trilaciclib

Trade name: Cosela

Small moleculeapprovedBreakthrough Therapy FDA

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

Phase 1
3
Phase 2
32
Phase 3
4
Phase 4
2

Earliest trial started Sep 1, 2014 (NCT02243150)

Timeline

2010s

  1. Jan 1, 2014

    G1 Therapeutics, Inc. — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2017

    G1 Therapeutics, Inc. — Earliest Phase 2 Sponsor(trial)

2020s

  1. Jan 1, 2020

    G1 Therapeutics, Inc. — Earliest Phase 3 Sponsor(trial)

  2. Feb 12, 2021

    G1 Therapeutics, Inc. — Earliest FDA Approval

  3. Feb 12, 2021

    G1 Therapeutics, Inc. — Marketing Organization

  4. Feb 12, 2021

    Pharmacosmos — Marketing Organization

  5. Feb 12, 2021

    G1 Therapeutics, Inc. — NDA Secondary Org

  6. Feb 12, 2021

    G1 Therapeutics, Inc. — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewBreakthroughFeb 12, 2021

Chemistry & pharmacology

Loading structure…

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

First in class

Sources

Also known as

  • g1t28
  • g1t28
  • trilaciclib
  • trilaciclib

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07255612Phase 2Nov 4, 2026Sun Yat-Sen University
NCT06992739Phase 2Jun 30, 2025Xiamen University
NCT06929936Phase 2May 9, 2025Xiamen University
NCT06752798Phase 2Dec 30, 2024Central South University
NCT06714266Phase 2Dec 15, 2024Shandong University
NCT06714383Phase 2Nov 13, 2024Peking University
NCT06698965Phase 2Oct 13, 2024Jiao Tong University, Simcere Pharmaceutical Co., Ltd
NCT06490081Phase 2Jun 26, 2024Chinese Academy of Medical Sciences
NCT06569485Phase 2May 23, 2024Sun Yat-Sen University
NCT06370416Phase 2Apr 30, 2024Henan Medical University, Simcere Pharmaceutical Co., Ltd
NCT06364904Phase 3Apr 15, 2024Sun Yat-Sen University
NCT06297811Phase 2Mar 1, 2024Sun Yat-Sen University
NCT06217003Phase 2Feb 1, 2024Xinxiang Medical University
NCT06027268Phase 2Dec 31, 2023G1 Therapeutics, Inc., Merck, Wake Forest University
NCT05874401Phase 4Oct 18, 2023G1 Therapeutics, Inc.
NCT05978648Phase 2Sep 20, 2023Sun Yat-Sen University
NCT06328049Phase 2Aug 10, 2023Taixing People's Hospital
NCT05862610Phase 2Jul 30, 2023Sun Yat-Sen University
NCT06955156Phase 2Jul 3, 2023Chinese Academy of Medical Sciences
NCT05910034Phase 2Jul 1, 2023Fudan University
Showing 20 of 36 trials
Page 1 / 2

Organizations

Research & Development (24)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
G1 Therapeutics, Inc.For profit171352014
Sun Yat-Sen UniversityAcademic/Hospital6622023
Simcere Pharmaceutical Co., LtdFor profit4232021
Chinese Academy of Medical SciencesAcademic/Hospital2212023
Shandong UniversityAcademic/Hospital2112023
Xiamen UniversityAcademic/Hospital2212025
Bionical EmasFor profit101
Central South UniversityAcademic/Hospital1112024
Chengdu Second people's hospitalAcademic/Hospital1012023
Fudan UniversityAcademic/Hospital1112023
Hainan People's HospitalAcademic/Hospital1012021
Henan Medical UniversityAcademic/Hospital1112024
Jiao Tong UniversityAcademic/Hospital1112024
MerckFor profit1012023
Mianyang Central HospitalAcademic/Hospital1012023
Peking UniversityAcademic/Hospital1112024
Pharmaceutical Research Associates, Inc. (PRA)For profit1012014
Shaanxi Provincial People's HospitalAcademic/Hospital1012023
Shandong Provincial Cancer HospitalAcademic/Hospital1012023
Sichuan UniversityAcademic/Hospital1112023
24 organizations
Page 1 / 2

Marketing (4)

OrganizationOrg typeRelationshipDate
G1 Therapeutics, Inc.For profitMKTGFeb 12, 2021
G1 Therapeutics, Inc.For profitNDA2Feb 12, 2021
G1 Therapeutics, Inc.For profitNDAFeb 12, 2021
PharmacosmosFor profitMKTGFeb 12, 2021