Last update 06 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),
RegulationAccelerated Approval (United States), Priority Review (China), Special Review Project (China), Breakthrough Therapy (United States)
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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
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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
Not Applicable
1,302
Palbociclib dose adjustments
iblrqxhnpq(boosixeldz) = nyhyiewmdr snklxkegsx (nwxxluqdff )
Positive
01 Jun 2025
No palbociclib dose adjustments
iblrqxhnpq(boosixeldz) = jmclpwszel snklxkegsx (nwxxluqdff )
Not Applicable
779
Palbociclib + Aromatase Inhibitor
oxtdzusfia(wrxogeujoo) = bhrtfjtkjv xnkodfxnnk (kgpmjbvodn )
Positive
01 Apr 2025
Aromatase Inhibitor Alone
oxtdzusfia(wrxogeujoo) = qkbwogphbt xnkodfxnnk (kgpmjbvodn )
Phase 3
Neoadjuvant
BRCA1/2
445
Palbociclib + Endocrine Therapy
chjtnacusd(zutwncjdeq) = obyfjggafj avaxnolhmp (ofntnrcceg )
Negative
01 Apr 2025
Placebo + Endocrine Therapy
chjtnacusd(zutwncjdeq) = fbyabqqbsd avaxnolhmp (ofntnrcceg )
Phase 1/2
24
niuuxzhlbt = troctpmjwj sjldzlclhx (hkmrmumofn, khugorbppj - wehfcwdejq)
-
24 Mar 2025
Phase 1/2
15
(HCQ at 400 mg)
etaatxwnhx = znxwpbzgcy odstznprfs (bfnlhsoacj, hvmcrmgtvd - ptlwoyoqnz)
-
17 Feb 2025
(HCQ at 600 mg)
etaatxwnhx = vacrzmaack odstznprfs (bfnlhsoacj, uxogddqugq - rbzxisrjau)
Not Applicable
-
Palbociclib-fulvestrant
plkayltfsn(wpjkbhncft) = yggjjixlhu xasqpuqxbm (diellqtmxo, 15.2 - 23.6)
-
02 Jan 2025
Phase 2
4
(Fulvestrant)
twgrrsupzx(pacbksialt) = havycarkfe sdizqapqdr (qhbtykeusd, mnipxhuxux - geprjtuwdk)
-
27 Dec 2024
twgrrsupzx(pacbksialt) = qursyeckyp sdizqapqdr (qhbtykeusd, kjnbpzouyj - xlevgruiot)
Phase 3
-
tupxkxbzcg(xyrhufvhht): mean change from baseline = 0.97 (95% CI, 0.05 - 1.89), P-Value = 0.038
Positive
19 Dec 2024
Placebo plus Letrozole
Phase 2
147
(Paclitaxel Plus Trastuzumab and Pertuzumab)
ynhzapfqbz = zisudzakla gsbtvrrcve (ootrwzhjdc, obphjgtnoq - qoclrmdvba)
-
13 Dec 2024
(Palbociclib Plus Letrozole Plus Trastuzumab and Pertuzumab)
ynhzapfqbz = ptwkhxltgm gsbtvrrcve (ootrwzhjdc, mbvtwiaddr - ligxiommta)
Phase 3
Hormone receptor positive HER2 positive breast cancer
First line
HER2 Positive | Hormone Receptor Positive
518
IBRANCE + anti-HER2 therapy + endocrine therapy
txcpihbcrg(towmnhmwgr) = hcnwxtntqk apjqxwnjfy (sizsqhjvbk, 32.4 - 60.9)
Positive
12 Dec 2024
Anti-HER2 therapy + endocrine therapy
txcpihbcrg(towmnhmwgr) = ishhitkmyv apjqxwnjfy (sizsqhjvbk, 23.3 - 38.6)
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