VERZENIO (abemaciclib)
VERZENIO is indicated for the treatment of Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence; Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as initial endocrine-based therapy; Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy; Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
How VERZENIO Works
Abemaciclib functions by inhibiting cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), which are enzymes that drive cell cycle progression. In certain breast cancer cells, these kinases promote the phosphorylation of the retinoblastoma protein, leading to cell proliferation. By blocking this activity, abemaciclib prevents cells from advancing from the G1 phase into the S phase of the cell cycle. This inhibition triggers cellular senescence and apoptosis, effectively reducing tumor size and growth.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-09-28
- Patent Cliff
- 2031
- Revenue
- $1.6B (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
VERZENIO Approval History
What VERZENIO Treats
4 indicationsVERZENIO is approved for 4 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence
- Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as initial endocrine-based therapy
- Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy
- Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting
VERZENIO Target & Pathway
ProTarget
VERZENIO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in VERZENIO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications VERZENIO treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
180 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06498648 | NCI-2024-05665 NCI-2024-05665, 10657 | Ph 1, Ph 2 | recruiting | Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma |
| NCT04633239 | NCI-2020-10084 NCI-2020-10084, 10422 | Ph 1 | recruiting | Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer |
| NCT06654037 | NCI-2024-08691 NCI-2024-08691, 10670 | Ph 1 | recruiting | Testing the Addition of an Anti-Cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (5-Fluorouracil) for Metastatic, Refractory Colorectal Cancer |
| NCT05372640 | NCI-2022-04100 NCI-2022-04100, 10509 | Ph 1 | recruiting | Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors |
| 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 |
| 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 |
| NCT02523014 | A071401 NCI-2015-00546 | Ph 2 | recruiting | Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas |
| NCT04523857 ABBY | UPCC 10119 | Ph 2 | recruiting | ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer |
| 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) |
| NCT04941274 | 210026 21-C-0026 | Ph 1, Ph 2 | recruiting | Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma |
| NCT05872204 ALEPRO | S66468 | Ph 2 | recruiting | Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer |
| NCT06835972 | 24-126 | Ph 1, Ph 2 | recruiting | A Study of Abemaciclib and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC) |
| NCT04305834 | 19206 NCI-2019-08847, 19206 | Ph 2 | recruiting | Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer. |
| NCT05608252 | 22-490 | Ph 1, Ph 2 | recruiting | VS-6766+Abema+Fulv in Met HR+/HER- BC |
| NCT05501704 | 22-225 | Ph 2 | recruiting | ETHAN - ET for Male BC |
| NCT03310879 | 17-343 | Ph 2 | recruiting | Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-Type Cyclins or Amplification of CDK4 or CDK6 |
| 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) |
| NCT03939897 results posted | NCI-2019-02752 NCI-2019-02752, 201911082 | Ph 1 | active not recruiting | Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer |
| NCT06630325 results posted | STUDY00026643 NCI-2024-07664, STUDY00026643 | Ph 2 | terminated | A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer |
| NCT07441369 | GWK-2026-002 | Ph 2 | enrolling by invitation | Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases 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 |
| NCT03706365 CYCLONE 2 results posted | 16598 I3Y-MC-JPCM, 2016-004276-21 | Ph 2, Ph 3 | active not recruiting | A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer |
| NCT03155997 monarchE results posted | 16338 I3Y-MC-JPCF, 2016-004362-26 | Ph 3 | active not recruiting | Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer |
| NCT04750928 | 210011 21-C-0011 | Ph 1, Ph 2 | recruiting | Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas |
| 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 |
| 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) |
| NCT07100106 MoonROSE | GO46021 2025-521128-31-00 | Ph 1, Ph 2 | recruiting | A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer |
| NCT05307705 PIKASSO-01 | 18394 2022-000175-40, J4C-OX-JZUA | Ph 1 | active not recruiting | A Study of LOXO-783 in Patients With Breast Cancer/Other 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) |
| NCT06413706 | 18646 I3Y-MC-JPEH, 2022-502269-13-00 | Ph 2 | active not recruiting | A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy |
| NCT06179303 | RG1122019 NCI-2022-06409, FHIRB0020029 | Ph 2 | recruiting | Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer |
| 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 |
| NCT03994796 | A071701 NCI-2019-00744, U10CA180821 | Ph 2 | active not recruiting | Genetic Testing in Guiding Treatment for Patients With Brain Metastases |
| NCT05440786 results posted | 18434 J1S-MC-JP04, 2023-506772-28-00 | Ph 2 | active not recruiting | CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma |
| NCT06810544 | TNG456-C101 | Ph 1, Ph 2 | recruiting | Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss |
| NCT05113537 UPLIFT | 215510 NCI-2021-11123 | Ph 1, Ph 2 | recruiting | Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer |
| NCT05095207 | GCO 21-0699 | Ph 1, Ph 2 | recruiting | Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer |
| NCT05386108 ELECTRA | ELA-0121 2024-512878-98-00 | Ph 1, Ph 2 | recruiting | Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer |
| NCT07112053 | RG1125521 NCI-2025-04692, 0020922 | Ph 2 | recruiting | A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer |
| 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 |
| NCT06365788 ABBICAR | S66466 2022-502272-23-00 | Ph 2 | recruiting | Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer |
| NCT04486352 EndoMAP | AFT-50 | Ph 1, Ph 2 | recruiting | A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer |
| NCT05735080 INX-315-01 | INX-315-01 | Ph 1, Ph 2 | recruiting | Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer |
| NCT04791384 | Lilly-I3Y-US-I026 | Ph 1, Ph 2 | terminated | Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer |
| NCT06025747 | RG1123382 NCI-2023-05595, RG1123382 | Ph 1 | recruiting | Evaluation of Abemaciclib and Radiation Therapy Before Surgery for the Treatment of High-Risk Adipocytic Retroperitoneal Sarcoma |
| NCT05999994 CAMPFIRE | 17304 J1S-MC-JAAA | Ph 2 | recruiting | A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer |
| NCT07487129 Clinical and P | 7-2025/5 | Ph 4 | completed | Clinical and Pharmacoeconomic Assessment of CDK4/6 Inhibitors for Treatment of Breast Cancer in Egypt |
| NCT05573126 | EP0062-101 | Ph 1, Ph 2 | recruiting | Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer |
| NCT07209449 | 25-164 | Ph 2 | recruiting | A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial 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 |
Showing 50 of 180 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
VERZENIO FDA Label Details
Indications & Usage
FDA Label (PDF)VERZENIO is indicated for the treatment of Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence; Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as initial endocrine-based therapy; Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy; Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
VERZENIO Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for VERZENIO
Revenue Insights
- • Q4-2025: $1.6B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 68 active patents
Trial Analysis
- • 5 total trials
- • Stage: Stable
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment