PI3K Inhibitors Clinical Trial Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 75+ Companies Working in the Domain

PI3K inhibitors are primarily used in the treatment of various cancers, including breast cancer, lymphoma, and leukemia. With the global burden of cancer expected to rise due to factors like aging populations and lifestyle changes, chemotherapy's limitations impacting patient adherence led to a transition from traditional chemotherapy to targeted therapies in cancer treatment. With growing demand for targeted therapies, competitive dynamics within the pharmaceutical industry, coupled with favorable regulatory environments and efforts to improve healthcare infrastructure and access, there will likely be a growing demand for effective cancer treatments, including PI3K inhibitors.


New York, USA, March 21, 2024 (GLOBE NEWSWIRE) -- PI3K Inhibitors Clinical Trial Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 75+ Companies Working in the Domain

PI3K inhibitors are primarily used in the treatment of various cancers, including breast cancer, lymphoma, and leukemia. With the global burden of cancer expected to rise due to factors like aging populations and lifestyle changes, chemotherapy's limitations impacting patient adherence led to a transition from traditional chemotherapy to targeted therapies in cancer treatment. With growing demand for targeted therapies, competitive dynamics within the pharmaceutical industry, coupled with favorable regulatory environments and efforts to improve healthcare infrastructure and access, there will likely be a growing demand for effective cancer treatments, including PI3K inhibitors.

DelveInsight’s 'PI3K Inhibitors Pipeline Insight 2024' report provides comprehensive global coverage of pipeline PI3K inhibitors in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the PI3K inhibitors pipeline domain.

Key Takeaways from the PI3K Inhibitors Pipeline Report

  • DelveInsight’s PI3K inhibitors pipeline report depicts a robust space with 75+ active players working to develop 80+ pipeline PI3K inhibitors. 
  • Key PI3K inhibitors companies such as TG Therapeutics, Pfizer, Relay Therapeutics, Curis, AUM Biosciences, Onconova Therapeutics, Kazia Therapeutics, Rhizen Pharmaceuticals, The Menarini Group, Inflection Biosciences, Totus Medicines, Hoffman-La-Roche, BeiGene, HUTCHMED, Nanjing Zenshine Pharmaceuticals, ARTham Therapeutics, Scorpion Therapeutics, Sumitomo Pharma America, BridgeBio Pharma, Novartis, Haihe Biopharma, Faeth Therapeutics, Shanghai Yingli Pharmaceutical, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., GlaxoSmithKline, and others are evaluating new PI3K Inhibitors drugs to improve the treatment landscape.
  • Promising pipeline PI3K inhibitors such as Umbralisib, Gedatolisib, RLY 2608, Fimepinostat, AUM 302, Rigosertib, Paxalisib, Tenalisib, MEN1611, IBL-202, TOS-358, Inavolisib, BGB-10188,  Amdizalisib, ZX-4081, ART 001, STX 478, TP 3654, BBO 10203, BYL719, CYH33, Serabelisib, Linperlisib, TQ-B3525, GSK2636771, and others are under different phases of PI3K inhibitors clinical trials.
  • In March 2024, BeiGene, Ltd. announced the presentation of emerging oncology pipeline data at the American Association for Cancer Research (AACR) Annual Meeting April 5-10 in San Diego. BeiGene has nine abstracts scheduled for poster presentations at AACR. An additional clinical presentation includes the first data from a Phase Ia dose escalation study of BGB-10188, a phosphatidylinositol 3 kinase delta (PI3Kδ) inhibitor, plus tislelizumab in patients with solid tumors.
  • In December 2023, Genentech a member of the Roche Group announced positive results from the Phase III INAVO120 study of the investigational therapy, inavolisib, in combination with palbociclib (Ibrance) and fulvestrant as a potential first-line treatment option for people with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer. 
  • In October 2023, the FDA had granted permission to proceed with clinical investigations of Roginolisib in the United States, according to iOnctura. It is currently being developed for patients with solid and hematologic malignancies, including uveal melanoma. Roginolisib is the first novel allosteric modulator of PI3K and utilizes a unique binding mode that when combined with high selectivity for PI3K. It is expected to improve safety and tolerability relative to that of earlier generation inhibitors.
  • In July 2023, the FDA granted fast track designation to paxalisib plus radiotherapy as a treatment for solid tumor brain metastases with PI3K pathway mutations. 
  • In May 2023, Scorpion Therapeutics announced that the first patient has been dosed in a Phase I/II first-in-human dose escalation and expansion clinical trial evaluating STX-478, Scorpion's highly differentiated, allosteric and central nervous-system (“CNS”) penetrant inhibitor of mutant phosphoinositide-3-kinase alpha (“PI3Kα”), for the treatment of HR+/HER2- breast cancer and other solid tumors. 
  • In April 2023, Totus Medicines presented four posters at the American Association for Cancer Research (AACR) Annual Meeting, regarding its lead program, TOS-358, the first highly specific, covalent PI3Kα inhibitor.

Request a sample and discover the recent advances in PI3K inhibitors drugs @ PI3K Inhibitors Pipeline Report

The PI3K inhibitors pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage PI3K inhibitors drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the PI3K inhibitors clinical trial landscape. 

PI3K Inhibitors Overview

Phosphoinositide 3-kinase (PI3K) inhibitors are a class of targeted therapeutic agents that have garnered significant attention in the field of cancer research and treatment. The PI3K pathway plays a crucial role in regulating cell growth, survival, proliferation, and metabolism, making it an attractive target for cancer therapy. Aberrant activation of the PI3K pathway is a common occurrence in many types of cancers, contributing to tumor development, progression, and resistance to conventional therapies.

PI3K inhibitors work by blocking the activity of one or more isoforms of PI3K enzymes. There are four main isoforms of PI3K: class I and class II. Class IA PI3Ks are the most frequently implicated in cancer, particularly the p110α subunit encoded by the PIK3CA gene. By inhibiting PI3K, these inhibitors aim to disrupt the signaling cascade downstream of PI3K, which includes the well-known protein kinase AKT and the mammalian target of rapamycin pathway. This signaling network regulates various cellular processes, including cell growth, survival, metabolism, and angiogenesis.

PI3K inhibitors have shown promising results in preclinical studies and clinical trials, particularly in cancers where the PI3K pathway is hyperactive due to genetic mutations. However, challenges remain, including drug resistance, off-target effects, and the need for patient stratification based on molecular markers. Combination therapies, such as combining PI3K inhibitors with other targeted agents or immune checkpoint inhibitors, are being explored to enhance their efficacy and overcome resistance.


Find out more about PI3K inhibitors drugs @ PI3K Inhibitors Analysis

A snapshot of the Pipeline PI3K Inhibitors Drugs mentioned in the report:

DrugsCompanyPhase IndicationRoA
UmbralisibTG TherapeuticsPhase IIIChronic lymphocytic leukemiaOral
Rigosertib Onconova TherapeuticsPhase IIIChronic myelomonocytic leukemia; Myelodysplastic SyndromesIntravenous 
FimepinostatCurisPhase IIMYC-altered CancersOral
BGB 10188BeiGenePhase I/IIHematological malignancies; Solid tumoursOral

Learn more about the emerging PI3K inhibitors @ PI3K Inhibitors Clinical Trials

PI3K Inhibitors Therapeutics Assessment

The PI3K inhibitors pipeline report proffers an integral view of the emerging PI3K inhibitors segmented by stage, product type, molecule type, and route of administration.

Scope of the PI3K Inhibitors 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: Infusion, Intradermal, Intramuscular, Intranasal, Intravaginal, Oral, Parenteral, Subcutaneous, Topical
  • Therapeutics Assessment By Molecule Type: Gene therapies, Small molecule, Vaccines, Polymers, Peptides, Monoclonal antibodies
  • Key PI3K Inhibitors Companies: TG Therapeutics, Pfizer, Relay Therapeutics, Curis, AUM Biosciences, Onconova Therapeutics, Kazia Therapeutics, Rhizen Pharmaceuticals, The Menarini Group, Inflection Biosciences, Totus Medicines, Hoffman-La-Roche, BeiGene, HUTCHMED, Nanjing Zenshine Pharmaceuticals, ARTham Therapeutics, Scorpion Therapeutics, Sumitomo Pharma America, BridgeBio Pharma, Novartis, Haihe Biopharma, Faeth Therapeutics, Shanghai Yingli Pharmaceutical, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., GlaxoSmithKline, and others
  • Key PI3K Inhibitors Pipeline Therapies: Umbralisib, Gedatolisib, RLY 2608, Fimepinostat, AUM 302, Rigosertib, Paxalisib, Tenalisib, MEN1611, IBL-202, TOS-358, Inavolisib, BGB-10188,  Amdizalisib, ZX-4081, ART 001, STX 478, TP 3654, BBO 10203, BYL719, CYH33, Serabelisib, Linperlisib, TQ-B3525, GSK2636771, and others

Dive deep into rich insights for new PI3K inhibitors, visit @ PI3K Inhibitors Drugs

Table of Contents

1.PI3K Inhibitors Pipeline Report Introduction
2.PI3K Inhibitors Pipeline Report Executive Summary
3.PI3K Inhibitors Pipeline: Overview
4.Analytical Perspective In-depth Commercial Assessment
5.PI3K Inhibitors Clinical Trial Therapeutics
6.PI3K Inhibitors Pipeline: Late-Stage Products (Pre-registration)
7.PI3K Inhibitors Pipeline: Late-Stage Products (Phase III)
8.PI3K Inhibitors Pipeline: Mid-Stage Products (Phase II)
9.PI3K Inhibitors Pipeline: Early-Stage Products (Phase I)
10.PI3K Inhibitors Pipeline Therapeutics Assessment
11.Inactive Products in the PI3K Inhibitors Pipeline
12.Company-University Collaborations (Licensing/Partnering) Analysis
13.Key Companies
14.Key Products in the PI3K Inhibitors Pipeline
15.Unmet Needs
16.Market Drivers and Barriers
17.Future Perspectives and Conclusion
18.Analyst Views
19.Appendix

For further information on the PI3K inhibitors pipeline therapeutics, reach out @ PI3K Inhibitors Therapeutics

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