Drugs / Ribociclib
Ribociclib
also known as
LEE011 · Kisqali · RIB · Birociclib · KisqaliTM · LEE-011 SUCCINATE · LEE-011-BBA · LEE-011A · +3 more
Small molecule targets CDK4, CDK6
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (7) | US (FDA) | KISQALI | — | 2018-07-18 – 2026-07-01 | fda.gov ↗ |
| Approved | EU (EMA) | Kisqali | — | 2017-08-22 | europa.eu ↗ |
| Approved | US (FDA) | KISQALI | — | 2017-03-13 | fda.gov ↗ |
Trials 151 · started per year
today
US approved 2017
EU approved 2017
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT06959979 | Nov 2024 → Aug 2026 overdue | childhood medulloblastoma | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | No outcome recorded |
| Phase 0 | NCT03834740 | Jan 2019 → Feb 2022 | brain glioma, glioblastoma | St. Joseph's Hospital and Medical Center, Phoenix | Completed | No outcome recorded |
| Phase 0 | NCT03179956 | Apr → Nov 2018 | head and neck squamous cell carcinoma | Fox Chase Cancer Center | Terminated | No outcome recorded |
| Phase 0 | NCT02933736 | Oct 2016 → Mar 2023 overdue | glioblastoma, meningioma | Nader Sanai | Active not recruiting | No outcome recorded |
| Phase 143 trials | ||||||
| Phase 1 | NCT05996107 | Feb 2024 → Oct 2026 expected | female breast carcinoma | University of Michigan Rogel Cancer Center | 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 | NCT05429502 | Dec 2022 → Feb 2025 | neuroblastoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT05508906 | Aug 2022 → Dec 2027 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma, metastatic malignant neoplasm | Olema Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05238922 | Jul 2022 → Jul 2027 expected | cancer | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 1 | NCT05252416 | Apr 2022 → Jul 2025 | carcinosarcoma, endometrial cancer, esophageal adenocarcinoma, gastric cancer +2 | Blueprint Medicines Corporation | Terminated | No outcome recorded |
| Phase 1 | NCT05216432 | Dec 2021 → Apr 2027 expected | Her2-receptor negative breast cancer, PIK3CA-related overgrowth spectrum | Relay Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT04315233 | May 2021 → Jun 2025 overdue | breast cancer, ovarian carcinoma | University of Utah | 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 |
| Phase 1 | NCT04213404 | Mar 2020 → Jan 2024 | head and neck squamous cell carcinoma | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT04000529 | Jul 2019 → Jan 2024 | colorectal cancer, esophageal squamous cell carcinoma, gastrointestinal stromal tumor, head and neck squamous cell carcinoma +1 | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT03740334 | Jan 2019 → Mar 2023 overdue | acute lymphoblastic leukemia | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03616587 | Oct 2018 → Sep 2024 overdue | estrogen-receptor positive breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03434262 | Mar 2018 → Sep 2022 | IDH-wildtype glioblastoma, RELA fusion-positive ependymoma, anaplastic ependymoma, anaplastic ganglioglioma +19 | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 1 | NCT03333343 | Jan 2018 → Oct 2026 expected | non-small cell lung carcinoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03387020 | Jan 2018 → Apr 2020 | atypical teratoid rhabdoid tumor, childhood ependymoma, diffuse intrinsic pontine glioma, medulloblastoma | Pediatric Brain Tumor Consortium | Completed | No outcome recorded |
| Phase 1 | NCT03237390 | Jan 2018 → May 2022 | metastatic malignant neoplasm | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT03355794 | Nov 2017 → Jul 2020 | anaplastic astrocytoma, diffuse intrinsic pontine glioma, glioblastoma | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 1 | NCT03294694 | Nov 2017 → Oct 2020 | hormone receptor-positive breast cancer, malignant epithelial tumor of ovary | Dana-Farber Cancer Institute | Terminated | No outcome recorded |
| Phase 1 | NCT03056833 | Jun 2017 → Jun 2020 | fallopian tube cancer, ovarian cancer, peritoneal carcinoma | Ronald Buckanovich | Completed | No outcome recorded |
| Phase 1 | NCT03009201 | Mar 2017 → Oct 2019 | angiosarcoma, epithelioid sarcoma, fibrosarcoma, leiomyosarcoma +7 | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02974725 | Feb 2017 → Apr 2024 | melanoma, non-small cell lung carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02754011 | Feb 2017 → Feb 2022 | breast cancer | UNICANCER | Completed | No outcome recorded |
| Phase 1 | NCT02780128 | Jul 2016 → Aug 2022 | cancer, neuroblastoma | Yael P Mosse | Terminated | No outcome recorded |
| Phase 1 | NCT02703571 | Jun 2016 → Sep 2019 | colorectal cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02734615 | Jun 2016 → Sep 2021 | estrogen-receptor positive breast cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02345824 | Mar 2016 → Sep 2019 | glioblastoma | University of Virginia | Unknown | No outcome recorded |
| Phase 1 | NCT02586675 | Feb 2016 → May 2017 | female breast carcinoma, male breast carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT02599363 | Jan 2016 → Mar 2019 | female breast carcinoma | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 1 | NCT02431481 | Oct 2015 → Sep 2017 | impaired renal function disease, medulloadrenal hyperfunction | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02370706 | May 2015 → Nov 2020 | myelofibrosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02292550 | May 2015 → Sep 2018 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02414724 | May 2015 → Apr 2016 | lymphoma | Roswell Park Cancer Institute | Terminated | No outcome recorded |
| Phase 1 | NCT02429089 | Apr 2015 → Sep 2017 | head and neck squamous cell carcinoma | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Terminated | No outcome recorded |
| Phase 1 | NCT02388620 | Mar 2015 → Jan 2017 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02343172 | Mar 2015 → Oct 2019 | liposarcoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02333370 | Feb 2015 → Sep 2022 | hormone receptor-positive breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02154776 | Jun 2014 → Oct 2016 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02088684 | May 2014 → Apr 2018 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01857193 | Sep 2013 → Mar 2018 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01747876 | May 2013 → Jun 2017 | neuroblastoma, rhabdoid tumor | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT01898845 | May 2013 → Jan 2015 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01237236 | Dec 2010 → Mar 2017 | lymphoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/225 trials | ||||||
| Phase 1/2 | NCT07164976 | Oct 2025 → Sep 2029 expected | breast cancer | Nagoya City University | 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 | NCT06726148 | Apr 2025 → Sep 2028 expected | hormone receptor-positive breast cancer, small cell lung carcinoma | Novartis Pharmaceuticals | 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 | NCT05664893 | Jun 2023 → Mar 2026 | Her2-receptor negative breast cancer | Centre Antoine Lacassagne | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05573555 | Mar 2023 → Dec 2026 expected | breast cancer | Pfizer | Active not 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 | NCT05358249 | Oct 2022 → Sep 2026 expected | colorectal carcinoma, non-small cell lung carcinoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05319873 | Apr 2022 → Apr 2027 expected | HER2 positive breast carcinoma, invasive breast carcinoma | Jonsson Comprehensive Cancer Center | Active not 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 | NCT03913234 | Jun 2019 → Oct 2023 | HER2 positive breast carcinoma | Yonsei University | Unknown | No outcome recorded |
| Phase 1/2 | NCT03090165 | May 2018 → Oct 2026 expected | triple-negative breast carcinoma | Kari Wisinski | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03424005 | Mar 2018 → Sep 2030 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02985125 | May 2017 → Jul 2019 | pancreatic adenocarcinoma | Georgetown University | Completed | No outcome recorded |
| Phase 1/2 | NCT02813135 | Aug 2016 → Feb 2031 expected | childhood malignant neoplasm | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02732119 | Jun 2016 → Feb 2020 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT02607124 | Apr 2016 → May 2018 | diffuse intrinsic pontine glioma, high grade astrocytic tumor | Children's Hospital Medical Center, Cincinnati | Terminated | No outcome recorded |
| Phase 1/2 | NCT02657343 | Mar 2016 → Aug 2020 | breast cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT02555189 | Dec 2015 → Dec 2022 | castration-resistant prostate carcinoma, metastatic carcinoma in the bone, metastatic prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Terminated | No outcome recorded |
| Phase 1/2 | NCT02494921 | Nov 2015 → Jul 2021 | prostate cancer | Rahul Aggarwal | Completed | No outcome recorded |
| Phase 1/2 | NCT01872260 | Oct 2013 → Feb 2027 expected | breast cancer | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01777776 | Jul 2013 → Apr 2015 | melanoma | Array BioPharma | Terminated | No outcome recorded |
| Phase 1/2 | NCT01781572 | Jun 2013 → Jan 2018 | melanoma | Pfizer | Completed | No outcome recorded |
| Phase 1/2 | NCT01543698 | May 2012 → Mar 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 251 trials | ||||||
| Phase 2 | NCT07423611 | Oct 2026 → Oct 2030 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07527806 | May 2026 → May 2029 expected | breast cancer | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07195227 | Mar 2026 → Feb 2028 expected | hormone receptor-positive breast cancer | MedSIR | Recruiting | No outcome recorded |
| Phase 2 | NCT06849947 | Feb 2026 → Jun 2031 expected | breast carcinoma | Yeon Hee Park | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07054190 | Sep 2025 → Jul 2027 expected | breast cancer | Hoffmann-La Roche | 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 | NCT06953882 | Jul 2025 → Sep 2030 expected | Her2-receptor negative breast cancer | Yale University | 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 | NCT05843253 | Aug 2024 → Aug 2029 expected | anaplastic astrocytoma, diffuse glioma, H3 G34 mutant, diffuse midline glioma, H3 K27M-mutant, glioblastoma +2 | Nationwide Children's Hospital | 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 | NCT06656624 | Aug 2024 → Dec 2025 overdue | female breast carcinoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06375707 | Jan 2024 → Nov 2025 | breast cancer | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT05900206 | Oct 2023 → Apr 2027 expected | breast cancer | Karolinska University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06481956 | Oct 2023 → Jan 2027 expected | HER2 positive breast carcinoma | Zheng Yabing | Enrolling by invitation | No outcome recorded |
| 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 | 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 | NCT05163106 | Dec 2022 → Jul 2024 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma, luminal A breast carcinoma +1 | University Hospital, Akershus | Completed | No outcome recorded |
| Phase 2 | NCT05467891 | Sep 2022 → Aug 2028 expected | hormone receptor-positive breast cancer | Oana Danciu | Recruiting | No outcome recorded |
| Phase 2 | NCT05296746 | May 2022 → Oct 2029 expected | breast cancer | SOLTI Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02645149 | Nov 2021 → Nov 2025 | melanoma | Melanoma Institute Australia | Completed | No outcome recorded |
| Phase 2 | NCT04417621 | Oct 2020 → Feb 2027 expected | melanoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04116541 | Jan 2020 → Oct 2026 expected | cancer | Centre Leon Berard | Recruiting | No outcome recorded |
| Phase 2 | NCT03283384 | Jun 2019 → Dec 2022 overdue | breast neoplasm | Dutch Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03822468 | Jun 2019 → Jun 2021 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT04256941 | May 2019 → Sep 2023 | female breast carcinoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT03673124 | May 2019 → Dec 2024 overdue | serous neoplasm | Gynecologic Oncology Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03839823 | Feb 2019 → Apr 2022 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03944434 | Dec 2018 → Dec 2024 overdue | breast cancer | Fondazione Sandro Pitigliani | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03484923 | Sep 2018 → Dec 2022 | melanoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03671330 | Aug 2018 → Apr 2022 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03477396 | Jun 2018 → Sep 2021 | hormone receptor-positive breast cancer | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03555877 | Mar 2018 → Jul 2022 | breast carcinoma | GBG Forschungs GmbH | Completed | No outcome recorded |
| Phase 2 | NCT03285412 | Dec 2017 → Apr 2026 overdue | breast cancer | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03008408 | Aug 2017 → Aug 2028 expected | endometrial carcinoma, endometrial endometrioid adenocarcinoma, uterine corpus cancer | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03114527 | Aug 2017 → Dec 2026 expected | soft tissue sarcoma | Fox Chase Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03248427 | Jul 2017 → Jun 2019 | breast cancer | SOLTI Breast Cancer Research Group | Completed | No outcome recorded |
| Phase 2 | NCT03078751 | Jun 2017 → Mar 2020 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03070301 | Feb 2017 → Jan 2024 | neuroendocrine neoplasm | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02934568 | Dec 2016 → Feb 2027 expected | — | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT02657928 | Jul 2016 → May 2018 | estrogen-receptor positive breast cancer, fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma +1 | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT03096912 | Jul 2016 → Dec 2019 | dedifferentiated liposarcoma, mixed liposarcoma, well-differentiated liposarcoma | Assaf-Harofeh Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02571829 | May 2016 → Aug 2017 | liposarcoma | Hadassah Medical Organization | Unknown | No outcome recorded |
| Phase 2 | NCT02524119 | Apr 2016 → Sep 2020 | hepatocellular carcinoma | University of Texas Southwestern Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT02632045 | Mar 2016 → Jan 2022 | breast carcinoma | Melissa K Accordino | Completed | No outcome recorded |
| Phase 2 | NCT02712723 | Feb 2016 → Aug 2018 overdue | breast cancer | Qamar Khan | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02420691 | Aug 2015 → Jun 2019 | duodenal neuroendocrine tumor, well differentiated, low or intermediate grade, functional pancreatic neuroendocrine tumor, gastric neuroendocrine neoplasm, lung neuroendocrine neoplasm +2 | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02187783 | Aug 2014 → Jan 2018 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02159066 | Jul 2014 → Jan 2023 | melanoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02035813 | Jan 2014 → Jan 2024 | hormone receptor-positive breast cancer | University of Ulm | Completed | No outcome recorded |
| Phase 2 | NCT01919229 | Oct 2013 → Sep 2014 | breast cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 321 trials | ||||||
| Phase 3 | NCT07391774 | Feb 2027 → Jul 2029 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 3 | NCT07400523 | Feb 2026 → Feb 2030 expected | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT07005557 | Jun 2025 → May 2030 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06377852 | Oct 2024 → Aug 2028 expected | breast cancer | American Society of Clinical Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT06380751 | Aug 2024 → Mar 2029 expected | female breast carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06044623 | Apr 2024 → Oct 2028 expected | breast cancer | Region Örebro County | Recruiting | No outcome recorded |
| Phase 3 | NCT05827081 | Feb 2024 → Sep 2029 expected | female breast carcinoma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT05207709 | Mar 2022 → Mar 2026 | breast cancer | SOLTI Breast Cancer Research Group | Terminated | No outcome recorded |
| Phase 3 | NCT04862663 | May 2021 → Nov 2027 expected | Her2-receptor negative breast cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT04055493 | Jul 2019 → Jul 2027 expected | female breast carcinoma | West German Study Group | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03905343 | Jun 2019 → Apr 2021 | breast cancer | Swiss Cancer Institute | Terminated | No outcome recorded |
| Phase 3 | NCT03701334 | Dec 2018 → May 2030 expected | breast cancer | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03462251 | May 2018 → Nov 2021 | hormone receptor-positive breast cancer | iOMEDICO AG | Completed | No outcome recorded |
| Phase 3 | NCT03081234 | Mar 2018 → Nov 2025 | breast cancer | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 3 | NCT03439046 | Feb 2018 → Dec 2023 | breast cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT02941926 | Nov 2016 → Nov 2019 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03096847 | Oct 2016 → Dec 2018 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02344472 | Sep 2015 → Jan 2025 | breast cancer | University of Ulm | Unknown | No outcome recorded |
| Phase 3 | NCT02422615 | Jun 2015 → Nov 2017 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02278120 | Nov 2014 → Aug 2017 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01958021 | Dec 2013 → Jan 2016 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT05691400 | Mar 2024 → Mar 2027 | leukodystrophy, hypomyelinating, 22 | University of Michigan Rogel Cancer Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT05452213 | Oct 2022 → Oct 2024 overdue | female breast carcinoma, hormone receptor-positive breast cancer | Institut fuer Frauengesundheit | Recruiting | No outcome recorded |
| Phase 4 | NCT05161195 | Jul 2022 → Jun 2030 expected | metastatic malignant neoplasm | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05203172 | Jul 2022 → Jul 2029 expected | cancer | Pfizer | Recruiting | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT06810492 | Apr → Dec 2025 overdue | female breast carcinoma | Hongmei Zheng, PhD | Not yet recruiting | No outcome recorded |
| — | NCT05977036 | Sep 2024 → Sep 2034 expected | breast carcinoma | Washington University School of Medicine | Recruiting | No outcome recorded |
| — | NCT04801966 | Sep 2021 → Dec 2022 | cancer | Peter MacCallum Cancer Centre, Australia | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 37 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT06625775 Background | Oct 2024 → Nov 2028 expected | HER2 positive breast carcinoma, colorectal cancer, hormone receptor-positive breast cancer, lung carcinoma | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) | Recruiting | No outcome recorded |
| Phase 1 | NCT06239467 Background | Feb 2024 → Dec 2026 expected | breast cancer | OnKure, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05870579 Background | Nov 2023 → Dec 2026 expected | breast cancer | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05683418 Background | Feb 2023 → Dec 2027 expected | hormone receptor-positive breast cancer | Totus Medicines | Recruiting | No outcome recorded |
| Phase 1 | NCT05384119 Background | Jan 2023 → Apr 2024 | female breast carcinoma | Tvardi Therapeutics, Incorporated | Terminated | No outcome recorded |
| Phase 1 | NCT02608216 Background | Nov 2015 → Nov 2026 expected | breast cancer | University of Pennsylvania | Active not recruiting | No outcome recorded |
| Phase 1/22 trials | ||||||
| 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 211 trials | ||||||
| Phase 2 | NCT07618390 Background | Jun 2026 → Dec 2028 expected | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07405801 Background | Apr 2026 → Dec 2028 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 2 | NCT07380646 Background | Jan 2026 → Jan 2028 expected | breast cancer, neutropenia, null-cell leukemia | Second Affiliated Hospital, School of Medicine, Zhejiang University | 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 | NCT05625087 Comparator | Oct 2023 → Jul 2028 expected | breast cancer | UNICANCER | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05816655 Background | May 2023 → Dec 2028 expected | breast cancer | Korea University Guro Hospital | 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 | 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 2 | NCT02300987 Comparator | Feb 2015 → Feb 2018 | teratoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 314 trials | ||||||
| Phase 3 | NCT07340658 Background | Aug 2026 → Feb 2029 expected | breast cancer | Rovi Pharmaceuticals Laboratories | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07647328 Background | Jun 2026 → Feb 2029 expected | breast carcinoma by gene expression profile | AstraZeneca | Recruiting | 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 |
| Phase 3 | NCT07174336 Background | Dec 2025 → May 2029 expected | breast cancer, metastatic neoplasm | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT07237256 Background | Dec 2025 → Nov 2033 expected | breast cancer | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT07085767 Background | Nov 2025 → Dec 2028 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | Olema Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06757634 Comparator | Jul 2025 → Mar 2029 expected | breast cancer | Celcuity Inc | 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 → Feb 2027 expected | estrogen-receptor positive breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT05670054 Comparator | Mar 2022 → Oct 2023 | female breast carcinoma | Mansoura University | Unknown | No outcome recorded |
| Phase 3 | NCT04964934 Background | Jun 2021 → Jun 2025 overdue | estrogen-receptor positive breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03425838 Comparator | Nov 2017 → Mar 2023 overdue | breast cancer | Dutch Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03050398 Background | Jun 2017 → Mar 2019 | breast cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07487129 Comparator | Aug 2024 → Oct 2025 | breast cancer | Beni-Suef University | Completed | No outcome recorded |
| Phase 4 | NCT04657679 Comparator | May 2021 → Oct 2023 | breast cancer | Georgetown University | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07706933 Comparator | Aug 2026 → Jun 2028 expected | breast cancer | Henan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05038631 Background | — | breast cancer | Novartis Pharmaceuticals | Available | No outcome recorded |
Press releases naming this drug 55 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-12-09 | Novartis Pharmaceuticals | 1 in 4 metastatic breast cancer patients treated with Novartis Kisqali® remain progression-free beyond 4 years novartis.com ↗ |
| 2025-10-17 | Novartis Pharmaceuticals | Novartis Kisqali® 5-year NATALEE data demonstrate 28% reduction in risk of recurrence in the broadest early breast cancer patient population novartis.com ↗ |
| 2025-06-01 | Novartis Pharmaceuticals | Novartis Kisqali® reduces risk of recurrence in younger patients with early breast cancer in NATALEE subgroup analysis novartis.com ↗ |
| 2024-12-10 | Novartis Pharmaceuticals | Longer-term Novartis Kisqali® NATALEE data show durable reduction in distant recurrence in broad population of patients with early breast cancer novartis.com ↗ |
| 2024-11-27 | Novartis Pharmaceuticals | Novartis Kisqali® receives European Commission approval in a broad population of patients with HR+/HER2- early breast cancer at high risk of recurrence novartis.com ↗ |
| 2024-11-25 | Novartis Pharmaceuticals | Novartis highlights new 96-week results from Phase III Scemblix® ASC4FIRST trial at ASH and late-breaking analysis from Phase III Kisqali® NATALEE trial at SABCS novartis.com ↗ |
| 2024-10-24 | Novartis Pharmaceuticals | Novartis ribociclib (Kisqali®) recognized as Category 1 preferred breast cancer adjuvant treatment by NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) novartis.com ↗ |
| 2024-10-18 | Novartis Pharmaceuticals | Novartis receives positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer novartis.com ↗ |
| 2024-09-17 | Novartis Pharmaceuticals | FDA approves Novartis Kisqali® to reduce risk of recurrence in people with HR+/HER2- early breast cancer novartis.com ↗ |
| 2024-09-16 | Novartis Pharmaceuticals | Novartis Kisqali® shows deepening benefit in new analysis, reducing the risk of recurrence by 28.5% in a broad population of patients with early breast cancer novartis.com ↗ |
| 2024-05-31 | Novartis Pharmaceuticals | Latest analysis of Novartis NATALEE study shows Kisqali® reduces risk of cancer recurrence for early breast cancer patients with high-risk node-negative disease novartis.com ↗ |
| 2023-12-08 | Novartis Pharmaceuticals | Latest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence across broad population of patients with early breast cancer; supports regulatory submissions novartis.com ↗ |
| 2023-11-20 | Novartis Pharmaceuticals | Novartis showcases significant data updates from Kisqali®, iptacopan and Scemblix® at SABCS and ASH novartis.com ↗ |
| 2023-10-20 | Novartis Pharmaceuticals | Novartis Kisqali® NATALEE analysis reinforces consistent reduction in risk of recurrence across key subgroups of patients with early breast cancer novartis.com ↗ |
| 2023-09-14 | Novartis Pharmaceuticals | Novartis Kisqali® reduced the risk of cancer recurrence while maintaining quality of life in patients diagnosed with early breast cancer novartis.com ↗ |
| 2023-06-02 | Novartis Pharmaceuticals | Novartis Kisqali® significantly reduced the risk of recurrence by 25% across a broad population of patients with early breast cancer; clinically meaningful benefit was consistent across subgroups novartis.com ↗ |
| 2023-04-26 | Novartis Pharmaceuticals | Novartis to present new data across oncology portfolio including Kisqali Phase III NATALEE trial in early breast cancer at ASCO novartis.com ↗ |
| 2023-03-27 | Novartis Pharmaceuticals | Novartis Kisqali® Phase III NATALEE trial meets primary endpoint at interim analysis demonstrating clinically meaningful benefit in broad population of patients with early breast cancer novartis.com ↗ |
| 2022-12-06 | Novartis Pharmaceuticals | Novartis Kisqali® prolonged PFS benefit for pre- and perimenopausal patients with aggressive HR+/HER2− metastatic breast cancer compared to chemotherapy novartis.com ↗ |
| 2022-11-22 | Novartis Pharmaceuticals | Novartis highlights scientific advances with Kisqali, iptacopan, Scemblix and YTB323 data at SABCS and ASH novartis.com ↗ |
| 2022-09-09 | Novartis Pharmaceuticals | Novartis Kisqali® adds one more year of survival benefit for broadest set of patients, including those with aggressive HR+/HER2- advanced breast cancer novartis.com ↗ |
| 2022-06-03 | Novartis Pharmaceuticals | 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 ↗ |
| 2022-05-04 | Novartis Pharmaceuticals | New Novartis data demonstrate only Kisqali® offers more life in the first-line setting for postmenopausal HR+/HER2- advanced breast cancer patients novartis.com ↗ |
| 2022-03-10 | Novartis Pharmaceuticals | NEJM publication of Novartis Kisqali® data shows longest median overall survival ever reported in HR+/HER2- advanced breast cancer novartis.com ↗ |
| 2021-12-08 | Novartis Pharmaceuticals | New Kisqali® data shows consistent overall survival benefit across genomic and clinical subtypes of interest in HR+/HER2- metastatic breast cancer novartis.com ↗ |
| 2021-09-19 | Novartis Pharmaceuticals | Novartis presents new Kisqali® data showing longest median overall survival ever reported in HR+/HER2- advanced breast cancer novartis.com ↗ |
| 2021-09-19 | Novartis Pharmaceuticals | Novartis announces collaboration on HARMONIA, a Phase III, head-to-head trial evaluating Kisqali® vs. Ibrance®* in patients with HR+/HER2- advanced breast cancer novartis.com ↗ |
| 2021-06-02 | Novartis Pharmaceuticals | Novartis Kisqali® reports longest median overall survival in postmenopausal HR+/HER2- metastatic breast cancer patients novartis.com ↗ |
| 2020-12-09 | Novartis Pharmaceuticals | Novartis Kisqali® demonstrates nearly five years median overall survival in metastatic breast cancer novartis.com ↗ |
| 2020-12-09 | Novartis Pharmaceuticals | Novartis Kisqali® data demonstrate superior benefit across main intrinsic subtypes in metastatic breast cancer novartis.com ↗ |
| 2020-09-21 | Novartis Pharmaceuticals | Novartis Kisqali® receives the highest rating of any CDK4/6 inhibitor on the ESMO Magnitude of Clinical Benefit Scale novartis.com ↗ |
| 2020-05-27 | Novartis Pharmaceuticals | Novartis Kisqali® shows overall survival benefit in HR+/HER2- advanced breast cancer with consistent findings in patients with more aggressive disease novartis.com ↗ |
| 2019-12-12 | Novartis Pharmaceuticals | Novartis Kisqali® data show superior overall survival compared to fulvestrant and consistent efficacy across advanced breast cancer patient subgroups in MONALEESA-3 novartis.com ↗ |
| 2019-09-29 | Novartis Pharmaceuticals | Novartis Kisqali® delivers consistently superior overall survival – MONALEESA-3 trial demonstrates more life for postmenopausal HR+/HER2- advanced breast cancer patients novartis.com ↗ |
| 2019-07-31 | Novartis Pharmaceuticals | Novartis Kisqali significantly prolongs life in women with HR+/HER2- advanced breast cancer now in two distinct Phase III trials novartis.com ↗ |
| 2019-06-01 | Novartis Pharmaceuticals | Novartis Kisqali significantly extends life in women with HR+/HER2- advanced breast cancer in MONALEESA-7 trial novartis.com ↗ |
| 2018-12-21 | Novartis Pharmaceuticals | Novartis receives European Commission (EC) approval for expanded indication for Kisqali® (ribociclib) novartis.com ↗ |
| 2018-12-08 | Novartis Pharmaceuticals | Novartis data demonstrates consistent efficacy and tolerability of Kisqali® combination therapy in HR+/HER2- advanced breast cancer in patients with difficult-to-treat visceral disease novartis.com ↗ |
| 2018-11-16 | Novartis Pharmaceuticals | Novartis receives positive CHMP opinion to expand Kisqali® combination therapy to all women with HR+/HER2- locally advanced or metastatic breast cancer novartis.com ↗ |
| 2018-07-18 | Novartis Pharmaceuticals | Novartis Kisqali® now first and only CDK4/6 inhibitor indicated in US as first-line therapy specifically for premenopausal women; and as initial therapy with fulvestrant in postmenopausal women novartis.com ↗ |
| 2018-06-03 | Novartis Pharmaceuticals | Third Novartis Phase III trial shows Kisqali® combination therapy significantly improves PFS in HR+/HER2- advanced breast cancer novartis.com ↗ |
| 2018-01-03 | Novartis Pharmaceuticals | Novartis Kisqali® received FDA Breakthrough Therapy designation for initial endocrine-based treatment in premenopausal women with HR+/HER2- advanced breast cancer novartis.com ↗ |
| 2017-12-06 | Novartis Pharmaceuticals | Kisqali® first and only CDK4/6 inhibitor to show superior efficacy vs. oral endocrine therapy as 1L treatment in randomized Phase III trial in premenopausal women with HR+/HER2- advanced breast cancer novartis.com ↗ |
| 2017-11-08 | Novartis Pharmaceuticals | Novartis reports positive results from Phase III trial of Kisqali® (ribociclib) combination therapy in premenopausal women with HR+/HER2- advanced or metastatic breast cancer novartis.com ↗ |
| 2017-08-24 | Novartis Pharmaceuticals | Novartis Kisqali® (ribociclib) receives EU approval as first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer in combination with any aromatase inhibitor novartis.com ↗ |
| 2017-06-23 | Novartis Pharmaceuticals | Novartis Kisqali® (ribociclib) receives positive CHMP opinion as first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer in combination with any aromatase inhibitor novartis.com ↗ |
| 2017-06-02 | Novartis Pharmaceuticals | Novartis presents updated data that reinforce the efficacy and safety of Kisqali® (ribociclib) plus letrozole as a first-line option for HR+/HER2- advanced or metastatic breast cancer novartis.com ↗ |
| 2017-03-23 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Ribociclib (LEE011) Receives Regulatory Approval in U.S. as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer with an aromatase inhibitor otsuka.co.jp ↗ |
| 2017-03-13 | Novartis Pharmaceuticals | Novartis Kisqali® (ribociclib, LEE011) receives FDA approval as first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor novartis.com ↗ |
| 2016-12-09 | Novartis Pharmaceuticals | Novartis LEE011 (ribociclib) plus letrozole analyses show superior PFS across broad spectrum of patients in first-line HR+/HER2- advanced breast cancer versus letrozole novartis.com ↗ |
| 2016-11-01 | Novartis Pharmaceuticals | Novartis LEE011 (ribociclib) granted FDA Priority Review for first-line treatment of HR+/HER2- advanced breast cancer novartis.com ↗ |
| 2016-10-19 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Positive Phase III Clinical Trial Results for Ribociclib (LEE011), an Investigational Compound for Advanced Breast Cancer in Development by Major Pharmaceutical Company under a Research Collaboration with Otsuka's Subsidiary Astex Pharmaceuticals otsuka.co.jp ↗ |
| 2016-10-08 | Novartis Pharmaceuticals | Novartis breakthrough therapy LEE011 plus letrozole demonstrates superior progression-free survival as first-line treatment for HR+/HER2- advanced breast cancer compared to a standard of care novartis.com ↗ |
| 2016-08-03 | Novartis Pharmaceuticals | Novartis CDK4/6 inhibitor LEE011 (ribociclib) receives FDA Breakthrough Therapy designation as first-line treatment for HR+/HER2- advanced breast cancer novartis.com ↗ |
| 2016-05-18 | Novartis Pharmaceuticals | MONALEESA-2 trial of Novartis' LEE011 (ribociclib) stopped due to positive efficacy results at interim analysis in HR+/HER2- advanced breast cancer novartis.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 191 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ribociclib | “This was a multi-center, randomized, double blind (investigator and subject), placebo controlled Phase II study to determine the efficacy and safety of treatment with...” NCT02300987 ↗163“An Open-label, Multi-center Rollover Protocol for Patients Who Have Participated in a Novartis-sponsored Ribociclib (LEE011) Study and Are Continuing to Benefit From Ribociclib...” NCT02934568 ↗ “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 ↗ “Cyclin dependant kinase inhibitors (CDK inhibitors) mainly Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM) are approved for treatment of hormone receptor positive,...” NCT05670054 ↗ “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 ↗ “Leucogen combined with Ribociclib (Kisqali®) and Endocrine Therapy (e.g., Letrozole, Anastrozol)” NCT07380646 ↗ “All patients will receive CDK4/6 inhibitor (abemaciclib/ribociclib/dalpiciclib/palbociclib)” NCT07005557 ↗ “CDK4/6 inhibitors：dalpiciclib,palbociclib,abemaciclib,ribociclib” NCT07130643 ↗ “palbociclib,Ibrance,ribociclib,Kisqali,abemaciclib,Verzenio” NCT03425838 ↗ “CDK4/6 inhibitor: * palbociclib * ribociclib * abemaciclib” NCT03227328 ↗ “palbociclib OR ribociclib OR abemaciclib OR dalpiciclib” NCT07180160 ↗ “CDK4/6 inhibitors: Palbociclib, Abemaciclib, Ribociclib” NCT07173556 ↗ “* CDK4/6i: Palbociclib, Ribociclib or Abemaciclib” NCT05826964 ↗ “Ribociclib is the preferred CDK4/6 inhibitor.” NCT05977036 ↗ “Ribociclib 600mg once daily every 21days” NCT07527806 ↗ “Abemaciclib / Ribociclib / Palbociclib” NCT04920708 ↗ “the CDK4/6 inhibitor ribociclib” PMID 32887722 ↗ Sep 2020 “Ribociclib + Trametinib” NCT02645149 ↗ “Drug: Ribociclib” NCT05625087 ↗ |
| Known as | Birociclib | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545110 ↗ |
| Known as | Kisqali | “provide access to ribociclib (LEE011, Kisqali®), for locally advanced or metastatic cancer resistant or refractory to available treatment options and candidate for therapy with...” NCT05038631 ↗2“Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle Other Names: • KISQALI®” NCT06757634 ↗ “Leucogen combined with Ribociclib (Kisqali®) and Endocrine Therapy (e.g., Letrozole, Anastrozol)” NCT07380646 ↗ |
| Known as | KisqaliTM | “Patients entered into this study will be given letrozole (FemarTM) in combination with ribociclib (KisqaliTM) for at least 6 months.” NCT05163106 ↗ |
| Known as | LEE-011 SUCCINATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545110 ↗ |
| Known as | LEE-011-BBA | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545110 ↗ |
| Known as | LEE-011A | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545110 ↗ |
| Known as | LEE011 | “Preclinical studies with ribociclib (LEE-011), a CDK4/6 cell cycle checkpoint inhibitor, demonstrate a synergistic effect with platinum chemotherapy and efficacy as a...” PMID 35972817 ↗ Sep 202230“A Phase 0/I Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection” NCT03834740 ↗ “Ribociclib (formerly LEE011) is an orally bioavailable, highly selective small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6).” NCT03673124 ↗ “Treatment of CDK4/6 Therapy/LEE011/Ribociclib” NCT03050398 ↗ “ribociclib (LEE011)” NCT01857193 ↗ “LEE011 (Ribociclib)” NCT02494921 ↗ “Ribociclib (LEE011)” NCT02599363 ↗ |
| Known as | NVP-LEE011 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545110 ↗ |
| Known as | RIB | “The phase 3 MONALEESA-2 study demonstrated that addition of ribociclib (RIB) to letrozole (LET) significantly improved progression-free survival (PFS) in patients (pts) with...” PMID 29404806 ↗ Feb 20181“Cyclin dependant kinase inhibitors (CDK inhibitors) mainly Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM) are approved for treatment of hormone receptor positive,...” NCT05670054 ↗ |
| Known as | Ribociclib Succinate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07391774 ↗ |
| Known as | Ribociclib succinate component of kisqali femara co-pack | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545110 ↗ |
| Action | Inhibit | “designed to inhibit the activity of an enzyme known as CDK4/6” NCT01237236 ↗ |
| Modality | Small molecule | “LEE011 is a small molecule inhibitor of CDK4/6.” NCT01747876 ↗ |
| Route | Oral | “LEE011 is a new oral drug” NCT01237236 ↗ |
| Target | CDK4 | “LEE011 is a new oral drug designed to inhibit the activity of an enzyme known as CDK4/6.” NCT01237236 ↗ |