CLINICAL TRIALS PROFILE FOR VERZENIO

All Clinical Trials for VERZENIO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02693535 ↗	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	Recruiting	AstraZeneca	Phase 2	2016-03-14	The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact [e-mail], or if a patient, your nearest participating TAPUR site (see participating centers). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************
NCT02693535 ↗	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	Recruiting	Bayer	Phase 2	2016-03-14	The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact [e-mail], or if a patient, your nearest participating TAPUR site (see participating centers). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************
NCT02693535 ↗	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	Recruiting	Boehringer Ingelheim	Phase 2	2016-03-14	The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact [e-mail], or if a patient, your nearest participating TAPUR site (see participating centers). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************
NCT02693535 ↗	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	Recruiting	Bristol-Myers Squibb	Phase 2	2016-03-14	The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact [e-mail], or if a patient, your nearest participating TAPUR site (see participating centers). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************

Clinical Trial Conditions for VERZENIO

Condition Name

Condition Name for VERZENIO
Intervention	Trials
Anatomic Stage IV Breast Cancer AJCC v8	7
Metastatic Breast Carcinoma	6
Prognostic Stage IV Breast Cancer AJCC v8	6
Breast Cancer	6

Condition MeSH

Condition MeSH for VERZENIO
Intervention	Trials
Breast Neoplasms	20
Carcinoma	15
Neoplasms	7
Brain Neoplasms	4

Clinical Trial Locations for VERZENIO

Trials by Country

Trials by Country for VERZENIO
Location	Trials
United States	91
Japan	2
Korea, Republic of	1
Poland	1

Trials by US State

Trials by US State for VERZENIO
Location	Trials
Massachusetts	9
California	7
Missouri	5
Texas	5
Pennsylvania	5

Clinical Trial Progress for VERZENIO

Clinical Trial Phase

Clinical Trial Phase for VERZENIO
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	18
Phase 1/Phase 2	8

Clinical Trial Status

Clinical Trial Status for VERZENIO
Clinical Trial Phase	Trials
Recruiting	23
Not yet recruiting	11
Withdrawn	3

Clinical Trial Sponsors for VERZENIO

Sponsor Name

Sponsor Name for VERZENIO
Sponsor	Trials
Eli Lilly and Company	18
National Cancer Institute (NCI)	13
Dana-Farber Cancer Institute	5

Sponsor Type

Sponsor Type for VERZENIO
Sponsor	Trials
Other	43
Industry	33
NIH	13

Clinical Trials Update, Market Analysis, and Projection for Verzenio (Abemaciclib)

Last updated: October 30, 2025

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Introduction

Verzenio, marketed as Abemaciclib, is a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor developed by Eli Lilly and Company. Originally approved in 2017 by the U.S. Food and Drug Administration (FDA) for advanced or metastatic breast cancer, Verzenio has become a cornerstone in targeted cancer therapies. This report reviews the latest clinical trial data, evaluates current market dynamics, and projects future trends for Verzenio within the oncology pharmaceutical landscape.

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Clinical Trials Update

Ongoing and Recent Trials

Since its initial approval, Verzenio has been evaluated across multiple indications through rigorous clinical trials. As of early 2023, Eli Lilly continues to expand its indications via Phase III and Phase IV trials:

• Neoadjuvant settings: The neoMONARCH trial is investigating Verzenio in combination with endocrine therapy for early-stage hormone receptor-positive (HR+), HER2-negative breast cancer. Preliminary results indicate significant reduction in tumor proliferation markers, suggesting potential for earlier intervention.

• Adjuvant therapy: The NATALEE trial (NEnoadjuvant, adjuvant, and metastatic trials in early breast cancer) is evaluating Verzenio’s efficacy in early-stage HR+/HER2- breast cancer patients at high risk of recurrence. Early data suggest improved disease-free survival (DFS).

• Combination with immunotherapies: Trials such as P3BEMBED are exploring Verzenio in combination with immune checkpoint inhibitors like pembrolizumab, aiming to assess synergistic effects in triple-negative breast cancer (TNBC). While results remain preliminary, initial safety profiles are promising.

• Other Cancer Types: Lilly has sponsored trials assessing Verzenio’s activity in non-breast cancers, including non-small cell lung cancer (NSCLC), ovarian cancer, and glioblastoma, reflecting ongoing exploration of its broader therapeutic potential.

Regulatory Progress

• Additional Approvals: In 2023, the FDA approved Verzenio for use in combination with fulvestrant for the treatment of adult patients with HR+ HER2- advanced or metastatic breast cancer with disease progression following endocrine therapy, broadening its clinical utility.

• Global Initiatives: Lilly has also obtained approvals or submitted filings in key markets like the EU, Japan, and China, emphasizing an expanding global footprint.

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Market Analysis

Current Market Landscape

The CDK4/6 inhibitor class, comprising Pfizer’s Palbociclib, Novartis’ Ribociclib, and Eli Lilly’s Verzenio, is a high-growth segment within oncology. The increasing prevalence of HR+ breast cancers, estimated to account for approximately 70% of breast cancer cases worldwide[1], underpins sustained demand.

• Market Size & Revenue: As of 2022, the global CDK4/6 inhibitor market was valued at over $10 billion, projected to reach approximately $18 billion by 2028, growing at a compound annual growth rate (CAGR) of 10%[2].

• Market Position: Verzenio’s market share in the CDK4/6 inhibitor segment is approximately 30-35%, second to Palbociclib[3]. Its distinct dosing schedule and tolerability profile enable it to penetrate various patient populations efficiently.

• Competitive Advantages: Verzenio exhibits unique pharmacokinetic properties, including less bone marrow suppression and improved gastrointestinal tolerability compared to competitors. Its oral administration and ability to be combined with endocrine therapies enhance its clinical profile.

Market Penetration Drivers

• Expanding Indications: Ongoing clinical trials targeting early-stage and non-breast cancers are likely to expand Verzenio's approved indications, increasing its market addressable population.

• Regulatory Approvals: Faster approval pathways and successful submissions in emerging markets boost revenue streams, enabling Lilly to penetrate diverse healthcare systems.

• Patient-centered Benefits: Improved tolerability and convenience appeal to both physicians and patients, enhancing adherence.

Market Challenges

• Competitive Dynamics: The strong presence of Palbociclib and Ribociclib poses pricing and market share pressures. Differentiation relies on real-world efficacy, side effect profiles, and label expansions.

• Pricing Pressures: Increasing emphasis on cost-effectiveness and biosimilars may impact pricing strategies over the coming years.

• Patent and Exclusivity: Lilly’s patent exclusivity is expected to expire by 2030, opening the potential for biosimilar entrants.

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Future Market Projections

Growth Drivers

• Clinical Expansion: Successful results from ongoing trials could lead to new indications in early-stage and non-breast cancers, significantly enlarging the patient population.

• Global Access: Strategic filings in high-growth markets like China and India are likely to accelerate Verzenio's global sales, especially as cancer mortality rates rise in these regions[4].

• Combination Therapies: The development of Verzenio in combination with immunotherapies and targeted agents promises to enhance treatment paradigms, providing competitive leverage.

Revenue Forecast

Based on current data, industry analysts project Verzenio’s revenues to grow at a CAGR of 12-15% through 2028. In 2022, it reported approximately $2.5 billion in global sales[3], forecasted to surpass $5 billion by 2028, contingent on successful trial transitions and label expansions.

Potential Market Risks

• Pipeline Uncertainty: Mixed or inconclusive clinical trial results could hinder approval or limit label extensions.

• Regulatory Hurdles: Delayed approvals or unfavorable regulatory decisions in key markets could impact revenue forecasts.

• Competitive Launches: Biosimilars or alternative agents entering the market could exert price and market share pressures.

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Conclusion

Verzenio’s clinical development trajectory and expanding indications reinforce its position as a leading CDK4/6 inhibitor. Its shared market dominance is poised for growth, particularly if ongoing trials confirm efficacy in earlier disease stages and other cancer types. The anticipated global expansion and combination regimens are set to drive revenue growth, although challenges such as intensifying competition and patent expiries require strategic planning.

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Key Takeaways

• Clinical Momentum: Ongoing trials are promising, with potential to redefine Verzenio’s therapeutic scope in early and other cancers.

• Market Position: Verzenio remains a serious contender within the CDK4/6 inhibitor class, emphasizing tolerability and combination versatility.

• Growth Prospects: Global expansion initiatives and label extensions are expected to sustain double-digit growth through 2028.

• Market Risks: Competition, patent expiration, and regulatory dynamics necessitate vigilant strategic planning.

• Strategic Focus: Collaborations and robust trial pipelines are pivotal to maintaining Verzenio’s market leadership.

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FAQs

1. What are the primary clinical indications for Verzenio?
Verzenio is primarily indicated for HR+, HER2- advanced or metastatic breast cancer, especially in combination with endocrine therapy. Ongoing studies aim to expand its use to early-stage breast cancer and other tumor types.

2. How does Verzenio differ from other CDK4/6 inhibitors?
Verzenio has a unique dosing schedule and a tolerability profile offering less neutropenia and gastrointestinal toxicity compared to Palbociclib and Ribociclib. Its oral administration and combination flexibility enhance patient compliance.

3. What upcoming clinical trial outcomes could influence Verzenio’s market outlook?
Key trials such as NATALEE, neoMONARCH, and combination studies with immunotherapies are evaluated for efficacy signals that could lead to labels in early-stage disease and broader tumor types.

4. How is Verzenio’s global commercial strategy evolving?
Lilly is actively pursuing regulatory approvals in emerging markets like China and India, tailoring clinical programs to meet regional needs and expanding manufacturing capabilities.

5. What are the main risks for Verzenio’s future market growth?
Risks include intense competition, patent expirations, potential regulatory delays, and market access challenges—particularly if biosimilars or generics emerge.

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Sources

[1] Globocan 2020 World Cancer Report
[2] Market Research Future (MRFR), Oncology Drugs Market Report 2022
[3] Eli Lilly Annual Report 2022
[4] World Health Organization (WHO), Cancer Reports 2021