TheraRadar
Data updated: May 26, 2026

VABOMERE (meropenem)

Priority Review Fast Track
Infectious Disease Approved 2017-08-29

Vabomere is a combination antibacterial containing meropenem (a carbapenem) and vaborbactam (a beta-lactamase inhibitor). It is indicated for adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative bacteria. Vaborbactam protects meropenem from degradation by certain beta-lactamases, extending its activity against resistant organisms including some carbapenem-resistant Enterobacteriaceae (CRE).

Source: FDA Label • REMPEX
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How VABOMERE Works

Meropenem is a bactericidal agent that inhibits bacterial cell wall synthesis. It penetrates the cell wall of most gram-positive and gram-negative bacteria to bind with high affinity to penicillin-binding proteins (PBPs). By binding to these target proteins, meropenem inhibits the transpeptidation step of peptidoglycan synthesis, leading to cell wall lysis and death.

Source: FDA Label
1
Indication
--
Phase 3 Trials
1
Priority Reviews
8
Years on Market

Details

Status
Prescription
First Approved
2017-08-29
Patent Cliff
2039

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Routes
INTRAVENOUS
Dosage Forms
POWDER

Companies

REMPEX
Active Ingredient: MEROPENEM , VABORBACTAM

VABOMERE Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2017 to 2026
Feb 2026 SUPPL
Label · Labeling
FDA Letter Label
Dec 2024 SUPPL
Label · Labeling
FDA Letter Label
Sep 2023 SUPPL
Label · Labeling
FDA Letter Label

What VABOMERE Treats

2 indications

VABOMERE is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Complicated Urinary Tract Infection
  • Pyelonephritis
Source: FDA Label

VABOMERE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

CONTEPO
MEITHEAL
2025 2 indic.
BLUJEPA
GSK
2025 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to VABOMERE

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FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

FETROJA
CEFIDEROCOL SULFATE TOSYLATE
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SHIONOGI
Shared indications:
Complicated Urinary Tract InfectionPyelonephritis
RECARBRIO
CILASTATIN SODIUM
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Merck
Shared indications:
Complicated Urinary Tract InfectionPyelonephritis
ZEMDRI
PLAZOMICIN SULFATE
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Cipla
Shared indications:
Complicated Urinary Tract InfectionPyelonephritis
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Clinical Trial Registry

63 trials
Trial Sponsor ID Phase Status Title
NCT07556107 VPS IRB00538615 BPS-2024C3-42018 Ph 4 not yet recruiting The Vancomycin Piperacillin/Tazobactam (VPT) Patient Safety Trial (VPS)
NCT04983901 results posted 2020-0074 NCI-2021-01957, 2020-0074 Ph 2 completed PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
NCT07445282 XDR-TY 110/SZMC/SZH 110/SZMC/SZH Ph 4 completed This Randomized Controlled Trial Evaluates the Comparative Efficacy of Intravenous Meropenem Alone Versus Intravenous Meropenem Combined With Oral Azithromycin in Children Aged 6 Months to Under 5 Years Diagnosed With Blood Culture-confirmed Extensively Drug-resistant Uncomplicated Typhoid Fever
NCT04478721 ASTARTÉ ASTARTÉ 2020-000064-39 Ph 3 completed Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Resistant to Third Gen Cephalosporins
NCT06916156 ANT3310-1003 Ph 1 completed Evaluation of the Concentration of ANT3310 and Meropenem in the Lung in Healthy Adult Participants
NCT04979806 W-5222-301 Ph 3 completed Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
NCT03452839 MERCY MERCY/9A/OSR 2016-002052-24 Ph 4 completed Bolus Versus Continuous Infusion of Meropenem
NCT05922124 CASCADE V0.1 May 2023 Ph 4 recruiting Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii
NCT03671967 PETERPEN MOH_2018-12-25_004857 Ph 4 recruiting PipEracillin Tazobactam Versus mERoPENem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae (PETERPEN)
NCT06527677 ANT3310-1002 Ph 1 completed Assessment of the Pharmacokinetics and Safety of ANT3310 Combined With Meropenem in Renally Impaired Subjects
NCT02687906 TANGOKIDS Rempex 507 2016-000656-99 Ph 1 active not recruiting Dose-finding, Pharmacokinetics, and Safety of VABOMERE in Pediatric Subjects With Bacterial Infections
NCT05355350 SPICE-M 0295-18-RMB Ph 4 withdrawn PipEracillin/Tazobactam Versus mERoPENem for Treatment of AmpC Producing Blood Stream Infections
NCT06184659 EMPRESS RH-ITA-010 2023-509703-33-00 Ph 4 recruiting Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis
NCT06168734 CERTAIN-2 VNRX-5133-301 2022-502682-16 Ph 3 withdrawn Cefepime-taniborbactam vs Meropenem in Adults With VABP or Ventilated HABP
NCT03840148 CERTAIN-1 results posted VNRX-5133-201 2018-001451-13 Ph 3 completed Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections
NCT06342115 CLEMENT CLEMENT TRIAL Ph 4 recruiting Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens
NCT06841731 HRS-8427-201 Ph 2 recruiting A Trial of HRS-8427 in the Treatment of Adults With Bacterial Pneumonia
NCT02820987 PAACS 15/493 Ph 3 completed PK/PD of Extended-infusion Meropenem, Piperacillin-tazobactam and Cefepime in the Early Phase of Septic Shock
NCT03891433 CAPITIS HUN-INF-CAPITIS-2018-1 Ph 4 suspended Piperacillin/Tazobactam Versus Carbapenems in Non-bacteremic UTI Due to -ESBL-producing Enterobacteriaceae
NCT05784844 IRB00088805 Ph 4 withdrawn Antimicrobial Revision in Persistent Febrile Neutropenia
NCT05905913 ANT3310-1001 Ph 1 completed FiH Study to Assess Safety and PK of SAD and MAD of ANT3310 Alone and in Combination With Meropenem in Healthy Subjects
NCT06072222 icu-22 Ph 1, Ph 2 completed Effect of Bronchoscopy on the Outcome of Patients With Severe Sepsis With ARDS and Complicated by VAP From Prolonged Ventilation
NCT06072248 icu-23 Ph 1, Ph 2 completed Effect of Bronchoscopy on the Outcome of Patients With Severe Sepsis With ARDS and Complicated by VAP From Prolonged Ventilation
NCT02437045 MERINO II HREC/14/QRBW/350 Ph 4 completed Trial of Meropenem Versus Piperacillin-Tazobactam on Mortality and Clinial Response
NCT03230838 results posted 7625A-034 2016-004153-32 Ph 2 completed MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)
NCT03217136 results posted 7625A-035 MK-7625A-035, 2016-004820-41 Ph 2 completed MK-7625A Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-Abdominal Infection (cIAI) (MK-7625A-035)
NCT00621192 results posted HHSN267200700051C HHSN267200700051C Ph 1, Ph 2 completed Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections
NCT05565222 PITAGORE APHP211034 Ph 3 recruiting Piperacillin-tazobactam and Temocillin as Carbapenem-alternatives for the Treatment of Severe Infections Due to Extended-spectrum Beta-lactamase-Producing Gram-negative Enterobacteriaceae in the Intensive Care Unit
NCT03830333 7625ACNPhase3 results posted 7625A-015 MK-7625A-015 Ph 3 completed Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015)
NCT05226923 KSP-1007-101 Ph 1 completed Study of the Safety and Pharmacokinetics of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects
NCT04876430 ABOVE 2019-0401 Ph 2, Ph 3 terminated Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With High Level of Resistance to Carbapenems
NCT04553367 ICU-40-20 Ph 1, Ph 2 completed Effect of Bronchoscopy on the Outcome of Patients With Severe Sepsis With ARDS and Complicated by VAP From Prolonged Ventilation
NCT04238390 MERINO III UQCCR-DP-AS-2019-001 Ph 3 withdrawn Ceftolozane-tazobactam Versus Meropenem for ESBL and AmpC-producing Enterobacterales Bloodstream Infection
NCT03485950 results posted 2017-0729 NCI-2018-00755, 2017-0729 Ph 2 completed Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam
NCT02784704 IGNITE4 results posted TP-434-025 Ph 3 completed Efficacy and Safety Study of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections
NCT03032380 APEKS-NP results posted 1615R2132 2016-003020-23 Ph 3 completed Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens
NCT02070757 ASPECT-NP results posted 7625A-008 CXA-NP-11-04, 163338 Ph 3 completed Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008)
NCT02047773 BLTBrIV BLTBrIVStudy Ph 4 completed Bacterial Load Guided Therapy for Severe Bronchiectasis Exacerbations
NCT03477422 PLEA VRL/CSE-1034/05/2012 CTRI/2013/11/004133 Ph 3 completed CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infections (cUTIs) Caused by ESBL Producing Gram Negative Bacteria
NCT02168946 results posted Rempex 506 Ph 3 completed Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults
NCT01445678 results posted 7625A-004 CXA-cIAI-10-09, CXA-cIAI-10-08 Ph 3 completed Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections
NCT01970371 CARE results posted ACHN-490-007 2013-001997-18, U1111-1151-2686 Ph 3 completed A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)
NCT02349841 TASK-001 Ph 2 completed Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of Meropenem Plus Amoxycillin/CA and Faropenem Plus Amoxycillin/CA in Adult Patients With Newly Diagnosed Pulmonary Tuberculosis
NCT02486627 EPIC results posted ACHN-490-009 2015-001588-37, U1111-1171-1554 Ph 3 completed A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)
NCT02475733 results posted D4280C00015 C3591004, 2014-003242-28 Ph 2 completed Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs).
NCT00752219 results posted NXL-104/2002 C3591014 Ph 2 completed Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections
NCT03174795 NP39596 2016-004478-16 Ph 1 completed A Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Participants With a Complicated Urinary Tract Infection
NCT03182504 NP39750 2016-004478-16 Ph 1 completed A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants
NCT01429259 results posted KUTI003498HE Ph 4 completed Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
NCT01381562 results posted 114689 Ph 2 terminated GSK2251052 in the Treatment of Complicated Intra-abdominal Infections

Showing 50 of 63 trials

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

VABOMERE FDA Label Details

Indications & Usage

FDA Label (PDF)

VABOMERE is indicated for the treatment of Complicated Urinary Tract Infection; Pyelonephritis.

View full patent landscape →
10 OB patents · 4 families · 151 international docs across 33 countries

VABOMERE Patents & Exclusivity

Latest Patent: May 2039
Exclusivity: Aug 2027

Patents (10 active)

US12533342 Expires May 20, 2039
US11376237 Expires Apr 6, 2039
US12478606 Expires Jan 8, 2038
US8680136 Expires Aug 29, 2031
US9694025 Expires Aug 8, 2031
US10561675 Expires Aug 8, 2031
US10183034 Expires Aug 8, 2031
US11007206 Expires Aug 8, 2031
US12171772 Expires Aug 8, 2031
US10172874 Expires Aug 8, 2031

Exclusivity

NCE Until Aug 2022
GAIN Until Aug 2027
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • • Cliff: 2039
  • • 10 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 13 similar drugs
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA209776 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.