Press release
PI3K Inhibitor Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies by DelveInsight
Stay ahead with the latest insights! Download DelveInsight's comprehensive PI3K Inhibitor Pipeline Report to explore emerging therapies, key PI3K Inhibitor Companies, and future PI3K Inhibitor 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
* In January 2025:- SynDevRx Inc.:- This is a Phase 1b/2, open-label, parallel-arms pilot study in post-menopausal women with hormone receptor positive (HR+), HER2- advanced or metastatic breast cancer with an alteration in the PI3K pathway, including a mutation of the PIK3CA gene, PTEN loss, or AKT1 mutation, designed to determine the safety of evexomostat (SDX-7320) plus standard of care treatment alpelisib (BYL-719) or capivasertib and fulvestrant (each combined, the 'triplet therapy'), to measure the severity and number of hyperglycemic events, and to assess clinical, anti-tumor benefit of the triplet therapy.
* In January 2025:- M.D. Anderson Cancer Center- mThe goal of this clinical research study is to learn if GSK2636771 given in combination with pembrolizumab can help to control the disease in patients with refractory (has not responded to treatment) metastatic melanoma. The safety of this drug combination will also be studied.
* In January 2025:- Menarini Group- This Phase Ib/II study will investigate the anti-tumour activity and safety of daily oral doses MEN1611 in combination with cetuximab in female and male patients affected by PIK3CA mutated, N-K-RAS wild-type and BRAF wild-type metastatic colorectal cancer. MEN1611 is a potent, selective Class I phosphoinositide 3-kinase (PI3K) inhibitor. The Maximum Tolerated Dose (MTD) of MEN1611 given as single agent was assessed in a phase I trial in patients with advanced solid tumors.
* DelveInsight's PI3K Inhibitor pipeline report depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for PI3K Inhibitor treatment.
* The leading PI3K Inhibitor Companies such as TG Therapeutics, Pfizer, Incyte Corporation, Yuhan, Inflection Biosciences/AUM Biosciences, Onconova Therapeutics, UCB, and others.
* Promising PI3K Inhibitor Therapies such as Evexomostat, Copanlisib, fulvestrant, BKM120, BYl719, and others.
Discover how the PI3K Inhibitor treatment paradigm is evolving. Access DelveInsight's in-depth PI3K Inhibitor Pipeline Analysis for a closer look at promising breakthroughs @ PI3K Inhibitor Clinical Trials and Studies [https://www.delveinsight.com/sample-request/pi3k-inhibitor-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
PI3K Inhibitor Emerging Drugs Profile
* Umbralisib: TG Therapeutics
Umbralisib (TGR-1202) is an oral, once daily, dual inhibitor of PI3K delta and CK1 epsilon. Umbralisib has nanomolar potency to the delta isoform of PI3K and high selectivity over the alpha, beta, and gamma PI3K isoforms. Umbralisib also uniquely inhibits casein kinase 1 epsilon (CK1 epsilon), which may have both direct anti-cancer effects and may also modulate T-cell activity associated with immune-mediated adverse events seen with previous PI3K inhibitors. Currently, umbralisib is being evaluated in Phase IIb and Phase III trials in patients with NHL and CLL.
* Gedatolisib: Pfizer
Gedatolisib (PF-05212384) is an experimental drug for treatment of cancer in development by Pfizer. It works by targeting PI3K/mTOR. The Phase II clinical trials of gedatolisib for treatment of endometrial cancer and colorectal cancer were terminated early due to enrollment issues. It is currently in phase II stage of development.
* Parsaclisib: Incyte Corporation
Parsaclisib is a potent, highly selective, next-generation PI3K inhibitor that is not associated with clinically meaningful transaminitis. It is in phase II stage of development.
* YH 25248: Yuhan
YH 25248 is an oral selective phosphatidylinositol 3-kinase (PI3K) delta inhibitor, being developed by Yuhan, for the treatment of cancer.
Get a detailed analysis of the latest innovations in the PI3K Inhibitor pipeline. Explore DelveInsight's expert-driven report today! @ PI3K Inhibitor Unmet Needs [https://www.delveinsight.com/sample-request/pi3k-inhibitor-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
PI3K Inhibitor Companies
TG Therapeutics, Pfizer, Incyte Corporation, Yuhan, Inflection Biosciences/AUM Biosciences, Onconova Therapeutics, UCB, 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
* Infusion
* Intradermal
* Intramuscular
* Intranasal
* Oral
* Parenteral
* Subcutaneous
* Topical.
* Molecule Type
PI3K Inhibitor Products have been categorized under various Molecule types such as
* Gene therapies
* Small molecule
* Vaccines
* Polymers
* Peptides
* Monoclonal antibodies
* Product Type
Download DelveInsight's latest report to gain strategic insights into upcoming PI3K Inhibitor Therapies and key PI3K Inhibitor 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- TG Therapeutics, Pfizer, Incyte Corporation, Yuhan, Inflection Biosciences/AUM Biosciences, Onconova Therapeutics, UCB , and others.
* PI3K Inhibitor 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 Content
* Introduction
* Executive Summary
* PI3K inhibitors: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* PI3K inhibitors - DelveInsight's Analytical Perspective
* In-depth Commercial Assessment
* PI3K inhibitors Collaboration Deals
* Late Stage Products (Phase III)
* Umbralisib: TG Therapeutics
* Mid Stage Products (Phase II)
* Gedatolisib: Pfizer
* Parsaclisib: Incyte Corporation
* Early Stage Products (Phase I)
* Drug Name: Company Name
* Pre-clinical and Discovery Stage Products
* YH 25248: Yuhan
* Inactive Products
* PI3K inhibitors Key Companies
* PI3K inhibitors Key Products
* PI3K inhibitors- Unmet Needs
* PI3K inhibitors- Market Drivers and Barriers
* PI3K inhibitors- Future Perspectives and Conclusion
* PI3K inhibitors Analyst Views
* PI3K inhibitors Key Companies
* Appendix
About Us
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
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