Drugs / Palbociclib
last change today re-read 2 minutes ago

Palbociclib

Small molecule targets CDK4, CDK6, RB1 via inhibition

Developed for
breast cancer · female breast carcinoma · hormone receptor-positive breast cancer · estrogen-receptor positive breast cancer · Her2-receptor negative breast cancer · HER2 positive breast carcinoma · head and neck squamous cell carcinoma · non-small cell lung carcinoma
+133 more · breast neoplasm · cancer · melanoma · metastatic malignant neoplasm · refractory malignant neoplasm · plasma cell myeloma · acute myeloid leukemia · breast carcinoma · colorectal cancer · non-Hodgkin lymphoma · ovarian cancer · clear cell renal carcinoma · Ewing sarcoma · invasive breast carcinoma · lung cancer · mantle cell lymphoma · metastatic malignant neoplasm in the brain · ovarian carcinoma · soft tissue sarcoma · triple-negative breast carcinoma · acute lymphoblastic leukemia · endometrial cancer · esophageal squamous cell carcinoma · head and neck cancer · hepatocellular carcinoma · medulloblastoma · neuroblastoma · pancreatic ductal adenocarcinoma · primary peritoneal carcinoma · progesterone-receptor positive breast cancer · prostate cancer · rhabdoid tumor · rhabdomyosarcoma · urinary bladder cancer · adult glioblastoma · anaplastic astrocytoma · cancer of unknown primary site · childhood medulloblastoma · chordoma · colon carcinoma · colorectal carcinoma · dedifferentiated liposarcoma · endometrial carcinoma · estrogen-receptor negative breast cancer · exocrine pancreatic carcinoma · fallopian tube carcinoma · gliosarcoma · hepatoblastoma · high grade malignant neoplasm · Langerhans cell histiocytosis · liposarcoma · lymphoma · malignant epithelial tumor of ovary · malignant germ cell tumor · malignant glioma · malignant pancreatic neoplasm · myelodysplastic syndrome · osteosarcoma · ovarian serous adenocarcinoma · peripheral primitive neuroectodermal tumor · primary organ-specific lymphoma · progesterone-receptor negative breast cancer · prostate carcinoma · renal cell carcinoma · sarcoma · small cell lung carcinoma · uterine corpus cancer · adult central nervous system germ cell tumor · adult teratoma · anaplastic oligodendroglioma · B-cell acute lymphoblastic leukemia · breast ductal adenocarcinoma · cancer or benign tumor · CDK4 linked melanoma · childhood acute lymphoblastic leukemia · childhood brain stem glioma · childhood cerebellar astrocytic neoplasm · childhood cerebral astrocytoma · childhood choroid plexus neoplasm · childhood ependymoma · colon adenocarcinoma · conventional osteosarcoma · COVID-19 · diffuse intrinsic pontine glioma · digestive system cancer · ductal breast carcinoma in situ · endometrioid adenocarcinoma · ependymoblastoma · ependymoma · esophageal cancer · extragonadal nonseminomatous germ cell tumor · extragonadal seminoma · female reproductive organ cancer · gastrointestinal stromal tumor · giant cell glioblastoma · gliomatosis cerebri · grade III meningioma · histiocytic sarcoma · hormone-resistant breast carcinoma · immature ovarian teratoma · immature teratoma · juvenile xanthogranuloma · kidney Wilms tumor · lung adenocarcinoma · lymphoblastic lymphoma · male breast carcinoma · malignant testicular germ cell tumor · mature ovarian teratoma · medulloepithelioma · metastatic carcinoma · metastatic carcinoma in the bone · metastatic neoplasm · nasopharyngeal carcinoma · non-small cell squamous lung carcinoma · oligoastrocytoma · oligodendroglioma · ovarian monodermal and highly specialized teratoma · pancreas disorder · pancreatic large cell neuroendocrine carcinoma · pancreatic neuroendocrine tumor · papillary renal cell carcinoma · pineoblastoma · rectum adenocarcinoma · salivary gland carcinoma · squamous cell lung carcinoma · supratentorial primitive neuroectodermal tumor · T lymphoblastic leukemia/lymphoma · T-cell acute lymphoblastic leukemia · testicular teratoma · thymus cancer · thyroid gland carcinoma · urothelial carcinoma · Wilms tumor
Investigated by
Pfizer · National Cancer Institute (NCI) · AstraZeneca · Dana-Farber Cancer Institute · Washington University School of Medicine · Genentech, Inc.
+264 more · Hoffmann-La Roche · SOLTI Breast Cancer Research Group · UNICANCER · Abramson Cancer Center at Penn Medicine · Alliance Foundation Trials, LLC. · Bayer · Breast International Group · Bristol-Myers Squibb · ETOP IBCSG Partners Foundation · Georgetown University · M.D. Anderson Cancer Center · Memorial Sloan Kettering Cancer Center · NSABP Foundation Inc · Royal Marsden NHS Foundation Trust · Amgen · Celcuity Inc · Emory University · Fudan University · GBG Forschungs GmbH · Incyte Corporation · Institute of Cancer Research, United Kingdom · MedSIR · Merck Sharp & Dohme LLC · Northwestern University · Novartis · Peter MacCallum Cancer Centre, Australia · Samsung Medical Center · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sun Yat-sen University · Thomas Jefferson University · UNC Lineberger Comprehensive Cancer Center · University of Michigan Rogel Cancer Center · Weill Medical College of Cornell University · West China Hospital · Alliance for Clinical Trials in Oncology · American Society of Clinical Oncology · Apices Soluciones S.L. · Arvinas Estrogen Receptor, Inc. · Assistance Publique - Hôpitaux de Paris · Boehringer Ingelheim · Canadian Cancer Trials Group · Celgene Corporation · Children's Oncology Group · City of Hope Medical Center · Criterium, Inc. · Eisai Inc. · Eli Lilly and Company · European Network of Gynaecological Oncological Trial Groups (ENGOT) · European Organisation for Research and Treatment of Cancer - EORTC · Fondazione Michelangelo · GlaxoSmithKline · Gustave Roussy, Cancer Campus, Grand Paris · Haykel Hospital · Institut Bergonié · Johns Hopkins University · Jonsson Comprehensive Cancer Center · Korean Cancer Study Group · Lebanese University · Massachusetts General Hospital · Mirati Therapeutics Inc. · National Center for Tumor Diseases, Heidelberg · National Institutes of Health (NIH) · OHSU Knight Cancer Institute · Oregon Health and Science University · Peking University Cancer Hospital & Institute · PrECOG, LLC. · Relay Therapeutics, Inc. · Roche Pharma AG · Sanofi · Shengjing Hospital · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Spanish Breast Cancer Research Group · Thomas Hatschek · all 270 on the full record

Regulatory milestones approvals, filings & regulatory actions · 12 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (10) US (FDA) IBRANCE 2016-02-19 – 2026-06-24 fda.gov
Approved EU (EMA) Ibrance 2016-11-09 europa.eu
Approved US (FDA) IBRANCE 2015-02-03 fda.gov

Trials 293 · started per year

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US approved 2015
EU approved 2016
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 05 trials
Phase 0 NCT06959979 Nov 2024 → Aug 2026 overdue childhood medulloblastoma Fondazione Policlinico Universitario Agostino Gemelli IRCCS Recruiting No outcome recorded
Phase 0 NCT04870034 Jan 2024 → Sep 2025 colorectal carcinoma, lung adenocarcinoma Roswell Park Cancer Institute Withdrawn No outcome recorded
Phase 0 NCT05432518 Jun 2023 → Jul 2027 expected adult glioblastoma AHS Cancer Control Alberta Recruiting No outcome recorded
Phase 0 NCT05238831 Jan 2023 → May 2026 female breast carcinoma, ovarian carcinoma, pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 OHSU Knight Cancer Institute Withdrawn No outcome recorded
Phase 0 NCT04130152 Nov 2019 → Jan 2022 breast cancer SOLTI Breast Cancer Research Group Completed No outcome recorded
Phase 179 trials
Phase 1 NCT06654297 Oct 2024 → Jun 2025 overdue esophageal squamous cell carcinoma West China Hospital Active not recruiting No outcome recorded
Phase 1 NCT06113809 Feb 2024 → Jul 2028 expected sarcoma John Rieth Recruiting No outcome recorded
Phase 1 NCT05655598 Sep 2023 → Aug 2024 endometrial cancer, female breast carcinoma, refractory malignant neoplasm, small cell lung carcinoma +2 Brown University Withdrawn No outcome recorded
Phase 1 NCT05627232 Aug 2023 → Jan 2028 expected acute myeloid leukemia Thomas Jefferson University Recruiting No outcome recorded
Phase 1 NCT05759949 Mar 2023 → Mar 2025 PIK3CA-related overgrowth spectrum, hormone receptor-positive breast cancer Relay Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT06307249 Feb 2023 → Dec 2025 overdue breast cancer, colorectal cancer, lung cancer, ovarian cancer Lebanese University Recruiting No outcome recorded
Phase 1 NCT05238922 Jul 2022 → Jul 2027 expected cancer Incyte Corporation Recruiting No outcome recorded
Phase 1 NCT05293964 May 2022 → Dec 2024 overdue breast cancer Jiangsu Simcere Pharmaceutical Co., Ltd. Active not recruiting No outcome recorded
Phase 1 NCT05178888 Jan 2022 → Jun 2023 cancer or benign tumor Mirati Therapeutics Inc. Completed No outcome recorded
Phase 1 NCT05216432 Dec 2021 → Apr 2027 expected Her2-receptor negative breast cancer, PIK3CA-related overgrowth spectrum Relay Therapeutics, Inc. Recruiting No outcome recorded
Phase 1/239 trials
Phase 1/2 NCT06753747 Sep 2025 → Sep 2027 expected esophageal cancer West China Hospital Recruiting No outcome recorded
Phase 1/2 NCT06947811 Jun 2025 → Mar 2027 expected CDK4 linked melanoma Sun Yat-sen University Recruiting No outcome recorded
Phase 1/2 NCT07002177 Jun 2025 → May 2028 expected estrogen-receptor positive breast cancer Forward Pharmaceuticals Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT06843967 Feb 2025 → Aug 2028 expected dedifferentiated liposarcoma, myxoid liposarcoma, pleomorphic liposarcoma, round cell liposarcoma +1 Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 1/2 NCT06757335 Jan 2025 → Jan 2026 overdue breast cancer Hinova Pharmaceuticals Inc. Not yet recruiting No outcome recorded
Phase 1/2 NCT06895733 Nov 2024 → Dec 2025 overdue cancer Tianjin Medical University Second Hospital Recruiting No outcome recorded
Phase 1/2 NCT06364956 May 2024 → Jun 2026 overdue urinary bladder cancer Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Recruiting No outcome recorded
Phase 1/2 NCT05665361 Apr 2024 → Jun 2027 expected clear cell renal carcinoma, papillary renal cell carcinoma National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 1/2 NCT06188520 Dec 2023 → Aug 2027 expected estrogen-receptor positive breast cancer, ovarian serous adenocarcinoma AstraZeneca Recruiting No outcome recorded
Phase 1/2 NCT05953350 Nov 2023 → May 2024 overdue Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Recruiting No outcome recorded
Phase 2131 trials
Phase 2 NCT07527806 May 2026 → May 2029 expected breast cancer Peking University Cancer Hospital & Institute Not yet recruiting No outcome recorded
Phase 2 NCT07191977 Jan 2026 → Dec 2027 expected esophageal squamous cell carcinoma West China Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07300215 Dec 2025 → Nov 2027 expected breast cancer The First Affiliated Hospital of Bengbu Medical University Not yet recruiting No outcome recorded
Phase 2 NCT07299890 Dec 2025 → Nov 2027 expected breast cancer Anhui Provincial Cancer Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07123090 Nov 2025 → Oct 2026 expected clear cell renal carcinoma Stephanie Berg Recruiting No outcome recorded
Phase 2 NCT07037199 Aug 2025 → Jun 2028 expected breast cancer Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Recruiting No outcome recorded
Phase 2 NCT06692491 Jan 2025 → Dec 2027 expected Peking University Shenzhen Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07130643 Dec 2024 → Dec 2026 expected hormone receptor-positive breast cancer Xinhong Wu, PhD Active not recruiting No outcome recorded
Phase 2 NCT06739395 Nov 2024 → Dec 2026 expected cancer Tianjin Medical University Second Hospital Recruiting No outcome recorded
Phase 2 NCT05176288 May 2024 → Aug 2026 clear cell renal carcinoma Bradley A. McGregor, MD Withdrawn No outcome recorded
Show all 131 trials opens the full record — a long page
Phase 2/32 trials
Phase 2/3 NCT02692755 Sep 2016 → Dec 2019 hormone receptor-positive breast cancer Georgetown University Completed No outcome recorded
Phase 2/3 NCT02785939 Sep 2014 → Jun 2017 non-small cell squamous lung carcinoma SWOG Cancer Research Network Completed No outcome recorded
Phase 326 trials
Phase 3 NCT07683754 Sep 2026 → Jul 2030 expected HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer Daiichi Sankyo Not yet recruiting No outcome recorded
Phase 3 NCT06757634 Jul 2025 → Mar 2029 expected breast cancer Celcuity Inc Recruiting No outcome recorded
Phase 3 NCT07005557 Jun 2025 → May 2030 expected breast cancer Fudan University Not yet recruiting No outcome recorded
Phase 3 NCT06377852 Oct 2024 → Aug 2028 expected breast cancer American Society of Clinical Oncology Recruiting No outcome recorded
Phase 3 NCT06380751 Aug 2024 → Mar 2029 expected female breast carcinoma AstraZeneca Recruiting No outcome recorded
Phase 3 NCT06044623 Apr 2024 → Oct 2028 expected breast cancer Region Örebro County Recruiting No outcome recorded
Phase 3 NCT05909397 Aug 2023 → Dec 2026 expected breast cancer Pfizer Active not recruiting No outcome recorded
Phase 3 NCT05501886 Dec 2022 → Jun 2026 overdue breast cancer Celcuity Inc Active not recruiting No outcome recorded
Phase 3 NCT04966481 Apr 2022 → Feb 2028 expected head and neck squamous cell carcinoma Washington University School of Medicine Recruiting No outcome recorded
Phase 3 NCT05207709 Mar 2022 → Mar 2026 breast cancer SOLTI Breast Cancer Research Group Terminated No outcome recorded
Phase 44 trials
Phase 4 NCT05691400 Mar 2024 → Mar 2027 leukodystrophy, hypomyelinating, 22 University of Michigan Rogel Cancer Center Withdrawn No outcome recorded
Phase 4 NCT04137640 Jul 2021 → Nov 2025 breast cancer Shengjing Hospital Unknown No outcome recorded
Phase 4 NCT03355157 Mar 2018 → Aug 2024 breast cancer GBG Forschungs GmbH Completed No outcome recorded
Phase 4 NCT02679755 Mar 2016 → Jul 2019 female breast carcinoma Pfizer Completed No outcome recorded
Phase not applicable6 trials
NCT06810492 Apr → Dec 2025 overdue female breast carcinoma Hongmei Zheng, PhD Not yet recruiting No outcome recorded
NCT06856200 Feb → Oct 2025 overdue Her2-receptor negative breast cancer, hormone-resistant breast carcinoma Fudan University Recruiting No outcome recorded
NCT06478927 Jan 2024 → Jan 2026 overdue hepatocellular carcinoma Henan Cancer Hospital Recruiting No outcome recorded
NCT04801966 Sep 2021 → Dec 2022 cancer Peter MacCallum Cancer Centre, Australia Terminated No outcome recorded
NCT03756090 Dec 2018 → Dec 2019 breast cancer Zhejiang Cancer Hospital Unknown No outcome recorded
NCT05063058 Jan 2016 → Nov 2019 melanoma Charite University, Berlin, Germany Completed No outcome recorded
Phase not stated1 trial
NCT02142868 Her2-receptor negative breast cancer Pfizer No longer available No outcome recorded
Also used as a comparator or background therapy in 45 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT02913430 Comparator Apr 2018 → Apr 2022 breast cancer Shannon Puhalla Completed No outcome recorded
Phase 19 trials
Phase 1 NCT06997029 Background Aug 2025 → Dec 2028 expected breast cancer, ovarian cancer Bristol-Myers Squibb Recruiting No outcome recorded
Phase 1 NCT06941142 Background Apr 2025 → Oct 2027 expected breast cancer CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Not yet recruiting No outcome recorded
Phase 1 NCT05683418 Background Feb 2023 → Dec 2027 expected hormone receptor-positive breast cancer Totus Medicines Recruiting No outcome recorded
Phase 1 NCT05384119 Background Jan 2023 → Apr 2024 female breast carcinoma Tvardi Therapeutics, Incorporated Terminated No outcome recorded
Phase 1 NCT05266105 Background Dec 2021 → Mar 2026 overdue breast cancer Olema Pharmaceuticals, Inc. Active not recruiting No outcome recorded
Phase 1/25 trials
Phase 1/2 NCT07173556 Background Sep 2025 → Feb 2027 expected breast cancer Qilu Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 1/2 NCT06736704 Background Feb 2025 → Apr 2027 expected cancer Pikavation Therapeutics, Inc. Recruiting No outcome recorded
Phase 1/2 NCT05768139 Background Apr 2023 → Jul 2030 expected breast cancer Eli Lilly and Company Recruiting No outcome recorded
Phase 1/2 NCT04946864 Background Aug 2021 → Aug 2024 breast cancer Ascentage Pharma Group Inc. Suspended No outcome recorded
Phase 1/2 NCT03774472 Background Aug 2018 → Apr 2024 female breast carcinoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 213 trials
Phase 2 NCT07180160 Background Sep 2025 → Sep 2027 expected female breast carcinoma Wenjin Yin Recruiting No outcome recorded
Phase 2 NCT06486883 Comparator Jun 2025 → Jan 2027 expected hormone receptor-positive breast cancer MedSIR Recruiting No outcome recorded
Phase 2 NCT06207734 Comparator Jan 2024 → Jan 2027 expected breast cancer Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Recruiting No outcome recorded
Phase 2 NCT06176534 Comparator Jan 2024 → Dec 2025 overdue Her2-receptor negative breast cancer, female breast carcinoma Henan Cancer Hospital Recruiting No outcome recorded
Phase 2 NCT04920708 Background Dec 2022 → Jun 2027 expected estrogen-receptor positive breast cancer Royal Marsden NHS Foundation Trust Active not recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04191499 Background Jan 2020 → Sep 2023 overdue breast cancer Hoffmann-La Roche Active not recruiting No outcome recorded
Phase 312 trials
Phase 3 NCT07492641 Comparator May 2026 → Apr 2029 expected hormone receptor-positive breast cancer BeOne Medicines Recruiting No outcome recorded
Phase 3 NCT07174336 Background Dec 2025 → May 2029 expected breast cancer, metastatic neoplasm Eli Lilly and Company Recruiting No outcome recorded
Phase 3 NCT07061717 Comparator Jul 2025 → Jul 2029 expected hormone receptor-positive breast cancer Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Not yet recruiting No outcome recorded
Phase 3 NCT06760637 Comparator Jan 2025 → Jan 2029 expected breast cancer Pfizer Active not recruiting No outcome recorded
Phase 3 NCT06065748 Background Dec 2023 → Feb 2027 expected estrogen-receptor positive breast cancer Hoffmann-La Roche Recruiting No outcome recorded
Phase 43 trials
Phase 4 NCT07487129 Comparator Aug 2024 → Oct 2025 breast cancer Beni-Suef University Completed No outcome recorded
Phase 4 NCT05949424 Comparator May 2024 → Mar 2025 breast carcinoma, endometrial carcinoma, ovarian carcinoma, renal cell carcinoma +1 University Medical Center Groningen Unknown No outcome recorded
Phase 4 NCT03220178 Background Jul 2017 → Dec 2021 breast cancer Palleos Healthcare GmbH Terminated No outcome recorded
Phase not applicable1 trial
NCT03870919 Background Oct 2019 → Aug 2024 overdue female breast carcinoma UNICANCER Active not recruiting No outcome recorded

Press releases naming this drug 29 releases

DateIssuerRelease
2026-06-24 Pfizer FDA Approves Pfizer’s IBRANCE Regimen for HR+, HER2+ Metastatic Breast Cancer Frontline Maintenance pfizer.com
2024-12-12 Pfizer Pfizer’s IBRANCE® in Combination with Standard-of-Care Therapies Extends Median Progression-Free Survival by Over 15 Months in Phase 3 PATINA Study in Patients with HR+, HER2+ Metastatic Breast Cancer pfizer.com
2022-06-04 Pfizer Pfizer Announces Overall Survival Results from Phase 3 PALOMA-2 Trial of IBRANCE® (palbociclib) for the First-Line Treatment of ER+, HER2- Metastatic Breast Cancer pfizer.com
2021-09-19 Novartis Pharmaceuticals Novartis announces collaboration on HARMONIA, a Phase III, head-to-head trial evaluating Kisqali® vs. Ibrance®* in patients with HR+/HER2- advanced breast cancer novartis.com
2021-03-25 Pfizer Real-World Evidence Supports Effectiveness of First-line IBRANCE® (palbociclib) Combination Therapy in HR+, HER2- Metastatic Breast Cancer pfizer.com
2021-02-05 Pfizer Pfizer Confirms U.S. Patent Term Extension for IBRANCE® (palbociclib) Until March 2027 pfizer.com
2020-10-09 Pfizer PENELOPE-B Trial of IBRANCE® (palbociclib) in Early Breast Cancer Did Not Meet Primary Endpoint pfizer.com
2020-05-29 Pfizer Pfizer Provides Update on Phase 3 PALLAS Trial of IBRANCE® (palbociclib) Plus Endocrine Therapy in HR+, HER2- Early Breast Cancer pfizer.com
2019-09-24 Pfizer Pfizer Presents New Evidence of IBRANCE® (palbociclib) Effectiveness in HR+, HER2- Metastatic Breast Cancer Patients in Four Real-World Studies at ESMO Congress 2019 pfizer.com
2019-04-04 Pfizer U.S. FDA Approves IBRANCE® (palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer pfizer.com
2018-10-20 Pfizer Pfizer Presents Overall Survival Data From PALOMA-3 Trial of IBRANCE® (palbociclib) in Patients With HR+, HER2- Metastatic Breast Cancer pfizer.com
2018-06-25 Pfizer Pfizer Announces Overall Survival Results from Phase 3 PALOMA-3 Trial of IBRANCE® (Palbociclib) in HR+, HER2- Metastatic Breast Cancer pfizer.com

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 342 sources stand behind the page.

FieldValueCited text
Known as Palbociclib Palbociclib (PD-0332991) is an oral, small-molecule inhibitor of cyclin-dependent kinases (CDKs) 4 and 6 with preclinical evidence of growth-inhibitory activity in oestrogen...” PMID 25524798 Dec 2014
319

“Full initial dose of either one of the CDK 4/6-inhibitors: Palbociclib 125 mg x 1 for 21 days with 7 days off; or Ribociclib 600 mg x 1 for 21 days with 7 days off; or...” NCT06044623

Palbociclib is a highly selective, reversible, oral inhibitor of cyclin-dependent kinases 4 and 6 that is approved to treat hormone receptor-positive/human epidermal growth...” PMID 32420697 May 2020

“Cyclin dependant kinase inhibitors (CDK inhibitors) mainly Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM) are approved for treatment of hormone receptor positive,...” NCT05670054

“A Drug-Drug Interaction Study To Investigate The Potential For Multiple Doses Of Palbociclib (PD-0332991) To Alter The Pharmacokinetics Of Oral Midazolam In Adult Healthy Women...” NCT01756781

“Patient receive standard endocrine therapy (ETH) in combination with Palbociclib. palbociclib administered according to standard dosing regimen (125mg /day ) for 3 consecutive...” NCT07487129

Palbociclib is an investigational (experimental) drug that works to induce early G1 arrest by inhibiting CDK4/6, which are two types of CDKs that are overexpressed in AML cell...” NCT03844997

“An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.” NCT00420056

“Phase I-II Open-Label Multicenter Study of Palbociclib + Vemurafenib in BRAF (V600MUT) Metastatic Melanoma Patients: Uncovering CHEK2 as a Major Response Mechanism.” PMID 33947696 May 2021

“Phase 1/2 study of cyclin-dependent kinase (CDK)4/6 inhibitor palbociclib (PD-0332991) with bortezomib and dexamethasone in relapsed/refractory multiple myeloma.” PMID 25813205 May 2015

“A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)” NCT01740427

Palbociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, blocks proliferation in a RB and cyclin D-dependent manner in preclinical prostate cancer models.” PMID 33727260 Mar 2021

“A Study Comparing the Plasma Drug Exposure of an Oral Dose of Palbociclib (PD-0332991) to an Intravenous Dose of Palbociclib (PD-0332991)” NCT01802476

“sequential Trastuzumab rezetecan followed by CDK4/6 inhibitors (Dalpiciclib, Abemaciclib, Ribociclib, Palbociclib) plus endocrine therapy” NCT07037199

“the neoadjuvant treatment regimen of trastuzumab dual-target combined with exemestane and palbociclib for 4 cycles.” NCT07300215

Palbociclib is a highly selective, reversible oral inhibitor of cyclin-dependent kinases (CDK) 4 and 6.” NCT05665361

“physician's choice of CDK4/6 inhibitor (CDK4/6i) including palbociclib, ribociclib, and abemaciclib” NCT06486883

“All patients will receive CDK4/6 inhibitor (abemaciclib/ribociclib/dalpiciclib/palbociclib)” NCT07005557

“Drug: Palbociclib 125mg, orally, once a day concomitantly with ulixertinib” NCT03454035

Palbociclib 125 mg once a day in3 weeks, hereafter pause for one week” NCT04644432

“CDK4/6 inhibitors:dalpiciclib,palbociclib,abemaciclib,ribociclib” NCT07130643

“CDK4/6 inhibitor: * palbociclib * ribociclib * abemaciclib” NCT03227328

palbociclib,Ibrance,ribociclib,Kisqali,abemaciclib,Verzenio” NCT03425838

palbociclib OR ribociclib OR abemaciclib OR dalpiciclib” NCT07180160

“CDK4/6 inhibitors: Palbociclib, Abemaciclib, Ribociclib” NCT07173556

“* CDK4/6i: Palbociclib, Ribociclib or Abemaciclib” NCT05826964

“Cell cycle Inhibitor (Palbociclib 125 mg/d)” NCT05063058

Palbociclib 125mg once daily every 21days” NCT07527806

palbociclib 125mg per day for 21days” NCT06176534

Palbociclib (125mg, po, qd)” NCT05429684

Palbociclib 125mg po D1-21” NCT04819243

palbociclib 125 mg PO qd” NCT06145308

NCT05564377

NCT02730429

NCT04985266

NCT04720768

NCT01904747

NCT04591431

NCT02400567

NCT03535506

NCT04964934

NCT04498520

NCT02530424

NCT04841148

NCT04075604

NCT06757335

NCT04563507

NCT07492641

NCT06997029

NCT03123744

NCT06692491

NCT04423185

NCT03936270

NCT03965845

NCT02592746

NCT02159755

NCT04438824

NCT02603679

NCT04191499

NCT02040857

NCT06757634

NCT02028507

NCT07123090

NCT03784014

NCT02041273

NCT05069038

NCT05067530

NCT03878524

NCT05909397

NCT02465060

NCT03573648

NCT04129151

NCT01209598

NCT03377101

NCT04494958

NCT06940349

NCT03355157

NCT04567420

NCT03526250

NCT04996160

NCT03756090

NCT02871791

NCT07061717

NCT03006172

NCT06947811

NCT05293964

NCT05432518

NCT06843967

NCT03297606

NCT03219554

NCT04856371

NCT05176288

NCT03969121

NCT02942355

NCT06113809

NCT05371275

NCT07683754

NCT01823835

NCT03054363

NCT04047758

NCT03079011

NCT05226871

NCT02085538

NCT05768139

NCT03239015

NCT05178888

NCT03685331

NCT02894398

NCT06307249

NCT02389842

NCT06753747

NCT05563220

NCT03284723

NCT02913430

NCT02806050

NCT06856200

NCT02448771

NCT04334330

NCT07191977

NCT03423199

NCT06377852

NCT05501886

NCT04711252

NCT02491983

NCT03709082

NCT03809988

NCT01906125

NCT02059330

NCT04870034

NCT03284957

NCT03242382

NCT03322215

NCT01942135

NCT02334527

NCT03472573

NCT02513394

NCT04693468

NCT03959891

NCT02605486

NCT06654297

NCT03498378

NCT03628066

NCT01918176

NCT02925234

NCT07299890

NCT06390839

NCT04360941

NCT05655598

NCT03304080

NCT03088059

NCT02549430

NCT02097329

NCT02297438

NCT03609047

NCT03819010

NCT05766410

NCT05683418

NCT04862663

NCT06895733

NCT04072952

NCT04130152

NCT05935748

NCT05190094

NCT07002177

NCT02905318

NCT02142868

NCT06810492

NCT03220178

NCT03132454

NCT05867251

NCT06570031

NCT04818632

NCT06188520

NCT02684032

NCT06364956

NCT05865132

NCT02738866

NCT03560531

NCT04931342

NCT03854903

NCT03220191

NCT05468697

NCT02536742

NCT02947685

NCT02384239

NCT02499120

NCT04946864

NCT02679755

NCT06760637

NCT02624973

NCT02501902

NCT03238196

NCT02693535

NCT02131298

NCT03792256

NCT04669587

NCT05949424

NCT04966481

NCT02630693

NCT02690480

NCT02334800

NCT04288089

NCT02296801

NCT03386929

NCT02778685

NCT02664935

NCT03560856

NCT03446157

NCT06062498

NCT04247633

NCT03774472

NCT06941142

NCT03065062

NCT05953350

NCT04483505

NCT01953731

NCT07174336

NCT03065387

NCT06126276

NCT03110744

NCT04224272

NCT04318223

NCT03981614

NCT03900884

NCT03709680

NCT03065621

NCT02499146

NCT03447132

NCT03332797

NCT02065063

NCT04185883

NCT03424005

NCT02806648

NCT04060862

NCT06065592

NCT03024489

NCT02222441

NCT02311946

NCT06065748

NCT02785939

NCT03128619

NCT02349633

NCT06478927

NCT02448420

NCT05039177

NCT05694871

NCT05759949

NCT03515200

NCT05076695

NCT02764541

NCT03616587

NCT03633331

NCT04858516

NCT02030483

NCT05554367

NCT03184090

NCT02530320

NCT04546009

NCT05691400

NCT03455270

NCT03478514

NCT04256941

NCT01864746

NCT05207709

NCT02626507

NCT02255461

NCT02592083

NCT03007979

NCT05238922

NCT04872608

NCT05266105

NCT03870919

NCT04220476

NCT03170206

NCT03158389

NCT06380751

NCT04553133

NCT05238831

NCT02022982

NCT03530696

NCT05384119

NCT03389477

NCT02907918

NCT04478266

NCT03194373

NCT05627232

NCT03471663

NCT04137640

NCT03454919

NCT04436744

NCT04802759

NCT06739395

NCT02083640

NCT04585724

NCT05725200

NCT03147287

NCT02668666

NCT04439201

NCT04605562

NCT03820830

NCT05216432

NCT03691493

NCT02774681

NCT04858997

NCT04801966

NCT03155620

NCT04920708

NCT03644186

NCT02692755

NCT02917005

NCT02310243

NCT06736704

NCT02600923

NCT04606446

NCT02760030

NCT06959979

NCT02599714

NCT02897375

NCT06207734

NCT02896335

Known as Ibrance “Palbociclib (IBRANCE®) is a kinase inhibitor FDA approved for the following indications: treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor...” NCT06843967
8

“This phase I study estimated the effect of food on bioavailability of palbociclib (IBRANCE®), and a selective inhibitor of cyclin-dependent kinase 4/6 approved for oncology...” PMID 28204912 Feb 2017

“(1) Palbociclib (trade name: Ibrance®; Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany; imported drug license No. H20180040): 125 mg/capsule, 1 capsule by mouth once a day” NCT04047758

“The purpose of this study is to find out what effects, good and/or bad, Palbociclib (Ibrance) (formerly known as PD0332991) has on the patient and on the liposarcoma.” NCT01209598

“Palbociclib (Ibrance) is an oral capsule or tablet administered once daily with food on Days 1-21 of every 28-day cycle in combination with telaglenestat.” NCT03965845

“Drug: Palbociclib Participants will receive oral palbociclib on days 1-21 of each 28-day cycle. Other Names: • IBRANCENCT06757634

“Part C: Daily oral dosages of ARV-471 for 28 days in combination with palbociclib (IBRANCE®) for 21 days” NCT04072952

“Palbociclib (Ibrance) (PO), dose= 125 mg PO daily, days=1-14, cycle length: 21 days” NCT03194373

“palbociclib (Ibrance®️, Pfizer Inc.)” NCT05266105

Known as PAL “Cyclin dependant kinase inhibitors (CDK inhibitors) mainly Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM) are approved for treatment of hormone receptor positive,...” NCT05670054
Known as Palbociclib isethiolate ChEMBL registry synonym — accepted as the source's own label CHEMBL189963
Known as palbociclib isethionate “This phase I trial studies the side effects and best dose of palbociclib isethionate in treating younger patients with central nervous system tumors that have grown, come back,...” NCT02255461
Known as palbociclib, PD-0332991 palbociclib, PD-0332991NCT01953731
4

Palbociclib, PD-0332991NCT02222441

“palbociclib (PD0332991)” NCT02806648

Palbociclib, PD-0332991NCT02334800

“Palbociclib=PD-0332991” NCT01976169

Known as PALBOCICLIBPD-0332991PD0332991IBRANCECS-0019A-1030 ChEMBL registry synonym — accepted as the source's own label CHEMBL189963
Known as PD 0332991-0054 ChEMBL registry synonym — accepted as the source's own label CHEMBL189963
Known as PD-0332991 “A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The...” NCT01684215
40

“Phase I Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell...” NCT03065062

“An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.” NCT00420056

“A Phase 1, Open-Label, 6 Sequence, 3 Period, Crossover Study Of Palbociclib (PD-0332991) In Healthy Volunteers To Estimate The Relative Bioavailability Of 3 Palbociclib Formulations” NCT02083640

“A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]” NCT02297438

“The purpose of this study is to find out what effects, good and/or bad, Palbociclib (Ibrance) (formerly known as PD0332991) has on the patient and on the liposarcoma.” NCT01209598

“A Phase 1, Open-label, Single Dose, Parallel-group Study To Evaluate The Pharmacokinetics Of Palbociclib (Pd-0332991) In Subjects With Impaired Renal Function” NCT02085538

“A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)” NCT01740427

“Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)” NCT01942135

“A Study Comparing the Plasma Drug Exposure of an Oral Dose of Palbociclib (PD-0332991) to an Intravenous Dose of Palbociclib (PD-0332991)” NCT01802476

“Drug Interaction Study To Investigate The Potential Effect Of Proton Pump Inhibitor On The Pharmacokinetics Of Palbociclib (PD-0332991)” NCT01918176

“This multicenter phase II trial will evaluate palbociclib (PD-0332991) in patients with metastatic urothelial carcinoma (UC)” NCT02334527

“A Study To Establish The Equivalence Of 2 Palbociclib (PD-0332991) Formulations To The Intended Final Market Product” NCT01906125

“Palbociclib (PD-0332991) is an oral, small-molecule inhibitor of cyclin-dependent kinases (CDKs) 4 and 6” PMID 25524798 Dec 2014

PD-0332991 was administrated orally, formulated as gelatin capsules of 100 mg and 25 mg respectively.” NCT01907607

“neratinib plus palbociclib (PD-0332991) compared to neratinib maleate (neratinib) alone” NCT06126276

“Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions” NCT02041273

“Palbociclib (PD-0332991), a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor” NCT01864746

“PD0332991 (Oral CDK 4/6 Inhibitor)” NCT01709370

“Palbociclib (PD-0332991)” NCT02097329

PD-0332991 (Palbociclib)” NCT02690480

“Palbociclib (PD0332991)” NCT02530320

NCT01821066

NCT02008734

NCT01111188

NCT01723774

NCT01536743

NCT00141297

NCT01756781

NCT01907607

NCT01976169

NCT01522989

NCT01227434

NCT01602887

NCT01320592

NCT01701375

NCT01356628

NCT01037790

NCT01291017

NCT02101034

NCT01709370

Known as PD-0332991, palbociclib PD-0332991, palbociclibNCT01821066
Known as PF-00080665-73 ChEMBL registry synonym — accepted as the source's own label CHEMBL189963
Known as PFE-PKIS 32 ChEMBL registry synonym — accepted as the source's own label CHEMBL189963
Action Inhibit “PD-0332991 is in a new class of drugs called cyclin-dependent kinase (CDK inhibitors).” NCT00141297
Modality Small molecule “Palbociclib (PD-0332991) is an oral, small-molecule inhibitor of cyclin-dependent kinases (CDKs) 4 and 6 with preclinical evidence of growth-inhibitory activity in oestrogen...” PMID 25524798 Dec 2014
Route Oral “Dose ranging study - evaluating two oral schedule: (1) 3/1 Schedule - PD-0332991 administered days 1-21 of a 28-day schedule, doses ranging from 25 to 150 mg once daily; (2)...” NCT00141297
Target CDK4 “selective CDK4/6 inhibitor PD0332991” PMID 22383795 Mar 2012