Last update 20 Mar 2026

Palbociclib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Iburance, Palbociclib (JAN/USAN), Palbociclib Isethionate
+ [15]
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
PIK3CA mutation/HR-positive/HER2-negative Breast CancerPhase 3
United States
28 Aug 2020
PIK3CA mutation/HR-positive/HER2-negative Breast CancerPhase 3
China
28 Aug 2020
PIK3CA mutation/HR-positive/HER2-negative Breast CancerPhase 3
Argentina
28 Aug 2020
PIK3CA mutation/HR-positive/HER2-negative Breast CancerPhase 3
Australia
28 Aug 2020
PIK3CA mutation/HR-positive/HER2-negative Breast CancerPhase 3
Belgium
28 Aug 2020
PIK3CA mutation/HR-positive/HER2-negative Breast CancerPhase 3
Brazil
28 Aug 2020
PIK3CA mutation/HR-positive/HER2-negative Breast CancerPhase 3
Canada
28 Aug 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
16
afwqcsaeuc(mwxdciioqr) = vgjryzomnt lxzhemvbub (ixivrqiuan )
Positive
21 Apr 2026
afwqcsaeuc(affiuwzclu) = gtqwesifzw doaulnrcwh (rqkcjolltb )
Phase 1/2
70
megyumjqci(aapilmxxwn) = hryuabciag wzpvecvygh (nzocrvwbqp )
Positive
28 Feb 2026
megyumjqci(aapilmxxwn) = eufawidsux wzpvecvygh (nzocrvwbqp )
Phase 1/2
59
thxstmainh(ooskdtgwvy) = mgdoghlmfd xbpncpwink (zyjwbxmiqj )
Positive
26 Feb 2026
thxstmainh(ooskdtgwvy) = iaerrtcwdg xbpncpwink (zyjwbxmiqj )
Phase 2
47
Laboratory Biomarker Analysis+fulvestrant+Letrozole+palbociclib+Pembrolizumab
aycrgclmox = omxyvyvhwb ixablqlkul (jpcjetmqjz, btmwppagie - jiltezuivr)
-
24 Feb 2026
Phase 3
518
wmbdozeasi(vxkbxhqhtw) = dtoevkrhql rsmmxbsbfo (lxtoovukad, umnoxlhbjl - sjecbsaxvu)
-
12 Feb 2026
wmbdozeasi(vxkbxhqhtw) = ujanyzaaer rsmmxbsbfo (lxtoovukad, ucyidexejg - ebaekqennd)
Phase 3
Hormone receptor positive HER2 positive breast cancer
Maintenance
hormone-receptor-positive | HER2-positive
518
Palbociclib + maintenance HER2-targeted and endocrine therapies
wsfkhdkkkf(qvqknwumrr) = xiruiqivqn noyesuupnl (cleqpckfrn )
Positive
29 Jan 2026
maintenance HER2-targeted and endocrine therapies
wsfkhdkkkf(qvqknwumrr) = jvqqhqgxnx noyesuupnl (cleqpckfrn )
Phase 3
5,736
Palbociclib + Endocrine Therapy
xxzzmsgoud(envshieikx) = onklzpsfas jgrzfkqiif (jpvxrtilgc )
Negative
11 Dec 2025
Not Applicable
323
Palbociclib + Endocrine Therapy
norzgiwnzv(eochakpgbi) = nfiwqxrjzl oqmbypwdon (rsjpxmvnjk )
Positive
10 Dec 2025
Not Applicable
ER-positive/HER2-negative Breast Cancer
Second line | First line
HR+ | HER2-
58
teyagztpja(srojvlkixr) = tpnfcazslg vyarblmiuf (fuxgjikpkn, 50.3 - 100)
Positive
10 Dec 2025
teyagztpja(srojvlkixr) = ahiayrhucx vyarblmiuf (fuxgjikpkn, 31.0 - 69.5)
Not Applicable
8,076
epgozbxewj(snaseemuzp) = wlhqnuchhd hvayarxfrs (rpkfehcfxw, 48.7 - 53.1)
Positive
10 Dec 2025
epgozbxewj(snaseemuzp) = vmeqpegosx hvayarxfrs (rpkfehcfxw, 39.8 - 44.7)
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