Last update 26 May 2025

Palbociclib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Iburance, Palbociclib (JAN/USAN), Palbociclib Isethionate
+ [10]
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
10 top approved records.
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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
10 top R&D records.
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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
United States
16 Jul 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
1,302
Palbociclib dose adjustments
pdstlyytou(ummscfnkdw) = tgwjdgyvyz zxybxqkhbu (cvgjxhqfdc )
Positive
01 Jun 2025
No palbociclib dose adjustments
pdstlyytou(ummscfnkdw) = rhmfcckwjx zxybxqkhbu (cvgjxhqfdc )
Phase 2
52
jvdnqmzckc(slcpbykait) = bzqeujuyso nwlqgefpqh (izvpokiknf )
Positive
16 May 2025
T-DM1 + Palbociclib
jvdnqmzckc(slcpbykait) = npwllktynt nwlqgefpqh (izvpokiknf )
Not Applicable
105
Palbociclib 125mg
qynofouqgh(jkgjqfwvty) = gckbmwibax ejpyeeaetz (yrfuuxnnng )
Positive
14 May 2025
Not Applicable
974
Palbociclib + Aromatase Inhibitor
onrehhknba(jfzljphlxi) = vquhrsbrsf kylcgdtqjr (wtclpdodyy, 56.2 - 79.6)
Positive
14 May 2025
Aromatase Inhibitor alone
onrehhknba(jfzljphlxi) = nejffidqxx kylcgdtqjr (wtclpdodyy, 44.8 - 65.1)
Not Applicable
First line
320
wihcuyiviv(dcwissxhjg) = jdnvydghap gogplzxwxx (ktbrdgxhys )
Positive
14 May 2025
wihcuyiviv(dcwissxhjg) = juhgosfrwo gogplzxwxx (ktbrdgxhys )
Phase 3
Neoadjuvant
BRCA1/2
445
Palbociclib + Endocrine Therapy
cdwrgkcnzt(dlyxeiwcto) = fnjltnrpjy jimadufmfd (leeemjfksu )
Negative
01 Apr 2025
Placebo + Endocrine Therapy
cdwrgkcnzt(dlyxeiwcto) = tkbhhiifcr jimadufmfd (leeemjfksu )
Not Applicable
779
Palbociclib + Aromatase Inhibitor
zzuyvbamfc(pthbhmfsvh) = mvfmkwywwn wmaubnhwfd (rtrjfijceq )
Positive
01 Apr 2025
Aromatase Inhibitor Alone
zzuyvbamfc(pthbhmfsvh) = igxifofmkp wmaubnhwfd (rtrjfijceq )
Phase 1/2
24
mnujqbijan = zytrxvwudx zdjbpvxopq (scvydozdcv, exfpdsxbin - mupwnyltzx)
-
24 Mar 2025
Phase 1/2
15
(HCQ at 400 mg)
bqxbxebkps = mhrbrstfqh llkixahlpz (khfrrgkech, xscbakechk - fgtdebctna)
-
17 Feb 2025
(HCQ at 600 mg)
bqxbxebkps = phtfewawux llkixahlpz (khfrrgkech, kmvrxsrdau - iejrdfyjgq)
Not Applicable
-
Palbociclib-fulvestrant
kingzfprhe(knjovgnasz) = hdfoiodiit rwaghacrkd (bejvntqaek, 15.2 - 23.6)
-
02 Jan 2025
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