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Cefadole (CEFAMANDOLE)
Cefadole (generic name: CEFAMANDOLE) is a cefamandole drug. It is currently in Phase 2 development for Bacterial infection due to Klebsiella pneumoniae, Bacterial peritonitis, Bacterial septicemia.
Cefadole works by inhibiting bacterial cell wall synthesis, ultimately leading to bacterial cell death.
Cefadole (Cefamandole) is a small molecule antibiotic in the cefamandole class, targeting the solute carrier family 15 member 1. It is used to treat various bacterial infections, including those caused by Klebsiella pneumoniae, E. coli, and Enterococcus. Cefadole is off-patent and available as a generic medication. Its commercial status is generic, with one generic manufacturer listed. Key safety considerations include its short half-life of 0.75 hours and high bioavailability of 96%.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | CEFAMANDOLE |
|---|---|
| Drug class | cefamandole |
| Target | Solute carrier family 15 member 1 |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Mechanism of action
Imagine your body's cells are like buildings, and bacteria are like construction workers. Cefadole stops the bacteria from building their cell walls, which are essential for their survival. Without these walls, the bacteria can't function and eventually die.
Approved indications
- Bacterial infection due to Klebsiella pneumoniae
- Bacterial peritonitis
- Bacterial septicemia
- Bacterial urinary infection
- E. Coli Peritonitis
- Enterococcus Urinary Tract Infection
- Escherichia coli urinary tract infection
- Haemophilus Septicemia
- Haemophilus influenzae pneumonia
- Infection due to Enterobacteriaceae
- Infection due to Escherichia coli
- Infection due to Staphylococcus aureus
- Infection of bone
- Infection of skin AND/OR subcutaneous tissue
- Infectious disease of abdomen
- Infectious disorder of joint
- Klebsiella cystitis
- Lower respiratory tract infection
- Osteomyelitis due to Staphylococcus aureus
- Peritonitis
Common side effects
Key clinical trials
- Evaluate Bioequivalence of Burotam (1/1 g/Vial) (PHASE4)
- Patients Response to Early Switch To Oral:Osteomyelitis Study (EARLY_PHASE1)
- Study on Ceftazidime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection (PHASE2)
- Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics. (NA)
- Population Pharmacokinetics of Cephalosporins and Macrolides in Chinese Children With Community Acquired Pneumonia
- The Effect of Nebulization of Alkaline Solution on Treating XDRAB Pneumonia With C/S Plus Minocycline (PHASE1,PHASE2)
- Multi-center Clinical Study of Early Antibios of Severe Acute Pancreatitis (PHASE4)
- A Comparative Phase IV Study Evaluating Efficacy & Safety Of Magnex(Cefoperazone-Sulbactam) In Intraabdominal Infections (PHASE4)
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:
- Cefadole CI brief — competitive landscape report
- Cefadole updates RSS · CI watch RSS
Frequently asked questions about Cefadole
What is Cefadole?
How does Cefadole work?
What is Cefadole used for?
What is the generic name of Cefadole?
What drug class is Cefadole in?
What development phase is Cefadole in?
What does Cefadole target?
Related
- Drug class: All cefamandole drugs
- Target: All drugs targeting Solute carrier family 15 member 1
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Bacterial infection due to Klebsiella pneumoniae
- Indication: Drugs for Bacterial peritonitis
- Indication: Drugs for Bacterial septicemia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing