trilaciclib
Trade name: Cosela
Approved
Feb 12, 2021
A CDK inhibitor is any chemical that inhibits the function of CDKs. They are used to treat cancers by preventing overproliferation of cancer cells. The US FDA approved the first drug of this type, palbociclib (Ibrance), a CDK4/6 inhibitor, in February 2015, for use in postmenopausal women with breast cancer that is estrogen receptor positive and HER2 negative. While there are multiple cyclin/CDK complexes regulating the cell cycle, CDK inhibitors targeting CDK4/6 have been the most successful; four CDK4/6 inhibitors have been FDA approved. No inhibitors targeting other CDKs have been FDA approved, but several compounds are in clinical trials. — Wikipedia
Clinical trial activity
36 trials · 24 clinical orgs · 2 marketing orgs
Earliest trial started Sep 1, 2014 (NCT02243150)
Timeline
2010s
- Jan 1, 2014
G1 Therapeutics, Inc. — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2017
G1 Therapeutics, Inc. — Earliest Phase 2 Sponsor(trial)
2020s
- Jan 1, 2020
G1 Therapeutics, Inc. — Earliest Phase 3 Sponsor(trial)
- Feb 12, 2021
G1 Therapeutics, Inc. — Earliest FDA Approval
- Feb 12, 2021
G1 Therapeutics, Inc. — Marketing Organization
- Feb 12, 2021
Pharmacosmos — Marketing Organization
- Feb 12, 2021
G1 Therapeutics, Inc. — NDA Secondary Org
- Feb 12, 2021
G1 Therapeutics, Inc. — NDA Organization
Indications
Studied for
- Bone Marrow Diseases · Phase 3
- Breast Neoplasms · Phase 3
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Carcinoma, Transitional Cell · Phase 2
- Colorectal Neoplasms · Phase 3
- Drug-Related Side Effects and Adverse Reactions · Phase 3
- Endometrial Neoplasms · Phase 2
- Epidermal Growth Factor · Phase 2
- Healthy Volunteers · Phase 1
- Lung Neoplasms · Phase 2
- Lymphoma, Large-Cell, Immunoblastic · Phase 2
- Osteosarcoma · Phase 2
- Small Cell Lung Carcinoma · Phase 4
- Squamous Cell Carcinoma of Head and Neck · Phase 2
- Triple Negative Breast Neoplasms · Phase 2
- Urinary Bladder Neoplasms · Phase 3
- Uterine Cervical Neoplasms · Phase 2
Mechanism of action
- CDK6/cyclin D1ANTAGONIST
CDK6/cyclin D1 antagonist
- CDK2/CDK4ANTAGONIST
CDK2/CDK4 antagonist
- Cyclin-dependent kinase 6INHIBITOR
Cyclin-dependent kinase 6 inhibitor
Myeloprotection therapy
- Cyclin-dependent kinase 4INHIBITOR
Cyclin-dependent kinase 4 inhibitor
Approval history
- approvedPriority reviewBreakthroughFeb 12, 2021
Chemistry & pharmacology
SMILES
CN1CCN(c2ccc(Nc3ncc4cc5n(c4n3)C3(CCCCC3)CNC5=O)nc2)CC1- Mol. weight
- 446.56 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaCDK inhibitor ↗
- ChEMBLCHEMBL4650272 ↗
- ChEMBLCHEMBL3894860 ↗
Also known as
- g1t28
- g1t28
- trilaciclib
- trilaciclib
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07255612 | Phase 2 | Nov 4, 2026 | Sun Yat-Sen University |
| NCT06992739 | Phase 2 | Jun 30, 2025 | Xiamen University |
| NCT06929936 | Phase 2 | May 9, 2025 | Xiamen University |
| NCT06752798 | Phase 2 | Dec 30, 2024 | Central South University |
| NCT06714266 | Phase 2 | Dec 15, 2024 | Shandong University |
| NCT06714383 | Phase 2 | Nov 13, 2024 | Peking University |
| NCT06698965 | Phase 2 | Oct 13, 2024 | Jiao Tong University, Simcere Pharmaceutical Co., Ltd |
| NCT06490081 | Phase 2 | Jun 26, 2024 | Chinese Academy of Medical Sciences |
| NCT06569485 | Phase 2 | May 23, 2024 | Sun Yat-Sen University |
| NCT06370416 | Phase 2 | Apr 30, 2024 | Henan Medical University, Simcere Pharmaceutical Co., Ltd |
| NCT06364904 | Phase 3 | Apr 15, 2024 | Sun Yat-Sen University |
| NCT06297811 | Phase 2 | Mar 1, 2024 | Sun Yat-Sen University |
| NCT06217003 | Phase 2 | Feb 1, 2024 | Xinxiang Medical University |
| NCT06027268 | Phase 2 | Dec 31, 2023 | G1 Therapeutics, Inc., Merck, Wake Forest University |
| NCT05874401 | Phase 4 | Oct 18, 2023 | G1 Therapeutics, Inc. |
| NCT05978648 | Phase 2 | Sep 20, 2023 | Sun Yat-Sen University |
| NCT06328049 | Phase 2 | Aug 10, 2023 | Taixing People's Hospital |
| NCT05862610 | Phase 2 | Jul 30, 2023 | Sun Yat-Sen University |
| NCT06955156 | Phase 2 | Jul 3, 2023 | Chinese Academy of Medical Sciences |
| NCT05910034 | Phase 2 | Jul 1, 2023 | Fudan University |
Organizations
Research & Development (24)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| G1 Therapeutics, Inc. | For profit | 17 | 13 | 5 | 2014 |
| Sun Yat-Sen University | Academic/Hospital | 6 | 6 | 2 | 2023 |
| Simcere Pharmaceutical Co., Ltd | For profit | 4 | 2 | 3 | 2021 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 2 | 2 | 1 | 2023 |
| Shandong University | Academic/Hospital | 2 | 1 | 1 | 2023 |
| Xiamen University | Academic/Hospital | 2 | 2 | 1 | 2025 |
| Bionical Emas | For profit | 1 | 0 | 1 | — |
| Central South University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Chengdu Second people's hospital | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Fudan University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Hainan People's Hospital | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Henan Medical University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Jiao Tong University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Merck | For profit | 1 | 0 | 1 | 2023 |
| Mianyang Central Hospital | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Peking University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Pharmaceutical Research Associates, Inc. (PRA) | For profit | 1 | 0 | 1 | 2014 |
| Shaanxi Provincial People's Hospital | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Shandong Provincial Cancer Hospital | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Sichuan University | Academic/Hospital | 1 | 1 | 1 | 2023 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| G1 Therapeutics, Inc. | For profit | MKTG | Feb 12, 2021 |
| G1 Therapeutics, Inc. | For profit | NDA2 | Feb 12, 2021 |
| G1 Therapeutics, Inc. | For profit | NDA | Feb 12, 2021 |
| Pharmacosmos | For profit | MKTG | Feb 12, 2021 |