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Benzyl penicillin
Benzyl penicillin is a Beta-lactam antibiotic Small molecule drug developed by KEMRI-Wellcome Trust Collaborative Research Program. It is currently in Phase 3 development for Bacterial infections caused by susceptible organisms (gram-positive cocci, some gram-negative bacteria, and spirochetes), Pneumococcal infections, Streptococcal infections. Also known as: Medipen, Cristapen.
Benzyl penicillin inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins and blocking peptidoglycan cross-linking.
Benzyl penicillin, also known as penicillin G, is a small molecule antibiotic used to treat various bacterial infections. It is indicated for conditions such as pneumonia, strep throat, syphilis, and others, but not typically for pneumococcal meningitis.
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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 | Benzyl penicillin |
|---|---|
| Also known as | Medipen, Cristapen |
| Sponsor | KEMRI-Wellcome Trust Collaborative Research Program |
| Drug class | Beta-lactam antibiotic |
| Target | Penicillin-binding proteins (PBPs) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Benzyl penicillin (penicillin G) is a beta-lactam antibiotic that covalently binds to penicillin-binding proteins in susceptible bacteria, preventing the cross-linking of peptidoglycan strands in the cell wall. This disruption of cell wall integrity leads to bacterial cell lysis and death. It is bactericidal and effective against a broad range of gram-positive and some gram-negative bacteria.
Approved indications
- Bacterial infections caused by susceptible organisms (gram-positive cocci, some gram-negative bacteria, and spirochetes)
- Pneumococcal infections
- Streptococcal infections
- Meningitis
Common side effects
- Hypersensitivity reactions (rash, urticaria)
- Anaphylaxis
- Diarrhea
- Nausea
- Seizures (high doses, renal impairment)
Key clinical trials
- Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting (NA)
- Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy
- APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis) (PHASE2)
- Tegoprazan-Based Therapies for H. Pylori Eradication: A Randomized Controlled Trial (NA)
- Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics (PHASE4)
- Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia (PHASE4)
- A Randomised Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients. (PHASE4)
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (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:
- Benzyl penicillin CI brief — competitive landscape report
- Benzyl penicillin updates RSS · CI watch RSS
- KEMRI-Wellcome Trust Collaborative Research Program portfolio CI
Frequently asked questions about Benzyl penicillin
What is Benzyl penicillin?
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Related
- Drug class: All Beta-lactam antibiotic drugs
- Target: All drugs targeting Penicillin-binding proteins (PBPs)
- Manufacturer: KEMRI-Wellcome Trust Collaborative Research Program — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Bacterial infections caused by susceptible organisms (gram-positive cocci, some gram-negative bacteria, and spirochetes)
- Indication: Drugs for Pneumococcal infections
- Indication: Drugs for Streptococcal infections
- Also known as: Medipen, Cristapen
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing