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. ********************************************************************************************* *********************************************************************************
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	Eli Lilly and Company	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	Genentech, Inc.	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	Merck Sharp & Dohme Corp.	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
Breast Cancer	6
Metastatic Breast Carcinoma	6
Prognostic Stage IV Breast Cancer AJCC v8	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
Florida	5
Arizona	5
Missouri	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
Suspended	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

VERZENIO (abemaciclib) clinical trials update and market projection

Last updated: July 25, 2026

VERZENIO (abemaciclib) is an approved CDK4/6 inhibitor with a broad label across HR+/HER2- advanced breast cancer, early-stage high-risk disease, and HR+/HER2+ metastatic breast cancer in combination regimens, plus non-breast oncology expansion programs. The current commercial trajectory is driven by (1) continued penetration of metastatic first-line and subsequent-line combinations, (2) uptake in adjuvant high-risk early breast cancer settings, and (3) incremental growth from new indications and line-of-therapy expansion.

Key market thesis: Near-term growth is supported by ongoing uptake in early breast cancer and continued metastatic share gains versus other CDK4/6 inhibitors. Over the medium term, growth depends on durability of label-driven use, competitive pricing and contracting, and probability-weighted outcomes in active pipeline trials that could extend abemaciclib into additional solid tumors or refine breast cancer combinations/durations.

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What clinical trials data updates exist for VERZENIO (abemaciclib) in 2024–2026?

Fast answer: The most commercially material updates for VERZENIO are expected from late-stage breast cancer trials evaluating abemaciclib-based combinations and duration strategies in early-stage disease and from ongoing metastatic studies that target earlier lines, expanded combinations (such as with endocrine therapy and other partners), and progression-free survival and overall survival endpoints.

Breast cancer: which trials are most likely to change use

The highest signal trials for market impact are those that change:

• eligibility (earlier line, higher-risk molecular subgroups, or broader HR+/HER2- definitions),
• endpoints (OS readouts after PFS-dominant earlier phases),
• regimen duration (fixed-course adjuvant strategies),
• combination partners (new doublet/triplet approaches in metastatic disease).

Primary commercial driver cohort

• Adjuvant high-risk early breast cancer (HR+/HER2-): trials that sustain or expand early-stage adoption and reduce ambiguity on eligible subgroups.
• Metastatic HR+/HER2- first-line: trials that increase the fraction of patients receiving abemaciclib-based regimens and potentially shift sequencing.
• Metastatic HR+/HER2+: programs that could broaden utility beyond existing combinations and improve persistence.

Non-breast oncology: which programs matter for diversification

Abemaciclib has active exploration in multiple tumor types where CDK pathway dysregulation is common. Market impact from non-breast programs typically requires:

• phase 3-level efficacy with differentiation,
• clean safety profile in combination settings,
• enforceable label that creates a new reimbursable indication line.

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What is the latest FDA regulatory status of VERZENIO (abemaciclib) by indication?

Fast answer: VERZENIO is FDA-approved for multiple settings in breast cancer, including advanced HR+/HER2- disease in combination with endocrine therapy and as monotherapy in later lines; it also includes an adjuvant high-risk early breast cancer indication. The regulatory expansion pattern is breast-centric, which keeps most near-term commercial volume tied to oncology breast oncology guidelines and payer coverage.

Regulatory footprint by setting

• Advanced breast cancer, HR+/HER2-: abemaciclib is established in combination endocrine therapy regimens and later-line use depending on prior treatment context.
• Adjuvant high-risk early breast cancer, HR+/HER2-: label exists to support adoption in post-surgery adjuvant treatment pathways for high-risk patients.
• Metastatic HR+/HER2+: approved combination contexts that allow clinicians to use abemaciclib as part of standard-of-care decision-making.

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What patents protect VERZENIO (abemaciclib) and how strong is the patent estate?

Fast answer: The VERZENIO patent estate is composed of layered protections across drug substance, specific formulations, crystalline forms, manufacturing processes, and method-of-use claims tied to breast cancer regimens. Strength is typically greatest where method-of-use and regimen patents align tightly with FDA labeling and where formulation patents cover commercially used presentations.

How patent layering affects biosimilar and generic risk

• Small molecule: biosimilar risk is not applicable; generic entry risk is driven by Paragraph IV challenges and whether FDA Orange Book listings support noninfringement/invalidity defenses.
• Method-of-use coverage: even with core composition-of-matter expiring, regimen-specific patents can block generic substitution if the generic is expected to be used in infringing dosing schedules or combinations.
• Combination regimens: combination-driven method claims can increase litigation leverage and delay generic launches.

Enforcement dynamics that influence timing

• If Orange Book listings tie to the currently prescribed regimen, litigation and stay agreements can extend exclusivity and delay market penetration by generics.
• If newer indications emerge, the patent estate may shift in value, often favoring the brand as long as method claims map to newly approved labels.

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When does VERZENIO lose exclusivity in the US and Europe?

Fast answer: US exclusivity and patent expiry are staggered by component patent sets: composition-of-matter, formulation, and method-of-use. The practical “effective exclusivity” date is the last-to-expire patent that blocks commercial launch for the labelled regimen and the dosing schedule tied to the FDA-approved indications.

Timing mechanics that matter to launch planners

• US: effective loss occurs after all relevant Orange Book patents expire, or after successful Paragraph IV litigation and any resulting settlement/stay.
• Europe: Supplementary Protection Certificates (SPCs) and national patent enforcement determine the actual effective expiry.
• Parallel protection: formulation and method claims often outlast substance protection, extending exclusion even when active ingredient patents expire.

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What generic entry risks exist for VERZENIO (abemaciclib)?

Fast answer: Generic entry risk is medium to high only after the last Orange Book-listed patents covering the approved abemaciclib regimens expire or are invalidated. Until then, the main entry pathway is likely to be Paragraph IV litigation with a probable settlement-based “pay-for-delay” style outcome in most branded oncology small-molecule contexts, though the specific outcome depends on the listed patents and infringement posture.

What to watch in Paragraph IV patterns

• Whether challengers target specific listed patents (formulation vs method-of-use),
• whether they certify noninfringement/invalidity for the most relevant method-of-use claims,
• whether the brand files for preliminary injunctions and obtains stays via settlement.

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How does VERZENIO compare with other CDK4/6 inhibitors for market share in HR+/HER2-?

Fast answer: In HR+/HER2- advanced breast cancer, VERZENIO is positioned among the CDK4/6 competitive set (with peers such as palbociclib and ribociclib). Competitive differentiators that typically drive share include:

• dosing schedule and tolerability profile,
• physician preference based on patient comorbidity and progression pattern,
• formulary placement and payer contracting.

Competitive implications for payer contracting

• Once a regimen becomes entrenched, payers often lock into contracting based on clinical differentiation plus negotiated rebates.
• If trial readouts extend OS or broaden eligible subgroups, brands can strengthen formulary retention and defend net price.

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What formulations of VERZENIO are protected and what does that mean for generics?

Fast answer: Formulation patents (including solid-state form, tablets/capsule composition, and manufacturing process claims) can delay generic approval even if composition-of-matter expires. For small molecules, the label-level substitution usually requires compliance with dissolution and bioequivalence specifications; formulation patents can also create separate infringement targets.

Why formulation patents matter commercially

• If brand formulations are tied to specific tablet strengths and dissolution behavior, challengers may need a “workaround” product design to avoid infringement.
• If formulation patents cover the currently marketed presentation, the generic launch date can slide even after some core patents expire.

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What patent litigation affects VERZENIO (abemaciclib) and how does it influence launch timelines?

Fast answer: Litigation risk in VERZENIO cases usually centers on Orange Book patents: drug product (formulation), method-of-use, and manufacturing claims. The outcome determines whether generic launches occur at first-available “technical” expiry or later due to stays and settlements.

What matters for investors and licensing

• Whether the court narrows infringement theories,
• whether the brand secures injunctions or dismissal of challengers,
• whether settlement agreements impose launch barriers.

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What clinical trial endpoints drive adoption for VERZENIO (abemaciclib)?

Fast answer: Adoption is driven by OS durability, PFS depth, and quality-of-life/tolerability in real-world patterns, especially for early breast cancer where clinicians weigh long-term benefit against chronic adverse event burden.

Endpoint categories that map to payer and guideline decisions

• OS readouts: influence long-term use and payer confidence.
• PFS in high-risk subgroups: supports stronger line-of-therapy recommendations.
• Adverse event management: diarrhea, neutropenia, fatigue, and adherence are central in practice.
• Biomarker-driven subgroup benefit: shifts eligible patient pools.

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Market projection for VERZENIO (abemaciclib): what is the growth outlook and key drivers?

Fast answer: VERZENIO’s growth outlook is positive in the short-to-medium term, primarily because early breast cancer adoption and continued metastatic regimen use create a larger treated-patient pool and improve prescription durability. The slope depends on trial outcomes that extend OS and expand eligible subgroups, plus the pace of competitor switching and the degree of formulary resilience.

Base-case growth drivers

• Adjuvant high-risk early breast cancer: incremental patient identification and clinician confidence drive sustained prescription volume.
• Metastatic HR+/HER2-: line-of-therapy expansion and persistence increase the covered addressable pool.
• Combination uptake: if combinations demonstrate superior outcomes in subgroups, the regimen becomes “preferred,” strengthening share.

Downside risks

• Competitive pricing pressure among CDK4/6 inhibitors leading to margin compression,
• Loss of exclusivity and timing of generics if patent barriers weaken earlier than expected,
• Safety/tolerability constraints that reduce persistence for some patient groups,
• Trial setbacks in non-breast indications that reduce diversification revenue upside.

Scenario framework (directional)

• Bull case: additional label expansions with OS support and strong subgroup differentiation; stable or improved net pricing; limited competitive erosion.
• Base case: incremental label/indication uptake continues; share remains stable; margin gradually compresses.
• Bear case: generic entry accelerates and/or competitor claims move prescribing away; adjuvant uptake slows due to cost or toxicity management.

Revenue exposure variables that determine net outcomes

• US contracting and net price versus list price,
• global reimbursement breadth for early-stage regimens,
• persistence (treatment duration and discontinuation rates),
• patient mix by risk level and prior therapy.

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Key takeaways

• VERZENIO’s commercial momentum is driven by breast cancer breadth, including early high-risk adjuvant use and established metastatic combinations.
• Clinical trial value is concentrated in OS and subgroup durability readouts that can expand eligibility or entrench preferred regimen status.
• The dominant generic risk pathway is Paragraph IV litigation tied to Orange Book-listed method-of-use and formulation patents; effective exclusivity timing is last-in-force patent across regimen-relevant claims.
• Market projection remains growth-positive near to mid term, with the largest upside tied to label expansion and the largest downside tied to effective exclusivity erosion and pricing pressure.

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FAQs

1) What are the main clinical trials categories that could expand VERZENIO’s label next?
Breast cancer early-stage duration/combination studies and metastatic line-of-therapy expansion trials with OS and subgroup-durability endpoints.

2) Which factors most affect VERZENIO persistence in real-world use?
Tolerability, adherence to dosing and dose modification protocols, and clinician comfort managing chronic adverse events.

3) How do Orange Book method-of-use patents influence generic approval for abemaciclib?
Even if composition-of-matter expires, method-of-use claims tied to labelled regimens can block generic entry or force design-around and litigation.

4) What is the generic launch bottleneck for VERZENIO if patents expire?
Paragraph IV litigation outcomes and settlement-based stays tied to the most relevant Orange Book patents for current labelled regimens.

5) Does VERZENIO’s competitive positioning depend more on efficacy or safety in HR+/HER2-?
Efficacy endpoints drive initial prescribing, while safety management and persistence determine durable share and revenue.

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References

No sources were provided in the prompt, and no external citations were used.