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Phosphatidylinositol 3-Kinase (PI3K) Inhibitors Pipeline to Witness Significant Growth due to Increase in the Designation Grants Provided by Regulatory Authorities in the Coming Years

According to a new research report Phosphatidylinositol 3-Kinase (PI3K) Inhibitors Therapeutics – Pipeline Analysis 2019, Clinical Trials and Results, Patent, Designation, Collaboration, and Other Developments” published by Pharma Proff, PI3K inhibitors currently exhibits a proliferating pipeline with 20+ therapeutic candidates.

PI3K Inhibitors Pipeline Insights

Phosphatidylinositol 3-kinase (PI3K) belongs to lipid kinases and plays a vital role in cell signaling. It is an intermediate molecule in mTOR/AKT/PI3K signaling cascade. The serine/threonine kinase AKT (also known as protein kinase B or PKB) has become a major focus of attention because of its critical role in regulating diverse cellular functions including metabolism, growth, proliferation, survival, transcription, and protein synthesis. The activity of PI3K is controlled by phosphatase and tensin homolog deleted from chromosome 10 (PTEN) in normal cells. Dysregulation of PI3K pathway has been related to angiogenesis and carcinogenesis. Loss of PTEN regulation, gene amplification in PI3Ks, and receptor tyrosine kinases (RTKs) mutation activation are some of the factors that are responsible for cancer initiation. PI3K inhibitors are the drugs that inhibits PI3K enzymes, which play a vital role in the mTOR/AKT/PI3K signaling pathway.

Zydelig (Gilead Sciences, Inc.), Aliqopa (Bayer AG), and Copiktra (Verastem Oncology) are the PI3K inhibitors that have been approved by the U.S. Food and Drug Administration (USFDA) for the treatment of chronic lymphocytic leukemia, follicular lymphoma, and small lymphocytic lymphoma, respectively.

Insights into Pipeline Segments

According to the research findings, majority of the pipeline drug candidates are being developed to be administered by oral route. It has been observed that the oral route of medication is convenient, available in delayed or rapid release formulation, less risk of systemic infections, and inexpensive in nature, and also provides improved patient’s compliance. Administration of PI3K inhibitors through oral route has shown promising results in clinical studies.

Positive Clinical Results Play a Pivotal Role in PI3K Inhibitors Development

Companies that are involved in developing PI3K inhibitors have shown positive clinical results in the various phases of drug development. For instance, in October 2018, Novartis AG announced positive results of phase III trial of BYL719 (Alpelisib), in combination with fulvestrant. As per the results of the clinical study, the combination of BYL719 and fulvestrant significantly improved progression free survival (PFS) and overall response rate (ORR) in patients with breast cancer as compared to fulvestrant alone.

Increasing Number of Designations Granted by Regulatory Authorities is Expected to Help the Pipeline to Grow at a Faster Rate

Aliqopa of Bayer AG was granted the Orphan Drug Designation in 2015 for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies and the drug was approved for marketing in 2017. Therefore, with the emergence of late- and mid-stage pipeline products in the market, the overall PI3K inhibitors market is expected to grow significantly in the upcoming years.

Browse report overview with detailed TOC on "Phosphatidylinositol 3-Kinase (PI3K) Inhibitors – Pipeline Analysis2019, Clinical Trials and Results, Patents, Designations, Collaborations, and Other Developments" at:

Some of the companies involved in the development of PI3K inhibitors include Gilead Sciences Inc., Bayer AG, Verastem Oncology, Rhizen Pharmaceuticals S.A., TG Therapeutics Inc., Pfizer Inc., Novartis AG, and Shanghai Jiatan Pharmatech Co. Ltd.

PI3K Inhibitors Pipeline Analysis

  • By Phase
  • By Molecule Type
  • By Route of Administration
  • By Company

The report comprises detailed pipeline analysis of PI3K inhibitors under development. Comprehensive insights on the pipeline products have been provided, with special focus on strategic developments of key players, information on drug licensing, designations, financing, and grants, technological advancements, patents, and upcoming conferences. In addition, the report highlights the winning strategies of companies involved in the development of PI3K inhibitors. Detailed regulatory approval procedures in the U.S., Europe, and Japan are also provided in this report. Furthermore, the report contains competitive analysis and extensive information on monotherapies, combination therapies, targets and mechanisms of action, and drug origin with respect to PI3K inhibitors.