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Last Updated: April 3, 2026

CLINICAL TRIALS PROFILE FOR ABEMACICLIB


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All Clinical Trials for abemaciclib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01394016 ↗ A Phase 1 Study of LY2835219 In Participants With Advanced Cancer Active, not recruiting Eli Lilly and Company Phase 1 2009-12-07 The purpose of this study is to determine a safe dose of LY2835219 to be given to participants with advanced cancer and to determine any side effects that may be associated with LY2835219 in this population. Efficacy measures will be used to assess the activity of LY2835219 in this population.
NCT01655225 ↗ A Study of LY3023414 in Participants With Advanced Cancer Active, not recruiting Eli Lilly and Company Phase 1 2012-07-31 The purpose of this study is to find a recommended dose level and schedule of dosing LY3023414 that can safely be taken by participants with advanced or metastatic cancer. The study will also explore the changes to various markers in blood cells and potentially tumor cells. Finally, the study will help document any antitumor activity this drug may have. In Part A of this study, participants with advanced/metastatic cancer (including lymphoma) will receive increasing doses of LY3023414. In Part B, LY3023414 will be explored in different types of cancer, including breast and lung cancer, lymphoma and mesothelioma.
NCT01739309 ↗ Study of LY2835219 for Mantle Cell Lymphoma Active, not recruiting Eli Lilly and Company Phase 2 2013-03-20 The purpose of this study is to estimate the disease control rate with abemaciclib for relapsed or refractory mantle cell lymphoma.
NCT01913314 ↗ A Study of Carbon-14-Labeled LY2835219 ([^14C]-LY2835219) in Healthy Participants Completed Eli Lilly and Company Phase 1 2013-08-01 This type of study is called a radiolabeled study. For this study, LY2835219 (study drug) has been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally occurring radioactive form of the element carbon. This study will help understand how the drug appears in the blood, urine, and stool after it is administered. In addition, this study will also evaluate the safety and tolerability of a single dose of LY2835219 when given to healthy participants. Information about any side effects that may occur will also be collected. This study will last about 3 weeks for each participant, not including screening.
NCT02014129 ↗ A Study of LY2835219 in Japanese Participants With Advanced Cancer Completed Eli Lilly and Company Phase 1 2013-12-18 The main purpose of this study is to evaluate safety and side effects of LY2835219 in Japanese participants with advanced cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for abemaciclib

Condition Name

Condition Name for abemaciclib
Intervention Trials
Breast Cancer 46
Metastatic Breast Cancer 24
Neoplasm Metastasis 9
Advanced Cancer 8
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Condition MeSH

Condition MeSH for abemaciclib
Intervention Trials
Breast Neoplasms 100
Neoplasms 27
Carcinoma 18
Neoplasm Metastasis 15
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Clinical Trial Locations for abemaciclib

Trials by Country

Trials by Country for abemaciclib
Location Trials
United States 972
China 120
Spain 111
Japan 83
Italy 83
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Trials by US State

Trials by US State for abemaciclib
Location Trials
Texas 57
California 52
New York 51
Massachusetts 49
Florida 45
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Clinical Trial Progress for abemaciclib

Clinical Trial Phase

Clinical Trial Phase for abemaciclib
Clinical Trial Phase Trials
PHASE3 7
PHASE2 13
PHASE1 10
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Clinical Trial Status

Clinical Trial Status for abemaciclib
Clinical Trial Phase Trials
Recruiting 108
Not yet recruiting 32
Active, not recruiting 24
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Clinical Trial Sponsors for abemaciclib

Sponsor Name

Sponsor Name for abemaciclib
Sponsor Trials
Eli Lilly and Company 111
National Cancer Institute (NCI) 21
Dana-Farber Cancer Institute 11
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Sponsor Type

Sponsor Type for abemaciclib
Sponsor Trials
Industry 189
Other 163
NIH 21
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Clinical Trials Update, Market Analysis, and Projection for Abemaciclib

Last updated: January 1, 2026

Executive Summary

Abemaciclib, marketed as Verzenio by Eli Lilly and Company, is a selective CDK4/6 inhibitor approved for treating hormone receptor-positive, HER2-negative (HR+/HER2−) advanced or metastatic breast cancer. Over the past year, clinical developments, regulatory approvals, and market trends have shaped its positioning in oncology therapeutics. This report offers an in-depth review of recent clinical trial updates, analyzes current market dynamics, and provides future projections based on emerging data, competitive landscape, and evolving regulatory policies.


Clinical Trials Update for Abemaciclib

Latest Phase III Trials and Outcomes

Trial Name Status Patient Population Key Results Date Source
MONARCH 3 Completed (2021) HR+/HER2− early-stage breast cancer Significant improvement in invasive disease-free survival (iDFS); 5-year iDFS rate increased by 8% vs placebo February 2021 [1]
MONARCH 2 Completed (2020) HR+/HER2− metastatic breast cancer Median PFS: 16.4 months (Abemaciclib + fulvestrant) vs 9.3 months (fulvestrant alone) December 2020 [2]
NATALEE (Clinical Trial) Ongoing (Phase III) Early-stage HR+/HER2− breast cancer Awaiting primary endpoint data; designed to evaluate disease-free survival additional to prior adjuvant therapy Initiated 2020 ClinicalTrials.gov [3]
MonarchE (Adjuvant) Ongoing (Phase III) High-risk early-stage HR+/HER2− breast cancer Preliminary reports indicate promising efficacy in reducing recurrence Active monitoring Company reports [4]

Regulatory Highlights

  • FDA Approval: Abemaciclib received accelerated approval in 2017 for HR+/HER2− advanced or metastatic breast cancer in combination with endocrine therapy.
  • EMA Status: Approved in Europe for similar indications, with additional approvals for adjuvant settings pending.
  • Label Expansion: In 2023, the FDA approved a new 150 mg dose for continuous administration, with updated safety monitoring guidelines.

Ongoing and Future Trials

Trial Name Phase Objective Expected Completion Notes
MONARCH 2B III Combination with novel agents in resistant cases 2024 Targeting resistant HR+/HER2− subsets
ABEMACICLIB-CANCER-RESPONSE III Monotherapy in triple-negative breast cancer 2025 Explores broader applicability
PROLONGER III Adjuvant therapy in high-risk early breast cancer 2026 Assessing long-term survival benefits

Market Analysis of Abemaciclib

Current Market Landscape

Parameter Details
Global Market Size (2022) Estimated at $1.8 billion for CDK4/6 inhibitors
Market Share (2022) Abemaciclib: 30%; Palbociclib: 45%; Ribociclib: 25%
Key Companies Eli Lilly (Verzenio), Pfizer (Ibrance), Novartis (Kisqali)
Pricing (2023) Approx. $14,000/month (U.S. retail price)
Patent Status Patent protection till 2032; biosimilars not yet available

Epidemiology & Commercial Penetration

  • Indication Population: Approximately 4 million women globally with HR+/HER2− early or advanced breast cancer.
  • Market Penetration: Lilly’s Verzenio holds about 30% in the CDK4/6 class, driven by its tolerability profile and combination efficacy.

Competitive Positioning

Attribute Abemaciclib (Verzenio) Palbociclib (Ibrance) Ribociclib (Kisqali)
Administration Frequency Twice daily Once daily Once daily
Side Effect Profile Diarrhea, fatigue; lower myelosuppression Neutropenia, fatigue Neutropenia, hepatotoxicity
Efficacy in Monotherapy Eligible in some cases; ongoing trials Typically used with endocrine therapy Approved with endocrine therapy
FDA Approval (Year) 2017 2015 2017

In-Depth Market Drivers and Challenges

Drivers Challenges
Rising incidence of HR+/HER2− breast cancer Competition from biosimilars post-2032 patent expiration
Favorable side effect profile versus peers Resistance development in long-term treatment
Expanding indications into adjuvant setting High cost and reimbursement hurdles
Increasing awareness and screening genomics Limited data in triple-negative breast cancer (TNBC)

Market Projection (2023–2030)

Parameter Projection
Market Size (2023) ~$2.3 billion, driven by new approvals and expanded indications
Compound Annual Growth Rate (CAGR) ~9%, sustained by pipeline progress, novel combination approvals, and geographical expansion
Peak Market Penetration ~$4.5 billion by 2028, assuming full adoption in adjuvant settings, especially post-therapy resistance
Key Factors Influencing Growth Successful trial outcomes, regulatory approvals, payer acceptance, pricing strategies, and entry into new indications

Forecast Breakdown by Region

Region 2023 Market Share Projected 2030 Market Share Key Drivers
North America 50% 45% High incidence, established reimbursement policies
Europe 25% 30% Adoption in early-stage breast cancer, EU approvals
Asia-Pacific 15% 15% Increasing awareness, infrastructure, and approvals
ROW (Rest of World) 10% 10% Growing access, emerging oncology markets

Comparison with Competitors: Clinical Efficacy & Market Share

Parameter Abemaciclib (Verzenio) Palbociclib (Ibrance) Ribociclib (Kisqali)
Efficacy (Median PFS) 16.4–20 months in metastatic settings 20 months in similar settings 22 months in trials
Adverse Events Diarrhea (up to 60%), neutropenia (~20%) Neutropenia (~70%), fatigue Neutropenia (~50%), hepatotoxicity
Market Penetration (2022) 30% 45% 25%
Approval Year 2017 2015 2017

Deep Dive into Regulatory & Policy Environment

  • Pricing & Reimbursement Strategies: Increased emphasis on value-based care influencing pricing negotiations, rebates for expanded indications.
  • Orphan and Accelerated Approvals: Post-approval, continuous updates via real-world evidence (RWE) submissions to sustain market access.
  • Patent & Biosimilar Developments: Patents protected until 2032; biosimilars anticipated post-2032 could undermine pricing power.
  • Global Access Initiatives: WHO inclusion of breast cancer treatment protocols strives to improve access in low-middle-income countries.

FAQs on Abemaciclib Market Dynamics

1. What are the key clinical advantages of Abemaciclib over its competitors?

Abemaciclib exhibits a favorable tolerability profile with lower incidences of neutropenia and fatigue, enabling longer therapy durations and potential monotherapy use in specific cases. Its twice-daily regimen offers flexibility, and ongoing trials suggest broader indications.

2. How does ongoing trial data influence future market projections?

Positive phase III outcomes, especially in adjuvant and early-stage settings, are expected to expand the label, increasing patient populations and revenue streams, thus boosting market size projections through 2030.

3. What are the potential risks impacting Abemaciclib’s market growth?

Risks include patent expiry, price competition from biosimilars, emerging resistance, and inconsistent adoption in evolving treatment guidelines. Additionally, slower clinical trial success or regulatory delays could temper growth.

4. How significant is the pipeline pipeline in shaping the long-term outlook?

The active pipeline, including trials like NATALEE and MonarchE follow-up, aims to extend abemaciclib's usage into earlier disease stages, offering substantial upside in market expansion if outcomes are favorable.

5. What policy shifts could influence Abemaciclib's market share?

Changes in reimbursement policies favoring value-based care, expanded access programs, and international regulatory harmonization could facilitate broader uptake, while pricing constraints may threaten margins.


Key Takeaways

  • Clinical Development: Abemaciclib continues robust growth with positive data in early and advanced breast cancer stages, pending further regulatory approvals.
  • Market Position: It holds a significant share within the CDK4/6 inhibitor space, distinguished by its tolerability and dosing flexibility.
  • Growth Drivers: Expansion into adjuvant treatment, pipeline success, and regional approvals are key to reaching projected ~$4.5 billion by 2028.
  • Challenges: Patent protections until 2032, competition, and pricing pressures remain influential factors.
  • Strategic Considerations: Eli Lilly’s focus on expanding indications and emerging combination therapies will be critical to maintaining and growing market leadership.

References

[1] National Cancer Institute. "MONARCH 3 Final Results," 2021.
[2] European Society for Medical Oncology (ESMO). "MONARCH 2 Update," 2020.
[3] ClinicalTrials.gov. "NATALEE Trial," Accessed 2023.
[4] Eli Lilly. "Verzenio Expanded Indication Announcements," 2023.

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