PI3K Inhibitor Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, MOA, ROA, NDA, IND, and Companies

DelveInsight's, "PI3K Inhibitor Pipeline Insight 2025" report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in PI3K Inhibitor pipeline landscape. It covers the PI3K Inhibitor pipeline drug profiles, including PI3K Inhibitor clinical and nonclinical stage products. It also covers the PI3K Inhibitor therapeutics assessment by product type, stage, PI3K Inhibitor route of administration, and PI3K Inhibitor molecule type. It further highlights the inactive PI3K Inhibitor pipeline products in this space.

Download DelveInsight's comprehensive PI3K Inhibitor Pipeline Report to explore emerging therapies, key players, and future treatment landscapes @ PI3K Inhibitor Pipeline Outlook Report [https://www.delveinsight.com/sample-request/pi3k-inhibitor-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Key Takeaways from the PI3K Inhibitor Pipeline Report

* On 22 August 2025, Incyte Corporation announced a study is to assess the safety and efficacy of parsaclisib in subjects with relapsed or refractory diffuse large B-cell lymphoma.
* On 01 August 2025, AstraZeneca conducted a study is to evaluate the effectiveness and safety of capivasertib + fulvestrant treatment administration in patients with locally advanced (inoperable) or metastatic HR+ / HER2- breast cancer with PIK3CA/AKT1/PTEN-altered following recurrence or progression on or after endocrine therapy and CDK4/6 inhibitor.
* DelveInsight's PI3K Inhibitor Pipeline analysis depicts a robust space with 20+ active players working to develop 25+ pipeline treatment therapies.
* The leading PI3K Inhibitor Companies such as 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 such as Evexomostat, Copanlisib, fulvestrant, BKM120, BYl719 , and others.

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PI3K Inhibitor Emerging Drugs Profile

* Gedatolisib: Celcuity

Gedatolisib is a dual inhibitor of PI3K and mTOR, targeting all class I isoforms of PI3K and mTORC1 and mTORC2. This unique mechanism of action distinguishes it from other inhibitors that target PI3K or mTOR alone. Gedatolisib aims to address drug resistance and potential resistance mechanisms that can occur with isoform-specific inhibitors. The drug has shown promising results in clinical trials, demonstrating manageable toxicity and potential efficacy in combination therapies for hormone receptor-positive, HER2-negative metastatic breast cancer patients who progressed after CDK4/6 inhibitor treatment. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Breast cancer.

* TBO-309: ThromBio

TBO-309 is a novel antiplatelet compound with truly remarkable properties. TBO-309 is a potent, selective and ATP competitive PI3K [beta] inhibitor which reduces platelet activation adhesion/aggregation particularly under conditions of disturbed blood flow and promotes platelet disaggregation. By targeting PI3K [beta], TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal hemostasis. A key point of differentiation between TBO-309 and currently approved antiplatelets is its wide therapeutic window. When combined with existing anti-clotting therapies, it does not cause a major increase in bleeding. This has been confirmed in several proof-of-concept studies in both animal models and two Phase I human clinical trials. In a broad range of preclinical animal models, and in two Phase I human clinical trials studies have demonstrated that TBO-309 (AZD6482) can inhibit arterial thrombus formation in a dose-dependent manner, without causing a major increase in bleeding and TBO-309 can be safely and effectively combined with other antithrombotic agents without causing a major increase in bleeding. Currently, the drug is in Phase II Stage of its clinical development for the treatment of Ischemic Stroke and Tandem Occlusion.

* TL117: Suzhou Teligene

TL117 is an orally bioavailable Phosphatidylinositol 3-Kinase (PI3K) inhibitor, with potential antineoplastic activity. Upon oral administration, PI3K inhibitor TL117 specifically inhibits the activity of PI3K, and prevents the activation of the PI3K/Akt (protein kinase B)-mediated signaling pathway. This may result in the inhibition of both tumor cell growth and survival in PI3K-overexpressing tumor cells. Activation of the PI3K signaling pathway is frequently associated with tumorigenesis. Dysregulated PI3K signaling may contribute to tumor resistance to a variety of antineoplastic agents. Currently, the drug is in Phase I/II Stage of its clinical development for the treatment of Head and Neck Squamous Cell Carcinoma.

The PI3K Inhibitor Pipeline Report Provides Insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of PI3K Inhibitor with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for PI3K Inhibitor Treatment.
* PI3K Inhibitor Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* PI3K Inhibitor Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the PI3K Inhibitor market

Explore groundbreaking therapies and clinical trials in the PI3K Inhibitor Pipeline. Access DelveInsight's detailed report now! @ New PI3K Inhibitor Drugs [https://www.delveinsight.com/sample-request/pi3k-inhibitor-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

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 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

PI3K Inhibitor Products have been categorized under various Molecule types such as

* Oligonucleotide
* Peptide
* Small molecule

Download DelveInsight's latest report to gain strategic insights into upcoming therapies and key developments @ PI3K Inhibitor Market Drivers and Barriers, and Future Perspectives [https://www.delveinsight.com/sample-request/pi3k-inhibitor-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

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 [https://www.delveinsight.com/sample-request/pi3k-inhibitor-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

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

About Us

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