Cosela

(Trilaciclib)

ApprovedSmall molecule

Trilaciclib is used to help protect bone marrow and reduce severe blood cell damage in cancer patients receiving chemotherapy, which helps patients recover faster and reduces the need for blood transfusions.[2] Cosela is currently approved and in use across 18 indications[4].[1]

Cosela is one of 457 small molecule programs targeting Esophageal Squamous Cell Carcinoma. It is currently in Approved.

Indications

Total Trials

Active Trials

456

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Esophageal Squamous Cell CarcinomaActive, not recruiting

Esophageal CancerRecruiting

OsteosarcomaUnknown status

Triple-Negative Breast CancerCompleted

Breast NeoplasmApproved

MyelosuppressionRecruiting

Breast CancerTerminated

Pancreatic CancerApproved

Head and Neck Squamous Cell CarcinomaNot yet recruiting

Diffuse Large B-Cell LymphomaApproved

Esophageal Squamous Cell CarcinomaPreclinical

Active, not recruiting

Esophageal CancerPhase 2

Recruiting

OsteosarcomaPhase 2

Unknown status

Triple-Negative Breast CancerPhase 3

Completed

Breast NeoplasmApproved

Approved

MyelosuppressionPhase 2

Recruiting

Breast CancerPhase 2

Terminated

Pancreatic CancerApproved

Approved

Head and Neck Squamous Cell CarcinomaPhase 2

Not yet recruiting

Diffuse Large B-Cell LymphomaApproved

Approved

Showing 10 of 18 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Cosela

PPharmacosmos A/S

Approved

4 2

Voltaren

Novartis

Preclinical

1 3

Zolymbus

AbbVie

Preclinical

1 4

Blenoxane

Bristol-Myers Squibb

Preclinical

1 5

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 6

Duragesic

CCephalon

Preclinical

1 7

Tricor

JJagotec

Preclinical

1 8

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 9

Vfend

PPrism Pharmaceuticals

Preclinical

—10

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Not yet recruiting

Triple-Negative Breast Cancer

NCT07255612

Phase 2Not yet recruiting

Head and Neck Squamous Cell Carcinoma

NCT06714266

Q3 2027

Phase 2Active, not recruiting

Metastatic Triple-Negative Breast Cancer

NCT06027268

Phase 2Recruiting

Myelosuppression

NCT06699472

Phase 3Active, not recruiting

Myelosuppression

NCT07881705

Phase 2Not yet recruiting

Squamous Cell Carcinoma

NCT07679997

Clinical

Trials by Indication[1]

Small Cell Lung Cancer4 trials

Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin

Recruiting·SShanghai Chest Hospital·Phase 2·NCT06698965·52 enrolled

Expanded Access to Trilaciclib for Patients Receiving Chemotherapy for Small Cell Lung Cancer

Approved for marketing·GG1 Therapeutics, Inc.··NCT04504513

Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study

Completed· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 4·NCT05071703·30 enrolled

Show 1 more trial

Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC)

Completed·GG1 Therapeutics, Inc.·Phase 1/2·NCT02499770·122 enrolled

Breast Cancer4 trials

Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy

Recruiting·Wwang shusen·Phase 2·NCT05978648·116 enrolled

Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer

Terminated·GG1 Therapeutics, Inc.·Phase 2·NCT05113966·30 enrolled

Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)

Terminated·GG1 Therapeutics, Inc.·Phase 2·NCT02978716·102 enrolled

Show 1 more trial

Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer

Completed·GG1 Therapeutics, Inc.·Phase 2·NCT05112536·24 enrolled

Myelosuppression3 trials

Trilaciclib Prevents Myelosuppression With Chemoradiotherapy

Recruiting·—·Phase 2·NCT06490081·40 enrolled

A Prospective, Randomized, Controlled Clinical Study on the Prevention of Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib

Recruiting·FFudan University·Phase 2·NCT06699472·22 enrolled

The Randomized, Double-blind, Multi-center Phase III Clinical Trial of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer Receiving Concurrent Chemo-radiotherapy

Active, not recruiting· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 3·NCT07881705·106 enrolled

Lung Cancer2 trials

Trilaciclib Prior to Chemotherapy Plus Tislelizumab as 1L Treatment for Advanced Squamous Non-Small-Cell Lung Cancer

Unknown status·SSichuan University·Phase 2·NCT05900921·132 enrolled

Study of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer

Recruiting·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT05578326·30 enrolled

Osteosarcoma2 trials

Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma

Recruiting·PPeking University People's Hospital·Phase 2·NCT06714383·50 enrolled

Trilaciclib Combined With Chemotherapy for Perioperative Treatment of Osteosarcoma

Unknown status·TThe First Affiliated Hospital of Xinxiang Medical College·Phase 2·NCT06217003·20 enrolled

17 more indications

Triple-Negative Breast Cancer2 trials

Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negative Breast Cancer)

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT07255612·29 enrolled

Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)

Completed·GG1 Therapeutics, Inc.·Phase 3·NCT04799249·194 enrolled

Chemotherapy2 trials

Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy

Completed·GG1 Therapeutics, Inc.·Phase 1/2·NCT02514447·123 enrolled

A Study of Trilaciclib Combined With Chemotherapy in the Treatment of NSCLC

Recruiting·—·Phase 2·NCT06328049·30 enrolled

Advanced NSCLC1 trial

the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib

Enrolling by invitation·HHenan Cancer Hospital·Phase 2·NCT06370416·41 enrolled

Metastatic Colorectal Cancer1 trial

Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):

Terminated·GG1 Therapeutics, Inc.·Phase 3·NCT04607668·326 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Not yet recruiting·SShandong Cancer Hospital and Institute·Phase 2·NCT06714266·30 enrolled

Non-Small Cell Lung Cancer1 trial

Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Docetaxel for Metastatic Non-Small Cell Lung Cancer (NSCLC) (PRESERVE 4)

Terminated·GG1 Therapeutics, Inc.·Phase 2·NCT04863248·10 enrolled

Bladder Cancer1 trial

Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab

Terminated·GG1 Therapeutics, Inc.·Phase 2·NCT04887831·92 enrolled

Recruiting·QQIAO LI·Phase 2·NCT06955156·50 enrolled

Cancer1 trial

Myeloprotection With Trilaciclib in Pan-cancer Population

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT06297811·132 enrolled

CDK4/6 Inhibitor1 trial

Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC

Completed·GG1 Therapeutics, Inc.·Phase 2·NCT03041311·107 enrolled

Extensive-stage Small-cell Lung Cancer1 trial

A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy

Active, not recruiting·PPharmacosmos A/S·Approved·NCT05874401·302 enrolled

Limited-stage Small-cell Lung Cancer1 trial

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Trial Comparing Efficacy and Safety of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer

Recruiting·PPharmacosmos A/S·Phase 3·NCT07473128·120 enrolled

Metastatic Triple-negative Breast Cancer1 trial

ToPCourT: A Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)

Active, not recruiting·WWake Forest University Health Sciences·Phase 2·NCT06027268·36 enrolled

Tumor Patients1 trial

A Single-arm, Multi-center, Phase II Exploratory Clinical Study to Evaluate the Efficacy and Safety of Trilaciclib in Preventing Myelosuppression Caused by Topoisomerase I Inhibitor Type ADC Drugs

Not yet recruiting·TTianjin Medical University Cancer Institute and Hospital·Preclinical·NCT07736001·96 enrolled

Squamous Cell Carcinoma1 trial

A Prospective, Single-Arm, Phase II Trial of Trilaciclib Combined With Immunotherapy and Chemotherapy as First-Line Treatment for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

Not yet recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT07679997·32 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 12, 2021

COSELA

NDA NDA214200

Sources

References

[1]
ClinicalTrials.gov — 34 trial records for Trilaciclib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cosela drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Trilaciclib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Trilaciclib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214200). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Cosela. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Pharmacosmos A/S company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cyclin-Dependent Kinase 6 Inhibitor; Cyclin-Dependent Kinase 4 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPharmacosmos A/S

Patent Landscape[6]

Patent Cliff

Oct 25, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11040042Oct 25, 2031

10189850Oct 25, 2031

10189849Oct 25, 2031

10927120Oct 25, 2031

8598197Oct 25, 2031

9 more patents

9957276Oct 25, 2031

10966984Mar 14, 2034

9487530Mar 14, 2034

10085992Mar 14, 2034

11717523Mar 14, 2034

8598186Dec 30, 2034

12527798Dec 5, 2037

11529352Jul 23, 2039

12168666Nov 13, 2040

Cosela

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Trials by Indication[1]

Small Cell Lung Cancer4 trials

Breast Cancer4 trials

Myelosuppression3 trials

Lung Cancer2 trials

Osteosarcoma2 trials

Triple-Negative Breast Cancer2 trials

Chemotherapy2 trials

Advanced NSCLC1 trial

Metastatic Colorectal Cancer1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Non-Small Cell Lung Cancer1 trial

Bladder Cancer1 trial

Esophageal Squamous Cell Carcinoma1 trial

Esophageal Cancer1 trial

Anti-PD-1 Antibody1 trial

Cancer1 trial

CDK4/6 Inhibitor1 trial

Extensive-stage Small-cell Lung Cancer1 trial

Limited-stage Small-cell Lung Cancer1 trial

Metastatic Triple-negative Breast Cancer1 trial

Tumor Patients1 trial

Squamous Cell Carcinoma1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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