Drug · Small Molecule

Palbociclib

CI-DRUG-00000447Explore in graph →NCIt C49176 CHEMBL189963 CIViC Approved

Regulatory

Approvals (40)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory40 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as PMS-PALBOCICLIB (DIN 02552140) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 27, 2024	health-canada-dpd

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 18 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	103	40	29	256	40	CA, EU, US	Feb 3, 2015	2004-09
Malignant Breast Neoplasm	Approved	Phase 4	42	12	11	113	8	EU, US	Feb 3, 2015	Sep 15, 2008
Malignant Ovarian Neoplasm	Phase4	Phase 4	8	5	0	13	0	—	—	Aug 17, 2015
Malignant Kidney Neoplasm	Phase4	Phase 4	3	1	0	7	0

Curated evidence

Clinical evidence (92)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 51–92 of 92 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
PIK3CA G1049A + PIK3CA G1049C + PIK3CA G1049D + PIK3CA G1049R + PIK3CA G1049S + PIK3CA G106A + PIK3CA G106D + PIK3CA G106R + PIK3CA G106S + PIK3CA G106V + PIK3CA G118D

Clinical trials

Trials with this intervention (283)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 283 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04711252	A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease(SERENA-4)	active not recruiting	Phase 3	1,371	AstraZenecaINDUSTRY	27	Sep 28, 2026	clinicaltrials
NCT05564377	Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

Molecule

Record

Kind: Small Molecule
Mechanism: CDK6/cyclin D1 inhibitor; Cyclin-dependent kinase 4/cyclin D1 inhibitor
Targets: 3 genes
UNII: G9ZF61LE7G
Aliases: 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, IBRANCE, NAT-PALBOCICLIB, Palbociclib, PALBOCICLIB ISETHIONATE, PALBOCICLIBPD-0332991PD0332991IBRANCECS-0019A-1030, Palbociclib Viatris, PD 0332991, PD-0332991, PD0332991, PD-03329910054, PD 332991, PD 991, PF-0008066573, PFE-PKIS 32, PMS-PALBOCICLIB, Pyrido(2,3-d)pyrimidin-7(8H)-one, 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(1-piperazinyl)-2-pyridinyl)amino)-, TARO-PALBOCICLIB

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (33)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EF01	PALBOCICLIB
DIN (Health Canada)	02453150

CCND1 Amplification2
Palbociclib	Malignant Ovarian Neoplasm	Predictive	D	Does Not Support Sensitivity Response	3	accepted	EID1599 A panel of 40 ovarian cancer cell lines with varied mutation profiles was assayed for sensitivity to the cdk4/6 inhibitor palbociclib (PD0332991) via measurement of IC50 values for inhibition of proli… (full text at CIViC) PMID 21278246 · Konecny et al., 2011 · Open in CIViC	civic
〃	Renal Cell CarcinomaCURATED_BROADER	Predictive	D	Does Not Support Sensitivity Response	2	accepted	EID1560 28 renal cell carcinoma cell lines were tested for sensitivity to CDK4/6 inhibitor Palbociclib (PD0332991). 19 were reported sensitive, and 9 resistant. 15 of the 28 cell lines had high levels of Cycl… (full text at CIViC) PMID 23898052 · Logan et al., 2013 · Open in CIViC	civic

CDKN2A Loss3
Palbociclib	Malignant Ovarian Neoplasm	Predictive	D	Supports Sensitivity Response	3	accepted	EID1377 Preclinical study of the effects of PD-0332991 on proliferation, cell-cycle, apoptosis, and Rb phosphorylation in a panel of 40 human ovarian cancer cell lines. Concentration-dependent antiproliferati… (full text at CIViC) PMID 21278246 · Konecny et al., 2011 · Open in CIViC	civic
〃	Renal Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID1373 Preclinical study of CDK4/6 inhibitor PD-0332991 in 28 renal carcinoma cell lines (25 malignant RCC and three non-malignant, transformed cell lines derived from kidney epithelium). Both p15 and p16 lo… (full text at CIViC) PMID 23898052 · Logan et al., 2013 · Open in CIViC	civic
Letrozole + PalbociclibCombination	HER2 Negative Breast CancerUNRESOLVED	Predictive	C	Supports Sensitivity Response	3	accepted	EID1765 A patient with metastatic ER-positive, her2-negative breast cancer with CDKN2A loss experienced a short-lived (~3-month) clinical response to palbociclib when given in combination with letrozole. PMID 26715889 · Gao et al., 2015 · Open in CIViC	civic

CCND1 Overexpression2
Palbociclib	Mantle Cell Lymphoma	Predictive	B	Does Not Support Sensitivity Response	2	accepted	EID1536 A pharmacodynamic study (NCT00420056) of 17 mantle cell lymphoma MCL patients was performed using the CDK4/6 inhibitor palbociclib (PD0332991). Patients were verified by IHC, FISH or molecular testing… (full text at CIViC) PMID 22383795 · Leonard et al., 2012 · Open in CIViC	civic
〃	Mantle Cell Lymphoma	Predictive	D	Supports Sensitivity Response	1	accepted	EID1563 In Mantle Cell Lymphoma (MCL), t(11:14)-induced overexpression of cyclin D1 was targeted by CDK4/6 inhibitor Palbociclib (PD0332991). Palbociclib caused Rb dephosphorylation in MCL cell lines and pati… (full text at CIViC) PMID 16690963 · Marzec et al., 2006 · Open in CIViC	civic

CDK4 EXPRESSION2
Palbociclib	Sarcoma	Predictive	D	Supports Sensitivity Response	4	accepted	EID4872 A preclinical study to explore the efficacy of CDK4/6 inhibition with palbociclib, in a panel of sarcoma cell lines and sarcoma tumor xenografts (PDXs). The responsiveness of these cell lines correlat… (full text at CIViC) PMID 26528855 · Perez et al., 2015 · Open in CIViC	civic
〃	Estrogen Receptor-positive Breast CancerUNRESOLVED	Predictive	B	Supports Sensitivity Response	3	rejected	EID345 Palbociclib has been shown to dramatically improve progression-free survival by over 18 months in patients with ER+ Breast Cancer. PMID 23898052 · Logan et al., 2013 · Open in CIViC	civic

CDK6 Overexpression2
Fulvestrant + PalbociclibCombination	Estrogen Receptor-positive Breast CancerUNRESOLVED	Predictive	D	Supports Sensitivity Response	2	accepted	EID1527 Four fulvestrant (estrogen receptor degrader) resistant cell lines were derived from parent fulvestrant sensitive ER+ MCF-7/SO.5 breast cancer cell line. Derivative cell lines showed some sensitivity … (full text at CIViC) PMID 27252418 · Alves et al., 2016 · Open in CIViC	civic
Palbociclib	Glioblastoma Proneural SubtypeUNRESOLVED	Predictive	D	Supports Sensitivity Response	2	accepted	EID7800 In this study twelve GBM cell lines and normal human astrocytes (NHA) were treated with the CDK4/6 inhibitor palbociclib. NHA and several GBM cell lines were resistant to palbociclib with IC50 values … (full text at CIViC) PMID 28903422 · Li et al., 2017 · Open in CIViC	civic