR2025ESDR_251;
Treatment with ESK-001 resulted in meaningful clinical improvements in patients with moderate-to-severe plaque psoriasis. Patients achieved stringent absolute thresholds in STRIDE, with continued PASI and BSA improvements and DLQI maintenance through 52 weeks of treatment in OLE.
- ||| envudeucitinib (ESK-001) / Alumis
Enrollment closed: LUMUS: Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus (clinicaltrials.gov) - Aug 1, 2025
P2, N=408, Active, not recruiting, Sponsor: Alumis Inc
Patients achieved stringent absolute thresholds in STRIDE, with continued PASI and BSA improvements and DLQI maintenance through 52 weeks of treatment in OLE. Recruiting --> Active, not recruiting
- ||||| envudeucitinib (ESK-001) / Alumis
Enrollment closed, Trial completion date, Trial primary completion date: ONWARD 2: A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (clinicaltrials.gov) - Jun 19, 2025
P3, N=840, Active, not recruiting, Sponsor: Alumis Inc
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Trial completion date: Jun 2026 --> Dec 2025 | Trial primary completion date: May 2026 --> Sep 2025
- ||||| envudeucitinib (ESK-001) / Alumis
Enrollment closed, Trial completion date, Trial primary completion date: ONWARD 1: A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - Jun 19, 2025
P3, N=840, Active, not recruiting, Sponsor: Alumis Inc
Recruiting --> Active, not recruiting | Trial completion date: Jun 2026 --> Dec 2025 | Trial primary completion date: May 2026 --> Sep 2025 Recruiting --> Active, not recruiting | Trial completion date: Jun 2026 --> Dec 2025 | Trial primary completion date: May 2026 --> Sep 2025
- || envudeucitinib (ESK-001) / Alumis
New P1 trial: An Investigational Study of ESK-001 in Participants With Normal Renal Function and Participants With Mild, Moderate, and Severe Impaired Renal Function (clinicaltrials.gov) - May 7, 2025
P1, N=48, Recruiting, Sponsor: Alumis Inc
- || envudeucitinib (ESK-001) / Alumis
New P1 trial: An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage (clinicaltrials.gov) - May 1, 2025
P1, N=48, Recruiting, Sponsor: Alumis Inc
- |||||||||| envudeucitinib (ESK-001) / Alumis
New P3 trial: ONWARD3: Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - Feb 26, 2025
P3, N=1680, Recruiting, Sponsor: Alumis Inc
- ESK-001 / Alumis
Patient-Reported Outcomes in the Phase 2 Studies of ESK-001, an Oral Allosteric TYK2 Inhibitor, in Adults with Moderate-to-Severe Plaque Psoriasis () - Feb 26, 2025 - Abstract #AAD2025AAD_3329;
P2
ESK-001 was generally safe and well tolerated in both STRIDE and the OLE. No deaths, treatment related AEs associated with the JAK inhibitor class, or clinically significant laboratory or ECG trends were observed.
- ESK-001 / Alumis
Pharmacokinetics, Safety, and Tolerability of ESK-001, an Allosteric TYK2 Inhibitor for Plaque Psoriasis: Evaluation in Asian Populations Compared to Caucasians () - Feb 21, 2025 - Abstract #AAD2025AAD_2834;
No deaths, treatment related AEs associated with the JAK inhibitor class, or clinically significant laboratory or ECG trends were observed. No clinically relevant differences in PK parameters, safety, or tolerability were observed across ethnicities, supporting the conclusion that the same therapeutic dosing regimen can be safely used for psoriasis treatment in these populations.
- ESK-001 / Alumis
ESK-001, an allosteric TYK2 inhibitor, modulates disease and TYK2-related pathway transcriptomic and proteomic biomarkers in Psoriasis STRIDE trial patients () - Feb 21, 2025 - Abstract #AAD2025AAD_2816;
Patients with high intrinsic IL23 pathway expression were most likely to achieve high and rapid PASI response in the dose group with maximal target engagement (40mg BID) compared to those with low expression. Disease-relevant transcriptomic analysis in skin indicates a return of key psoriasis biomarkers to non-lesional baseline levels.
- ESK-001 / Alumis
Efficacy and safety of ESK-001, a highly selective oral TYK2 inhibitor, in moderate-to-severe plaque psoriasis: long term Phase 2 results (Chapin Theater - Level III) - Feb 21, 2025 - Abstract #AAD2025AAD_2162;
- || ESK-001 / Alumis
Clinical, PK/PD data, Journal: Safety, tolerability, pharmacokinetics, and pharmacodynamics of the oral allosteric TYK2 inhibitor (Pubmed Central) - Nov 28, 2024
In conclusion, ESK-001 was generally safe and well-tolerated in healthy participants, showed linear dose-dependent PK characteristics, and maximally inhibited TYK2-dependent pathways with a predictable concentration-dependent PK/PD relationship. These findings were used to select the dose range of ESK-001 for the STRIDE phase II trial in plaque psoriasis and to support further clinical development of ESK-001 in other TYK2-mediated diseases.
- || envudeucitinib (ESK-001) / Alumis
Trial completion date, Trial primary completion date: LUMUS: Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus (clinicaltrials.gov) - Nov 21, 2024
P2, N=388, Recruiting, Sponsor: Alumis Inc
These findings were used to select the dose range of ESK-001 for the STRIDE phase II trial in plaque psoriasis and to support further clinical development of ESK-001 in other TYK2-mediated diseases. Trial completion date: Dec 2025 --> Sep 2027 | Trial primary completion date: May 2025 --> Jul 2026
- |||||||||| envudeucitinib (ESK-001) / Alumis
New P3 trial: ONWARD 1: A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - Sep 20, 2024
P3, N=840, Recruiting, Sponsor: Alumis Inc
- |||||||||| envudeucitinib (ESK-001) / Alumis
New P3 trial: ONWARD 2: A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (clinicaltrials.gov) - Sep 19, 2024
P3, N=840, Recruiting, Sponsor: Alumis Inc
- ESK-001 / Alumis
Efficacy and safety of ESK-001, a highly selective oral TYK2 inhibitor, in moderate-to-severe plaque psoriasis: Phase 2 results through week 28 (Auditorium) - Sep 17, 2024 - Abstract #EADV2024EADV_5557;
P2
At the highest dose, 40 mg BID, maximal clinical responses were safely achieved at Week 28. Indirect comparisons of historical data suggest that ESK-001 has the potential for best-in-class efficacy, with efficacy in the range reported for many biologic therapies for psoriasis.
- ||| envudeucitinib (ESK-001) / Alumis
Trial completion date, Trial termination: OPTYK-1: POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU (clinicaltrials.gov) - Aug 28, 2024
P2, N=36, Terminated, Sponsor: Alumis Inc
Indirect comparisons of historical data suggest that ESK-001 has the potential for best-in-class efficacy, with efficacy in the range reported for many biologic therapies for psoriasis. Trial completion date: Apr 2025 --> Aug 2024 | Active, not recruiting --> Terminated; Terminated based on interim efficacy data that did not meet the Sponsor's criteria.
- ESK-001 / Alumis
Exploratory Exposure Response (E-R) Analysis of ESK-001, An allosteric oral TYK2 inhibitor, in Patients with Psoriasis (Poster Area) - Aug 5, 2024 - Abstract #EADV2024EADV_4946;
P2
The E-R analysis revealed a strong positive correlation between exposure and the key efficacy endpoints. Also, there was a positive correlation between time on treatment and the key efficacy endpoints.
- ESK-001 / Alumis
Patient-Reported Outcomes in the Randomized, Double Blind Phase 2 Study of ESK-001, an Oral Allosteric TYK2 Inhibitor, in Adults with Moderate-to-Severe Plaque Psoriasis (Poster Area) - Aug 5, 2024 - Abstract #EADV2024EADV_2694;
P2
Improvements in PROs were maintained with ongoing treatment in the OLE study. These PRO outcomes highlight the positive impact on the lives of patients with psoriasis, while receiving ESK-001.
- ESK-001 / Alumis
ESK-001, an allosteric TYK2 inhibitor, modulates disease and TYK2-related pathway transcriptomic biomarkers in Psoriasis STRIDE trial patients (G104-G105) - Jul 18, 2024 - Abstract #EADV2024EADV_1493;
Disease-relevant transcriptomic analyses indicate a return of key psoriasis biomarkers to non-lesional baseline levels. These effects are in line with biomarker data previously reported by high-efficacy biologics such as secukinumab.
- || envudeucitinib (ESK-001) / Alumis
Enrollment closed: ESK-001-007: Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis (clinicaltrials.gov) - May 12, 2024
P2, N=165, Active, not recruiting, Sponsor: Alumis Inc
These effects are in line with biomarker data previously reported by high-efficacy biologics such as secukinumab. Enrolling by invitation --> Active, not recruiting
- | envudeucitinib (ESK-001) / Alumis
Enrollment closed: OPTYK-1: POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU (clinicaltrials.gov) - Apr 8, 2024
P2, N=36, Active, not recruiting, Sponsor: Alumis Inc
Enrolling by invitation --> Active, not recruiting Recruiting --> Active, not recruiting
- ESK-001 / Alumis
Efficacy and Safety of ESK-001, a highly selective oral TYK2 inhibitor, in a Phase 2 study in adults with moderate-to-severe plaque psoriasis (STRIDE) (Room 20B) - Mar 1, 2024 - Abstract #AAD2024AAD_3662;
- ESK-001 / Alumis
Pharmacokinetic and Pharmacodynamic Characteristics of ESK-001, an Oral Allosteric TYK2 Inhibitor, in Phase 1 Healthy Volunteer Trials () - Feb 20, 2024 - Abstract #AAD2024AAD_2221;
Based on these findings, the dose range for the STRIDE Phase 2 trial in plaque psoriasis was selected to include minimal to maximal TYK2 inhibition. The PK/PD characteristics support further clinical development in a broad range of TYK2 mediated diseases.
- || Review, Journal: Recent progress on tyrosine kinase 2 JH2 inhibitors. (Pubmed Central) - Oct 22, 2023
Interest in TYK2 JH2 inhibitors has increased as a result of safety concerns with JAK inhibitors. This overview introduces TYK2 JH2 inhibitors that are already on the market, including Deucravactinib (BMS-986165), as well as those currently in clinical trials, such as BMS-986202, NDI-034858, and ESK-001.
- |||| envudeucitinib (ESK-001) / Alumis
Trial completion: A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis (clinicaltrials.gov) - Aug 28, 2023
P2, N=228, Completed, Sponsor: Alumis Inc
This overview introduces TYK2 JH2 inhibitors that are already on the market, including Deucravactinib (BMS-986165), as well as those currently in clinical trials, such as BMS-986202, NDI-034858, and ESK-001. Active, not recruiting --> Completed
- ||||| envudeucitinib (ESK-001) / Alumis
New P2 trial: LUMUS: Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus (clinicaltrials.gov) - Jul 31, 2023
P2, N=388, Recruiting, Sponsor: Alumis Inc
- || envudeucitinib (ESK-001) / Alumis
New P2 trial: OPTYK-1: POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU (clinicaltrials.gov) - Jul 20, 2023
P2, N=30, Recruiting, Sponsor: Alumis Inc
- || envudeucitinib (ESK-001) / Alumis
Trial completion: Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy Participants (clinicaltrials.gov) - May 9, 2023
P1, N=49, Completed, Sponsor: Alumis Inc
Active, not recruiting --> Completed Recruiting --> Completed
- || envudeucitinib (ESK-001) / Alumis
Trial completion: Relative Bioavailability of ESK-001 Tablet Versus Liquid in Healthy Participants (clinicaltrials.gov) - May 9, 2023
P1, N=14, Completed, Sponsor: Alumis Inc
Recruiting --> Completed Active, not recruiting --> Completed
- ||| envudeucitinib (ESK-001) / Alumis
Enrollment closed: A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis (clinicaltrials.gov) - May 3, 2023
P2, N=210, Active, not recruiting, Sponsor: Alumis Inc
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||||| envudeucitinib (ESK-001) / Alumis
New P2 trial: ESK-001-007: Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis (clinicaltrials.gov) - Feb 22, 2023
P2, N=210, Enrolling by invitation, Sponsor: Alumis Inc
- | Journal: Clinical Implications of Targeting the JAK-STAT Pathway in Psoriatic Disease: Emphasis on the TYK2 Pathway. (Pubmed Central) - Dec 16, 2022
Other novel TYK2 allosteric inhibitors, NDI-034858 and ESK-001, are currently being investigated in adult patients with plaque psoriasis. This article reviews the details of the JAK-STAT pathway in psoriasis pathophysiology, the rationale for selective targeting of JAKs in the treatment of psoriasis, and provides clinical perspective on clinical trial data for JAK and TYK2 inhibitors.
- ||||| envudeucitinib (ESK-001) / Alumis
New P2 trial: A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis (clinicaltrials.gov) - Oct 31, 2022
P2, N=210, Recruiting, Sponsor: Alumis Inc
- || envudeucitinib (ESK-001) / Alumis
Enrollment closed, Trial completion date, Trial primary completion date: Relative Bioavailability of ESK-001 Tablet Versus Liquid in Healthy Participants (clinicaltrials.gov) - Sep 19, 2022
P1, N=15, Active, not recruiting, Sponsor: Alumis Inc
This article reviews the details of the JAK-STAT pathway in psoriasis pathophysiology, the rationale for selective targeting of JAKs in the treatment of psoriasis, and provides clinical perspective on clinical trial data for JAK and TYK2 inhibitors. Recruiting --> Active, not recruiting | Trial completion date: Apr 2022 --> Sep 2022 | Trial primary completion date: Apr 2022 --> Jun 2022
- || envudeucitinib (ESK-001) / Alumis
New P1 trial: Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy Participants (clinicaltrials.gov) - Jun 23, 2022
P1, N=48, Recruiting, Sponsor: Alumis Inc