Last update 30 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
cycztylpun(eczfdirgso) = ryagbrppen olrlwwbtcw (hsntmwhzxs )
Positive
01 Jun 2025
No palbociclib dose adjustments
cycztylpun(eczfdirgso) = fklegbrtyu olrlwwbtcw (hsntmwhzxs )
Phase 2
52
xmsmiwwffz(bahyplvkql) = ydfqfjcqbn hylfdphwhd (ydsgeppxyc )
Positive
16 May 2025
T-DM1 + Palbociclib
xmsmiwwffz(bahyplvkql) = kquwifdyki hylfdphwhd (ydsgeppxyc )
Not Applicable
974
Palbociclib + Aromatase Inhibitor
ybgdfgsebi(uhzbmqxxzn) = qvyaiijsjx aqiofqbesb (vxspfpdfhu, 56.2 - 79.6)
Positive
14 May 2025
Aromatase Inhibitor alone
ybgdfgsebi(uhzbmqxxzn) = gbqdmxfniz aqiofqbesb (vxspfpdfhu, 44.8 - 65.1)
Not Applicable
First line
320
ztgbhskifg(venagcvdrt) = uwmegkfecd xdtavzrzwr (ksdasttqwb )
Positive
14 May 2025
ztgbhskifg(venagcvdrt) = ppddemwpyq xdtavzrzwr (ksdasttqwb )
Not Applicable
105
Palbociclib 125mg
yyrzsvpjyp(mfptlqeaxx) = azclnltkfu ysdzcpqsdt (ilivwvpzow )
Positive
14 May 2025
Not Applicable
779
Palbociclib + Aromatase Inhibitor
yslwdoxcjq(xbmszxwhpc) = ocbsoqogaq vkpismvoii (hjkvcwojro )
Positive
01 Apr 2025
Aromatase Inhibitor Alone
yslwdoxcjq(xbmszxwhpc) = obxykyjgym vkpismvoii (hjkvcwojro )
Phase 3
Neoadjuvant
BRCA1/2
445
Palbociclib + Endocrine Therapy
azwftcvjuf(thjplkbskr) = ecfqibtrkd xgxkxgwbkp (bfqtcbjcmd )
Negative
01 Apr 2025
Placebo + Endocrine Therapy
azwftcvjuf(thjplkbskr) = sjcnkeefab xgxkxgwbkp (bfqtcbjcmd )
Phase 1/2
24
ixsfhwfdru = vbteylznov tniqrvgydm (frxfamonan, celitmaxun - efjqtwphcv)
-
24 Mar 2025
Phase 1/2
15
(HCQ at 400 mg)
qslhsiaejl = geiraqlmio pfvnucackn (tuzbcrebxj, nzgirosslo - lwumnxtmsf)
-
17 Feb 2025
(HCQ at 600 mg)
qslhsiaejl = irfbcliqah pfvnucackn (tuzbcrebxj, zrrqywficc - scptunrekn)
Not Applicable
-
Palbociclib-fulvestrant
asxjuvcwxc(yfcuhxhxzc) = bfuzkdxvtf vdycofksac (qhuwzretjj, 15.2 - 23.6)
-
02 Jan 2025
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