Drugs / Trilaciclib
last change 3 days ago re-read 2 minutes ago

Trilaciclib

also known as Cosela

targets CDK4 via inhibition

Developed for
small cell lung carcinoma · non-small cell lung carcinoma · triple-negative breast carcinoma · chemotherapy-induced toxicity · head and neck squamous cell carcinoma · breast cancer · bone marrow failure syndrome · myelolymphatic insufficiency
+12 more · urinary bladder cancer · biliary tract neoplasm · breast neoplasm · conventional osteosarcoma · diffuse large B-cell lymphoma · esophageal squamous cell carcinoma · malignant pancreatic neoplasm · myeloid hemopathy · non-small cell squamous lung carcinoma · osteosarcoma · pancreatic neoplasm · urothelial carcinoma
Investigated by
G1 Therapeutics, Inc. · Jiangsu Simcere Pharmaceutical Co., Ltd. · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sun Yat-sen University · Fudan University · Pharmacosmos A/S
+31 more · Shandong Cancer Hospital and Institute · The First Affiliated Hospital of Xiamen University · Bionical Emas · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Chengdu First People's Hospital · Chengdu Second people's hospital · Chengdu Seventh People's Hospital · Enshi Central Hospital · Hebei Medical University Fourth Hospital · Heilongjiang Provicial Hospital · Henan Cancer Hospital · Hunan Cancer Hospital · Jiangsu Province Nanjing Brain Hospital · Merck Sharp & Dohme LLC · Mianyang Central Hospital · Neijiang Hospital of Traditional Chinese Medicine · Peking University People's Hospital · QIAO LI · QuantumLeap Healthcare Collaborative · Roche-Genentech · Shanghai Chest Hospital · Shanxi Province Cancer Hospital · Sichuan University · Taixing People's Hospital · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · The First Affiliated Hospital of Xinxiang Medical College · The First Affiliated Hospital with Nanjing Medical University · The Second Affiliated Hospital of Shandong First Medical University · UNC Lineberger Comprehensive Cancer Center · Wake Forest University Health Sciences · wang shusen

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) COSELA 2021-02-12 fda.gov

Trials 43 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT07490236 Jan 2023 → Aug 2027 expected Hebei Medical University Fourth Hospital Recruiting No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT02514447 Oct 2015 → Sep 2018 small cell lung carcinoma G1 Therapeutics, Inc. Completed No outcome recorded
Phase 1/2 NCT02499770 Jun 2015 → Jul 2017 small cell lung carcinoma G1 Therapeutics, Inc. Completed No outcome recorded
Phase 233 trials
Phase 2 NCT07255612 Nov → Dec 2026 expected breast cancer Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT07679997 Jun 2026 → Sep 2027 expected head and neck squamous cell carcinoma Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Not yet recruiting No outcome recorded
Phase 2 NCT06992739 Dec 2025 → Mar 2027 expected bone marrow failure syndrome, non-small cell lung carcinoma The First Affiliated Hospital of Xiamen University Recruiting No outcome recorded
Phase 2 NCT07160283 Sep 2025 → Sep 2027 expected biliary tract neoplasm, pancreatic neoplasm The Second Affiliated Hospital of Shandong First Medical University Not yet recruiting No outcome recorded
Phase 2 NCT06929936 May 2025 → May 2026 overdue myelolymphatic insufficiency, non-small cell lung carcinoma The First Affiliated Hospital of Xiamen University Recruiting No outcome recorded
Phase 2 NCT06752798 Dec 2024 → Sep 2025 overdue head and neck squamous cell carcinoma Hunan Cancer Hospital Recruiting No outcome recorded
Phase 2 NCT06714266 Dec 2024 → Aug 2026 overdue head and neck squamous cell carcinoma Shandong Cancer Hospital and Institute Not yet recruiting No outcome recorded
Phase 2 NCT06714383 Nov 2024 → Jul 2025 overdue conventional osteosarcoma Peking University People's Hospital Recruiting No outcome recorded
Phase 2 NCT06699472 Oct 2024 → Sep 2026 expected Ewing sarcoma, chemotherapy-induced toxicity Fudan University Recruiting No outcome recorded
Phase 2 NCT06698965 Oct 2024 → Oct 2029 expected small cell lung carcinoma Shanghai Chest Hospital Recruiting No outcome recorded
Phase 34 trials
Phase 3 NCT07473128 Jun 2026 → Jun 2027 expected small cell lung carcinoma Pharmacosmos A/S Recruiting No outcome recorded
Phase 3 NCT06364904 Oct 2025 → Apr 2027 expected urinary bladder cancer Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Not yet recruiting No outcome recorded
Phase 3 NCT04799249 May 2021 → May 2024 triple-negative breast carcinoma G1 Therapeutics, Inc. Completed No outcome recorded
Phase 3 NCT04607668 Jan 2021 → Feb 2023 chemotherapy-induced toxicity, colorectal cancer, myeloid hemopathy G1 Therapeutics, Inc. Terminated No outcome recorded
Phase 42 trials
Phase 4 NCT05874401 Oct 2023 → Oct 2027 expected small cell lung carcinoma Pharmacosmos A/S Recruiting No outcome recorded
Phase 4 NCT05071703 Aug 2021 → Apr 2022 small cell lung carcinoma Jiangsu Simcere Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase not stated1 trial
NCT04504513 chemotherapy-induced toxicity, myelolymphatic insufficiency, small cell lung carcinoma G1 Therapeutics, Inc. Approved for marketing No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT04902885 Comparator May → Dec 2021 small cell lung carcinoma Jiangsu Simcere Pharmaceutical Co., Ltd. Completed No outcome recorded

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 45 sources stand behind the page.

FieldValueCited text
Known as Trilaciclib Trilaciclib: 240 mg/m², administered via intravenous infusion over 30 minutes, completed within 4 hours prior to chemotherapy on the same day.” NCT07160283
43

NCT06714266

NCT02514447

NCT06151262

NCT06569459

NCT04887831

NCT06027268

NCT06297811

NCT05112536

NCT02499770

NCT04799249

NCT07490236

NCT06490081

NCT07679997

NCT07255612

NCT04607668

NCT06370416

NCT06929936

NCT06992739

NCT06714383

NCT06955156

NCT05578326

NCT06332287

NCT02978716

NCT05874401

NCT06698965

NCT07473128

NCT05113966

NCT01042379

NCT05900921

NCT05071703

NCT03041311

NCT05910034

NCT06569485

NCT06364904

NCT04902885

NCT06699472

NCT04863248

NCT06217003

NCT06328049

NCT05978648

NCT06752798

NCT04504513

NCT05862610

Known as Cosela “Experimental: trilaciclib group Intervention: Drug: Trilaciclib Injection \[Cosela\] 240 mg/m\^2, intravenous drip over 30 min within 4 hours before chemotherapy administration...” NCT06297811
2

“Trilaciclib Injection [Cosela]” NCT06569459

“Trilaciclib Injection [Cosela]” NCT06699472

Action Inhibit “CDK4/6 inhibitor” PMID 33595690 Feb 2021
Route Intravenous “Trilaciclib: 240 mg/m2 IV weekly cycle 1-16” NCT01042379
Target CDK4 CDK4/6 inhibitor” PMID 33595690 Feb 2021