Phosphatidylinositol 3-Kinase (PI3K) Inhibitors- Pipeline Insight, 2025

DelveInsight’s, “Phosphatidylinositol 3-Kinase (PI3K) Inhibitors- Pipeline Insight, 2025” report provides comprehensive insights about 22+ companies and 24+ pipeline drugs in Phosphatidylinositol 3-Kinase (PI3K) Inhibitors pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Phosphatidylinositol 3-Kinase (PI3K) Inhibitors: Understanding

Phosphatidylinositol 3-Kinase (PI3K) Inhibitors: Overview

Phosphatidylinositol 3-kinases (PI3Ks) are lipid kinases that regulate diverse cellular processes including proliferation, adhesion, survival, and motility. Dysregulated PI3K pathway signaling occurs in one-third of human tumors. Aberrantly activated PI3K signaling also confers sensitivity and resistance to conventional therapies. PI3K has been recognized as an attractive molecular target for novel anti-cancer molecules. In the last few years, several classes of potent and selective small molecule PI3K inhibitors have been developed, and at least fifteen compounds have progressed into clinical trials as new anticancer drugs.

PI3K are believed to be one of the key therapeutic targets for cancer treatment based on the observation that hyperactivity of PI3K signaling is significantly correlated with human tumor progression, increased tumor microvessel density and enhanced chemotaxis and invasive potential of cancer cells. While PI3K inhibitors are subdivided into dual PI3K/mTOR inhibitors, pan-PI3K inhibitors and isoform-specific inhibitors. Enormous efforts have been dedicated to the development of drugs.

PI3K is a group of plasma membrane-associated lipid kinases, consisting of three subunits: p85 regulatory subunit, p55 regulatory subunit, and p110 catalytic subunit. According to their different structures and specific substrates, PI3K is divided into 3 classes: classes I, II, and III. Class I PI3Ks comprised of class IA and class IB PI3Ks. Class IA PI3K, a heterodimer of p58 regulatory subunit and p110 catalytic subunit, is the type most clearly implicated in human cancer. Class IA PI3K contains p110α, p110β and p110δ catalytic subunits produced from different genes (PIK3CA, PIK3CB and PIK3CD, respectively), while p110γ produced by PIK3CG represents the only catalytic subunit in class IB PI3K.

The phospatidylinositol-3 kinase (PI3K) pathway is a crucial intracellular signaling pathway which is mutated or amplified in a wide variety of cancers including breast, gastric, ovarian, colorectal, prostate, glioblastoma and endometrial cancers. PI3K signaling plays an important role in cancer cell survival, angiogenesis and metastasis, making it a promising therapeutic target. There are several ongoing and completed clinical trials involving PI3K inhibitors (pan, isoform-specific and dual PI3K/mTOR) with the goal to find efficient PI3K inhibitors that could overcome resistance to current therapies.

""Phosphatidylinositol 3-Kinase (PI3K) Inhibitors- Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Phosphatidylinositol 3-Kinase (PI3K) Inhibitors pipeline landscape is provided which includes the disease overview and Phosphatidylinositol 3-Kinase (PI3K) Inhibitors treatment guidelines. The assessment part of the report embraces, in depth Phosphatidylinositol 3-Kinase (PI3K) Inhibitors commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Phosphatidylinositol 3-Kinase (PI3K) Inhibitors collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Phosphatidylinositol 3-Kinase (PI3K) Inhibitors R&D. The therapies under development are focused on novel approaches to treat/improve Phosphatidylinositol 3-Kinase (PI3K) Inhibitors.

Phosphatidylinositol 3-Kinase (PI3K) Inhibitors Emerging Drugs Chapters

This segment of the Phosphatidylinositol 3-Kinase (PI3K) Inhibitors report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Phosphatidylinositol 3-Kinase (PI3K) Inhibitors Emerging Drugs

• Gedatolisib: Celcuity, Inc.

Gedatolisib is an investigational, intravenously administered pan-class I isoform PI3K and mTOR inhibitor with low nanomolar potency for the p110α, p110β, p110γ, and p110δ isoforms and mTORC1 and mTORC2. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. VIKTORIA-1 is a Phase III study evaluating gedatolisib plus fulvestrant with and without palbociclib in patients previously treated with a CDK4/6 therapy and an aromatase inhibitor.

• Zandelisib: Kyowa Kirin Co., Ltd.

Zandelisib (formerly called ME-401), a selective PI3Kδ (Delta) inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies in Japan. MIRAGE is a Phase II study in Japan evaluating patients with Indolent B-cell non-Hodgkin's lymphoma (iB-NHL) without small lymphocytic (SLL), lymphoplasmacytic lymphoma (LPL), and Waldenström's macroglobulinemia (WM) conducted by Kyowa Kirin. It is currently being investigated in Phase III clinical trial to treat Follicular Lymphoma and Non-hodgkin Lymphoma. Moreover, the company is also conducting the TIDAL study which is a global Phase II study evaluating Zandelisib as a monotherapy across two study cohorts: one for the treatment of adults with relapsed and refractory follicular lymphoma and a second for relapsed and refractory marginal zone lymphomas, both after two or more prior lines of treatment.

• ZX-4081: Nanjing Zenshine Pharmaceuticals Co., Ltd.

PI3Kγ is a molecular switch that controls immune suppression and activates integrin α4 and promotes immune suppressive myeloid polarization during tumor progression. It was demonstrated that inhibition of PI3Kγ (Gamma) overcomes resistaSnce to checkpoint blockade therapy.

ZX-4081 is the most selective and potent PI3Kγ inhibitor up to date. In preclinical studies, it showed favorable pharmacokinetic profile and efficacy was confirmed in solid tumor models. ZX-4081 is on the way to become best-in-class PI3Kγ inhibitor for the treatment of solid tumors, either as single agent or combination with other anticancer agents. ZX-4081 is currently in Phase I clinical trial development in the United States.

Further product details are provided in the report……..

Phosphatidylinositol 3-Kinase (PI3K) Inhibitors: Therapeutic Assessment

This segment of the report provides insights about the different Phosphatidylinositol 3-Kinase (PI3K) Inhibitors drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Phosphatidylinositol 3-Kinase (PI3K) Inhibitors

There are approx. 22+ key companies which are developing the therapies for Phosphatidylinositol 3-Kinase (PI3K) Inhibitors. The companies which have their Phosphatidylinositol 3-Kinase (PI3K) Inhibitors drug candidates in the most advanced stage, i.e. phase III include, Celcuity, Inc.

Phases

DelveInsight’s report covers around 24+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Phosphatidylinositol 3-Kinase (PI3K) Inhibitors 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
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal
• Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Phosphatidylinositol 3-Kinase (PI3K) Inhibitors: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Phosphatidylinositol 3-Kinase (PI3K) Inhibitors therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Phosphatidylinositol 3-Kinase (PI3K) Inhibitors drugs.

Phosphatidylinositol 3-Kinase (PI3K) Inhibitors Report Insights

• Phosphatidylinositol 3-Kinase (PI3K) Inhibitors Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Phosphatidylinositol 3-Kinase (PI3K) Inhibitors Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Phosphatidylinositol 3-Kinase (PI3K) Inhibitors drugs?
• How many Phosphatidylinositol 3-Kinase (PI3K) Inhibitors drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Phosphatidylinositol 3-Kinase (PI3K) Inhibitors?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Phosphatidylinositol 3-Kinase (PI3K) Inhibitors therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Phosphatidylinositol 3-Kinase (PI3K) Inhibitors and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Celcuity, Inc.
• Incyte Corporation
• Kyowa Kirin Co., Ltd.
• Nanjing Zenshine Pharmaceuticals Co., Ltd
• Gilead Sciences, Inc.
• TG Therapeutics
• HUTCHMED
• BeiGene, Inc.
• CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
• Nanjing Shenghe Pharmaceutical Co., Ltd.
• Hoffman-La-Roche
• Totus Medicines
• Inflection Biosciences
• The Menarini Group

Key Products

• Gedatolisib
• Umbralisib
• Parsaclisib
• Zandelisib
• ZX-4081
• Idelalisib
• Amdizalisib
• BGB-10188
• TQ-B3525
• SHC014748M
• Inavolisib
• TOS-358
• IBL-202
• MEN1611