Table 3.
The FDA-approved and clinically developed CDK4/6 inhibitors
| Target | Drug | Highest Phase | Indications | Company/identifier | Status |
|---|---|---|---|---|---|
| CDK4/6 | Palbociclib (PD0332991) | Approved | HR+, HER2− advanced breast cancer in combination with hormonal therapy | Pfizer | / |
| Ribociclib (LEE-011) | Approved | HR+, HER2− advanced breast cancer in combination with hormonal therapy | Novartis | / | |
| Abemaciclib (LY2835219) | Approved | HR+, HER2− advanced breast cancer in combination with hormonal therapy, monotherapy for advanced HR+, HER2− breast cancer, adjuvant therapy for high-risk, early-stage HR+, HER2− breast cancer in combination with hormonal therapy | Eli Lilly | / | |
| Trilaciclib | Approved | Approved to reduce chemotherapy-induced bone marrow suppression in patients with extensive-stage small cell lung cancer | G1 Therapeutics | / | |
| TQB3616 | III | HR+, HER2− in advanced breast cancer | NCT05375461 | Recruiting | |
| III | Breast cancer | NCT05780567 | Recruiting | ||
| III | HR+, HER2− breast neoplasms | NCT05365178 | Not yet recruiting | ||
| SPH4336 | III | Locally advanced or metastatic breast cancer | NCT05860465 | Not yet recruiting | |
| III | Locally advanced or metastatic breast cancer | NCT05744687 | Recruiting | ||
| Dalpiciclib (SHR6390) | III | Advanced breast cancer | NCT05861830 | NCT05861830 | |
| III | Female breast cancer | NCT04842617 | NCT04842617 | ||
| III | Advanced breast cancer | NCT03966898 | NCT03966898 | ||
| Flavopiridol (L86-8275) | I/II | Lymphoma | NCT00445341 | NCT00445341 | |
| I/II | B-cell chronic lymphocytic leukemia, recurrent small lymphocytic lymphoma, refractory chronic lymphocytic leukemia, waldenström macroglobulinemia | NCT00058240 | NCT00058240 | ||
| II | Leukemia, lymphocytic, chronic | NCT00464633 | Recruiting | ||
| II | B-cell chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia, stage I–IV chronic lymphocytic leukemia, | NCT00003620 | Completed | ||
| II | Refractory multiple myeloma, stage I–III multiple myeloma | NCT00047203 | Completed | ||
| II | Adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage IV pancreatic cancer | NCT00331682 | Completed | ||
| II | Sarcoma | NCT00005974 | Completed | ||
| II | Prostate cancer | NCT00003256 | Completed | ||
| II | Adenocarcinoma of the gastroesophageal junction, diffuse adenocarcinoma of the stomach, intestinal adenocarcinoma of the stomach, mixed adenocarcinoma of the stomach, recurrent gastric cancer, stage IIIA gastric cancer, stage IIIB gastric cancer, stage IIIC gastric cancer, stage IV gastric cancer | NCT00991952 | Completed | ||
| II | Lymphoma | NCT00003039 | Completed | ||
| II | Kidney cancer | NCT00016939 | Completed | ||
| II | Melanoma (skin) | NCT00005971 | Completed | ||
| II | Endometrial cancer | NCT00023894 | Completed | ||
| II | Lymphoma | NCT00005074 | Completed | ||
| II | Liver cancer | NCT00087282 | Completed | ||
| I/II | Recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, secondary acute myeloid leukemia, untreated adult acute lymphoblastic leukemia, untreated adult acute myeloid leukemia | NCT00016016 | Completed | ||
| II | B-cell chronic lymphocytic leukemia, prolymphocytic leukemia, refractory chronic lymphocytic leukemia | NCT00098371 | Terminated | ||
| II | Head and neck cancer | NCT00020189 | Completed | ||
| II | Esophageal cancer | NCT00006245 | Completed | ||
| II | Breast cancer | NCT00020332 | Completed |
Source: All the information is derived from ClinicalTrials.gov (https://www.clinicaltrials.gov) and the United States Food and Drug Administration.gov (https://www.fda.gov/)