Drugs / Abemaciclib
Abemaciclib
also known as
LY2835219 · VERZENIO · ABEMACICLIB (LY2835219) · CDK4/6 DUAL INHIBITOR · LY-28352192-PYRIMIDINAMINE · LY2835219 FREE BASE · N-[5-[(4-ETHYL-1-PIPERAZINYL)METHYL]-2-PYRIDINYL]-5-FLUORO-4-[4-FLUORO-2-METHYL-1-(1-METHYLETHYL)-1H-BENZIMIDAZOL-6-YL]- · VERZENIO (R) · +1 more
Small molecule targets CDK4, CDK6, PIM1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed female breast nipple and areola cancer 2 milestones | |||||
| Filed | US (FDA) | Verzenio | female breast nipple and areola cancer | 2022-12-06 | “We are pleased with these results and have submitted an application with the FDA to expand our adjuvant indication in the U.S.” lilly.com ↗ |
| Filed | US (FDA) | — | female breast nipple and areola cancer | 2017-07-10 | “The U.S. Food and Drug Administration (FDA) has accepted and filed its New Drug Application (NDA) for abemaciclib” lilly.com ↗ |
| Approved Indication not stated 5 milestones | |||||
| Label expansions (5) | US (FDA) | VERZENIO | — | 2020-03-30 – 2026-07-13 | fda.gov ↗ |
| Approved | EU (EMA) | Verzenios | — | 2018-09-26 | europa.eu ↗ |
| Approved | US (FDA) | VERZENIO | — | 2017-09-28 | fda.gov ↗ |
| Filed | EU (EMA) | — | — | — | “In the third quarter of 2017, Lilly completed EU and Japan regulatory submissions for abemaciclib.” lilly.com ↗ |
| Filed | Japan (PMDA) | — | — | — | “In the third quarter of 2017, Lilly completed EU and Japan regulatory submissions for abemaciclib.” lilly.com ↗ |
Trials 211 · started per year
today
US approved 2017
EU approved 2018
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 07 trials | ||||||
| Phase 0 | NCT06959979 | Nov 2024 → Aug 2026 overdue | childhood medulloblastoma | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | No outcome recorded |
| Phase 0 | NCT04391595 | Jul 2020 → Jul 2023 | glioblastoma | Nader Sanai | Completed | No outcome recorded |
| Phase 0 | NCT04220892 | Jul 2020 | high grade astrocytic tumor | Jose Carrillo | Withdrawn | No outcome recorded |
| Phase 0 | NCT04074785 | Dec 2019 → Oct 2023 | brain neoplasm, glioblastoma | University of Texas Southwestern Medical Center | Terminated | No outcome recorded |
| Phase 0 | NCT04088032 | Oct 2019 → Dec 2020 | female breast carcinoma, hormone receptor-positive breast cancer | Alison Stopeck | Withdrawn | No outcome recorded |
| Phase 0 | NCT04049227 | Aug 2019 → Apr 2023 | endometrial endometrioid adenocarcinoma | Northwestern University | Completed | No outcome recorded |
| Phase 0 | NCT03837821 | Feb 2019 → Jul 2024 overdue | urinary bladder cancer | Weill Medical College of Cornell University | Active not recruiting | No outcome recorded |
| Phase 148 trials | ||||||
| Phase 1 | NCT07818967 | Sep → Nov 2026 expected | — | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 1 | NCT06654037 | Apr 2025 → Apr 2027 expected | colorectal cancer | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT06025747 | Mar 2025 → Aug 2027 expected | dedifferentiated liposarcoma, retroperitoneal sarcoma | University of Washington | Recruiting | No outcome recorded |
| Phase 1 | NCT06678269 | Nov 2024 → Nov 2028 expected | hormone receptor-positive breast cancer | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06139107 | Aug 2024 → Sep 2026 overdue | breast cancer | Mridula George, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT05999968 | Jan → Feb 2024 | prostate neoplasm | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 1 | NCT05372640 | Aug 2023 → Jun 2027 expected | female breast carcinoma, invasive breast carcinoma, metastatic malignant neoplasm, nut midline carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT05617885 | Aug 2023 → Jul 2025 | metastatic prostate carcinoma | Praful Ravi, MB BCHir, MRCP | Completed | No outcome recorded |
| Phase 1 | NCT05774886 | May → Sep 2023 | female breast carcinoma, triple-negative breast carcinoma | Dana-Farber Cancer Institute | Withdrawn | No outcome recorded |
| Phase 1 | NCT05413304 | Apr 2023 → Oct 2025 overdue | glioma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05759949 | Mar 2023 → Mar 2025 | PIK3CA-related overgrowth spectrum, hormone receptor-positive breast cancer | Relay Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05714072 | Jan 2023 → Jan 2027 expected | myelofibrosis | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06570031 | Nov 2021 → Apr 2026 | hormone receptor-positive breast cancer | Ono Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04316169 | Oct 2021 → Jan 2027 | female breast carcinoma | Medical College of Wisconsin | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT04633239 | Jul 2021 → Nov 2026 expected | ovarian serous adenocarcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT04481113 | Jun 2021 → Oct 2023 | female breast carcinoma, hormone receptor-positive breast cancer, invasive breast carcinoma | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT04627064 | Dec 2020 → Feb 2024 | clear cell renal carcinoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT03846583 | Jun → Sep 2020 | breast cancer | Dana-Farber Cancer Institute | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03939897 | Jun 2020 → Jun 2023 overdue | female breast carcinoma, hormone receptor-positive breast cancer | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04585724 | Jun 2020 → Sep 2021 | female breast carcinoma, metastatic malignant neoplasm in the brain | Emory University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04071262 | Dec 2019 → Feb 2021 | cancer of unknown primary site | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04188548 | Dec 2019 → Jun 2020 overdue | breast cancer, endometrial cancer | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03905889 | Jun 2019 → Mar 2022 | renal cell carcinoma | Brown University | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03616587 | Oct 2018 → Sep 2024 overdue | estrogen-receptor positive breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02919696 | Aug 2017 → Nov 2018 | cancer of unknown primary site, metastatic malignant neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03099174 | May 2017 → May 2023 | breast neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02779751 | Nov 2016 → Feb 2020 overdue | breast cancer, non-small cell lung carcinoma | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02784795 | Nov 2016 → Aug 2018 | breast cancer, cholangiocarcinoma, colon carcinoma, soft tissue sarcoma | Eli Lilly and Company | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02857270 | Sep 2016 → Feb 2021 | colorectal cancer, metastatic melanoma, non-small cell lung carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02884089 | Aug → Dec 2016 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02791334 | Jun 2016 → May 2020 | cutaneous melanoma, hormone receptor-positive breast cancer, malignant pancreatic neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02688088 | Mar 2016 → Feb 2018 | metastatic neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02677844 | Feb → Jul 2016 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02672423 | Feb → Oct 2016 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02644460 | Feb 2016 → Oct 2023 | Ewing sarcoma, diffuse intrinsic pontine glioma, neuroblastoma, osteosarcoma +2 | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT02411591 | Jun 2015 → Jun 2017 | metastatic neoplasm, non-small cell lung carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02482935 | Jun → Sep 2015 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02387814 | Mar → Aug 2015 | liver disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02327143 | Jan → Feb 2015 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02256267 | Oct → Nov 2014 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02117648 | Apr 2014 → Feb 2015 | metastatic neoplasm, neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02079636 | Mar 2014 → May 2018 | non-small cell lung carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02057133 | Mar 2014 → Mar 2021 overdue | breast neoplasm | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02059148 | Feb → Aug 2014 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02014129 | Dec 2013 → Apr 2015 | lymphoma, metastatic neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01913314 | Aug → Oct 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01394016 | Dec 2009 → May 2014 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/232 trials · 1 missed | ||||||
| Phase 1/2 | NCT06498648 | Mar 2026 → Jan 2027 expected | dedifferentiated liposarcoma, leiomyosarcoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07100106 | Oct 2025 → Aug 2028 expected | breast cancer | Genentech, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07002177 | Jun 2025 → May 2028 expected | estrogen-receptor positive breast cancer | Forward Pharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06810544 | Mar 2025 → Mar 2027 expected | brain neoplasm, glioblastoma, lung adenocarcinoma | Tango Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06835972 | Feb 2025 → Feb 2027 expected | renal cell carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06594679 | Sep 2024 → Mar 2027 expected | ovarian cancer | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06188520 | Dec 2023 → Aug 2027 expected | estrogen-receptor positive breast cancer, ovarian serous adenocarcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05867251 | Aug 2023 → Jan 2028 expected | endometrial cancer, fallopian tube cancer, hormone receptor-positive breast cancer, malignant epithelial tumor of ovary +2 | Avenzo Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05774899 | Jun 2023 → Jun 2027 expected | adenoid cystic carcinoma | Michael J. Dennis, MD | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05548127 | Feb 2023 → Mar 2027 expected | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05608252 | Feb 2023 → Dec 2027 expected | hormone receptor-positive breast cancer | Adrienne G. Waks | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05563220 | Jan 2023 → Dec 2026 expected | breast cancer | Stemline Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05386108 | Aug 2022 → Dec 2026 expected | brain neoplasm, breast neoplasm | Stemline Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05113537 | Jul 2022 → May 2026 overdue | castration-resistant prostate carcinoma, prostate adenocarcinoma | Vadim S Koshkin | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05464173 | Jul 2022 → Feb 2025 | breast cancer | Biyun Wang, MD | Unknown | No outcome recorded |
| Phase 1/2 | NCT04791384 | Apr 2022 → Sep 2024 | breast cancer | Criterium, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT04923542 | Nov 2021 → Jul 2027 expected | hormone receptor-positive breast cancer, metastatic malignant neoplasm in the brain | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04750928 | Nov 2021 → Dec 2028 expected | neurofibromatosis type 1 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04486352 | Oct 2021 → Oct 2026 expected | endometrial cancer | Alliance Foundation Trials, LLC. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04941274 | Sep 2021 → Mar 2028 expected | Kaposi's sarcoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05095207 | Sep 2021 → Jun 2027 expected | breast cancer, metastatic neoplasm | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04802759 | Jun 2021 → May 2029 expected | estrogen-receptor positive breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04921904 | Jun 2021 → Dec 2024 | esophageal adenocarcinoma, gastroesophageal junction adenocarcinoma | Baylor Research Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT04594005 | Feb 2021 → Jul 2024 | neoplasm | Yonsei University | Completed | No outcome recorded |
| Phase 1/2 | NCT04616183 | Dec 2020 → Dec 2028 expected | colon adenocarcinoma, rectum adenocarcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04238819 | Nov 2020 → Mar 2024 | refractory malignant neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/2 | NCT04092673 | Oct 2019 → Dec 2024 | cancer | Effector Therapeutics | Unknown | No outcome recorded |
| Phase 1/2 | NCT03655444 | May 2019 → Aug 2020 | head and neck squamous cell carcinoma | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 1/2 | NCT03732703 | Apr 2019 → Dec 2024 | refractory plasma cell neoplasm | Multiple Myeloma Research Consortium | Completed | No outcome recorded |
| Phase 1/2 | NCT03424005 | Mar 2018 → Sep 2030 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03280563 | Dec 2017 → Sep 2024 | breast neoplasm | Hoffmann-La Roche | Completed | Missed primary |
| Phase 1/2 | NCT03284957 | Sep 2017 → Nov 2024 | breast cancer | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 293 trials · 5 met primary · 6 missed | ||||||
| Phase 2 | NCT07832227 | Dec 2026 → Dec 2028 expected | endometrial cancer, ovarian serous adenocarcinoma | Dana-Farber Cancer Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07826052 | Sep 2026 → Sep 2031 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07410559 | Jul 2026 → Apr 2029 expected | female breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07441369 | May 2026 → Apr 2027 expected | metastasis from malignant tumor of colon | Fudan University | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT07191717 | Apr 2026 → Apr 2030 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma, invasive breast carcinoma | Jonsson Comprehensive Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07428018 | Apr 2026 → Apr 2029 expected | HER2 positive breast carcinoma, hormone receptor-positive breast cancer | Mario Negri Institute for Pharmacological Research | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07340541 | Feb 2026 → Jun 2031 expected | estrogen-receptor positive breast cancer, triple-negative breast carcinoma | UNC Lineberger Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07292207 | Jan 2026 → Nov 2028 expected | breast cancer | Nagoya City University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07209449 | Oct 2025 → Oct 2028 expected | endometrial cancer | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07037199 | Aug 2025 → Jun 2028 expected | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06630325 | Jun 2025 → Mar 2026 | exocrine pancreatic carcinoma, female breast carcinoma, ovarian carcinoma, prostate carcinoma +1 | OHSU Knight Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT06813079 | Apr 2025 → Feb 2028 expected | pancreatic ductal adenocarcinoma | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT05940493 | Mar 2025 → Sep 2028 expected | meningioma | Nader Sanai | Recruiting | No outcome recorded |
| Phase 2 | NCT06259929 | Jan 2025 → Apr 2026 overdue | breast cancer | Fondazione Oncotech | Recruiting | No outcome recorded |
| Phase 2 | NCT07130643 | Dec 2024 → Dec 2026 expected | hormone receptor-positive breast cancer | Xinhong Wu, PhD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06413706 | Oct 2024 → Feb 2027 expected | glioma | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06366347 | Sep 2024 → Sep 2027 expected | endometrial cancer | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT05933395 | Sep 2024 → Oct 2030 expected | breast cancer | Dartmouth-Hitchcock Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06409390 | Aug 2024 → Apr 2027 expected | breast cancer | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06179303 | Jul 2024 → Mar 2027 expected | female breast carcinoma, hormone receptor-positive breast cancer | University of Washington | Recruiting | No outcome recorded |
| Phase 2 | NCT06365788 | Apr 2024 → Dec 2027 expected | triple-negative breast carcinoma | Universitaire Ziekenhuizen KU Leuven | Recruiting | No outcome recorded |
| Phase 2 | NCT05708235 | Apr 2024 → Jun 2028 expected | breast cancer | MedSIR | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05872204 | Nov 2023 → Jan 2028 expected | ovarian granulosa cell tumor, ovarian serous adenocarcinoma | Universitaire Ziekenhuizen KU Leuven | Recruiting | No outcome recorded |
| Phase 2 | NCT05501704 | Oct 2023 → Apr 2027 expected | hormone receptor-positive breast cancer, male breast carcinoma | Jose Pablo Leone | Recruiting | No outcome recorded |
| Phase 2 | NCT06001762 | Oct 2023 → Jan 2025 overdue | breast carcinoma | Dana-Farber Cancer Institute | Active not recruiting | Met primary |
| Phase 2 | NCT06062498 | Sep 2023 → Jul 2028 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | Northwestern University | Recruiting | No outcome recorded |
| Phase 2 | NCT06145308 | Aug 2023 → Jul 2028 expected | salivary gland carcinoma | Peking Union Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT05826964 | Jun 2023 → Jul 2026 overdue | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | University of Miami | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05440786 | Sep 2022 → Jan 2025 overdue | Ewing sarcoma, metastatic neoplasm | Eli Lilly and Company | Active not recruiting | Mixed |
| Phase 2 | NCT05524584 | Aug 2022 → Dec 2028 expected | hormone receptor-positive breast cancer | University of California, Irvine | Recruiting | No outcome recorded |
| Phase 2 | NCT05159245 | Dec 2021 → Nov 2026 expected | cancer, hematopoietic and lymphoid cell neoplasm | Helsinki University Central Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04118036 | Dec 2021 → Dec 2023 | glioblastoma | Dana-Farber Cancer Institute | Withdrawn | No outcome recorded |
| Phase 2 | NCT04523857 | Nov 2021 → Dec 2027 expected | breast cancer | Abramson Cancer Center at Penn Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT04931342 | Oct 2021 → Feb 2028 expected | ovarian cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04003896 | Sep 2021 → Aug 2023 | biliary tract cancer | Milton S. Hershey Medical Center | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04751929 | Aug 2021 → Jun 2024 | castration-resistant prostate carcinoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT04169074 | Jul 2021 → Dec 2024 | head and neck squamous cell carcinoma | University of Arizona | Terminated | No outcome recorded |
| Phase 2 | NCT04603183 | Jun 2021 → Jun 2024 | breast carcinoma | MedSIR | Completed | No outcome recorded |
| Phase 2 | NCT04614194 | Apr 2021 → Apr 2027 expected | breast cancer | University of Texas Southwestern Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05305924 | Feb 2021 → Dec 2026 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | The Methodist Hospital Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04298983 | Feb 2021 → Jul 2024 | prostate cancer | University of Alabama at Birmingham | Terminated | No outcome recorded |
| Phase 2 | NCT04408924 | Jan 2021 → Apr 2022 | castration-resistant prostate carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT04545710 | Nov 2020 → Dec 2025 overdue | lung cancer | University of California, San Diego | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04351230 | Nov 2020 → Feb 2022 | HER2 positive breast carcinoma | Academic and Community Cancer Research United | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04469764 | Oct 2020 → Jul 2027 expected | endometrial carcinoma, fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04393285 | Oct 2020 → Dec 2026 expected | endometrial cancer | Gynecologic Oncology Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04534283 | Oct 2020 → Aug 2023 | metastatic malignant neoplasm | Anita Turk | Terminated | No outcome recorded |
| Phase 2 | NCT04293393 | Oct 2020 → Jun 2023 overdue | female breast carcinoma | Spanish Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04272645 | Oct 2020 → Oct 2022 | prostate cancer | University of Michigan Rogel Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT04432454 | Sep 2020 → Jan 2025 | breast cancer | Sermonix Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04552769 | Sep 2020 → Apr 2023 | thyroid gland undifferentiated (anaplastic) carcinoma | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT04305236 | Jul 2020 → Feb 2022 | hormone receptor-positive breast cancer | University of California, Irvine | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04305834 | Mar 2020 → May 2027 expected | hormone receptor-positive breast cancer | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05999994 | Jan 2020 → May 2027 expected | neoplasm | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 2 | NCT04010357 | Jan 2020 → Apr 2026 | pulmonary large cell neuroendocrine carcinoma, small cell lung carcinoma | Case Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03979508 | Jan 2020 → Dec 2024 | breast fibrocystic disease, ductal breast carcinoma in situ, female breast carcinoma, invasive breast carcinoma +2 | Mayo Clinic | Terminated | No outcome recorded |
| Phase 2 | NCT04227327 | Jan 2020 → Jul 2024 | breast cancer | University of Milano Bicocca | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03891784 | Oct 2019 → Nov 2025 overdue | intestinal neuroendocrine neoplasm, pancreatic neuroendocrine tumor | University of Washington | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03994796 | Oct 2019 → Nov 2025 overdue | NTRK fusion positive cancer, metastatic malignant neoplasm in the brain | Alliance for Clinical Trials in Oncology | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03969706 | Oct 2019 → Sep 2024 | adult oligodendroglioma | Stephen Bagley, MD, MSCE | Completed | No outcome recorded |
| Phase 2 | NCT03938337 | Oct 2019 → Apr 2020 | head and neck cancer | University of Alabama at Birmingham | Terminated | No outcome recorded |
| Phase 2 | NCT04040205 | Oct 2019 → Jun 2027 expected | chondrosarcoma, osteosarcoma, soft tissue sarcoma | Medical College of Wisconsin | Recruiting | No outcome recorded |
| Phase 2 | NCT03997448 | Aug 2019 → Jan 2020 | adenocarcinoma, gastroesophageal cancer | Nataliya Uboha | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03531645 | Aug 2019 → Sep 2027 expected | ovarian cancer | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03781960 | Jul 2019 → Apr 2022 | hepatocellular carcinoma | Abramson Cancer Center at Penn Medicine | Terminated | No outcome recorded |
| Phase 2 | NCT04256941 | May 2019 → Sep 2023 | female breast carcinoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03654833 | Jan 2019 → Oct 2023 | malignant mesothelioma | University of Leicester | Unknown | Met primary |
| Phase 2 | NCT03675893 | Dec 2018 → Aug 2028 expected | endometrial cancer | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT03339843 | Dec 2018 → Nov 2021 | cholangiocarcinoma, endometrial cancer, esophageal adenocarcinoma, esophageal squamous cell carcinoma +1 | Jules Bordet Institute | Completed | No outcome recorded |
| Phase 2 | NCT03703466 | Nov 2018 → Jul 2019 | breast cancer | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT03643510 | Aug 2018 → Mar 2026 | endometrium adenocarcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03356223 | Feb 2018 → Nov 2022 | head and neck cancer, metastatic malignant neoplasm | Centre Leon Berard | Completed | No outcome recorded |
| Phase 2 | NCT03310879 | Nov 2017 → Jan 2027 expected | cancer | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT03356587 | Oct 2017 → Jan 2020 | head and neck squamous cell carcinoma | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03292250 | Sep 2017 → Mar 2020 | head and neck squamous cell carcinoma | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03220646 | Jul 2017 → Jul 2027 expected | primary brain neoplasm | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03130439 | May 2017 → Aug 2021 | breast cancer | Dana-Farber Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02977780 | Feb 2017 → Feb 2028 expected | glioblastoma | Patrick Wen, MD | Recruiting | Missed primary |
| Phase 2 | NCT02981940 | Feb 2017 → Jun 2024 overdue | glioblastoma | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02981342 | Jan 2017 → Apr 2018 | pancreatic ductal adenocarcinoma | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT02747004 | Sep 2016 → Jun 2018 overdue | breast cancer | Eli Lilly and Company | Active not recruiting | Missed primary |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | Mixed |
| Phase 2 | NCT02846987 | Jul 2016 → Jul 2027 expected | dedifferentiated liposarcoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02675231 | May 2016 → Apr 2019 | HER2 positive breast carcinoma, hormone receptor-positive breast cancer | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT02831530 | Mar 2016 → Feb 2018 | breast cancer | Gustave Roussy, Cancer Campus, Grand Paris | Completed | No outcome recorded |
| Phase 2 | NCT02693535 | Mar 2016 → Dec 2027 expected | non-Hodgkin lymphoma, plasma cell myeloma | American Society of Clinical Oncology | Recruiting | Mixed |
| Phase 2 | NCT02523014 | Sep 2015 → Jan 2027 expected | NF2-related schwannomatosis, intracranial meningioma | Alliance for Clinical Trials in Oncology | Recruiting | Met primary |
| Phase 2 | NCT02450539 | Aug 2015 → Mar 2017 | non-small cell lung carcinoma | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT02441946 | Aug 2015 → Aug 2016 | hormone receptor-positive breast cancer | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT02308020 | Apr 2015 → Nov 2018 | breast cancer, melanoma, metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT02102490 | Jun 2014 → Apr 2016 | breast cancer | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT01739309 | Mar 2013 → Sep 2015 | mantle cell lymphoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT03706365 | Nov 2018 → Jan 2024 overdue | prostate cancer | Eli Lilly and Company | Active not recruiting | Missed primary |
| Phase 320 trials · 6 met primary · 1 missed | ||||||
| Phase 3 | NCT07005557 | Jun 2025 → May 2030 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07190443 | Feb 2025 → Feb 2034 expected | breast cancer | Japanese Foundation for Cancer Research | Recruiting | No outcome recorded |
| Phase 3 | NCT06380751 | Aug 2024 → Dec 2029 expected | breast cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06341621 | Apr 2024 → Feb 2027 expected | breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 3 | NCT06044623 | Apr 2024 → Oct 2028 expected | breast cancer | Region Örebro County | Recruiting | No outcome recorded |
| Phase 3 | NCT05288166 | Apr 2022 → Feb 2024 overdue | metastatic neoplasm, prostate neoplasm | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05065411 | Apr 2022 → Oct 2023 | breast cancer | Veru Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT05169567 | Mar 2022 → Feb 2024 overdue | breast neoplasm, metastatic neoplasm | Eli Lilly and Company | Active not recruiting | Met primary |
| Phase 3 | NCT04967521 | Nov 2021 → Dec 2027 expected | dedifferentiated liposarcoma | Sarcoma Alliance for Research through Collaboration | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04975308 | Oct 2021 → Jun 2024 overdue | breast cancer, metastatic malignant neoplasm | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04752332 | May 2021 → Jun 2024 | breast neoplasm | Eli Lilly and Company | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04862663 | May 2021 → Nov 2027 expected | Her2-receptor negative breast cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT04584853 | Dec 2020 → Oct 2030 expected | female breast carcinoma | Institute of Cancer Research, United Kingdom | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04565054 | Sep 2020 → Jun 2028 expected | female breast carcinoma | West German Study Group | Active not recruiting | Met primary |
| Phase 3 | NCT04158362 | Jun 2020 → Apr 2025 overdue | metastatic malignant neoplasm | UNICANCER | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03155997 | Jul 2017 → Mar 2020 overdue | breast cancer | Eli Lilly and Company | Active not recruiting | Met primary |
| Phase 3 | NCT02763566 | Dec 2016 → Mar 2019 overdue | breast cancer | Eli Lilly and Company | Active not recruiting | Met primary |
| Phase 3 | NCT02246621 | Nov 2014 → Jan 2017 overdue | breast cancer | Eli Lilly and Company | Active not recruiting | Met primary |
| Phase 3 | NCT02152631 | Oct 2014 → Sep 2017 overdue | non-small cell lung carcinoma | Eli Lilly and Company | Active not recruiting | Missed primary |
| Phase 3 | NCT02107703 | Jul 2014 → Feb 2017 overdue | breast neoplasm | Eli Lilly and Company | Active not recruiting | Met primary |
| Phase 46 trials | ||||||
| Phase 4 | NCT07599137 | May 2026 → Dec 2027 expected | hormone receptor-positive breast cancer | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05691400 | Mar 2024 → Mar 2027 | leukodystrophy, hypomyelinating, 22 | University of Michigan Rogel Cancer Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT06169371 | Dec 2023 → Nov 2030 expected | breast cancer | University of Illinois at Chicago | Recruiting | No outcome recorded |
| Phase 4 | NCT05362760 | Apr 2022 → Apr 2029 expected | hormone receptor-positive breast cancer | University of Ulm | Recruiting | No outcome recorded |
| Phase 4 | NCT04707196 | Feb 2021 → Jan 2023 | breast cancer, metastatic malignant neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT04031885 | Aug 2019 → Aug 2020 | breast cancer | Eli Lilly and Company | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable2 trials | ||||||
| — | NCT06810492 | Apr → Dec 2025 overdue | female breast carcinoma | Hongmei Zheng, PhD | Not yet recruiting | No outcome recorded |
| — | NCT04801966 | Sep 2021 → Dec 2022 | cancer | Peter MacCallum Cancer Centre, Australia | Terminated | No outcome recorded Stop: Enrollment |
| Phase not stated2 trials | ||||||
| — | NCT02792725 | — | breast cancer | Eli Lilly and Company | Approved for marketing | No outcome recorded |
| — | NCT03763604 | — | breast cancer | Eli Lilly and Company | Approved for marketing | No outcome recorded |
| Comparator or background therapy32 trials | ||||||
| Phase 1 | NCT07114601 Background | Aug 2025 → Apr 2030 expected | breast neoplasm, colorectal neoplasm, endometrium neoplasm, gastric neoplasm +3 | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 1 | NCT05307705 Background | May 2022 → Dec 2026 expected | breast cancer | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 1 | NCT05189717 Background | Feb 2022 → Oct 2024 | breast cancer | Shandong Suncadia Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04514159 Background | Nov 2020 → Oct 2022 | breast cancer | Zeno Alpha Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02745769 Background | Oct 2016 → Nov 2018 | colorectal cancer, mantle cell lymphoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01655225 Background | Jul 2012 → Apr 2019 | breast cancer, cancer of unknown primary site, malignant mesothelioma, metastatic malignant neoplasm +2 | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/2 | NCT07173556 Background | Sep 2025 → Feb 2027 expected | breast cancer | Qilu Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05768139 Background | Apr 2023 → Jul 2030 expected | breast cancer | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05735080 Background | Mar 2023 → Jul 2027 expected | hormone receptor-positive breast cancer, metastatic malignant neoplasm, ovarian cancer | Incyclix Bio | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05573126 Background | Jan 2023 → Feb 2028 expected | hormone receptor-positive breast cancer | Ellipses Pharma | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04165031 Background | Nov 2019 → Oct 2020 | colorectal cancer, non-small cell lung carcinoma | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 2 | NCT07112053 Background | Nov 2025 → Jul 2028 expected | female breast carcinoma, hormone receptor-positive breast cancer | University of Washington | Recruiting | No outcome recorded |
| Phase 2 | NCT07180160 Background | Sep 2025 → Sep 2027 expected | female breast carcinoma | Wenjin Yin | Recruiting | No outcome recorded |
| Phase 2 | NCT06486883 Comparator | Jun 2025 → Jan 2027 expected | hormone receptor-positive breast cancer | MedSIR | Recruiting | No outcome recorded |
| Phase 2 | NCT06561022 Background | Aug 2024 → Dec 2025 overdue | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06207734 Comparator | Jan 2024 → Jan 2027 expected | breast cancer | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting | No outcome recorded |
| Phase 2 | NCT04920708 Comparator | Dec 2022 → Jun 2027 expected | estrogen-receptor positive breast cancer | Royal Marsden NHS Foundation Trust | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05766410 Comparator | Sep 2022 → Sep 2025 overdue | hormone receptor-positive breast cancer | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04352777 Comparator | Sep 2020 → Jun 2025 | hormone receptor-positive breast cancer | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT03227328 Comparator | Aug 2017 → Feb 2022 | hormone receptor-positive breast cancer | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS | Completed | No outcome recorded |
| Phase 3 | NCT07492641 Comparator | May 2026 → Apr 2029 expected | hormone receptor-positive breast cancer | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 3 | NCT06585969 Comparator | Jan 2026 | basal-like breast carcinoma, estrogen-receptor positive breast cancer, luminal B breast carcinoma | Danish Breast Cancer Cooperative Group | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT07174336 Background | Dec 2025 → May 2029 expected | breast neoplasm, metastatic neoplasm | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT06760637 Comparator | Jan 2025 → Jan 2029 expected | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06065748 Background | Dec 2023 → Apr 2028 expected | estrogen-receptor positive breast cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05696626 Comparator | Oct 2023 → Apr 2027 expected | breast cancer | LeonaBio | Recruiting | No outcome recorded |
| Phase 3 | NCT05952557 Background | Oct 2023 → Mar 2030 expected | breast carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT05891093 Background | Jun 2023 → May 2028 expected | breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 3 | NCT04964934 Background | Jun 2021 → Jun 2025 overdue | estrogen-receptor positive breast cancer | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT03425838 Comparator | Nov 2017 → Mar 2023 overdue | breast cancer | Dutch Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 4 | NCT07487129 Comparator | Aug 2024 → Oct 2025 | breast cancer | Beni-Suef University | Completed | No outcome recorded |
| — | NCT07706933 Comparator | Aug 2026 → Jun 2028 expected | breast cancer | Henan Cancer Hospital | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 54
| Date | Issuer | Release |
|---|---|---|
| 2026-09-18 | Eli Lilly and Company | Regulatory U.S. FDA approves Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer lilly.com ↗ |
| 2026-09-04 | Alexion Pharmaceuticals, Inc. | Regulatory Etcamah in combination with a CDK4/6 inhibitor approved in the US for 1st-line advanced HR-positive breast cancer astrazeneca.com ↗ |
| 2026-07-23 | AstraZeneca | Regulatory Etcamah (camizestrant) in combination with a CDK4/6 inhibitor approved in the EU for 1st-line advanced ER-positive breast cancer astrazeneca.com ↗ |
| 2026-06-02 | AstraZeneca | Results Camizestrant combination delayed time to first progression by 55% and to second progression by 37% in patients with advanced HR-positive breast cancer with an emergent ESR1 tumour mutation in SERENA-6 trial astrazeneca.com ↗
Median PFS2 was 25.7 months for the camizestrant combination compared with 19.1 months for the AI combination. |
| 2026-05-22 | AstraZeneca | Regulatory Camizestrant in combination with a CDK4/6 inhibitor recommended for approval in the EU by CHMP for 1st-line advanced ER-positive breast cancer astrazeneca.com ↗ |
| 2026-04-09 | Zenith Epigenetics | Results Zenith Epigenetics Provides Update on ZEN-3694 NUT Carcinoma Program zenithepigenetics.com ↗
2 patients who received both ZEN-3694 and abemaciclib had positive treatment responses (67% of those who received this combination) |
| 2025-12-12 | Eli Lilly and Company | Results Updated data for Lilly's Inluriyo™ (imlunestrant) reinforce efficacy results as monotherapy and in combination with Verzenio® (abemaciclib) in ER+, HER2- advanced breast cancer lilly.com ↗
In all patients, imlunestrant plus abemaciclib reduced the risk of progression or death by 41% versus imlunestrant alone, demonstrated a favorable OS trend and numerically delayed time to chemotherapy (TTC) by more than a year. |
| 2025-10-17 | Eli Lilly and Company | Results Lilly's Verzenio® (abemaciclib) prolonged survival in HR+, HER2-, high-risk early breast cancer with two years of treatment lilly.com ↗
Seven-year results from the Phase 3 monarchE trial also show Verzenio plus endocrine therapy demonstrated sustained benefits in invasive disease-free survival and distant relapse-free survival |
| 2025-08-27 | Eli Lilly and Company | Results Lilly's Verzenio® (abemaciclib) increases overall survival in HR+, HER2-, high-risk early breast cancer with two years of therapy lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the primary overall survival (OS) analysis of the Phase 3 monarchE trial. |
| 2025-06-01 | AstraZeneca | Results Camizestrant reduced the risk of disease progression or death by 56% in patients with advanced HR-positive breast cancer with an emergent ESR1 tumour mutation in SERENA-6 Phase III trial astrazeneca.com ↗
Results showed the camizestrant combination reduced the risk of disease progression or death by 56% compared to standard-of-care treatment (based on a hazard ratio [HR] of 0.44; 95% confidence interval [CI] 0.31–0.60; p<0.00001) as assessed by investigator. |
| 2025-02-26 | AstraZeneca | Results Camizestrant demonstrated highly statistically significant and clinically meaningful improvement in progression-free survival in 1st-line advanced HR-positive breast cancer with an emergent ESR1 tumour mutation in SERENA-6 Phase III trial astrazeneca.com ↗ |
| 2024-12-11 | Eli Lilly and Company | Results Lilly's Imlunestrant, an Oral SERD, Significantly Improved Progression-Free Survival as Monotherapy and in Combination with Verzenio® (abemaciclib) in Patients with ER+, HER2- Advanced Breast Cancer lilly.com ↗
Imlunestrant in combination with Verzenio (abemaciclib; CDK4/6 inhibitor) reduced the risk of progression or death by 43% versus imlunestrant alone, in all patients. |
| 2024-12-10 | Pfizer | Results Arvinas and Pfizer Announce Initial Phase 1b Data from the TACTIVE-U Sub-Study of Vepdegestrant in Combination with Abemaciclib at 2024 San Antonio Breast Cancer Symposium pfizer.com ↗
An encouraging clinical benefit rate of 62.5% was observed among patients with both mutant ESR1 and wild-type ESR1 disease who had all been previously treated with a CDK4/6 inhibitor. |
| 2024-12-10 | Arvinas Inc. | Results Arvinas and Pfizer Announce Initial Phase 1b Data from the TACTIVE-U Sub-Study of Vepdegestrant in Combination with Abemaciclib at 2024 San Antonio Breast Cancer Symposium arvinas.com ↗
Preliminary results from 16 patients in the Phase 1b sub-study demonstrated a tolerable safety profile for the combination of abemaciclib 150 mg twice daily (BID) with the recommended Phase 3 monotherapy dose of vepdegestrant (200mg once daily; QD). |
| 2024-11-26 | Menarini Group | Results Menarini Group Presents New and Expanded Data at the 2024 San Antonio Breast Cancer Symposium Reinforcing the Role of ORSERDU® (Elacestrant) for Patients with ER+, HER2- Advanced or Metastatic Breast Cancer (mBC) menarini.com ↗
Updated results of elacestrant in combination with abemaciclib show favorable efficacy regardless of the ESR1 mutation status, with a manageable and predictable safety profile in patients with ER+/HER2- mBC. |
| 2024-05-24 | Menarini Group | Results Menarini Group Presents Updated Data from ELECTRA and ELEVATE Combination Studies of Elacestrant (ORSERDU®) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the ASCO 2024 Annual Meeting menarini.com ↗
Updated results from the ELECTRA study, evaluating elacestrant in combination with abemaciclib regardless of metastatic site, show a safety profile consistent with previous results. |
| 2023-12-11 | Menarini Group | Results Menarini Group Presented Initial Safety and Efficacy Data from Phase 1b/2 ELEVATE and ELECTRA Combination Studies of ORSERDU® (Elacestrant) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2023 San Antonio Breast Cancer Symposium menarini.com ↗
A preliminary analysis of data in the phase 1b part of the ELEVATE trial demonstrates antitumor activity of the combination evaluating ORSERDU with inhibitors of the PI3K/AKT/mTOR pathway and CDK 4/6 inhibitors. |
| 2023-12-05 | Eli Lilly and Company | Results Lilly to Present Final Overall Survival Analysis from the MONARCH 3 Study of Verzenio® (abemaciclib) and Additional Results from Its Breast Cancer Portfolio at the 2023 San Antonio Breast Cancer Symposium lilly.com ↗
For women with visceral organ metastases, data showed a median OS of more than five years, with an increase in median OS of 14.9 months in the Verzenio arm compared to the control arm (63.7 vs 48.8 months). |
| 2023-10-20 | Eli Lilly and Company | Results Landmark 5-Year monarchE Outcome Data Demonstrate Verzenio® (abemaciclib)'s Long-Term Impact on Cancer Recurrence in High-Risk Early Breast Cancer lilly.com ↗
Impact of two years of adjuvant Verzenio treatment is observed well beyond the treatment period, reducing the risk of long-term recurrence by 32% and improving invasive disease-free survival by 7.6% at 5 years |
| 2023-06-02 | Eli Lilly and Company | Results Lilly Highlights Verzenio® (abemaciclib) and Jaypirca™ (pirtobrutinib) Data at 2023 ASCO® Annual Meeting lilly.com ↗
New analyses from the Phase 3 monarchE trial of two years of Verzenio treatment in node-positive, high risk early breast cancer show similar efficacy across age groups |
| 2023-03-03 | Eli Lilly and Company | Regulatory U.S. FDA Broadens Indication for Verzenio® (abemaciclib) in HR+, HER2-, Node-Positive, High Risk Early Breast Cancer lilly.com ↗
This expanded adjuvant indication removes the Ki-67 score requirement for patient selection. |
| 2022-12-06 | Eli Lilly and Company | Results Lilly Announces Updated Data from the Verzenio® (abemaciclib) Phase 3 monarchE Trial Presented at SABCS and Simultaneously Published in The Lancet Oncology lilly.com ↗
The absolute increase in invasive disease-free survival (IDFS) and distance relapse-free survival (DRFS) continued to deepen in magnitude at four years, to 6.4% and 5.9%, respectively, reflecting improvements from the two- and three-year rates. |
| 2022-06-03 | Novartis Pharmaceuticals | Results New CDK4/6i data at ASCO reinforce Novartis Kisqali® as only drug in class with consistently proven overall survival benefit in HR+/HER2- metastatic breast cancer novartis.com ↗
A matching-adjusted indirect comparison analysis shows Kisqali plus an aromatase inhibitor (AI) is associated with better symptom-related quality of life when compared to Verzenio ®* plus AI when used in 1L |
| 2021-10-28 | Eli Lilly and Company | Results Additional Verzenio® (abemaciclib) Phase 3 monarchE Trial Data Published in the Annals of Oncology lilly.com ↗
Today, overall survival (OS) data from Eli Lilly and Company's (NYSE: LLY) Verzenio® (abemaciclib) Phase 3 monarchE study were published in a Letter to the Editor in the Annals of Oncology. |
| 2021-10-14 | Eli Lilly and Company | Results Lilly Announces Updated Verzenio® (abemaciclib) Phase 3 monarchE Trial Data Presented at ESMO Virtual Plenary and Simultaneously Published in the Annals of Oncology lilly.com ↗
These data were presented at today's ESMO Virtual Plenary and simultaneously published in the Annals of Oncology. |
| 2021-10-13 | Eli Lilly and Company | Regulatory FDA Approves Verzenio® (abemaciclib) as the First and Only CDK4/6 Inhibitor for Certain People with HR+ HER2- High Risk Early Breast Cancer lilly.com ↗
Verzenio is the first and only CDK4/6 inhibitor approved for this patient population. |
| 2021-06-04 | Eli Lilly and Company | Results Lilly Announces New Clinical Data from Verzenio and Oral SERD Programs at the American Society of Clinical Oncology Annual Meeting lilly.com ↗
In an exploratory analysis of a pre-specified subgroup of patients who received neoadjuvant chemotherapy (n=2,056), the addition of Verzenio to endocrine therapy (ET) resulted in a numerically greater effect size when compared to the intent-to-treat (ITT) population (n=5,637). |
| 2021-03-17 | Eli Lilly and Company | Results Lilly Presents Patient-Reported Outcomes from the Positive Phase 3 monarchE Trial for Verzenio® at St. Gallen Virtual Congress 2021 lilly.com ↗
This analysis revealed the addition of Verzenio to ET did not result in a clinically meaningful difference in patients reporting being bothered by treatment side effects. |
| 2020-12-09 | Eli Lilly and Company | Results Lilly Presents Positive Primary Outcome Data from monarchE that Builds on Previous Definitive Analysis for Verzenio® lilly.com ↗
The addition of Verzenio to ET also resulted in an improvement in distant relapse-free survival (DRFS), or time to developing breast cancer that has spread to other parts of the body. |
| 2020-09-20 | Eli Lilly and Company | Results Verzenio® Significantly Reduced the Risk of Cancer Recurrence by 25% for People with HR+, HER2- High Risk Early Breast Cancer lilly.com ↗
This statistically significant benefit was consistent across all pre-specified subgroups and corresponds to a 3.5 percent difference between arms (92.2 percent in the Verzenio arm and 88.7 percent in the control arm) at two years. |
| 2020-09-10 | Eli Lilly and Company | Results Lilly Oncology to Showcase New Data from Robust Cancer Research Pipeline at ESMO Virtual Congress 2020 lilly.com ↗
The data include positive results from the Phase 3 monarchE study of Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) for the treatment of high risk HR+, HER2- early breast cancer. |
| 2020-06-16 | Eli Lilly and Company | Results Verzenio® (abemaciclib) Significantly Reduced the Risk of Cancer Returning in People with High Risk HR+, HER2- Early Breast Cancer lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) has met the primary endpoint of invasive disease-free survival (IDFS), significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant ET alone. |
| 2019-09-29 | Eli Lilly and Company | Results Verzenio® (abemaciclib) Significantly Extends Life by a Median of 9.4 Months for Women with HR+, HER2- Advanced Breast Cancer in MONARCH 2 Study lilly.com ↗
These results were presented today as a late-breaking abstract in the Presidential Symposium at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain and simultaneously published in JAMA Oncology. |
| 2019-09-23 | Eli Lilly and Company | Results Lilly Oncology to Present Robust Data across Its Growing Portfolio at ESMO 2019 lilly.com ↗ |
| 2019-07-30 | Eli Lilly and Company | Results Lilly's Verzenio® (abemaciclib) Significantly Extended Life in Women with HR+, HER2- Advanced Breast Cancer in MONARCH 2 lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that Verzenio (abemaciclib) demonstrated a statistically significant improvement in overall survival in the Phase 3 MONARCH 2 clinical trial. |
| 2018-12-18 | Eli Lilly and Company | Results Lilly announces publication of analyses showing benefit of the addition of Verzenio® (abemaciclib) in multiple subgroups of patients with advanced breast cancer identified as having a more concerning prognosis lilly.com ↗ |
| 2018-02-26 | Eli Lilly and Company | Regulatory Lilly Receives Additional FDA Approval for VerzenioTM (abemaciclib), as Initial Treatment for Advanced Breast Cancer lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved VerzenioTM (abemaciclib) in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. |
| 2017-11-15 | AstraZeneca | Regulatory Faslodex receives US FDA approval for the treatment of advanced breast cancer in combination with abemaciclib astrazeneca.com ↗ |
| 2017-10-12 | Eli Lilly and Company | Regulatory FDA Grants Priority Review for Potential New Indication for Lilly's Verzenio™ (abemaciclib) as Initial Treatment of Advanced Breast Cancer lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for its New Drug Application (NDA) for Verzenio™ (abemaciclib), a cyclin-dependent kinase (CDK)4 & 6 inhibitor. |
| 2017-10-10 | Eli Lilly and Company | Results Lilly Reports Topline Results from Phase 3 JUNIPER Trial Evaluating Verzenio™ (abemaciclib) in KRAS-Mutated, Advanced Non-Small Cell Lung Cancer lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that its Phase 3 JUNIPER study evaluating Verzenio™ (abemaciclib), a cyclin-dependent kinase (CDK)4 and CDK6 inhibitor, as monotherapy in KRAS-mutated, advanced non-small lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS). |
| 2017-10-06 | Eli Lilly and Company | Results Lilly MONARCH 3 Study Published in Journal of Clinical Oncology Demonstrates Benefit of Verzenio™ (abemaciclib) Plus NSAI in Advanced Breast Cancer lilly.com ↗
MONARCH 3 met a rigorous threshold for demonstrating efficacy at the time of pre-planned interim analysis with a 46 percent reduction in the risk of progression or death in patients receiving initial therapy for metastatic disease. |
| 2017-10-04 | Eli Lilly and Company | Regulatory Lilly Receives U.S. FDA Approval of Verzenio™ (abemaciclib) lilly.com ↗
The approval of Verzenio was received on September 28, 2017. |
| 2017-07-10 | Eli Lilly and Company | Regulatory FDA Grants Priority Review for Lilly's Abemaciclib for the Treatment of Advanced Breast Cancer lilly.com ↗ |
| 2017-06-03 | Eli Lilly and Company | Results Lilly Builds Upon Body of Data for Abemaciclib with Phase 3 MONARCH 2 Data Demonstrating Superior Progression-Free Survival in Advanced Breast Cancer lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that results from the Phase 3 MONARCH 2 study showed that abemaciclib, a cyclin-dependent kinase (CDK)4 & 6 inhibitor, in combination with fulvestrant, significantly improved progression-free survival (PFS) compared to treatment with fulvestrant alone in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer who have relapsed or progressed after endocrine therapy (median PFS, 16.4 vs. 9.3 months, respectively, HR: 0.553; 95% CI: 0.449, 0.681, P < .0000001). |
| 2017-04-24 | Eli Lilly and Company | Results Lilly Announces Phase 3 MONARCH 3 Breast Cancer Study of Abemaciclib Demonstrated Superior Progression-Free Survival at Interim Analysis lilly.com ↗
INDIANAPOLIS, April 24, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that following a pre-planned interim analysis for MONARCH 3, the trial met its primary endpoint of demonstrating statistically significant improvement in progression-free survival (PFS). |
| 2017-03-20 | Eli Lilly and Company | Results Lilly Announces Phase 3 MONARCH 2 Breast Cancer Study of Abemaciclib Met Primary Endpoint of Progression-Free Survival lilly.com ↗
The results demonstrated the addition of abemaciclib to fulvestrant resulted in a statistically significant improvement in PFS, when compared to the control arm of placebo plus fulvestrant. |
| 2016-12-08 | Eli Lilly and Company | Results Lilly Presents neoMONARCH Phase 2 Data on Abemaciclib in Early-Stage Breast Cancer lilly.com ↗
The results showed that abemaciclib monotherapy and abemaciclib in combination with anastrozole significantly reduced Ki67 more than anastrozole alone. |
| 2016-08-10 | Eli Lilly and Company | Results Lilly Provides Update on MONARCH 2 Phase 3 Trial of Abemaciclib lilly.com ↗
INDIANAPOLIS, Aug. 10, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that following a pre-planned interim analysis for MONARCH 2, an independent Data Monitoring Committee (DMC) provided the recommendation to continue the study without modification as the interim efficacy criteria were not met. |
| 2016-06-03 | Eli Lilly and Company | Results Lilly Announces Results from MONARCH 1 Trial of Abemaciclib Monotherapy lilly.com ↗
The MONARCH 1 results (abstract #510) confirmed objective response (ORR), durability of response (DoR), clinical benefit rate (CBR) and progression-free survival (PFS). |
| 2015-10-08 | Eli Lilly and Company | Regulatory Lilly Receives FDA Breakthrough Therapy Designation for Abemaciclib - a CDK 4 and 6 Inhibitor - in Advanced Breast Cancer lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer. |
| 2015-04-20 | Eli Lilly and Company | Results Lilly Releases Early-Stage Pipeline Data at AACR Annual Meeting 2015 lilly.com ↗
The study identified three distinct mechanisms of action when luminal ER+ breast cancer cells are treated with abemaciclib at relevant pharmacological concentrations: potent cell-cycle arrest, efficient senescence response and induction of metabolic alterations. |
| 2014-05-14 | Eli Lilly and Company | Results Abemaciclib - Lilly's Oral CDK 4/6 Inhibitor - Shows Single-Agent Activity In A Phase I Study For Patients With A Specific Type Of Lung Cancer lilly.com ↗ |
| 2014-04-06 | Eli Lilly and Company | Results Lilly To Release Early-Stage Pipeline Data Targeting Key Cancer Pathways At AACR 2014 lilly.com ↗
The single-agent activity we've observed for bemaciclib is encouraging in this setting and we believe the data support the need for further development in metastatic breast cancer. |
| 2013-04-10 | Eli Lilly and Company | Results Lilly Debuts Early Oncology Pipeline Data At AACR Annual Meeting lilly.com ↗
These studies suggest that LY2835219 may have potential therapeutic application in the treatment of human cancers where the CDK4/6 pathway is key to regulating cancer cell growth (such as genetic subtypes of NSCLC, melanoma, MCL, and ovarian cancer). |
All press releases naming this drug 69 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 245 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Abemaciclib | “Full initial dose of either one of the CDK 4/6-inhibitors: Palbociclib 125 mg x 1 for 21 days with 7 days off; or Ribociclib 600 mg x 1 for 21 days with 7 days off; or...” NCT06044623 ↗236“The study is evaluating if a drug holiday (post CDK inhibitors progression) will reset the cell cycle machinery to be responsive to Abemaciclib and Fulvestrant.” NCT05305924 ↗ “sequential Trastuzumab rezetecan followed by CDK4/6 inhibitors (Dalpiciclib, Abemaciclib, Ribociclib, Palbociclib) plus endocrine therapy” NCT07037199 ↗ “physician's choice of CDK4/6 inhibitor (CDK4/6i) including palbociclib, ribociclib, and abemaciclib” NCT06486883 ↗ “All patients will receive CDK4/6 inhibitor (abemaciclib/ribociclib/dalpiciclib/palbociclib)” NCT07005557 ↗ “Abemaciclib will be taken orally twice a day on each day of the cycle, 150 mg per dose.” NCT03997448 ↗ “Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks” NCT03938337 ↗ “Fulvestrant, Imlunestrant, Aromatase Inhibitors, Capecitabine, Abemaciclib” NCT07114601 ↗ “Patients receiving postoperative abemaciclib step-up dosing regimen.” NCT07599137 ↗ “CDK4/6 inhibitors：dalpiciclib,palbociclib,abemaciclib,ribociclib” NCT07130643 ↗ “palbociclib,Ibrance,ribociclib,Kisqali,abemaciclib,Verzenio” NCT03425838 ↗ |
| Known as | ABEMACICLIB (LY2835219) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301610 ↗ |
| Known as | CDK4/6 DUAL INHIBITOR | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301610 ↗ |
| Known as | LY-28352192-PYRIMIDINAMINE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301610 ↗ |
| Known as | LY2835219 | “Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer” NCT05169567 ↗11“A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer” NCT03703466 ↗ “A Study of Abemaciclib (LY2835219) in Healthy Participants” NCT07818967 ↗ “study drug called abemaciclib (LY2835219)” NCT03220646 ↗ “Abemaciclib (LY2835219)” NCT02846987 ↗ “Abemaciclib (LY2835219)” NCT04118036 ↗ |
| Known as | LY2835219 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301610 ↗ |
| Known as | N-[5-[(4-ETHYL-1-PIPERAZINYL)METHYL]-2-PYRIDINYL]-5-FLUORO-4-[4-FLUORO-2-METHYL-1-(1-METHYLETHYL)-1H-BENZIMIDAZOL-6-YL]- | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301610 ↗ |
| Known as | VERZENIO | “A Pilot Study to Evaluate the Response and Tolerability of Verzenio (Abemaciclib) in Patients With Advanced Biliary Tract Carcinoma” NCT04003896 ↗1“Abemaciclib (VERZENIO®) is an approved drug.” NCT04514159 ↗ |
| Known as | VERZENIO (R) | “Lasofoxifene and abemaciclib (VERZENIO (R)).” NCT04432454 ↗ |
| Known as | VERZENIOS | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301610 ↗ |
| Action | Inhibit | “LY2835219 inhibits CDK4 and CDK6 with low nanomolar potency” PMID 24919854 ↗ Jun 2014 |
| Modality | Small molecule | “In summary, we have identified a potent, orally active small-molecule inhibitor of CDK4/6 that is active in xenograft tumors.” PMID 24919854 ↗ Jun 2014 |
| Route | Oral | “Abemaciclib (Verzenio), 150mg BID, p.o.” NCT01042379 ↗ |
| Target | CDK4 | “LY2835219 inhibits CDK4 and CDK6 with low nanomolar potency” PMID 24919854 ↗ Jun 2014 |
| Target | CDK6 | “LY2835219 inhibits CDK4 and CDK6 with low nanomolar potency” PMID 24919854 ↗ Jun 2014 |