DelveInsight’s "PI3K Inhibitor Pipeline Insight 2025" report offers extensive analysis on over 20 companies and more than 25 pipeline drugs in the PI3K Inhibitor treatment landscape. It features in-depth profiles of PI3K Inhibitor pipeline drugs, covering PI3K Inhibitor clinical and nonclinical development phases. Furthermore, it assesses PI3K Inhibitor therapeutics by product category, development stage, PI3K Inhibitor delivery route, and PI3K Inhibitor molecular structure. It also identifies discontinued PI3K Inhibitor pipeline products in this domain.

Obtain DelveInsight’s thorough PI3K Inhibitor Pipeline Report to explore emerging treatments, key players, and future treatment landscapes @ PI3K Inhibitor Pipeline Outlook Report

Key Takeaways from the PI3K Inhibitor Pipeline Report

On October 16, 2025, AstraZeneca conducted a trial to assess the effectiveness and safety of capivasertib + fulvestrant in patients with locally advanced (inoperable) or metastatic HR+ / HER2- breast cancer with PIK3CA/AKT1/PTEN alterations after recurrence or progression on endocrine therapy and CDK4/6 inhibitor. 

On October 16, 2025, Eli Lilly and Company disclosed a Phase 1/2 trial evaluating the safety, tolerability, pharmacokinetics (PK), and initial antitumor effects of STX-478 (LY4064809) in participants with advanced solid tumors harboring P13Ka mutations. DelveInsight’s PI3K Inhibitor Pipeline analysis showcases a dynamic field with over 20 active contributors developing more than 25 pipeline therapies. 

The top PI3K Inhibitor Companies include Celcuity, ThromBio, Suzhou Teligene, BeBetter Med Inc, Kazia Therapeutics, Risen Pharma, Advenchen Laboratories, Curis, Leapfrog Bio, Cogent Biosciences, and others. 

Promising PI3K Inhibitor Pipeline Therapies include Evexomostat, Copanlisib, fulvestrant, BKM120, BYl719, and others. 

Access DelveInsight’s in-depth PI3K Inhibitor Pipeline Analysis for a closer look at promising breakthroughs @ PI3K Inhibitor Clinical Trials and Studies

PI3K Inhibitor Overview

Phosphoinositide 3-kinases (PI3Ks) are a group of enzymes crucial for essential cellular processes like growth, proliferation, metabolism, and survival. The PI3K/AKT/mTOR pathway is often hyperactivated in various cancers, usually due to genetic alterations, especially in the PIK3CA gene. This has positioned PI3Ks as prime targets for cancer treatment, leading to the creation of inhibitors to disrupt this pathway and curb tumor expansion.

PI3K Inhibitor Emerging Drugs Profile

Gedatolisib: Celcuity Gedatolisib is a dual blocker of PI3K and mTOR, targeting all class I PI3K isoforms as well as mTORC1 and mTORC2. This distinctive action sets it apart from inhibitors that focus on PI3K or mTOR individually. Gedatolisib seeks to overcome resistance and potential resistance issues linked to isoform-selective inhibitors. The drug has delivered encouraging outcomes in trials, showing controllable toxicity and potential benefits in combo regimens for hormone receptor–positive, HER2-negative metastatic breast cancer patients who advanced after CDK4/6 inhibitor therapy. The drug is currently in Phase III trials for Breast cancer.

TBO-309: ThromBio TBO-309 is an innovative antiplatelet agent with exceptional characteristics. TBO-309 is a strong, selective, and ATP-competitive PI3K [beta] inhibitor that diminishes platelet activation, adhesion/aggregation especially in turbulent blood flow, and facilitates platelet disaggregation. By focusing on PI3K [beta], TBO-309 selectively curbs thrombosis while limiting effects on normal hemostasis. A major advantage over existing antiplatelets is its broad therapeutic range. When paired with current anti-clotting drugs, it avoids significant bleeding escalation. This has been validated in multiple proof-of-concept studies in animal models and two Phase I human trials. Across diverse preclinical animal models and two Phase I human studies, TBO-309 (AZD6482) has inhibited arterial thrombus formation dose-dependently, without major bleeding increases, and can be safely combined with other antithrombotic agents without substantial bleeding risks. The drug is in Phase II development for Ischemic Stroke and Tandem Occlusion.

TL117: Suzhou Teligene TL117 is an orally available Phosphatidylinositol 3-Kinase (PI3K) inhibitor, with potential anti-cancer properties. Upon oral intake, PI3K inhibitor TL117 selectively blocks PI3K function, preventing activation of the PI3K/Akt (protein kinase B)-mediated pathway. This may lead to suppression of tumor cell growth and viability in PI3K-overexpressing cancers. Activation of the PI3K pathway is commonly linked to cancer development. Aberrant PI3K signaling may foster tumor resistance to various anti-cancer drugs. The drug is in Phase I/II trials for Head and Neck Squamous Cell Carcinoma.

The PI3K Inhibitor Pipeline Report Provides Insights into

The report delivers comprehensive details on firms advancing therapies for PI3K Inhibitor, including the cumulative treatments each company is developing. It reviews diverse therapeutic candidates categorized into initial, intermediate, and advanced development stages for PI3K Inhibitor management. PI3K Inhibitor Companies are focused on precision therapeutics with ongoing and paused (inactive or terminated) programs. PI3K Inhibitor Drugs in development, sorted by development phase, administration route, target receptor, single or combined therapy, unique action mechanisms, and molecular category. Comprehensive examination of partnerships (corporate alliances and academic ties), licensing arrangements, and funding details to propel future progress in the PI3K Inhibitor market Explore innovative treatments and clinical trials in the PI3K Inhibitor Pipeline. Obtain DelveInsight's detailed report today! @ New PI3K Inhibitor Drugs

PI3K Inhibitor Companies

Celcuity, ThromBio, Suzhou Teligene, BeBetter Med Inc, Kazia Therapeutics, Risen Pharma, Advenchen Laboratories, Curis, Leapfrog Bio, Cogent Biosciences, and others

PI3K Inhibitor pipeline report assesses the therapeutic potential of pipeline drugs by Route of Administration. Products are grouped under different ROAs, including

Intra-articular Intraocular Intrathecal Intravenous Oral Parenteral Subcutaneous Topical Transdermal PI3K Inhibitor Products have been categorized under various Molecule types such as

Oligonucleotide Peptide Small molecule Obtain DelveInsight’s latest report to gain strategic insights into upcoming therapies and key developments @ PI3K Inhibitor Market Drivers and Barriers, and Future Perspectives

Scope of the PI3K Inhibitor Pipeline Report

Coverage- Global 

PI3K Inhibitor Companies- Celcuity, ThromBio, Suzhou Teligene, BeBetter Med Inc, Kazia Therapeutics, Risen Pharma, Advenchen Laboratories, Curis, Leapfrog Bio, Cogent Biosciences, and others. 

PI3K Inhibitor Pipeline Therapies- Evexomostat, Copanlisib, fulvestrant, BKM120, BYl719, and others. PI3K Inhibitor Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination PI3K Inhibitor Therapeutic Assessment by Clinical 

Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Which companies are leading the race in PI3K Inhibitor drug development?

Find out in DelveInsight’s exclusive PI3K Inhibitor Pipeline Report—access it now! @ PI3K Inhibitor Emerging Drugs and Major Companies

Table of Contents

Introduction Executive Summary PI3K Inhibitor: Overview Pipeline Therapeutics Therapeutic Assessment PI3K Inhibitor – DelveInsight’s Analytical Perspective Late Stage Products (Phase III) Gedatolisib: Celcuity Mid Stage Products (Phase II) TBO-309: ThromBio Early Stage Products (Phase I/II) TL117: Suzhou Teligene Preclinical Stage Products Drug Name: Company Name Inactive Products PI3K Inhibitor - Collaborations Assessment- Licensing / Partnering / Funding PI3K Inhibitor - Unmet Needs PI3K Inhibitor - Market Drivers and Barriers Appendix

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