PI3K Inhibitor Pipeline 2025: Key Companies, MOA, ROA, and Clinical Trials Evaluation by DelveInsight | OnKure Therapeutics, Eli Lilly, BeiGene, Relay Therapeutics, Rhizen Pharmaceuticals, Curis

July 10 10:32 2025
PI3K Inhibitor Pipeline 2025: Key Companies, MOA, ROA, and Clinical Trials Evaluation by DelveInsight | OnKure Therapeutics, Eli Lilly, BeiGene, Relay Therapeutics, Rhizen Pharmaceuticals, Curis
(Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, PI3K Inhibitor pipeline constitutes 20+ key companies continuously working towards developing 25+ PI3K Inhibitor treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

 

PI3K Inhibitor Pipeline Insight, 2025 report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the PI3K Inhibitor Market.

 

The PI3K Inhibitor Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

 

Some of the key takeaways from the PI3K Inhibitor Pipeline Report:

  • Companies across the globe are diligently working toward developing novel PI3K Inhibitor treatment therapies with a considerable amount of success over the years.

  • PI3K Inhibitor companies working in the treatment market are OnKure Therapeutics, Eli Lilly, BeiGene, Relay Therapeutics, Rhizen Pharmaceuticals, Curis, Celcuity, ThromBio, Suzhou Teligene, and others, are developing therapies for the PI3K Inhibitor treatment

  • Emerging PI3K Inhibitor therapies in the different phases of clinical trials are- OKI 219, STX 478, BGB 10188, RLY 2608, Tenalisib, Fimepinostat, Gedatolisib, TBO-309, TL117, and others are expected to have a significant impact on the PI3K Inhibitor market in the coming years.

  • 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 May 2024, The FDA had granted breakthrough therapy designation to inavolisib (GDC-0077) plus palbociclib (Ibrance) and fulvestrant (Faslodex) for the treatment of patients with hormone receptor–positive, HER2- negative locally advanced or metastatic breast cancer harboring a PIK3CA mutation following recurrence on or within 12 months of completing adjuvant endocrine therapy.

  • 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) metastatic breast cancer.

 

PI3K Inhibitor Overview

A PI3K inhibitor is a type of targeted cancer therapy that blocks the activity of phosphoinositide 3-kinases (PI3Ks), enzymes involved in cell growth, survival, and metabolism. The PI3K/AKT/mTOR pathway is often overactive in various cancers, leading to uncontrolled cell proliferation and resistance to cell death.

PI3K inhibitors are designed to interrupt this signaling pathway, thereby slowing down or stopping tumor growth. These inhibitors may target different PI3K isoforms (α, β, γ, δ), with some therapies selectively inhibiting specific isoforms to reduce side effects.

PI3K inhibitors are approved or under investigation for cancers such as chronic lymphocytic leukemia (CLL), follicular lymphoma, and breast cancer. Examples include idelalisib, alpelisib, and duvelisib. Common side effects may include diarrhea, rash, liver toxicity, and immune suppression.

 

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https://www.delveinsight.com/report-store/pi3k-inhibitor-pipeline-insight

 

Emerging PI3K Inhibitor Drugs Under Different Phases of Clinical Development Include:

  • OKI 219: OnKure Therapeutics

  • STX 478: Eli Lilly

  • BGB 10188: BeiGene

  • RLY 2608: Relay Therapeutics

  • Tenalisib: Rhizen Pharmaceuticals

  • Fimepinostat: Curis

  • Gedatolisib: Celcuity

  • TBO-309: ThromBio

  • TL117: Suzhou Teligene

 

PI3K Inhibitor Route of Administration

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

  • Oral

  • Parenteral

  • Intravenous

  • Subcutaneous

  • Topical

 

PI3K Inhibitor Molecule Type

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

  • Monoclonal Antibody

  • Peptides

  • Polymer

  • Small molecule

  • Gene therapy

 

PI3K Inhibitor Pipeline Therapeutics Assessment

  • PI3K Inhibitor Assessment by Product Type

  • PI3K Inhibitor By Stage and Product Type

  • PI3K Inhibitor Assessment by Route of Administration

  • PI3K Inhibitor By Stage and Route of Administration

  • PI3K Inhibitor Assessment by Molecule Type

  • PI3K Inhibitor by Stage and Molecule Type

 

DelveInsight’s PI3K Inhibitor Report covers around 25+ products under different phases of clinical development like

  • Late-stage products (Phase III)

  • Mid-stage products (Phase II)

  • Early-stage product (Phase I)

  • Pre-clinical and Discovery stage candidates

  • Discontinued & Inactive candidates

  • Route of Administration

 

Further PI3K Inhibitor product details are provided in the report. Download the PI3K Inhibitor pipeline report to learn more about the emerging PI3K Inhibitor therapies

 

Some of the key companies in the PI3K Inhibitor Therapeutics Market include:

Key companies developing therapies for PI3K Inhibitor are – Pfizer, Incyte Corporation, Yuhan, TG Therapeutics, Inflection Biosciences/AUM Biosciences, Onconova Therapeutics, UCB, and others.

 

PI3K Inhibitor Pipeline Analysis:

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 key 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.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

 

Download Sample PDF Report to know more about PI3K Inhibitor drugs and therapies

 

PI3K Inhibitor Pipeline Market Drivers

  • Increasing Prevalence of Cancer, Increasing research on the effect of PI3K Inhibitors, are some of the important factors that are fueling the PI3K Inhibitor Market.

 

PI3K Inhibitor Pipeline Market Barriers

  • However, Increasing research on the effect of PI3K Inhibitors, Adverse effects associated with the PI3K inhibitors, and other factors are creating obstacles in the PI3K Inhibitor Market growth.

 

Scope of PI3K Inhibitor Pipeline Drug Insight

  • Coverage: Global

  • Key PI3K Inhibitor Companies: OnKure Therapeutics, Eli Lilly, BeiGene, Relay Therapeutics, Rhizen Pharmaceuticals, Curis, Celcuity, ThromBio, Suzhou Teligene, and others

  • Key PI3K Inhibitor Therapies: OKI 219, STX 478, BGB 10188, RLY 2608, Tenalisib, Fimepinostat, Gedatolisib, TBO-309, TL117, and others

  • PI3K Inhibitor Therapeutic Assessment: PI3K Inhibitor current marketed and PI3K Inhibitor emerging therapies

  • PI3K Inhibitor Market Dynamics: PI3K Inhibitor market drivers and PI3K Inhibitor market barriers

 

Request for Sample PDF Report for PI3K Inhibitor Pipeline Assessment and clinical trials

 

Table of Contents

1. PI3K Inhibitor Report Introduction

2. PI3K Inhibitor Executive Summary

3. PI3K Inhibitor Overview

4. PI3K Inhibitor- Analytical Perspective In-depth Commercial Assessment

5. PI3K Inhibitor Pipeline Therapeutics

6. PI3K Inhibitor Late Stage Products (Phase II/III)

7. PI3K Inhibitor Mid Stage Products (Phase II)

8. PI3K Inhibitor Early Stage Products (Phase I)

9. PI3K Inhibitor Preclinical Stage Products

10. PI3K Inhibitor Therapeutics Assessment

11. PI3K Inhibitor Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. PI3K Inhibitor Key Companies

14. PI3K Inhibitor Key Products

15. PI3K Inhibitor Unmet Needs

16 . PI3K Inhibitor Market Drivers and Barriers

17. PI3K Inhibitor Future Perspectives and Conclusion

18. PI3K Inhibitor Analyst Views

19. Appendix

20. About DelveInsight

 

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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