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

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

DelveInsight’s, “Cyclin Dependent Kinase Inhibitor Pipeline Insight” report provides comprehensive insights about 45+ companies and 50+ pipeline drugs in Cyclin Dependent Kinase Inhibitor pipeline landscape. It covers the Cyclin Dependent Kinase Inhibitor pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Cyclin Dependent Kinase Inhibitor therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive Cyclin Dependent Kinase Inhibitor pipeline products in this space.

 

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

 

Key Takeaways from the Cyclin Dependent Kinase Inhibitor Pipeline Report

  • In January 2025:- Alliance for Clinical Trials in Oncology– This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
  • DelveInsight’s Cyclin Dependent Kinase Inhibitor pipeline report depicts a robust space with 45+ active players working to develop 50+ pipeline therapies for Cyclin Dependent Kinase Inhibitor treatment.
  • The leading Cyclin Dependent Kinase Inhibitor Companies such as Syros Pharmaceuticals, Exelixis, Prelude Therapeutics, Blueprint Medicines, Vincerx Pharma, Carrick Therapeutics, Tiziana Life Sciences, Xuanzhu Biopharmaceutical, Eli Lilly and Company, Reverie Labs, Aucentra Therapeutics, NiKang Therapeutics, BeiGene, AstraZeneca, Sellas Life Sciences Group, and others.
  • Promising Cyclin Dependent Kinase Inhibitor Therapies such as Palbociclib PD-0332991, Abemaciclib, Anastrozole, Letrozole, Vismodegib, and others.

 

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

 

Cyclin Dependent Kinase Inhibitor Emerging Drugs Profile

 

  • Atirmociclib: Pfizer

Atirmociclib is a potential best-in-class, highly selective cyclin-dependent kinase 4 (CDK4) inhibitor currently in Phase III development by Pfizer for treating hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC). CDK4 is a protein that regulates cell division and is often overactive in certain types of breast cancer. By selectively inhibiting CDK4, atirmociclib can help slow or stop the growth of cancer cells. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Advanced or Metastatic Breast Cancer.

 

  • BLU-222: Blueprint Medicines

BLU-222 is a highly selective and potent investigational CDK2 inhibitor with first- and best-in-class potential, designed by scientists at Blueprint Medicines. CDK2 is a cell cycle regulator and an important cancer target, with relevance in HR+/HER2- breast cancer and other malignancies, such as subsets of ovarian and endometrial cancer. Across multiple cancer types, aberrant CCNE1 hyperactivates CDK2, resulting in cell cycle dysregulation and tumor proliferation. Aberrant CCNE1 has been observed as a primary driver of disease, as well as a mechanism of resistance to CDK4/6 inhibitors. In HR+/HER2- breast cancer, the advent of CDK4/6 inhibitors has improved treatment; however, disease progression is nearly universal, and new innovation is needed to improve outcomes and prolong clinical benefit. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of HER2 negative breast cancer.

 

  • SY-5609: Syros Pharmaceuticals

SY-5609 is a selective and potent oral inhibitor of cyclin-dependent kinase 7 (CDK7), initially developed for select solid tumors. It has shown single-agent activity in various tumor types, including metastatic pancreatic cancer, characterized by prolonged stable disease and tumor shrinkage, uncommon in this refractory patient population. Combination with chemotherapy also demonstrated clinical activity, including a confirmed partial response in pancreatic cancer patients resistant to frontline therapy. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Advanced Solid Tumors.

 

  • NKT 3447: NiKang Therapeutics

NKT-3447 is an investigational small molecule developed by NiKang Therapeutics, primarily targeting various metastatic solid tumors, including gastric cancer, ovarian cancer, and small-cell lung cancer. It functions as a selective inhibitor of cyclin-dependent kinase 2 (CDK2), which plays a critical role in cell cycle regulation. By inhibiting CDK2, NKT-3447 aims to reduce cyclin E expression, a factor often amplified in several cancers. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Solid Tumors. 

 

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Cyclin Dependent Kinase Inhibitor Companies

Syros Pharmaceuticals, Exelixis, Prelude Therapeutics, Blueprint Medicines, Vincerx Pharma, Carrick Therapeutics, Tiziana Life Sciences, Xuanzhu Biopharmaceutical, Eli Lilly and Company, Reverie Labs, Aucentra Therapeutics, NiKang Therapeutics, BeiGene, AstraZeneca, Sellas Life Sciences Group and others.

 

Cyclin Dependent Kinase 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

  • Intra-articular
  • Intraocular
  • Intrathecal
  • Intravenous
  • Oral
  • Parenteral
  • Subcutaneous
  • Topical
  • Transdermal

 

Cyclin Dependent Kinase Inhibitor Products have been categorized under various Molecule types such as

  • Oligonucleotide
  • Peptide
  • Small molecule

 

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

 

Scope of the Cyclin Dependent Kinase Inhibitor Pipeline Report

  • Coverage- Global
  • Cyclin Dependent Kinase Inhibitor Companies- Syros Pharmaceuticals, Exelixis, Prelude Therapeutics, Blueprint Medicines, Vincerx Pharma, Carrick Therapeutics, Tiziana Life Sciences, Xuanzhu Biopharmaceutical, Eli Lilly and Company, Reverie Labs, Aucentra Therapeutics, NiKang Therapeutics, BeiGene, AstraZeneca, Sellas Life Sciences Group, and others.
  • Cyclin Dependent Kinase Inhibitor Therapies- Palbociclib PD-0332991, Abemaciclib, Anastrozole, Letrozole, Vismodegib, and others.
  • Cyclin Dependent Kinase Inhibitor Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Cyclin Dependent Kinase Inhibitor Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

 

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

 

Table of Content

  1. Introduction
  2. Executive Summary
  3. Cyclin-Dependent Kinase Inhibitor: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Cyclin-Dependent Kinase Inhibitor – DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Atirmociclib: Pfizer
  9. Mid Stage Products (Phase II)
  10. Drug Name: Company Name
  11. Early Stage Products (Phase I)
  12. SY-5609: Syros Pharmaceuticals
  13. Preclinical Stage Products
  14. Drug Name: Company Name
  15. Inactive Products
  16. Cyclin-Dependent Kinase Inhibitor – Collaborations Assessment- Licensing / Partnering / Funding
  17. Cyclin-Dependent Kinase Inhibitor – Unmet Needs
  18. Cyclin-Dependent Kinase Inhibitor – Market Drivers and Barriers
  19. Appendix

 

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