JAK Inhibitor Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies by DelveInsight

JAK Inhibitor Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies by DelveInsight

DelveInsight’s, “JAK Inhibitor Pipeline Insight” report provides comprehensive insights about 50+ companies and 55+ pipeline drugs in JAK Inhibitor pipeline landscape. It covers the JAK Inhibitor pipeline drug profiles, including clinical and nonclinical stage products. It also covers the JAK Inhibitor therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive JAK Inhibitor pipeline products in this space.

 

Stay ahead with the latest insights! Download DelveInsight’s comprehensive JAK Inhibitor Pipeline Report to explore emerging therapies, key JAK Inhibitor Companies, and future JAK Inhibitor treatment landscapes @ JAK Inhibitor Pipeline Outlook Report

 

Key Takeaways from the JAK Inhibitor Pipeline Report

  • In February 2025:- Karyopharm Therapeutics Inc.:- The main purpose of this study with corresponding optional expansion is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and moderate thrombocytopenia based on spleen volume reduction (SVR). Additional efficacy and safety parameters will also be assessed during the study.
  • In January 2025:- Geron Corporation- The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory (R/R) to Janus Kinase (JAK)-Inhibitor treatment.
  • In January 2025:- Sanofi:- The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy.
  • In January 2025:- Celon Pharma SA;- The purpose of the following phase II clinical trial is to determine safety and effectiveness of Janus kinases and Rho-kinases inhibitor (JAK/ROCKi) in patients with Rheumatoid arthritis after oral administration of investigational medicinal product (IMP) called CPL409116. JAK inhibitors are a new class of small molecule drugs that modulate inflammatory pathways by blocking one or more JAK receptors.
  • DelveInsight’s JAK Inhibitor pipeline report depicts a robust space with 90+ active players working to develop 90+ pipeline therapies for JAK Inhibitor treatment.
  • The leading JAK Inhibitor Companies such as Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, Takeda, AstraZeneca, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Arcutis Biotherapeutics/Reistone Biopharma and others.
  • Promising JAK Inhibitor Therapies such as Baricitinib, Busulfan, Cyclophosphamide, Ruxolitinib, Selinexor 60 mg, Ruxolitinib, Ritlecitinib, and others

 

Discover how the JAK Inhibitor treatment paradigm is evolving. Access DelveInsight’s in-depth JAK Inhibitor Pipeline Analysis for a closer look at promising breakthroughs @ JAK Inhibitor Clinical Trials and Studies

 

JAK Inhibitor Emerging Drugs Profile

 

  • Povorcitinib: Incyte Corporation

Povorcitinib (INCB054707) is an oral small-molecule JAK1 inhibitor. The chemical structure for povorcitinib was revealed in WHO proposed INN list 126 (Jan 2022), in which it was described as a Janus kinase inhibitor and anti-inflammatory agent. The drug is also being evaluated in Phase II clinical trials for Prurigo Nodularis, and others. Currently, the drug is in Phase III stage of its development for the treatment of Hidradenitis suppurativa, vitiligo.

 

  • CPL409116: Celon Pharma

CPL 409116 is the first in class dual JAK/ROCK inhibitor in clinical development and is designed to generate anti-inflammatory and anti-fibrotic effects in selected autoimmune diseases. CPL’116 was administered orally in single ascending doses in healthy volunteers in order to assess safety and pharmacokinetic parameters (PK). No adverse events associated with administration of the investigational drug were observed, and the trial met its primary endpoint. Currently the drug is in Phase II stage of development for autoimmune indications including in patients with rheumatoid arthritis with coexisting interstitial lung disease.

 

  • ATI-2138: Aclaris Therapeutics

ATI-2138 is an investigational oral covalent ITK/JAK3 inhibitor that is being developed as a potential therapeutic option across a variety of T cell-mediated diseases. ITK is a T cell receptor activated kinase involved in driving T cell effector functions while JAK3 is a non-receptor tyrosine kinase responsible for the signal transduction of common gamma receptor cytokines, IL-2, IL-4, IL-7, IL-9, IL-15, and IL-21. In blocking both T cell receptor function and cytokine signaling, ATI-2138 has potential utility in T cell driven diseases. ATI-2138 is currently in clinical development and its safety and efficacy has not been evaluated by regulatory authorities.

 

  • SDC 1802: Sareum

SDC-1802 is an investigational Sareum’s TYK2/JAK1 preclinical development candidate molecule that demonstrates high selectivity for TYK2 and JAK1 kinases (particularly over related JAK2 and JAK3). SDC-1802 shows compelling efficacy in blocking cancer cell proliferation in cellular and disease models of T-cell acute lymphoblastic leukaemia (T-ALL) and B-cell lymphoma, the potential for once-daily oral dosing and a good early safety profile. Sareum is progressing SDC-1802 through preclinical development and pending satisfactory progress, into human clinical trials. SDC-1802 has the potential to act as a back-up molecule for these autoimmune indications. Currently, the drug is in Preclinical stage of its development for the treatment of cancer.

 

Get a detailed analysis of the latest innovations in the JAK Inhibitor pipeline. Explore DelveInsight’s expert-driven report today! @ JAK Inhibitor Unmet Needs

 

JAK Inhibitor Companies

Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, Takeda, AstraZeneca, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Arcutis Biotherapeutics/Reistone Biopharma and others.

 

JAK Inhibitor pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

  • Oral
  • Intravenous
  • Subcutaneous
  • Parenteral
  • Topical

 

JAK Inhibitor Products have been categorized under various Molecule types such as

  • Recombinant fusion proteins
  • Small molecule
  • Monoclonal antibody
  • Peptide
  • Polymer
  • Gene therapy

 

Download DelveInsight’s latest report to gain strategic insights into upcoming JAK Inhibitor Therapies and key JAK Inhibitor Developments @ JAK Inhibitor Market Drivers and Barriers, and Future Perspectives

 

Scope of the JAK Inhibitor Pipeline Report

  • Coverage- Global
  • JAK Inhibitor Companies- Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, Takeda, AstraZeneca, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Arcutis Biotherapeutics/Reistone Biopharma and others.
  • Promising JAK Inhibitor Therapies – Baricitinib, Busulfan, Cyclophosphamide, Ruxolitinib, Selinexor 60 mg, Ruxolitinib, Ritlecitinib, and others
  • JAK Inhibitor Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • JAK Inhibitor Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

 

Which companies are leading the race in JAK Inhibitor drug development? Find out in DelveInsight’s exclusive JAK Inhibitor Pipeline Report—access it now! @ JAK Inhibitor Emerging Drugs and Major Companies

 

Table of Content

  1. Introduction
  2. Executive Summary
  3. Janus Kinase (JAK) Inhibitor: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Janus Kinase (JAK) Inhibitor– DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Povorcitinib: Incyte Corporation
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. CPL409116: Celon Pharma
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I)
  14. ATI-2138: Aclaris Therapeutics
  15. Drug profiles in the detailed report…..
  16. Preclinical and Discovery Stage Products
  17. SDC 1802: Sareum
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Janus Kinase (JAK) Inhibitor Key Companies
  21. Janus Kinase (JAK) Inhibitor Key Products
  22. Janus Kinase (JAK) Inhibitor- Unmet Needs
  23. Janus Kinase (JAK) Inhibitor- Market Drivers and Barriers
  24. Janus Kinase (JAK) Inhibitor- Future Perspectives and Conclusion
  25. Janus Kinase (JAK) Inhibitor Analyst Views
  26. Janus Kinase (JAK) Inhibitor Key Companies
  27. Appendix

 

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