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Meropenem intravenous
Meropenem intravenous is a Carbapenem antibiotic Small molecule drug developed by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. It is currently in Phase 3 development for Serious bacterial infections (meningitis, intra-abdominal infections, pneumonia, sepsis), Hospital-acquired and community-acquired infections caused by susceptible organisms. Also known as: Generic name: Meropenem, Pharmaceutical form: solution for infusion, ATC code: J01D5.
Meropenem is a broad-spectrum beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins.
Meropenem is a broad-spectrum beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins. Used for Serious bacterial infections (meningitis, intra-abdominal infections, pneumonia, sepsis), Hospital-acquired and community-acquired infections caused by susceptible organisms.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Meropenem intravenous |
|---|---|
| Also known as | Generic name: Meropenem, Pharmaceutical form: solution for infusion, ATC code: J01D5 |
| Sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
| Drug class | Carbapenem antibiotic |
| Target | Penicillin-binding proteins (PBPs) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Meropenem is a carbapenem antibiotic that penetrates bacterial cell walls and binds to penicillin-binding proteins, inhibiting cross-linking of peptidoglycan and causing cell wall disruption and bacterial death. It has activity against a wide range of gram-positive and gram-negative bacteria, including anaerobes, making it useful for serious infections caused by susceptible organisms.
Approved indications
- Serious bacterial infections (meningitis, intra-abdominal infections, pneumonia, sepsis)
- Hospital-acquired and community-acquired infections caused by susceptible organisms
Common side effects
- Diarrhea
- Nausea
- Vomiting
- Rash
- Phlebitis at injection site
- Seizures (in meningitis or renal impairment)
Key clinical trials
- Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial (NA)
- 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 (PHASE4)
- Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Resistant to Third Gen Cephalosporins (PHASE3)
- Meropenem vs Azithromycin Efficacy in Case XDR Enteric Fever (PHASE4)
- Pancreatic Antibiotic Concentration Evaluation Assessment
- Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of Care (PHASE4)
- Temocillin Versus a Carbapenem as Initial Intravenous Treatment for ESBL Related Urinary Tract Infections (PHASE3)
- Evaluation of the Concentration of ANT3310 and Meropenem in the Lung in Healthy Adult Participants (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Meropenem intravenous CI brief — competitive landscape report
- Meropenem intravenous updates RSS · CI watch RSS
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla portfolio CI
Frequently asked questions about Meropenem intravenous
What is Meropenem intravenous?
How does Meropenem intravenous work?
What is Meropenem intravenous used for?
Who makes Meropenem intravenous?
Is Meropenem intravenous also known as anything else?
What drug class is Meropenem intravenous in?
What development phase is Meropenem intravenous in?
What are the side effects of Meropenem intravenous?
What does Meropenem intravenous target?
Related
- Drug class: All Carbapenem antibiotic drugs
- Target: All drugs targeting Penicillin-binding proteins (PBPs)
- Manufacturer: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Serious bacterial infections (meningitis, intra-abdominal infections, pneumonia, sepsis)
- Indication: Drugs for Hospital-acquired and community-acquired infections caused by susceptible organisms
- Also known as: Generic name: Meropenem, Pharmaceutical form: solution for infusion, ATC code: J01D5
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing