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Last update 20 Aug 2025

Palbociclib

Last update 20 Aug 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Iburance, Palbociclib (JAN/USAN), Palbociclib Isethionate

+ [10]

Target

CDK4 x CDK6

Action

inhibitors

Mechanism

CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesImmune System Diseases+ [10]

Active Indication

Breast cancer recurrentHormone receptor positive HER2 negative breast cancerER-positive/HER2-negative Breast Cancer+ [111]

Inactive Indication

acute leukemiaAcute myeloid leukaemia with 11q23 abnormalityAdvanced HER2-Positive Breast Carcinoma+ [51]

Originator Organization

Pfizer Inc.

Active Organization

Invitae Corp.

Pfizer Inc.

The Vanderbilt-Ingram Cancer Center

+ [19]

Inactive Organization

SWOGXynomic Pharmaceuticals, Inc.

Celgene Corp.

+ [6]

License Organization

Dr. Reddy's Laboratories Ltd.

Amgen, Inc.

Ascentage Pharma Group International Co., Ltd.

+ [11]

Drug Highest PhaseApproved

First Approval Date

United States (03 Feb 2015),

ER-positive/HER2-negative Breast Cancer

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Priority Review (China), Special Review Project (China)

Structure/Sequence

Molecular FormulaC24H29N7O2

InChIKeyAHJRHEGDXFFMBM-UHFFFAOYSA-N

CAS Registry571190-30-2

418

Clinical Trials associated with Palbociclib

NCT07123090

/ Not yet recruitingPhase 2IIT

A Phase 2 Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma - SPARCC

The goal of this research study is to evaluate how well and safely the study drugs sasanlimab, palbociclib, and axitinib work for treatment of participants with advanced clear cell renal cell carcinoma (ccRCC) or translocation renal cell carcinoma (tRCC).
The name of the study drugs involved in this research study is:
* Sasanlimab (a type of monoclonal antibody)
* Palbociclib (a type of kinase inhibitor)
* Axitinib (a type of Vascular endothelial growth factor inhibitor)

Start Date01 Feb 2026

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06997029

/ RecruitingPhase 1

A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4/6 Inhibitor Pre-treated Advanced Breast Cancer

The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.

Start Date01 Aug 2025

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT07061717

/ Not yet recruitingPhase 3IIT

A Phase III, Randomized, Open-Label Clinical Trial Comparing Endocrine Therapy Combined With High-Dose Palbociclib and Hydroxychloroquine to Endocrine Therapy Combined With Standard-Dose Palbociclib for Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer

This is a a phase III, randomized, open-label clinical trial comparing endocrine therapy combined with high-dose palbociclib and hydroxychloroquine to endocrine therapy combined with standard-dose palbociclib for hormone receptor-positive and her2-negative advanced breast cancer.

Start Date01 Jul 2025

Sponsor / Collaborator

Sun Yat-Sen Memorial Hospital

100 Clinical Results associated with Palbociclib

100 Translational Medicine associated with Palbociclib

100 Patents (Medical) associated with Palbociclib

3,332

Literatures (Medical) associated with Palbociclib

01 Jan 2026·BIOMATERIALS

Targeting the senescent surfaceome through DPP4 antibody-functionalized nanoparticles. An application to cancer therapy

Article

Author: Escriche-Navarro, Blanca ; Garrido, Eva ; Martínez-Máñez, Ramón ; Sancenón, Félix ; García-Fernández, Alba ; Montoya-Méndez, Isabel ; Escudero, Andrea

Due to the heterogeneity of the senescent phenotype and the lack of a universal biomarker of senescence, the targeting of senescent cells is still an unresolved challenge, and the elimination of senescent cells using specific drugs (senolytics) is still limited in clinical use due to the off-target effects and associated toxicities of current therapeutic strategies. In this study, the induction of senescence in human melanoma cells by palbociclib is found to lead to a senescent phenotype characterized by overexpression of the membrane protein dipeptidyl peptidase 4 (DPP4), previously identified only in ageing contexts. Based on this discovery, a nanoparticle targeting DPP4 overexpression in the senescent surfaceome is designed, synthesized, and characterized to target senescent cancer cells. The nanoparticle based on mesoporous silica is loaded with the senolytic navitoclax, coated with disulfide-containing poly(ethylene glycol) to generate a redox-sensitive gatekeeper (S-S-PEG), and functionalized with an antibody against the DPP4 protein. The ability of the nanoparticles to effectively detect and eliminate senescent cells was confirmed in vitro and in vivo using a mouse model of palbociclib-induced senescent in melanoma. The DPP4-targeted nanoparticle effectively reduces tumor growth and selectively removes senescent cells. Taken together, this study highlights the potential of surfaceome-targeted nanoparticles, as a clinically relevant strategy for improving senolytic therapies.

01 Dec 2025·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Identification of natural inhibitors against CDK6 target using pharmacophore-based screening, molecular docking, molecular dynamic simulations, and quantitative electrostatic potential analysis maps: A comprehensive study

Article

Author: Hosseinzadeh, Elaheh ; Amanlou, Massoud ; Firoozpour, Loghman

In this study, a mixing of pharmacophore-based screening, molecular docking virtual screening, molecular dynamic simulation, and quantitative electrostatic potential map analysis was performed at the binding cavity of the CDK6 target. The generated pharmacophore model has five features. After the validation of the model, a virtual screening process was conducted on the natural coconut database. The screened ligands were selected for molecular docking virtual screening. 800 ligands were docked, and the ligands were selected based on the docking scores and main interactions. The first four top-ranked compounds in the docking process were selected for the assessment of the stability of the interactions and binding site cavity through molecular dynamic simulation. Finally, MM-PBSA and electrostatic potential surface analyzes were performed on the compounds A-D and the standard and co-crystalized compounds. Compound A reveals superior features, including binding affinity, stability and binding-free energy compared to compound palbociclib ligand. These analyses lead to a deeper insight into the stability and charge distribution of selected hit compounds for further optimization of the natural ligands to achieve novel natural selective CDK6 inhibitors.

01 Dec 2025·JOURNAL OF COLLOID AND INTERFACE SCIENCE

Engineering an advanced multicomponent pentacyclic triterpenoid nanoplatform for synergistic co-delivery of cyclin-dependent kinase 4/6 inhibitors to enhance cancer chemoimmunotherapy

Article

Author: Cheng, Jianjun ; Du, Guanhua ; Shi, Jiahua ; Lian, Yajie ; Zhou, Conglei ; Liu, Hongjun

Immune checkpoint inhibitors such as monoclonal antibodies anti-PD-L1 hold huge promise for triple-negative breast cancer (TNBC) therapy but face limited immune efficacy due to the cold tumor nature and suppressive tumor immune microenvironment (TIME). To address these challenges, we engineered an innovative multi-component natural triterpenoid (PT)-co-assembled nano-platform that simultaneously serves as immunogenic cell death (ICD)-inducing chemotherapeutics for synergistic delivery of palbociclib (Pal), a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor with distinct immunomodulatory effects but lacking effective synergistic agents. By systematically screening four PT molecules, we identified that all binary PT systems could effectively regulate Pal delivery behavior. Analysis of representative nano-OMPal, composed of oleanolic acid (OA), maslinic acid (MA), and Pal, revealed that π-π stacking, hydrogen bonding, and hydrophobic interactions among its components are key driving forces behind successful co-assembly. Importantly, the combination of OA and MA not only enhances apoptotic and necrotic effects but also amplifies Pal-induced G1/S phase arrest by strongly suppressing key cell cycle regulators. Moreover, the as-prepared nano-assemblies exhibit multiple therapeutic benefits and cumulative ICD induction, synergistically activating anti-PD-L1 immune responses and effectively reversing the TIME. This study highlights the potential of natural product-based multi-component nanoplatforms as a transformative strategy for integrating ICD induction, chemotherapy, and immunotherapy, offering a potential avenue to address CDK4/6 inhibitor deficiencies and advance TNBC precision therapy.

444

News (Medical) associated with Palbociclib

30 Jul 2025

·www.globenewswire.com

Celcuity Inc. Announces Pricing of Concurrent Public Offerings of 2.750% Convertible Senior Notes Due 2031 and Common Stock and Pre-Funded Warrants

MINNEAPOLIS, July 30, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC) (the “Company”), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the pricing of its underwritten public offering of $175,000,000 aggregate principal amount of its 2.750% convertible senior notes due 2031 (the “Convertible Notes” and such offering, the “Convertible Notes Offering”), and its underwritten public offering of 1,836,842 of shares of its common stock (the “Common Stock”) at a public offering price of $38.00 per share and, in lieu of Common Stock to investors who so choose, pre-funded warrants to purchase up to 400,000 shares of Common Stock (the “Pre-Funded Warrants”) at a public offering price of $37.999 per Pre-Funded Warrant, which represents the per share public offering price of each share of Common Stock less the $0.001 per share exercise price of each Pre-Funded Warrant (such offering, the “Common Stock Offering”). The Company has granted the underwriters of the offerings a 30-day option to purchase up to an additional $26,250,000 aggregate principal amount of Convertible Notes, solely to cover over-allotments, if any, in the Convertible Notes Offering and a 30-day option to purchase up to an additional 335,526 shares of Common Stock at the public offering price less the underwriting discounts and commissions in the Common Stock Offering. The Convertible Notes will be general, unsecured, senior obligations of the Company. The Convertible Notes will accrue interest payable semiannually in arrears on February 1 and August 1 of each year, beginning on February 1, 2026, at a rate equal to 2.750% per year. The Convertible Notes will mature on August 1, 2031, unless earlier converted, redeemed or repurchased by the Company. At any time until the close of business on the scheduled trading day immediately before the maturity date, the Convertible Notes will be convertible at the option of the holders based on an initial conversion rate of 19.4932 shares of Common Stock per $1,000 principal amount of the Convertible Notes, which is equivalent to an initial conversion price of approximately $51.30 per share of Common Stock, representing a premium of approximately 35% above the public offering price per share of Common Stock in the Common Stock Offering. In connection with the closing of the Convertible Notes Offering, the Company will irrevocably elect to settle conversions, if any, of the Convertible Notes in shares of Common Stock together with cash in lieu of any fractional share, if applicable. The Convertible Notes Offering is expected to close on August 1, 2025, while the Common Stock Offering is expected to close on July 31, 2025, in each case, subject to satisfaction of customary closing conditions. The closing of neither the Convertible Notes Offering nor the Common Stock Offering is conditioned upon the closing of the other offering. The Company estimates that the net proceeds from the Convertible Notes Offering and the Common Stock Offering will be approximately $248.7 million, after deducting underwriting discounts and commissions and the Company’s estimated offering expenses. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, which may include clinical trial expenditures, commercial launch expenditures, research and development expenditures, capital expenditures, expansion of business development activities and other general corporate purposes. If the underwriters exercise their over-allotment option, the Company expects to use any additional proceeds from the offering for the purposes described in the preceding sentence. In connection with the pricing of the Convertible Notes Offering, the Company has determined that it will not enter into the capped call transactions with one or more of the underwriters or affiliates thereof and/or other financial institutions (the “option counterparties”) as initially contemplated and as disclosed in the preliminary prospectus supplement relating to the Convertible Notes Offering and the preliminary prospectus supplement relating to the Common Stock Offering. As a result of the Company’s determination not to enter into the capped call transactions, certain investors in the Convertible Notes that were expecting to hedge their equity price risk through certain derivative transactions with the option counterparties may instead hedge their equity price risk after the pricing of the Convertible Notes Offering by entering into derivative transactions with other parties or selling shares of Common Stock, which could adversely affect the market price of our Common Stock and the Convertible Notes. Jefferies, TD Cowen and Leerink Partners are acting as joint book-running managers for the Convertible Notes Offering and the Common Stock Offering. LifeSci Capital is acting as lead manager for the Convertible Notes Offering and passive bookrunner for the Common Stock Offering. ICR Capital LLC is acting as financial advisor to the Company in connection with the Convertible Notes Offering. The Company has filed a registration statement (including a prospectus) with the Securities and Exchange Commission (the “SEC”) as well as a preliminary prospectus supplement with respect to each of the offerings to which this communication relates. Before you invest, you should read the applicable preliminary prospectus supplement and the prospectus in that registration statement and other documents the Company has filed with the SEC for more complete information about the Company and these offerings. You may obtain these documents by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, the Company, any underwriter or any dealer participating in the applicable offering will arrange to send you the applicable preliminary prospectus supplement (or, when available, the applicable final prospectus supplement) and the accompanying prospectus upon request to: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, or by telephone at (877) 821-7388, or by email at Prospectus Department@Jefferies.com; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at TD.ECM_Prospectus@tdsecurities; or Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105 or by email at syndicate@leerink.com. This press release does not constitute an offer to sell or a solicitation of an offer to buy the Convertible Notes, any shares of Common Stock issuable upon conversion of the Convertible Notes, the shares of Common Stock, the Pre-Funded Warrants, any shares of Common Stock issuable upon the exercise of the Pre-Funded Warrants or any other securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration and qualification under the securities laws of such state or jurisdiction. ABOUT CELCUITY Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company’s lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PI3K/AKT/mTOR (“PAM”) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer is currently enrolling patients. Celcuity is headquartered in Minneapolis. FORWARD-LOOKING STATEMENTS This press release contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the Convertible Notes Offering, the Common Stock Offering, our ability to complete such offerings on the anticipated timeline or at all and the anticipated use of the net proceeds therefrom, together with other statements that are not historical facts, are forward-looking statements that are estimates reflecting management’s best judgment based upon currently available information. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” "confidence," "encouraged," “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management’s current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including our limited operating history; our potential inability to develop, validate and commercialize gedatolisib on a timely basis or at all; the uncertainties and costs associated with clinical studies and with developing and commercializing biopharmaceuticals; the complexity and difficulty of demonstrating the safety and sufficient magnitude of benefit to support regulatory approval of gedatolisib and other products we may develop; challenges we may face in developing and maintaining relationships with pharmaceutical company partners; the uncertainty and costs associated with clinical trials; the uncertainty regarding market acceptance by physicians, patients, third-party payors and others in the medical community, and with the size of market opportunities available to us; difficulties we may face in managing growth, such as hiring and retaining a qualified sales force and attracting and retaining key personnel; changes in government regulations; tightening credit markets and limitations on access to capital; stock market volatility or other factors that may affect our ability to access capital on favorable terms or at all; and obtaining and maintaining intellectual property protection for our technology and time and expense associated with defending third-party claims of intellectual property infringement, investigations or litigation threatened or initiated against us. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024, and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as such risks may be updated in our subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof. CONTACTS: Celcuity Inc.Brian Sullivan, bsullivan@celcuity.comVicky Hahne, vhahne@celcuity.com(763) 392-0123 ICR HealthcarePatti Bank, patti.bank@icrhealthcare.com(415) 513-1284

Phase 3

28 Jul 2025

·pipelinereview.com

Celcuity Announces Clinically Meaningful Improvement in Both Progression-Free Survival (“PFS”) Primary Endpoints from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial

Hazard Ratios and Improvements in Median PFS are Unprecedented in HR+/HER2- Advanced Breast Cancer (“ABC”) MINNEAPOLIS, MN, USA I July 28, 2025 I Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA wild-type, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. In the trial, the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 76% compared to fulvestrant (based on a hazard ratio [HR] of 0.24, 95% confidence interval [CI] 0.17-0.35; p<0.0001). The mPFS, as assessed by blinded independent central review (“BICR”), was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months. The gedatolisib doublet also demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 67% compared to fulvestrant (HR of 0.33, 95% CI 0.24-0.48; p<0.0001). The mPFS, as assessed by BICR, was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months. The topline efficacy data from the VIKTORIA-1 PIK3CA wild-type cohort established several new milestones in the history of drug development for HR+/HER2- advanced breast cancer: Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine and co-principal investigator for the trial said: “Patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer whose disease has progressed while on, or after, treatment with a CDK4/6 inhibitor typically derive limited benefit from subsequent endocrine-based therapy. The topline data for both gedatolisib regimens from VIKTORIA-1 are potentially practice-changing. To my knowledge, we have not seen Phase 3 results in patients with HR-positive, HER2-negative advanced breast cancer before where there was a quadrupling of the likelihood of survival without disease progression relative to the study control.” Treatment discontinuation due to a treatment-related adverse event for the gedatolisib triplet and gedatolisib doublet was lower than was observed in Arm D of the Phase 1b trial in patients with ABC, and lower than observed in any Phase 3 trials for currently approved drug combinations in HR+/HER2- ABC. Additionally, the gedatolisib triplet and gedatolisib doublet were better tolerated than was observed in the Phase 1b trial in patients with ABC, including lower rates of hyperglycemia and stomatitis. Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity said: “The topline data from VIKTORIA-1 demonstrate the potential for gedatolisib to become a transformative new medicine for the treatment of patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer whose disease progressed on or after treatment with CDK4/6 inhibitors. The 7.3 and 5.4-months incremental improvement in median PFS relative to fulvestrant for the gedatolisib regimens are potentially paradigm shifting results. We are also very excited that treatment with gedatolisib combined with fulvestrant with or without palbociclib was well-tolerated by the VIKTORIA-1 patients and that only a few patients discontinued treatment due to an adverse event.” Brian Sullivan, Chairman, Chief Executive Officer and co-founder of Celcuity said, “The efficacy improvement relative to the control that each of the gedatolisib regimens demonstrated was historic for this patient population. We are excited about the potential opportunity to provide a breakthrough therapeutic option for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer.” Full data from the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial will be presented at an upcoming medical conference later this year. Celcuity expects to submit a New Drug Application for gedatolisib to the U.S. Food and Drug Administration in the fourth quarter of 2025. Topline data for the VIKTORIA-1 PIK3CA mutation cohort is expected by the end of 2025. Webcast and Conference Call Information The Celcuity management team will host a webcast/conference call on Monday, July 28, 2025, at 8:00 a.m. ET to discuss the topline results from the Phase 3 VIKTORIA-1 trial. Those who would like to participate may access the live webcast here , or register in advance for the teleconference here . A replay of the webcast will be available on the Celcuity website following the live event. Notes HR+/HER2- Breast cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 1 More than two million breast cancer cases were diagnosed globally in 2022. 1 While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis. 2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers. 2 Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and PI3K/AKT/mTOR (PAM), are primary oncogenic drivers of HR+, HER2- breast cancer. 3 Therapies inhibiting these pathways are approved and used in various combinations for advanced breast cancer. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT, or mTORC1. 4,5,6,7 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease. 8 Survival rates are low with 30% of patients anticipated to live beyond five years after diagnosis. 2 Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research. VIKTORIA-1 VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant with or without palbociclib in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The clinical trial is enrolling subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Subjects who meet eligibility criteria and do not have confirmed PI3KCA mutations (WT) were randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant, gedatolisib and fulvestrant, or fulvestrant. Subjects who meet eligibility criteria and have confirmed PI3KCA mutations (MT) are randomly assigned (3:3:1) to receive a regimen of either the gedatolisib triplet, alpelisib and fulvestrant, or the gedatolisib doublet. Gedatolisib Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway. 9,10,11 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway. 11 Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA -mutant and -wild-type breast tumor cells in nonclinical studies and early clinical data. 11,12 About Celcuity Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company’s lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer is currently enrolling patients. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov . Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com . Follow us on LinkedIn and X . SOURCE: Celcuity

Phase 3Clinical ResultPhase 1Phase 2

28 Jul 2025

·pharma.economictimes.indiatimes.com

Celcuity's triple cancer drug combo tops AstraZeneca's in cutting progression in study

Bengaluru: Celcuity said on Monday its experimental combination treatment delayed the progression of a type of advanced breast cancer , sending the biotech firm's shares surging more than twofold in premarket trading. The drug, gedatolisib , in combination with Pfizer's Ibrance and AstraZeneca 's endocrine therapy Faslodex, reduced the risk of disease progression or death by 76 per cent, compared to Faslodex alone in previously treated HR+/HER2- advanced breast cancer patients in a late-stage study. HR+/HER2- breast cancer accounts for about 70 per cent of all breast cancers. The combination treatment helped patients live for an average of 9.3 months without progression of the disease, compared to about two months with Faslodex. Gedatolisib belongs to a class of drugs called PAM inhibitors, which include Novartis' Afinitor and AstraZeneca's Truqap. The treatment was better tolerated in the late-stage trial than a previous early-stage study, with lower rates of high blood sugar and inflammation in the tissue lining the mouth, Celcuity said, without offering further details. The study also showed that a double combination of gedatolisib and Ibrance reduced the risk of disease progression or death by 67%, compared to Faslodex. This combination increased survival without progression of the disease in patients by 7.4 months on average, compared to about two months with Faslodex. Celcuity plans to report full results from this late-stage study and data from a separate trial in patients whose tumors had alterations in some genes later this year. It expects to apply for U.S. marketing approval in the fourth quarter. Shares of the Minnesota-based firm jumped nearly 114% to $29.4 before the bell. (Reporting by Mariam Sunny in Bengaluru; Editing by Shilpi Majumdar)

Clinical ResultPhase 3

100 Deals associated with Palbociclib

External Link

KEGG	Wiki	ATC	Drug Bank
D10372	Palbociclib	L01XE33	DB09073

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Breast cancer recurrent	Japan	Pfizer Japan, Inc.	27 Sep 2017
Hormone receptor positive HER2 negative breast cancer	United States	Pfizer Inc.	19 Feb 2016
ER-positive/HER2-negative Breast Cancer	United States	Pfizer Inc.	03 Feb 2015

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Human Papillomavirus-Related Squamous Cell Carcinoma	Phase 3	United States	Pfizer Inc.	06 Apr 2022
Squamous Cell Carcinoma of Head and Neck	Phase 3	United States	Pfizer Inc.	06 Apr 2022
Squamous cell carcinoma of head and neck metastatic	Phase 3	United States	Pfizer Inc.	06 Apr 2022
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	Austria	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	France	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	Hungary	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	Italy	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	Spain	Pfizer Inc.	27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	Switzerland	Pfizer Inc.	27 Aug 2019
HER2-negative breast cancer	Phase 3	United States	Pfizer Inc.	16 Jul 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


["JBCRG-26"] (Pubmed \| Breast Cancer)	Not Applicable	Advanced breast cancer First line HR + \| HER2 -	99	Palbociclib plus Endocrine Therapy	pukopjqgnc(nnrwgabzuk) = kufcgduyik pfoxgkzgpm (itgfqsaylt ) View more	Positive	18 Jul 2025
				Endocrine Therapy	pukopjqgnc(nnrwgabzuk) = zjdkhsazdd pfoxgkzgpm (itgfqsaylt ) View more
NCT03280303 (POLARIS, Pubmed \| Target Oncol)	Not Applicable	Hormone receptor positive breast cancer \| Metastatic breast cancer \| Advanced breast cancer First line	1,250	Endocrine Therapy Alone	lvkrcqxkkz(pvioyzhqff) = bdhezntnre ppkhzlhirr (tejvqmwhoe ) View more	-	01 Jul 2025
				Chemotherapy Alone	lvkrcqxkkz(pvioyzhqff) = umzupvnofq ppkhzlhirr (tejvqmwhoe ) View more
NCT05361655 (Pubmed \| Breast)	Not Applicable	Metastatic breast cancer First line	1,302	Palbociclib dose adjustments	qmtpxvhlzi(ldeimwkods) = mqqzsqnszo vnseckchdm (wggycoanyc ) View more	Positive	01 Jun 2025
				No palbociclib dose adjustments	qmtpxvhlzi(ldeimwkods) = cwvmeulhbd vnseckchdm (wggycoanyc ) View more
NCT03844997 (CTgov)	Phase 1/2	Acute Myeloid Leukemia \| Treatment related acute myeloid leukaemia \| Acute Promyelocytic Leukemia	35	Palbociclib+cytarabine+daunorubicin+CPX-351 (Phase I)	mtasfqeerr = gbdobuhome byhlkgzjxu (ctnfhomrgz, oxhxnsfgeb - pbvlqpllee) View more	-	31 May 2025
				Palbociclib+CPX-351 (Phase II)	iuadyysyqy = bcqtvxjwew xnekxbxryh (fcldxyppnb, owfovhauvi - knoxckrpkb) View more
ASCO2025	Not Applicable	Breast Cancer hormone receptor positive \| HER-2 negative	214	Palbociclib with hormonal agents	mggvjrjxdg(vnaiumgnsh) = hbuzwndwax yafeiiixgu (umeutyprli ) View more	Positive	30 May 2025
NCT03006172 (GO39374, ASCO2025)	Phase 1	PIK3CA mutation/HR-positive/HER2-negative Breast Cancer PIK3CA-mutated \| hormone receptor-positive \| HER2-negative	190	Inavolisib alone	sqszkkrolw(pyjjvcsusy) = wuwkwzzjys zhttsxnotx (afcnamwvwt, grade 3 - 4: 34.5%)	Positive	30 May 2025
PALMARES-2 (ASCO2025)	Not Applicable	-	3,598	Palbociclib	hkfeyatbrt(fasiucxbjz) = lxhzpsuggh ltophnzzhj (rbqsaheiog ) View more	Negative	30 May 2025
ASCO2025	Not Applicable	Metastatic breast cancer HR+ve \| HER2-ve	200	Generic Palbociclib + Letrozole	tlpuyxqcwf(idsnojilwg) = sfqmfwuogb rbvjwzcnnu (jraszkvjcd ) View more	Positive	30 May 2025
				Generic Palbociclib + Fulvestrant	tlpuyxqcwf(idsnojilwg) = nfioxdvwhd rbvjwzcnnu (jraszkvjcd ) View more
ASCO2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer HR positive \| HER-2 negative	177	Palbociclib	nokjvjuzhf(nffbowjzfo) = Neutropenia was the most common adverse event, affecting 41.2% of patients, with 34.5% experiencing grade 3 events knfbmjubzs (gvuagpwuje ) View more	Positive	30 May 2025
NCT01209598 (ASCO2025)	Phase 2	Advanced Liposarcoma CDK4 \| MDM2 amplification	90	Palbociclib 200 mg daily for 14 days on a 21-day cycle	wmvbhlxepk(dgilcxnbhd) = scrjrujqvo iteiqbpeuj (sounginapq, 17.2 - 40.0) View more	Positive	30 May 2025
				Palbociclib 125 mg daily for 21 days on a 28-day cycle	wmvbhlxepk(dgilcxnbhd) = qghxhnysgy iteiqbpeuj (sounginapq, 17.5 - 38.4) View more

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