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Fropenem (FAROPENEM)
Fropenem (generic name: FAROPENEM) is a faropenem drug. It is currently in Phase 3 development for Bacterial infection of skin, Respiratory tract infection.
Faropenem works by inhibiting bacterial cell wall synthesis, ultimately leading to bacterial cell death.
Fropenem, also known as Faropenem, is a small molecule antibiotic belonging to the faropenem class. It is used to treat bacterial infections of the skin and respiratory tract. The commercial status of Faropenem is unclear, but it is likely patented. Key safety considerations include its short half-life of 1.4 hours. Faropenem's exact target is unknown.
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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 | FAROPENEM |
|---|---|
| Drug class | faropenem |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Imagine your body's cells are like houses, and bacteria are like unwanted guests. Faropenem helps to stop the bacteria from building new 'houses' by blocking the tools they need to do so, ultimately leading to their demise.
Approved indications
- Bacterial infection of skin
- Respiratory tract infection
Common side effects
Key clinical trials
- Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP) (PHASE4)
- Trial of Faropenem and Cefadroxil (in Combination With Amoxicillin/Clavulanic Acid and Standard TB Drugs) in Patients With Pulmonary Tuberculosis: Measurement of Early Bactericidal Activity and Effects on Novel Biomarkers (PHASE2)
- 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 (PHASE2)
- Whole Blood Bactericidal Activity (WBA) Against Mycobacterium Tuberculosis of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers (PHASE1)
- A Phase III Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia (PHASE3)
- A Phase II Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia (PHASE2)
- A Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil In the Treatment of Chronic Bronchitis (PHASE3)
- A Trial to Evaluate Faropenem Medoxomil in the Treatment of Acute Otitis Media (PHASE2)
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:
- Fropenem CI brief — competitive landscape report
- Fropenem updates RSS · CI watch RSS
Frequently asked questions about Fropenem
What is Fropenem?
How does Fropenem work?
What is Fropenem used for?
What is the generic name of Fropenem?
What drug class is Fropenem in?
What development phase is Fropenem in?
Related
- Drug class: All faropenem drugs
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Bacterial infection of skin
- Indication: Drugs for Respiratory tract infection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing