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cefepime/AAI101 combination
cefepime/AAI101 combination is a beta-lactam antibiotic Small molecule drug developed by Allecra. It is currently in Phase 3 development for Complicated urinary tract infections, Nosocomial pneumonia.
Cefepime/AAI101 combination is a beta-lactam antibiotic that inhibits bacterial cell wall synthesis.
The cefepime/AAI101 combination is being studied for the treatment of complicated urinary tract infections, as seen in a Phase 3 clinical trial (NCT03687255) registered on ClinicalTrials.gov. Cefepime, a small molecule antibiotic, is combined with AAI101 in this treatment, according to information on ClinicalTrials.gov and ChEMBL.
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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 | cefepime/AAI101 combination |
|---|---|
| Sponsor | Allecra |
| Drug class | beta-lactam antibiotic |
| Target | bacterial cell wall synthesis |
| Modality | Small molecule |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 3 |
Mechanism of action
Cefepime is a fourth-generation cephalosporin antibiotic that has a broad spectrum of activity against Gram-positive and Gram-negative bacteria. AAI101 is a beta-lactamase inhibitor that prevents bacterial resistance to cefepime by inhibiting the action of beta-lactamase enzymes.
Approved indications
- Complicated urinary tract infections
- Nosocomial pneumonia
Common side effects
- Nausea
- Vomiting
- Diarrhea
Key clinical trials
- Pharmacokinetics of Cefepime and AAI101 in Subjects With Renal Insufficiency and Healthy Subjects (PHASE1)
- Lung Pharmacokinetics (PK) in Epithelial Lining Fluid (ELF) (PHASE1)
- Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections (PHASE3)
- Investigation of AAI101 Safety, Tolerability & PK in Healthy Volunteers (PHASE1)
- Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI (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:
- cefepime/AAI101 combination CI brief — competitive landscape report
- cefepime/AAI101 combination updates RSS · CI watch RSS
- Allecra portfolio CI
Frequently asked questions about cefepime/AAI101 combination
What is cefepime/AAI101 combination?
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What is cefepime/AAI101 combination used for?
Who makes cefepime/AAI101 combination?
What drug class is cefepime/AAI101 combination in?
What development phase is cefepime/AAI101 combination in?
What are the side effects of cefepime/AAI101 combination?
What does cefepime/AAI101 combination target?
Related
- Drug class: All beta-lactam antibiotic drugs
- Target: All drugs targeting bacterial cell wall synthesis
- Manufacturer: Allecra — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for Complicated urinary tract infections
- Indication: Drugs for Nosocomial pneumonia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing