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Janus Kinase (JAK) Inhibitor - Pipeline Insight, 2024

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    Drug Pipelines

  • 240 Pages
  • July 2024
  • Region: Global
  • DelveInsight
  • ID: 5987232
This “Janus Kinase (JAK) Inhibitor- Pipeline Insight, 2024” report provides comprehensive insights about 50+ companies and 55+ pipeline drugs in Janus Kinase (JAK) Inhibitor pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

  • Global coverage

Janus Kinase (JAK) Inhibitor: Understanding

Janus Kinase (JAK) Inhibitor: Overview

Janus kinase (JAK) inhibitors are small molecules approximately 400 Da that could be administrated as oral medicines. JAKs are phosphotransferases that bind to the intracellular domains of cytokine receptors and transmit signals to activate immune responses. The family of cytokines that signal via JAKs includes many interleukins, interferons, colony stimulating factors and hormonelike cytokines (such as erythropoietin). The receptors for these cytokines signal via various combinations of four JAKs (JAK1, JAK2, JAK3 and TYK2). First-generation jakinibs, such as tofacitinib and baricitinib (and oclacitinib in dogs), block more than one JAK, and thereby can inhibit a large number of cytokines; these and other pan-jakinibs are being investigated as therapeutic agents for a wide variety of autoimmune diseases.

JAK-STAT pathways are utilised by type I and II cytokine receptors, as well as by receptors for interferons and growth factors. These receptors lack intrinsic catalytic activity and rely on JAKs for downstream responses and subsequent modulation of gene expression Janus is the Greek god of doorways, looking both outside and inside a room, and illustrates how JAKs facilitate signals from the cell surface into the cell. Each cytokine receptor is paired with a different JAK pair, usually as heterodimers.

Upon cross-linking by its cytokine, the receptor-associated JAKs transphosphorylate one another. The activated JAKs in turn phosphorylate the cytokine receptor tail. The phosphorylated receptor forms a docking site for STATs, that otherwise reside in the cytosol. These STATs are then phosphorylated by the JAKs before dissociating from the receptor and themselves forming heterodimers or homodimers. They then translocate to the nucleus where they act as transcription factors, regulating gene expression. There are seven mammalian STATS which, like JAKs, associate with different signaling pathways.

Dysregulation of Jak catalytic activity can manifest as either a reduction or an increase in kinase activity, and is observed in pathogeneses including immunodeficiency, inflammatory diseases, hematological defects, autoimmune and myeloproliferative disorders, and susceptibility to infection. Altered Jak regulation occurs by multiple mechanisms, including: gene translocations, somatic or inherited point mutations, receptor mutations, and alterations in the activity of Jak regulators such as SOCS or phosphatases. The development of kinase inhibitors has offered new therapies for diverse clinical entities ranging from malignancy to autoimmunity. Jak inhibitors or Jakinibs initially launched to treat a rare hematologic disorder are now progressing to be used in not only malignancies but common autoimmune disorders as well.

The linkage of these pathologies with altered Jak catalytic activity has increased interest in development of Jak-specific inhibitors to treat classical myeloproliferative disorders and cancers, or to be used as immunosuppressant. Structural biology plays an important role in rational inhibitor design, and consequently, over the last few years crystal structures for all of the enzymatically active Jak kinase domains have been determined in complex with various ATP-competitive inhibitors.

"Janus Kinase (JAK) Inhibitor- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Janus Kinase (JAK) Inhibitor pipeline landscape is provided which includes the disease overview and Janus Kinase (JAK) Inhibitor treatment guidelines. The assessment part of the report embraces, in depth Janus Kinase (JAK) Inhibitor commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Janus Kinase (JAK) Inhibitor collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Janus Kinase (JAK) Inhibitor R&D. The therapies under development are focused on novel approaches to treat/improve Janus Kinase (JAK) Inhibitor.

Janus Kinase (JAK) Inhibitor Emerging Drugs Chapters

This segment of the Janus Kinase (JAK) Inhibitor report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Janus Kinase (JAK) Inhibitor Emerging Drugs

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.

Janus Kinase (JAK) Inhibitor: Therapeutic Assessment

This segment of the report provides insights about the different Janus Kinase (JAK) Inhibitor drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Janus Kinase (JAK) Inhibitor

  • There are approx. 50+ key companies which are developing the therapies for Janus Kinase (JAK) Inhibitor. The companies which have their Janus Kinase (JAK) Inhibitor drug candidates in the most advanced stage, i.e. phase III include, Incyte Corporation

Phases

This report covers around 55+ products under different phases of clinical development like

  • Late stage products (Phase III)
  • Mid-stage products (Phase II)
  • Early-stage product (Phase I) along with the details of
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates

Route of Administration

Janus Kinase (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
  • Molecule Type

Products have been categorized under various Molecule types such as

  • Recombinant fusion proteins
  • Small molecule
  • Monoclonal antibody
  • Peptide
  • Polymer
  • Gene therapy
  • Product Type
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Janus Kinase (JAK) Inhibitor: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Janus Kinase (JAK) Inhibitor therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Janus Kinase (JAK) Inhibitor drugs.

Janus Kinase (JAK) Inhibitor Report Insights

  • Janus Kinase (JAK) Inhibitor Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

Janus Kinase (JAK) Inhibitor Report Assessment

  • Pipeline Product Profiles
  • Therapeutic Assessment
  • Pipeline Assessment
  • Inactive drugs assessment
  • Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

  • How many companies are developing Janus Kinase (JAK) Inhibitor drugs?
  • How many Janus Kinase (JAK) Inhibitor drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Janus Kinase (JAK) Inhibitor?
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Janus Kinase (JAK) Inhibitor therapeutics?
  • What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for Janus Kinase (JAK) Inhibitor and their status?
  • What are the key designations that have been granted to the emerging drugs?

Key Players

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

Key Products

  • Povorcitinib
  • CPL409116
  • ATI-2138
  • SDC 1802
  • Zasocitinib
  • AZD 4604
  • INCB-160058

Research programme: JAK2 inhibitors

  • Ritlecitinib
  • Momelotinib
  • DZD4205
  • ATI 2138
  • CPL 409116
  • Itacitinib
  • Ivarmacitinib


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Table of Contents

IntroductionExecutive Summary
Janus Kinase (JAK) Inhibitor: Overview
  • Causes
  • Pathophysiology
  • Signs and Symptoms
  • Diagnosis
  • Disease Management
Pipeline Therapeutics
  • Comparative Analysis
Therapeutic Assessment
  • Assessment by Product Type
  • Assessment by Stage and Product Type
  • Assessment by Route of Administration
  • Assessment by Stage and Route of Administration
  • Assessment by Molecule Type
  • Assessment by Stage and Molecule Type
Janus Kinase (JAK) Inhibitor- Analytical Perspective
Late Stage Products (Phase III)
  • Comparative Analysis
Povorcitinib: Incyte Corporation
  • Product Description
  • Research and Development
  • Product Development Activities
Mid Stage Products (Phase II)
  • Comparative Analysis
CPL409116: Celon Pharma
  • Product Description
  • Research and Development
  • Product Development Activities
Early Stage Products (Phase I)
  • Comparative Analysis
ATI-2138: Aclaris Therapeutics
  • Product Description
  • Research and Development
  • Product Development Activities
Preclinical and Discovery Stage Products
  • Comparative Analysis
SDC 1802: Sareum
  • Product Description
  • Research and Development
  • Product Development Activities
Inactive Products
  • Comparative Analysis
Janus Kinase (JAK) Inhibitor Key CompaniesJanus Kinase (JAK) Inhibitor Key ProductsJanus Kinase (JAK) Inhibitor- Unmet NeedsJanus Kinase (JAK) Inhibitor- Market Drivers and BarriersJanus Kinase (JAK) Inhibitor- Future Perspectives and ConclusionJanus Kinase (JAK) Inhibitor Analyst ViewsJanus Kinase (JAK) Inhibitor Key CompaniesAppendix
List of Tables
Table 1 Total Products for Janus Kinase (JAK) Inhibitor
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

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