JAK Inhibitor Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, MOA, ROA, NDA, IND, and Companies

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.

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Key Takeaways from the JAK Inhibitor Pipeline Report

* On 19 August 2025, Geron Corporation announced a 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.
* On 14 August 2025, Pfizer announced a Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug.
* On 12 August 2025, Incyte Corporation conducted a study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).
* DelveInsight's JAK Inhibitor pipeline report depicts a robust space with 50+ active players working to develop 55+ 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

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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.

The JAK Inhibitor Pipeline Report provides insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of JAK Inhibitor with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for JAK Inhibitor Treatment.
* JAK Inhibitor Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* JAK Inhibitor Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the JAK Inhibitor market.

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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

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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

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Table of Content

* Introduction
* Executive Summary
* Janus Kinase (JAK) Inhibitor: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Janus Kinase (JAK) Inhibitor- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Povorcitinib: Incyte Corporation
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* CPL409116: Celon Pharma
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* ATI-2138: Aclaris Therapeutics
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* SDC 1802: Sareum
* Drug profiles in the detailed report.....
* Inactive Products
* Janus Kinase (JAK) Inhibitor Key Companies
* Janus Kinase (JAK) Inhibitor Key Products
* Janus Kinase (JAK) Inhibitor- Unmet Needs
* Janus Kinase (JAK) Inhibitor- Market Drivers and Barriers
* Janus Kinase (JAK) Inhibitor- Future Perspectives and Conclusion
* Janus Kinase (JAK) Inhibitor Analyst Views
* Janus Kinase (JAK) Inhibitor Key Companies
* Appendix

About Us

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