Drugs / Penicillin G, Benzathine
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) | BICILLIN | — | 1951-11-22 | fda.gov ↗ |
Trials 1
1950195119521953195419551956195719581959196019611962196319641965196619671968196919701971197219731974197519761977197819791980198119821983198419851986198719881989199019911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03612557 | Aug → Oct 2018 | — | Pfizer | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| 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 | NCT01382004 Comparator | Sep 2010 → Sep 2011 | yaws | Lihir Medical Centre | Completed | Met primary |
| — | NCT01156740 Comparator | Aug 2001 → Apr 2003 | pharyngitis, streptococcal infection | Johns Hopkins University | Completed | No outcome recorded |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| 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 ↗ |