Abemaciclib
Also known as Verzenio
ELI LILLY & Co LLY · Breast Neoplasms; Neoplasm Metastasis; Breast Cancer; Abiraterone Acetate; Androgens
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
11
From ClinicalTrials.gov
Latest FDA action
Approved
NDA208716,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ELI LILLY & Co LLY Source: Company record for ELI LILLY & Co (opens in a new tab)
- Indications
- Breast Neoplasms; Neoplasm Metastasis; Breast Cancer; Abiraterone Acetate; Androgens Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Applications
- NDA 208716 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 208716 (opens in a new tab)
- NDA 208855 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 208855 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 CompletedFirst trial start 26 Nov 20181 linked trial
- Phase 3 CompletedFirst trial start 22 Jul 201411 linked trials
- Filed Completed
- Approved Current stageFirst approval 28 Sep 2017
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Abemaciclib. Editors add each one with its source.
Filed application
No filed application is on record for Abemaciclib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Abemaciclib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT07174336ClinicalTrials.gov record for NCT07174336 (opens in a new tab) | A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) | Phase 3 | Recruiting | 800 (estimated) | May 2029 (estimated) | No |
| NCT05288166ClinicalTrials.gov record for NCT05288166 (opens in a new tab)CYCLONE 3 | A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) | Phase 3 | Active, not recruiting | 925 (actual) | 15 Feb 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT05288166 (opens in a new tab) |
Posted results on ClinicalTrials.gov for CYCLONE 3 Serious adverse events (Baseline up to 22 months): Abemaciclib 145 of 460; Placebo 68 of 460 Source: ClinicalTrials.gov results for NCT05288166 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT05169567ClinicalTrials.gov record for NCT05169567 (opens in a new tab)postMONARCH | Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer | Phase 3 | Active, not recruiting | 368 (actual) | 8 Feb 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT05169567 (opens in a new tab) |
Posted results on ClinicalTrials.gov for postMONARCH
Serious adverse events (Baseline up to 22 months): Arm A: Abemaciclib Plus Fulvestrant 44 of 181; Arm B: Placebo Plus Fulvestrant 20 of 185 Source: ClinicalTrials.gov results for NCT05169567 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing postMONARCH (3), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT04975308ClinicalTrials.gov record for NCT04975308 (opens in a new tab)EMBER-3 | A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer | Phase 3 | Active, not recruiting | 874 (actual) | 24 Jun 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04975308 (opens in a new tab) |
Posted results on ClinicalTrials.gov for EMBER-3
Serious adverse events (Baseline up to 28 months): Arm A: Imlunestrant 46 of 327; Arm B: Investigator's Choice of Endocrine Therapy - Exemestane 6 of 32; Arm B: Investigator's Choice of Endocrine Therapy - Fulvestrant 49 of 292; Arm C: Imlunestrant + Abemaciclib 42 of 208 Source: ClinicalTrials.gov results for NCT04975308 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing EMBER-3 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT04752332ClinicalTrials.gov record for NCT04752332 (opens in a new tab)eMonarcHER | A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer | Phase 3 | Terminated | 111 (actual) | 26 Jun 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04752332 (opens in a new tab) |
Posted results on ClinicalTrials.gov for eMonarcHER Serious adverse events (Baseline Up To 890 Days): 150 mg Abemaciclib + ET 6 of 55; Placebo + ET 2 of 56 Source: ClinicalTrials.gov results for NCT04752332 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT03706365ClinicalTrials.gov record for NCT03706365 (opens in a new tab)CYCLONE 2 | A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer | Phase 2/3 | Active, not recruiting | 393 (actual) | 2 Jan 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03706365 (opens in a new tab) |
Posted results on ClinicalTrials.gov for CYCLONE 2
Serious adverse events (Baseline Up to 60 Months): Abemaciclib 89 of 206; Placebo 66 of 185 Source: ClinicalTrials.gov results for NCT03706365 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing CYCLONE 2 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT03155997ClinicalTrials.gov record for NCT03155997 (opens in a new tab)monarchE | Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer | Phase 3 | Active, not recruiting | 5,637 (actual) | 16 Mar 2020 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03155997 (opens in a new tab) |
Posted results on ClinicalTrials.gov for monarchE
Serious adverse events (Baseline to 32 Months): 150 mg Abemaciclib + Endocrine Therapy 344 of 2791; Endocrine Therapy 202 of 2800 Source: ClinicalTrials.gov results for NCT03155997 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing monarchE (13), newest first
All 13 publications for NCT03155997 Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT02763566ClinicalTrials.gov record for NCT02763566 (opens in a new tab)MONARCH plus | A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer | Phase 3 | Active, not recruiting | 463 (actual) | 29 Mar 2019 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02763566 (opens in a new tab) |
Posted results on ClinicalTrials.gov for MONARCH plus
Serious adverse events (Up to 28 Months): Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI) 40 of 205; Placebo + NSAI 9 of 99; Abemaciclib + Fulvestrant 16 of 104; Placebo + Fulvestrant 4 of 53 Source: ClinicalTrials.gov results for NCT02763566 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing MONARCH plus (2), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT02246621ClinicalTrials.gov record for NCT02246621 (opens in a new tab)MONARCH 3 | A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer | Phase 3 | Active, not recruiting | 493 (actual) | 31 Jan 2017 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02246621 (opens in a new tab) |
Posted results on ClinicalTrials.gov for MONARCH 3
Serious adverse events (Baseline Up to 32 Months): Abemaciclib + NSAI 102 of 327; Placebo + NSAI 27 of 161 Source: ClinicalTrials.gov results for NCT02246621 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing MONARCH 3 (4), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT02152631ClinicalTrials.gov record for NCT02152631 (opens in a new tab)JUNIPER | A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer | Phase 3 | Active, not recruiting | 453 (actual) | 15 Sep 2017 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02152631 (opens in a new tab) |
Posted results on ClinicalTrials.gov for JUNIPER
Serious adverse events (From Baseline to End of Study (Up to 47 Months)): Abemaciclib 112 of 265; Erlotinib 43 of 175 Source: ClinicalTrials.gov results for NCT02152631 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing JUNIPER (2), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT02107703ClinicalTrials.gov record for NCT02107703 (opens in a new tab)MONARCH 2 | A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer | Phase 3 | Active, not recruiting | 669 (actual) | 14 Feb 2017 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02107703 (opens in a new tab) |
Posted results on ClinicalTrials.gov for MONARCH 2
Serious adverse events (Up To 7 years 7.7 Months): Abemaciclib + Fulvestrant 129 of 441; Placebo + Fulvestrant 33 of 223 Source: ClinicalTrials.gov results for NCT02107703 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing MONARCH 2 (5), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Authorised
Verzenios (EMEA/H/C/004302)
- Authorised
- Therapeutic area
- Breast Neoplasms
- Marketing authorisation holder
- Eli Lilly Nederland B.V.
- Active substance (INN)
- abemaciclib
- ATC code
- L01EF03
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Verzenios (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 208716 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07174336 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05288166 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05169567 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04975308 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04752332 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03706365 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03155997 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02763566 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02246621 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02152631 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02107703 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA208716 (opens in a new tab) Licence: cc0. Fetched
- Drugs@FDA via openFDA NDA208855 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.