Cyclin-Dependent Kinase Clinical Trials Analysis 2024: FDA Approvals, Clinical Trials, Therapies, Mechanism of Action, Route of Administration by DelveInsight

Cyclin-Dependent Kinase Pipeline

(Albany, USA) DelveInsight’s ‘Cyclin-Dependent Kinase Inhibitor Pipeline Insight 2024’ report provides comprehensive global coverage of pipeline cyclin-dependent kinase inhibitors in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the cyclin-dependent kinase inhibitor pipeline domain.

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Key Takeaways from the Cyclin-Dependent Kinase Inhibitor Pipeline Report

• DelveInsight’s cyclin-dependent kinase inhibitor pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline cyclin-dependent kinase inhibitors. 
• Key cyclin-dependent kinase inhibitors companies such as Syros Pharmaceuticals, Jiangsu Hengrui Medicine, Aucentra Therapeutics, MEI Pharma, Vincerx Pharma, Chordia Therapeutics, Pfizer, Novartis Pharmaceuticals, TYK Medicine, BioTheryX, Concarlo Therapeutics, Eli Lilly and Company, Kronos Bio, OnQuality Pharmaceuticals, Incyte Corporation, G1 Therapeutics, Blueprint Medicines, Cyclacel Pharmaceuticals, Nerviano Medical Sciences, Vichem Chemie, Prelude Therapeutics, Exelixis, -Qurient Co. Ltd., Kirilys Therapeutics, Sumitomo Pharma Oncology, Insilico Medicine, Cedilla Therapeutics, Relay Therapeutics, and others are evaluating new cyclin-dependent kinase inhibitor drugs to improve the treatment landscape.
• Promising cyclin-dependent kinase inhibitors in the pipeline such as SY-5609, SHR-6390, Auceliciclib, AU2-94, AU14-5, AU2-85, AU4-53, Voruciclib, VIP-152, CTX-439, Palbociclib, Ribociclib, TY-0540, BTX-9341, NP-ALT, Abemaciclib, KB-0742, OQL-051, INCB0123667, Lerociclib, BLU-222, Fadraciclib, Milciclib, Otviciclib, PRT2527, XL 102, Q 901,  KRLS 017, TP-1287, PRT3645, RLY-2139, and others are under different phases of cyclin-dependent kinase inhibitor clinical trials.
• In April 2023, Insilico Medicine announced that it has successfully discovered a potent, selective, and orally bioavailable small molecule inhibitor of CDK8 for the treatment of cancer using a structure-based generative chemistry approach enabled by the Chemistry42 multi-modal generative reinforcement learning platform. The research was published in the American Chemical Society’s Journal of Medicinal Chemistry, a leading journal in medicinal chemistry.
• In April 2023, Sumitomo Pharma Oncology, Inc., announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for TP-1287, an investigational oral CDK9 inhibitor, for the treatment of Ewing sarcoma. TP-1287 is an investigational oral phosphate prodrug of the CDK9 inhibitor alvocidib.
• In March 2023, Prelude Therapeutics Incorporated (Prelude)announced a clinical trial collaboration with BeiGene, for future evaluation of its investigational CDK9 inhibitor, PRT2527, in combination with BeiGene’s BTK inhibitor, zanubrutinib, in hematologic malignancies. Under the terms of the clinical trial collaboration agreement, BeiGene will provide zanubrutinib to Prelude, and Prelude will retain all global operational, development, and commercialization rights and responsibilities for PRT2527.
• In September 2022, Syros Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to SY-5609 for the treatment of pancreatic cancer. SY-5609, a highly selective and potent oral cyclin-dependent kinase 7 (CDK7) inhibitor, is currently being evaluated in combination with chemotherapy for the treatment of patients with relapsed metastatic pancreatic cancer.
• In September 2022, Qurient Co. Ltd. announced that the company has entered into a clinical collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ., USA), for clinical study of Q901, a selective CDK7 inhibitor in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab). Under this agreement, Qurient will conduct a phase 1/2 study in the U.S. to evaluate the safety and efficacy of Q901 in combination with KEYTRUDA for the treatment of selected advanced solid tumors.
• In March 2022, Kirilys Therapeutics, Inc., announced that the Company completed a seed financing led by Lightspeed Venture Partners. The company licensed its lead compound, KRLS-017, from Ube Industries, Ltd., a premier Japanese chemical manufacturer. The company also completed a partnership agreement with D2G Oncology, Inc. which uses genetically defined animal tumor models to reveal relationships between cancer genotypes and drug efficacy. This financing round enabled Kirilys to complete all activities through the IND filing of KRLS-017, as well as preparatory work for the Phase 1 clinical development program.

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The cyclin-dependent kinase inhibitor pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage cyclin-dependent kinase inhibitor drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the cyclin-dependent kinase inhibitor clinical trial landscape.

Cyclin-Dependent Kinase Inhibitor Overview

Cyclin-dependent kinase (CDK) inhibitors are a class of therapeutic agents designed to disrupt the activity of cyclin-dependent kinases, enzymes that play a critical role in regulating the cell cycle. By inhibiting CDKs, these drugs aim to halt the uncontrolled proliferation of cancer cells, making them a significant focus in oncology research and treatment.

Cyclin-Dependent Kinase Inhibitor regulate the progression of cells through the cell cycle by phosphorylating target proteins, which are essential for cell division and replication. In many cancers, CDK activity is dysregulated, leading to unchecked cell growth. CDK inhibitors, such as palbociclib, ribociclib, and abemaciclib, specifically target CDK4 and CDK6, which are involved in the transition from the G1 phase to the S phase of the cell cycle.

Cyclin-Dependent Kinase Inhibitor have shown considerable efficacy in treating hormone receptor-positive breast cancer and are being investigated for other cancer types. By arresting the cell cycle, CDK inhibitors can slow tumor growth and enhance the effects of other therapies, such as hormonal treatments and chemotherapy.

Common side effects include neutropenia, fatigue, and gastrointestinal issues, which require careful management. Ongoing research aims to improve the specificity and efficacy of Cyclin-Dependent Kinase Inhibitor, reduce side effects, and explore their potential in combination therapies.

Overall, CDK inhibitors represent a promising advancement in cancer treatment, offering a targeted approach to managing various malignancies and improving patient outcomes.

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A snapshot of the Cyclin-Dependent Kinase Inhibitor Pipeline Drugs mentioned in the report:

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Cyclin-Dependent Kinase Inhibitor Therapeutics Assessment

The cyclin-dependent kinase inhibitor pipeline report proffers an integral view of the emerging cyclin-dependent kinase inhibitor segmented by stage, product type, molecule type, mechanism of action, and route of administration.

Scope of the Cyclin-Dependent Kinase Inhibitor Pipeline Report 

• Coverage: Global 
• Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
• Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
• Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical
• Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy
• Key Cyclin-Dependent Kinase Inhibitor Companies: Syros Pharmaceuticals, Jiangsu Hengrui Medicine, Aucentra Therapeutics, MEI Pharma, Vincerx Pharma, Chordia Therapeutics, Pfizer, Novartis Pharmaceuticals, TYK Medicine, BioTheryX, Concarlo Therapeutics, Eli Lilly and Company, Kronos Bio, OnQuality Pharmaceuticals, Incyte Corporation, G1 Therapeutics, Blueprint Medicines, Cyclacel Pharmaceuticals, Nerviano Medical Sciences, Vichem Chemie, Prelude Therapeutics, Exelixis, -Qurient Co. Ltd., Kirilys Therapeutics, Sumitomo Pharma Oncology, Insilico Medicine, Cedilla Therapeutics, Relay Therapeutics and others
• Key Cyclin-Dependent Kinase Inhibitor Pipeline Therapies: SY-5609, SHR-6390, Auceliciclib, AU2-94, AU14-5, AU2-85, AU4-53, Voruciclib, VIP-152, CTX-439, Palbociclib, Ribociclib, TY-0540, BTX-9341, NP-ALT, Abemaciclib, KB-0742, OQL-051, INCB0123667, Lerociclib, BLU-222, Fadraciclib, Milciclib, Otviciclib, PRT2527, XL 102, Q 901,  KRLS 017, TP-1287, PRT3645, RLY-2139 and others

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Table of Contents

1. Cyclin-Dependent Kinase Inhibitor Pipeline Report Introduction

2. Cyclin-Dependent Kinase Inhibitor Pipeline Report Executive Summary

3. Cyclin-Dependent Kinase Inhibitor Pipeline: Overview

4. Analytical Perspective In-depth Commercial Assessment

5. Cyclin-Dependent Kinase Inhibitor Clinical Trial Therapeutics

6. Cyclin-Dependent Kinase Inhibitor Pipeline: Late-Stage Products (Pre-registration)

7. Cyclin-Dependent Kinase Inhibitor Pipeline: Late-Stage Products (Phase III)

8. Cyclin-Dependent Kinase Inhibitor Pipeline: Mid-Stage Products (Phase II)

9. Cyclin-Dependent Kinase Inhibitor Pipeline: Early-Stage Products (Phase I)

10. Cyclin-Dependent Kinase Inhibitor Pipeline Therapeutics Assessment

11. Inactive Products in the Cyclin-Dependent Kinase Inhibitor Pipeline

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Key Companies

14. Key Products in the Cyclin-Dependent Kinase Inhibitor Pipeline

15. Unmet Needs

16. Market Drivers and Barriers

17. Future Perspectives and Conclusion

18. Analyst Views

19. Appendix

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