Trilaciclib

Overview

Trilaciclib, or G1T28, is a CDK4 and CDK6 inhibitor, indicated to reduce the incidence of chemotherapy induced myelosuppression in patients before topotecan-containing or platinum and etoposide-containing chemotherapy for extensive stage small cell lung cancer. CDK4 and CDK6 inhibitors have been investigated since the mid 1990s for their use in tumorigenesis and chemotherapy. Trilaciclib was first described in the literature in 2016. Trilaciclib was granted FDA approval on 12 February 2021.

Indication

Trilaciclib is indicated to reduce the incidence of chemotherapy induced myelosuppression in patients prior to receiving platinum and etoposide-containing or topotecan-containing chemotherapy regimens for extensive-stage small cell lung cancer.

Associated Conditions

Bone Marrow Suppression caused by Chemotherapy

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Trilaciclib Combined With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced TNBC	2025/05/02	NCT06955156	Phase 2	Recruiting	QIAO LI
Bone Marrow Protective Effect of Trilaciclib in Postoperative CCRT for LA-HNSCC	2024/12/31	NCT06752798	Phase 2	Recruiting	Hunan Cancer Hospital
Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma	2024/12/03	NCT06714266	Phase 2	Not yet recruiting	Shandong Cancer Hospital and Institute
Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma	2024/12/03	NCT06714383	Phase 2	Recruiting	Peking University People's Hospital
Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin	2024/11/21	NCT06698965	Phase 2	Recruiting	Shanghai Chest Hospital
A Prospective, Randomized, Controlled Clinical Study on the Prevention of Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib	2024/11/21	NCT06699472	Phase 2	Recruiting	Fudan University
Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma	2024/11/21	NCT06698692	N/A	Recruiting	The First Affiliated Hospital with Nanjing Medical University
Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy in the Treatment of Esophageal Cancer	2024/08/26	NCT06569459	Phase 2	Recruiting	The First Affiliated Hospital with Nanjing Medical University
Trilaciclib Prevents Myelosuppression With Chemoradiotherapy	2024/07/08	NCT06490081	Phase 2	ENROLLING_BY_INVITATION	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib	2024/04/17	NCT06370416	Phase 2	Not yet recruiting	Henan Cancer Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
COSELA	G1 Therapeutics, Inc.	73462-101	INTRAVENOUS	300 mg in 20 mL	8/3/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Simcere Zaiming Initiates US Phase 1 Trial of Trispecific Antibody SIM0500 for Relapsed/Refractory Multiple Myeloma

a month ago

Simcere Zaiming has dosed the first US patient in a Phase 1 trial of SIM0500, a trispecific antibody targeting GPRC5D, BCMA, and CD3 for relapsed/refractory multiple myeloma treatment.

NextCure and Simcere Zaiming Form Strategic Partnership for CDH6-Targeting ADC SIM0505

a month ago

NextCure gains global rights to SIM0505, a novel antibody-drug conjugate targeting CDH6 for solid tumors, while Simcere Zaiming retains Greater China rights.

Trilaciclib Shows Strong Myeloprotection but Mixed Efficacy Results in Metastatic Colorectal Cancer Trial

5 months ago

Phase 3 PRESERVE 1 trial demonstrates trilaciclib significantly reduced chemotherapy-induced neutropenia when combined with FOLFOXIRI/bevacizumab in metastatic colorectal cancer patients.

mTNBC Pipeline Shows Promise with Novel Therapies in Clinical Trials

8 months ago

• The mTNBC pipeline includes over 12 drugs from 10+ companies, targeting novel approaches to improve treatment outcomes for this aggressive breast cancer. • Trilaciclib, a CDK4/6 inhibitor by G1 Therapeutics, is in Phase III trials to preserve bone marrow and immune function during chemotherapy in mTNBC patients. • Olinvacimab, an anti-angiogenic antibody by PharmAbcine/Merck, is in Phase II trials, blocking the VEGF/VEGFR2 pathway to inhibit tumor growth and metastasis. • Emerging therapies focus on intravenous, subcutaneous, and oral routes of administration, with molecule types including monoclonal antibodies and small molecules.

Advances in Small Cell Lung Cancer Treatment: New Approvals and Promising Therapies in Clinical Trials

9 months ago

• The FDA recently approved Imdelltra (tarlatamab-dlle) for extensive-stage SCLC, showing a 44% tumor shrinkage rate in relapsed or treatment-resistant cases. • Trilaciclib (Cosela) received FDA approval to reduce chemotherapy-induced myelosuppression in extensive-stage SCLC, potentially enabling higher chemotherapy doses. • Ongoing clinical trials are evaluating novel therapies like Ivonescimab, PM8002, and Adebelimab, offering hope for improved outcomes in SCLC treatment. • Durvalumab (Imfinzi) was approved for first-line treatment of extensive-stage SCLC in combination with chemotherapy, improving median survival by 2.7 months.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access