TheraRadar
Data updated: Jul 17, 2026

BICILLIN L-A (penicillin g benzathine) · Pfizer

Trial Activity: Expansion 1 active trials
Infectious Disease Approved 1952-06-27
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Hospital de Niños R. Gutierrez de Buenos Aires conducting 1 trials (33%)
5 indications explored (Moderate)
→ syphilis acquired (1 trials)
→ healthy (1 trials)
→ yaws (1 trials)
6
Indications
--
Phase 3 Trials
74
Years on Market

Details

Status
Discontinued
First Approved
1952-06-27
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Pfizer KING PHARMS LLC
Active Ingredient: PENICILLIN G BENZATHINE

BICILLIN L-A Approval History

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Original
New Indication
New Form
Label Update
443 FDA actions from 1952 to 2026 · 4 indication expansions
Jun 2026 SUPPL
Label · Labeling
FDA Letter Label
Jan 2021 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Dec 2020 SUPPL
Label · Labeling
FDA Letter Label

What BICILLIN L-A Treats

6 FDA approvals

Originally approved for its first indication in 1952 . Covers 6 distinct patient populations.

  • Other (6)
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT03612557 B8441001 Ph 1 completed A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BICILLIN L-A FDA Label Details

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Data Sources

FDA Approval: NDA050131 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment