Cyclin-Dependent Kinase Inhibitor- Pipeline Insight, 2025

DelveInsight's, "Cyclin-Dependent Kinase Inhibitor- Pipeline Insight, 2025" report provides comprehensive insights about 45+ companies and 52+ pipeline drugs in Cyclin-Dependent Kinase 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

Cyclin-Dependent Kinase Inhibitor: Understanding

Cyclin-Dependent Kinase Inhibitor: Overview

Cyclin-dependent kinase inhibitor protein (also known as CKIs, CDIs, or CDKIs) is a protein which inhibits the enzyme cycling-dependent kinase (CDK) and Cyclin activity by stopping the cell cycle if there are unfavorable conditions, therefore, acting as tumor suppressors. Cell cycle progression is stopped by Cyclin-dependent kinase inhibitor protein at the G1 phase. CKIs are vital proteins within the control system that point out whether the process of DNA synthesis, mitosis, and cytokines control one another. If a malfunction prevents the successful completion of DNA synthesis during the G1 phase, a signal is sent to delay or stop the progression to the S phase. Cyclin-dependent kinase inhibitor proteins are essential in the regulation of the cell cycle. If cell mutations surpass the cell cycle checkpoints during cell cycle regulation, it can result in various types of cancer.

In the cyclin-dependent kinase (CDK) family or CDK, Cyclin, and CKIs, serine/threonine kinases play an integral role in regulating the eukaryotic cell cycle. The structure of CDK2-CyclinA and p27 is determined by crystallography, demonstrating that the inhibitor of p27 stretches at the top of the Cyclin-CDK complex. The amino terminal of p27 has an RXL motif exhibiting a hydrophobic patch of cyclin A. The carboxyl-terminal end of the p27 fragment interacts with the beta sheet of CDKs, causing interference of the structure; p27 slides into the ATP- binding site of CDK2 and inhibits ATP binding.

Cyclin-dependent kinase inhibitor proteins work by inactivating the CDKs by degradation. The typical inactivation mechanism of the CDK/ Cyclin complex is based on binding a CDK inhibitor to the CDK cyclin complex and a partial conformational rotation of the CDK. The cyclin is thus forced to release the T loop and detach from the CDK. Then, the CDK inhibitor initiates a small Helix into the cleft blocking the cleft and blocking the active site of the CDK. Eventually, it releases the ATP out of the aperture of the CDK and deactivates it. Cyclin-dependent kinase inhibitor proteins use ATP as a phosphate contributor to phosphorylate serine and threonine residues.

Human cells contain many different cyclins binding to different CDKs. CDKs and cyclins appear and activate at specific cell cycle phases. Seven cyclin-dependent kinase inhibitor proteins have been identified. They are p15, p16, p18, p19, p21, p27, and p57. These cyclin-dependent kinase inhibitor protein emerges only in their specific cell cycle phase. Each Cyclin/CDK complex are specific to the part of the cell cycle phase. Each CDK and cyclin can be identified based on the location of the cell cycle. CKIs fall within two categories; those that inhibit CDKI, CDK2, and CDK5 and those that inhibit CDK4 and CDK6. These checkpoints' cell cycle blocks at both the G1/S and G2/M checkpoints are consistent with the inhibition profile of the enzymes.

CDK-inhibitors can be used as an anti-cancer drug by blocking CDK's and therefore halting the uncontrolled cellular proliferation seen in cancer. Cyclin-dependent kinases (CDKs) that promote transition through the cell cycle were expected to be key therapeutic targets because many tumorigenic events ultimately drive proliferation by impinging on CDK4 or CDK6 complexes in the G1 phase of the cell cycle. Moreover, perturbations in chromosomal stability and aspects of S phase and G2/M control mediated by CDK2 and CDK1 are pivotal tumorigenic events. The US FDA approved the first drug of this type, palbociclib (Ibrance), a CDK4/6 inhibitor, in February 2015, for use in postmenopausal women with breast cancer that is estrogen receptor positive and HER2 negative. Several compounds are in clinical trials.

"Cyclin-Dependent Kinase Inhibitor- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Cyclin-Dependent Kinase Inhibitor pipeline landscape is provided which includes the disease overview and Cyclin-Dependent Kinase Inhibitor treatment guidelines. The assessment part of the report embraces, in depth Cyclin-Dependent Kinase 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, Cyclin-Dependent Kinase 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 Cyclin-Dependent Kinase Inhibitor R&D. The therapies under development are focused on novel approaches to treat/improve Cyclin-Dependent Kinase Inhibitor.

Cyclin-Dependent Kinase Inhibitor Emerging Drugs Chapters

This segment of the Cyclin-Dependent Kinase 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.

Cyclin-Dependent Kinase Inhibitor Emerging Drugs

• Abemaciclib: Eli Lilly and Company

Abemaciclib selectively inhibits CDK4 and CDK6 with low nanomolar potency. These enzymes are responsible for phosphorylating and thus deactivating the retinoblastoma protein, which plays a role in cell cycle progression from the G1 (first gap) to the S (synthesis) phase. Blocking this pathway prevents cells from progressing to the S phase, thereby inducing apoptosis (cell death). In vitro analysis using cancer cell lines shows that abemaciclib induces non-apoptotic cell death characterized by the formation of cytoplasmic vacuoles derived from lysosomes. The drug was approved for use in combination with endocrine therapy (such as tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. Currently, the drug is in the Phase III stage of its development for the treatment of Liposarcoma and Prostate cancer.

• GFH-009: GenFleet Therapeutics/ Sellas Life Sciences Group

GFH009 is a potent and highly selective small-molecule inhibitor of CDK9 with more than 100 times selectivity over other CDK subtypes. Preclinical data have also suggested the potential anti-tumor effects of GFH009 in combination with BCL-2 inhibitors. As a potent and highly selective small molecule CDK9 inhibitor, GFH009 exhibits strong apoptosis-inducing and anti-proliferative activities in multiple human cell lines and animal models of diseases. It effectively inhibits the growth of tumor in various xenograft models and significantly improves survival of tumor bearing animals. The drug is currently in Phase II stage of Clinical trial evaluation for the treatment Hematological malignancies.

• Enitociclib: Vincerx Pharma

Enitociclib is a potent and selective CDK9 inhibitor currently in clinical development. The small molecule inhibitor targets P-TEFb/CDK9 and has shown robust pathway modulation as well as efficacy and safety in several preclinical tumor models and in early phase clinical studies. Enitociclib was identified as a top hit in small molecule inhibitor screening and exposure to Enitociclib for 96 hours against a representative panel of MM cell lines (NCI-H929, MM.1S, OPM-2, and U266B1) demonstrated significant cytotoxic activity, with IC50 values ranging from 36 to 78 nM. Vincerx Pharma is focused on Phase I/II study with the National Institutes of Health (NIH) evaluating combination of Enitociclib and Venetoclax and prednisone (VVIP) in diffuse large B-cell lymphoma (DLBCL) and peripheral T Cell Lymphoma (PTCL).

• AVZO-021: Avenzo Therapeutics Inc.

AVZO-021, also known as ARTS-021, is a promising clinical-stage drug developed by Avenzo Therapeutics, Inc. It is a highly potent and selective inhibitor of cyclin-dependent kinase 2 (CDK2), primarily aimed at treating hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer, as well as cancers with cyclin E1 (CCNE1) amplification. Currently, the drug is in the Phase I/II stage of its development for the treatment of triple negative breast cancer.

Cyclin-Dependent Kinase Inhibitor: Therapeutic Assessment

This segment of the report provides insights about the different Cyclin-Dependent Kinase Inhibitor drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Cyclin-Dependent Kinase Inhibitor
• There are approx. 45+ key companies which are developing the therapies for Cyclin-Dependent Kinase Inhibitor. The companies which have their Cyclin-Dependent Kinase Inhibitor drug candidates in the most advanced stage, include, Eli Lilly and Company.
• Phases

DelveInsight's report covers around 52+ 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

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

• 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.

Cyclin-Dependent Kinase Inhibitor: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Cyclin-Dependent Kinase 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 Cyclin-Dependent Kinase Inhibitor drugs.

Cyclin-Dependent Kinase Inhibitor Report Insights

• Cyclin-Dependent Kinase Inhibitor Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Cyclin-Dependent Kinase 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 Cyclin-Dependent Kinase Inhibitor drugs?
• How many Cyclin-Dependent Kinase Inhibitor drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Cyclin-Dependent Kinase Inhibitor?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Cyclin-Dependent Kinase 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 Cyclin-Dependent Kinase Inhibitor and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• G1 Therapeutics
• Betta Pharmaceuticals Co Ltd
• Eli Lilly and Company
• Pfizer
• Tiziana Life Sciences LTD
• GenFleet Therapeutics
• Vincerx Pharma
• Syros Pharmaceuticals
• BeyondBio
• Kronos Bio
• Qurient Co
• Sumitomo Pharma
• OnKure Therapeutics
• Biolexis Therapeutics
• InSilico Medicine
• Avenzo Therapeutics

Key Products

• Trilaciclib
• BPI 16350
• Abemaciclib
• Palbociclib
• Milciclib
• GFH009
• Enitociclib
• SY 5609
• BEY 1107
• KB-0742
• Q 901
• TP-1287
• BLX 3030
• OKI-1546
• ISM6466A
• AVZO-021