Cyclin-Dependent Kinase Inhibitor - Pipeline Insight, 2025

DelveInsight’s, “Cyclin-Dependent Kinase Inhibitor - Pipeline Insight, 2025” report provides comprehensive insights about 45+ companies and 50+ 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.

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.

“Cyclin-Dependent Kinase Inhibitor - Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the mechanism of action. 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 III, 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

• 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.

Further product details are provided in the report……..

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, i.e. Phase III include, Pfizer.

Phases

DelveInsight’s report covers around 50+ 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

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

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule
• 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 III,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

• 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

Key Products

• SY-5609
• XL 102
• PRT3645
• BLU 222
• Enitociclib
• CT-7001
• Milciclib
• XZP 3287
• Abemaciclib
• RVL 101
• AU2 94
• NKT 3447
• BGB 43395
• AZD-8421
• SLS 009

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