Drugs / Benzylpenicillin
Benzylpenicillin
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | BICILLIN L-A | — | 1954-10-21 – 1982-09-16 | fda.gov ↗ |
| Approved | US (FDA) | PENICILLIN G POTASSIUM | — | 1947-02-06 | fda.gov ↗ |
Trials 11 · a red edge is where a trial was stopped
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04053140 | Nov 2019 → May 2024 | — | Imperial College London | Completed | No outcome recorded |
| Phase 1 | NCT03612557 | Aug → Oct 2018 | — | Pfizer | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06406114 | May 2025 → Jul 2028 expected | anaphylaxis, drug allergy, drug pseudoallergy | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07575009 | Apr 2026 → Dec 2028 expected | infectious disease | Tampere University Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT04041791 | Aug 2019 → Apr 2024 | pneumonia | University of Oxford | Completed | No outcome recorded |
| Phase 3 | NCT01818336 | Dec 2012 → Jun 2013 | IgE responsiveness, atopic | AllerQuest LLC | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT06726395 | Mar 2025 → Apr 2028 expected | staphylococcus aureus infection | Region Skane | Recruiting | No outcome recorded |
| Phase 4 | NCT04876131 | May 2022 → May 2028 expected | urinary tract infection | Murdoch Childrens Research Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT05137119 | Feb 2022 → Dec 2028 expected | staphylococcus aureus infection | University of Melbourne | Recruiting | No outcome recorded |
| Phase 4 | NCT03108690 | Oct 2017 → Mar 2023 | bacterial infectious disease | Sara Thønnings | Withdrawn | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00000648 | ? → Feb 1996 | HIV infectious disease, neurosyphilis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
Also used as a comparator or background therapy in 11 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT06616168 Background | Sep 2023 → Aug 2026 overdue | bacterial vaginosis | Danylo Halytsky Lviv National Medical University | Active not recruiting | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07107477 Comparator | May 2025 → Sep 2027 expected | preterm premature rupture of the membranes | The Central and Eastern European Gynecologic Oncology Group | Recruiting | No outcome recorded |
| Phase 3 | NCT06877351 Comparator | Aug 2024 → Jan 2027 expected | syphilis | Hospital de Niños R. Gutierrez de Buenos Aires | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03174236 Comparator | Sep 2017 → Jan 2020 | poisoning, protein-energy malnutrition | University of Oxford | Unknown | No outcome recorded |
| Phase 3 | NCT01399723 Comparator | Sep 2011 → Sep 2013 | pneumonia | KEMRI-Wellcome Trust Collaborative Research Program | Completed | No outcome recorded |
| Phase 3 | NCT01382004 Comparator | Sep 2010 → Sep 2011 | yaws | Lihir Medical Centre | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT03632642 Comparator | Jul → Dec 2019 | staphylococcus aureus infection | The University of Queensland | Withdrawn | No outcome recorded |
| Phase 4 | NCT02436083 Comparator | Jul 2007 → Jun 2012 | — | Technical University of Munich | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT04215770 Comparator | Jan 2018 → Nov 2019 | streptococcal sore throat | Combined Military Hospital, Pakistan | Completed | No outcome recorded |
| — | NCT01156740 Comparator | Aug 2001 → Apr 2003 | pharyngitis, streptococcal infection | Johns Hopkins University | Completed | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | benzylpenicillin | “Penicillin G (benzylpenicillin) 5mil IU IV initially and then 2-3 IU (dose adjusted to body weight) IV every 4h twice, then every 6h” NCT07107477 ↗14“Wound infections developed in 33 of 122 patients (27%) who received benzylpenicillin” PMID 26251066 ↗ Aug 2015 “Intravenous benzylpenicillin 1.8g (3 million units) every 4 or 6 hours.” NCT05137119 ↗ “Benzylpenicillin treatment of PSSA bacteraemia will be evaluated.” NCT06726395 ↗ “benzylpenicillin” NCT01818336 ↗ “Benzylpenicillin” NCT03108690 ↗ “Benzylpenicillin” NCT02099240 ↗ |
| Known as | penicillin G | “Penicillin G (benzylpenicillin) 5mil IU IV initially and then 2-3 IU (dose adjusted to body weight) IV every 4h twice, then every 6h” NCT07107477 ↗ |
| Known as | Penicillin G, Benzathine | “Intramuscular Penicillin G Benzathine: Administered as a single dose of 50,000 IU/kg for early syphilis” NCT06877351 ↗ |
| Route | Intramuscular | “intramuscularly administered intramuscular benzathine penicillin G” NCT01156740 ↗ |