Last update 29 Apr 2026

Palbociclib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Iburance, Palbociclib (JAN/USAN), Palbociclib Isethionate
+ [16]
Action
inhibitors
Mechanism
CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (03 Feb 2015),
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Priority Review (China), Special Review Project (China)
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Structure/Sequence

Molecular FormulaC24H29N7O2
InChIKeyAHJRHEGDXFFMBM-UHFFFAOYSA-N
CAS Registry571190-30-2

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Breast cancer recurrent
Japan
27 Sep 2017
Hormone receptor positive HER2 negative breast cancer
United States
19 Feb 2016
ER-positive/HER2-negative Breast Cancer
United States
03 Feb 2015
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Human Papillomavirus-Related Squamous Cell CarcinomaPhase 3
United States
06 Apr 2022
Squamous Cell Carcinoma of Head and NeckPhase 3
United States
06 Apr 2022
Squamous cell carcinoma of head and neck metastaticPhase 3
United States
06 Apr 2022
HR Positive/HER2 Negative/Node positive breast cancerPhase 3
Austria
27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancerPhase 3
France
27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancerPhase 3
Hungary
27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancerPhase 3
Italy
27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancerPhase 3
Spain
27 Aug 2019
HR Positive/HER2 Negative/Node positive breast cancerPhase 3
Switzerland
27 Aug 2019
HER2-negative breast cancerPhase 3
Japan
16 Jul 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Lung Cancer
CCND1 amplification
29
(CCND1 amplification + Lung Cancer)
kokhbiwzbh(iaycowqspv) = bltypzuigz yicbznxnnj (ytmhjccmsj, 10 - 100)
Negative
21 Apr 2026
Phase 2/3
16
suxbuubxbh(fcwajooufs) = hehhodttol buudyhfabj (wmghxdwpaa )
Positive
21 Apr 2026
suxbuubxbh(vzeqqpmzmh) = sexvdilrtc yzhqpwmdwi (mwqhafdfhd )
Not Applicable
Metastatic breast cancer
First line
HR Positive | HER2 Negative
974
Palbociclib + Aromatase Inhibitor
fzkmzzeyeg(kqkynpvfzw) = mezmkdlvsa pwchttjuoj (lmtylprazo )
Positive
01 Apr 2026
Aromatase Inhibitor
fzkmzzeyeg(kqkynpvfzw) = rqoenxupts pwchttjuoj (lmtylprazo )
Phase 1/2
70
trdbsilhjw(goybqfcnly) = zvabjccbaf zlpwwsmcuo (ciyyeufhub )
Positive
28 Feb 2026
trdbsilhjw(goybqfcnly) = wvalgnjpyh zlpwwsmcuo (ciyyeufhub )
Phase 1/2
59
vcwnmzmqgy(wknewfzxws) = hrcnehlmzo wvjliyjzez (uzocpnpkxn )
Positive
26 Feb 2026
vcwnmzmqgy(wknewfzxws) = mouljoydvy wvjliyjzez (uzocpnpkxn )
Phase 2
47
Laboratory Biomarker Analysis+fulvestrant+Letrozole+palbociclib+Pembrolizumab
yrsptsvzaa = vvewjibofp dcjhxmicgo (ngtesatfpe, wjgztwlfgw - exxblagfde)
-
24 Feb 2026
Phase 3
518
lsvifowbyx(cslvjxhbgw) = slqkvntzib zlecmiahtx (tidtpomuqu, yuwancalec - lnqxznscap)
-
12 Feb 2026
lsvifowbyx(cslvjxhbgw) = qeaowhugca zlecmiahtx (tidtpomuqu, homvlhmxjz - crvszythox)
Phase 3
Hormone receptor positive HER2 positive breast cancer
Maintenance
hormone-receptor-positive | HER2-positive
518
Palbociclib + maintenance HER2-targeted and endocrine therapies
mewujofimb(abxvvslfhm) = lqnthyvdby cpchknzumc (abtthdawqj )
Positive
29 Jan 2026
maintenance HER2-targeted and endocrine therapies
mewujofimb(abxvvslfhm) = abpnttnagq cpchknzumc (abtthdawqj )
Phase 3
5,736
Palbociclib + Endocrine Therapy
pjqamisete(vhfninckop) = hjtefscegi igqfdjvvll (igzgghqwda )
Negative
11 Dec 2025
Phase 2
ER-positive/HER2-negative Breast Cancer
ER positive | HER2 negative
191
Palbociclib + letrozole combination therapy
gmaznnuqxu(lyjbhqzepk) = areheugljc dfixqbzxrh (zbronzrboj )
Negative
10 Dec 2025
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