TheraRadar
Data updated: May 26, 2026

PALBOCICLIB

Oncology Approved 2024-06-05
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Years on Market

Details

Status
None (Tentative Approval)
First Approved
2024-06-05
Routes
ORAL
Dosage Forms
CAPSULE, TABLET

Companies

Dr. Reddy's AIZANT DRUG RESEARCH SOLUTIONS PVT LTD NATCO PHARMA LTD Sun Pharma Cipla MSN PHARMACEUTICALS INC ZYDUS LIFESCIENCES EUGIA PHARMA SPECLTS
Active Ingredient: PALBOCICLIB

PALBOCICLIB Approval History

2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2024 to 2024
Jun 2024 ORIGINAL
Update
FDA Letter

What PALBOCICLIB Treats

1 FDA approvals

Originally approved for its first indication in 2024 .

  • Other (1)
📋

Clinical Trial Registry

185 trials
Trial Sponsor ID Phase Status Title
NCT02465060 NCI-2015-00054 NCI-2015-00054, EAY131 Ph 2 active not recruiting Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
NCT05554367 NCI-2022-07266 NCI-2022-07266, EAY191-A3 Ph 2 active not recruiting Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial
NCT06377852 Pro00075309 Ph 3 recruiting The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study
NCT06126276 NCI-2023-09270 NCI-2023-09270, EAY191-N5 Ph 2 recruiting Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
NCT05564377 NCI-2022-06842 NCI-2022-06842, EAY191 Ph 2 recruiting Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
NCT07405164 6482-043 U1111-1325-4582, 2025-524160-38-00 Ph 3 recruiting Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
NCT03609047 Appalaches EORTC 1745-ETF-BCG Ph 2 active not recruiting Adjuvant Palbociclib in Elderly Patients With Breast Cancer
NCT04802759 CO42867 2020-004889-19, 2023-507495-48-00 Ph 1, Ph 2 recruiting A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
NCT05694871 A092107 NCI-2022-08568 Ph 2 active not recruiting Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma
NCT06188520 CYCAD-1 D8470C00001 Ph 1, Ph 2 recruiting A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors
NCT06065748 CO44657 2022-502980-39-00 Ph 3 recruiting A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
NCT03155620 results posted NCI-2017-01251 NCI-2017-01251, APEC1621SC Ph 2 active not recruiting Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)
NCT02942355 IRB00081369 00017766, LCI-BRE-H2N-ANPA-001 Ph 2 active not recruiting Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer
NCT03633331 results posted A171601 NCI-2017-01596 Ph 2 completed Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer
NCT07174336 27726 J6M-MC-JSGD, 2025-522791-92-00 Ph 3 recruiting A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
NCT03784014 MULTISARC C16-40 2024-514873-22-00, 2017-002851-27 Ph 3 completed Molecular Profiling of Advanced Soft-tissue Sarcomas
NCT02664935 RG_14-072 2014-000814-73, ISRCTN38344105 Ph 2 completed National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer
NCT07492641 KANDELA-302 BGB-43395-302 2025-523960-19-00 Ph 3 not yet recruiting BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease
NCT05768139 PIKALO-1 27691 2023-504807-94-00, 2023-000442-41 Ph 1, Ph 2 recruiting First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
NCT05683418 TOS-358-001 2023-505346-26-01 Ph 1 recruiting A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer
NCT04964934 SERENA-6 D8534C00001 2023-503990-39-00, 2021-000546-17 Ph 3 active not recruiting Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
NCT03389477 results posted 201802162 Ph 2 active not recruiting Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma
NCT06997029 CA243-0001 2025-524334-26-00, U1111-1330-3304 Ph 1 recruiting A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
NCT04862663 CAPItello-292 D361DC00001 2020-004637-20 Ph 3 recruiting Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
NCT04966481 202108203 Ph 3 recruiting Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor
NCT04996160 IRB-60392 NCI-2021-09313 Ph 1 completed Palbociclib in Combo w/Chemotherapy in Peds Relapsed/Refractory Acute Lymphoblastic Leukemia
NCT04606446 KAT6 C4551001 NCT04606446 Ph 2 recruiting Study of PF-07248144 in Advanced or Metastatic Solid Tumors
NCT03132454 2016-0772 NCI-2018-01194, 2016-0772 Ph 1 active not recruiting Palbociclib and Sorafenib, Decitabine, or Dexamethasone in Treating Patients With Recurrent or Refractory Leukemia
NCT05238922 INCB 123667-101 2021-005357-91 Ph 1 recruiting Study of INCB123667 in Subjects With Advanced Solid Tumors
NCT06380751 EvoPAR-BR01 D9722C00001 Ph 3 recruiting Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
NCT04439201 results posted NCI-2020-03171 NCI-2020-03171, EAY131-Z1B Ph 2 active not recruiting Testing Palbociclib (PD-0332991) as a Potential Targeted Treatment in Cancers With CCND1, 2, 3 Amplification (MATCH-Subprotocol Z1B)
NCT02159755 NCI-2014-01202 NCI-2014-01202, 1403014853 Ph 1 active not recruiting Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma
NCT06390839 results posted NCI-2024-01137 NCI-2024-01137, EAY131-Z1C Ph 2 active not recruiting Testing Palbociclib (PD-0332991) as Potentially Targeting Treatment in Cancers With CDK4 or CDK6 Amplification (MATCH - Subprotocol Z1C)
NCT04841148 PALAVY UPCC 01121 IRB# 848471, TBCRC 046 Ph 2 recruiting Avelumab or Hydroxychloroquine With or Without Palbociclib to Eliminate Dormant Breast Cancer
NCT03478514 AFT-32 Ph 2 active not recruiting Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma
NCT04360941 PAveMenT CCR4884 Ph 1 recruiting PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer
NCT03526250 results posted NCI-2018-00863 NCI-2018-00863, APEC1621I Ph 2 completed Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial)
NCT02693535 TAPUR Pro00014171 Ph 2 recruiting TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer
NCT03297606 CAPTUR PM1 ESR-17-12831, CA209-9DL Ph 2 recruiting Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)
NCT05039177 HERKULES-3 ERAS-007-03 Ph 1, Ph 2 completed A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies
NCT07123090 SPARCC 25-258 Ph 2 recruiting A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma
NCT03573648 ImmunoADAPT J1836 IRB00164275, WI231034 Ph 2 active not recruiting Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer
NCT04191499 INAVO120 results posted WO41554 2019-002455-42, 2023-505812-39-00 Ph 2, Ph 3 active not recruiting A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
NCT03424005 Morpheus-panBC CO40115 2017-002038-21, 2023-503629-20-00 Ph 1, Ph 2 recruiting A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
NCT06843967 24-344 Ph 1, Ph 2 recruiting A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma
NCT06736704 SNV4818-101 Ph 1, Ph 2 recruiting SNV4818 in Participants With Advanced Solid Tumors
NCT02896335 16-254 Ph 2 recruiting Palbociclib and Pembrolizumab In Central Nervous System Metastases
NCT05627232 22G.769 JT 24252, 4100095617 Ph 1 recruiting Tazemetostat and Palbociclib With CPX-351for R/R AML
NCT03006172 GO39374 2016-003022-17, 2023-508124-36-00 Ph 1 active not recruiting To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer
NCT03446157 results posted LCCC1717 Ph 2 completed Palbociclib and Cetuximab in Metastatic Colorectal Cancer

Showing 50 of 185 trials

🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PALBOCICLIB FDA Label Details

Looking for the branded version?

IBRANCE

Full clinical data, patents, trials, and competitive landscape for palbociclib.

See IBRANCE

Data Sources

FDA Approval: ANDA213091 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.