Invanz

(Ertapenem)

ApprovedSmall molecule

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Ertapenem is an antibiotic used to treat bacterial infections in various parts of the body, including the abdomen, urinary tract, skin, and gynecological infections.[2] Invanz is currently approved and in use across 20 indications[4].[1]

Invanz is one of 339 small molecule programs targeting Burn. It is currently in Approved.

Indications

Total Trials

Active Trials

338

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

BurnCompleted

Chronic Kidney DiseaseApproved

OsteomyelitisApproved

Recurrent Urinary Tract InfectionsApproved

EndometritisApproved

TuberculosisApproved

PneumoniaApproved

AmputationActive, not recruiting

Bacterial DiseaseActive, not recruiting

Hidradenitis SuppurativaActive, not recruiting

BurnApproved

Completed

Chronic Kidney DiseaseApproved

Approved

OsteomyelitisApproved

Approved

Recurrent Urinary Tract InfectionsApproved

Approved

EndometritisApproved

Approved

TuberculosisApproved

Approved

PneumoniaApproved

Approved

AmputationPreclinical

Active, not recruiting

Bacterial DiseaseApproved

Active, not recruiting

Hidradenitis SuppurativaPreclinical

Active, not recruiting

Showing 10 of 20 indications

Competition

Competitive Landscape

172 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Invanz

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

47 2

Uloric

Takeda

Preclinical

2 3

Sovaldi

Gilead

Preclinical

1 4

Glucotrol

Pfizer

Preclinical

1 5

Vemlidy

Gilead

Preclinical

1 6

Lorelco

Sanofi

Preclinical

1 7

Activase

Flomax

PROCRIT

1 10

Verquvo

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Post-ApprovalNot yet recruiting

Clinical Trial

NCT06920147

Q3 2027

Phase 2Recruiting

Staphylococcus Aureus Bacteremia

NCT04886284

Q2 2029

N/AActive, not recruiting

Appendicitis

NCT03236961

Q4 2030

Post-ApprovalRecruiting

Antibiotic Prophylaxis

NCT04140578

Clinical

Trials by Indication[1]

Urinary Tract Infection6 trials

Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Participants With Complicated Urinary Tract Infections

Completed·TTetraphase Pharmaceuticals, Inc·Phase 3·NCT03032510·1,205 enrolled

An Observational Study of Ertapenem in Outpatient Parenteral Antibiotic Therapy (OPAT) for Complicated Urinary Tract Infections.

Unknown status·NNational University Hospital, Singapore··NCT01173068·60 enrolled

Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy

Completed·RRoswell Park Cancer Institute·Phase 4·NCT04502095·89 enrolled

Show 3 more trials

A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Completed·SSihuan Pharmaceutical Holdings Group Ltd.·Phase 2/3·NCT04505683·112 enrolled

Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Completed·SSpero Therapeutics·Phase 3·NCT03788967·1,372 enrolled

Sitafloxacin and Ertapenem Treatment for Acute Urinary Tract Infection Caused by E. Coli or K. Pneumoniae in Post-kidney Transplantation Patients

Unknown status·KKhon Kaen University·Phase 2/3·NCT02729116·30 enrolled

Complicated Intra-abdominal Infections3 trials

Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections

Completed·TTetraphase Pharmaceuticals, Inc·Phase 2·NCT01265784·143 enrolled

Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections

Completed·TTetraphase Pharmaceuticals, Inc·Phase 3·NCT01844856·541 enrolled

Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem

Completed· Bayer logo

Bayer·Phase 3·NCT00492726·804 enrolled

Appendicitis2 trials

Antibiotics Versus Surgery in Acute Appendicitis

Unknown status·AA.O. Ospedale Papa Giovanni XXIII·Phase 4·NCT01421901·218 enrolled

Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis

Active, not recruiting·TTurku University Hospital·N/A·NCT03236961·552 enrolled

Infections2 trials

Ertapenem Versus Meropenem/Imipenem for ESBL+ Gram-negative Infections

Unknown status·MMahidol University·Phase 4·NCT01297842·100 enrolled

Pharmacokinetics of Ertapenem Following Subcutaneous or Intravenous Infusion in Patients Aged Over 75 (PHACINERTA)

Completed·UUniversity Hospital, Bordeaux·Approved·NCT02505386·27 enrolled

Bacterial Pneumonia2 trials

A Phase III Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia

Unknown status· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 3·NCT01937832·540 enrolled

A Phase II Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia

Completed· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 2·NCT01886053·189 enrolled

28 more indications

Intravenous2 trials

Pharmacokinetics (PK) of Ertapenem Intravenous (IV) Bolus Versus Standard Infusion

Completed·HHartford Hospital·Phase 4·NCT01148771·12 enrolled

Safety Study of Intravenous Ertapenem in Combination With Zidebactam (WCK 6777)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT05645757·54 enrolled

Concentration2 trials

Concentration of Ertapenem in Colorectal Tissue

Completed·UUniversity of Ulm·Phase 4·NCT00535652·23 enrolled

Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT02041767·20 enrolled

Complicated Appendicitis2 trials

Antibiotics vs. Placebo in Acute Uncomplicated Appendicitis

Enrolling by invitation·TTurku University Hospital·N/A·NCT03234296·147 enrolled

Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis

Unknown status·TTurku University Hospital·N/A·NCT01022567·530 enrolled

Intra-abdominal Infection2 trials

Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection

Completed· Bayer logo

Bayer·Phase 3·NCT01069900·458 enrolled

Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)

Completed·IIterum Therapeutics, International Limited·Phase 3·NCT03358576·674 enrolled

Clinical Trial1 trial

PRevention Of Trauma-related Infections Through an Embedded Clinical Trials Network

Not yet recruiting·TThe University of Texas Health Science Center, Houston·Phase 4·NCT06920147·300 enrolled

Bacteremia1 trial

Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia

Completed·PPhramongkutklao College of Medicine and Hospital··NCT03925402·427 enrolled

Ampicillin1 trial

T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam

Completed·UUniversity of Bologna·Phase 4·NCT00630513·142 enrolled

Antibiotic Prophylaxis1 trial

Antibiotic Prophylaxis in Patients Undergoing GVO

Recruiting·TTaipei Veterans General Hospital, Taiwan·Phase 4·NCT04140578·150 enrolled

Diverticulitis1 trial

Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid Diverticulitis

Unknown status·UUnknown Sponsor·Phase 4·NCT00097734·540 enrolled

Intensive Care Unit1 trial

Prospective, Open-label Study of Pharmacokinetics of Ertapenem in the Muscle Using Microdialysis in Mechanically Ventilated Intensive Care Unit Patients, Treated or Not by Norepinephrine

Terminated·AAssistance Publique Hopitaux De Marseille·Phase 4·NCT00489138·9 enrolled

Hemodialysis1 trial

Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis

Completed·UUniversity of Michigan·Phase 4·NCT00877370·8 enrolled

Adult1 trial

Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults

Completed·IIterum Therapeutics, International Limited·Phase 3·NCT03357614·1,395 enrolled

Liver abscess1 trial

Antibiotics for Klebsiella Liver Abscess Study

Completed·NNational University Hospital, Singapore·Phase 4·NCT01723150·152 enrolled

PK/PD1 trial

PK/PD of Ertapenem In Patients With TB

Completed·UUniversity Medical Center Groningen·Phase 2·NCT01730664·12 enrolled

Bone1 trial

Penetration of Ertapenem Into Bone

Withdrawn·HHaEmek Medical Center, Israel·N/A·NCT00392028·12 enrolled

Peritoneal Dialysis1 trial

Ertapenem Pharmacokinetics in Patients in Continuous Ambulatory Peritoneal Dialysis

Completed·—·Phase 4·NCT00939952·7 enrolled

Hidradenitis Suppurativa1 trial

A Single Center, Prospective Clinical Trial of Intravenous Ertapenem in the Treatment of Hurley Stage II or III Hidradenitis Suppurativa

Withdrawn·HHenry Ford Health System··NCT05255575

Antibiotic1 trial

New AntiBiotic Treatment Options for Uncomplicated Anogenital GOnorrhoea

Completed·PPublic Health Service of Amsterdam·Phase 3·NCT03294395·346 enrolled

Sepsis1 trial

Ertapenem in Patients With Urosepsis

Unknown status·PPrince of Songkla University·Phase 4·NCT03859362·12 enrolled

CAR1 trial

Piperacillin/Tazobactam Versus Carbapenems in Non-bacteremic UTI Due to -ESBL-producing Enterobacteriaceae

Suspended·UUniversidad del Norte·Phase 4·NCT03891433·198 enrolled

Postpartum Period1 trial

Pharmacokinetics and Safety of Ertapenem in the Postpartum Period

Terminated·DDaniel Benjamin·Phase 1·NCT01587495·3 enrolled

Antibiotic Therapy1 trial

Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days

Completed·—·Phase 2/3·NCT01203046·56 enrolled

Dialysis Patients1 trial

Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients

Completed·CCorewell Health East·Phase 2·NCT02159859·7 enrolled

Pyelonephritis1 trial

Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Escherichia Coli

Unknown status·MMahidol University·Phase 2·NCT02537847·96 enrolled

Diabetic Foot1 trial

Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.

Completed· Pfizer logo

Pfizer·Phase 3·NCT00366249·1,061 enrolled

Acute Lymphoblastic Leukemia1 trial

Safety of Ertapenem in Beta-lactam Allergic Patients.

Unknown status·—·Phase 4·NCT01159379·30 enrolled

Burn1 trial

Pharmacokinetics of Ertapenem When Used in Empiric Treatment in Burn Patients. Prospective Open Label Study.

Completed·NNantes University Hospital·Approved·NCT01497990·8 enrolled

Staphylococcus Aureus Bacteremia1 trial

Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia (CERT)

Recruiting·TTodd C. Lee MD MPH FIDSA·Phase 2·NCT04886284·60 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 21, 2001

INVANZ

NDA NDA021337

Sources

References

[1]
ClinicalTrials.gov — 47 trial records for Ertapenem. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Invanz drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ertapenem compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ertapenem. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021337). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cell Shape Peptidoglycan Synthetase Penicillin-Binding Protein 2 Inhibitor; Peptidoglycan D,D-Transpeptidase Ftsi Inhibitor; Bacterial Penicillin-Binding Protein Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Invanz

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2027

Q2 2029

Q4 2030

Trials by Indication[1]

Urinary Tract Infection6 trials

Complicated Intra-abdominal Infections3 trials

Appendicitis2 trials

Infections2 trials

Bacterial Pneumonia2 trials

Intravenous2 trials

Concentration2 trials

Complicated Appendicitis2 trials

Intra-abdominal Infection2 trials

Clinical Trial1 trial

Bacteremia1 trial

Ampicillin1 trial

Antibiotic Prophylaxis1 trial

Diverticulitis1 trial

Intensive Care Unit1 trial

Hemodialysis1 trial

Adult1 trial

Liver abscess1 trial

PK/PD1 trial

Bone1 trial

Peritoneal Dialysis1 trial

Hidradenitis Suppurativa1 trial

Antibiotic1 trial

Sepsis1 trial

CAR1 trial

Postpartum Period1 trial

Antibiotic Therapy1 trial

Dialysis Patients1 trial

Pyelonephritis1 trial

Diabetic Foot1 trial

Acute Lymphoblastic Leukemia1 trial

Burn1 trial

Staphylococcus Aureus Bacteremia1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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