TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

PROTOPAM CHLORIDE

PRALIDOXIME CHLORIDE
Neurology Approved 1964-03-11
2
Indications
--
Phase 3 Trials
2
Priority Reviews
62
Years on Market

Details

Status
Prescription
First Approved
1964-03-11
Routes
INJECTION, ORAL
Dosage Forms
INJECTABLE, TABLET

Companies

Active Ingredient: PRALIDOXIME CHLORIDE

PROTOPAM CHLORIDE Approval History

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What PROTOPAM CHLORIDE Treats

3 indications

PROTOPAM CHLORIDE is approved for 3 conditions since its original approval in 1964. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Organophosphate Poisoning
  • Anticholinesterase Overdose
  • Myasthenia Gravis
Source: FDA Label
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

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.

PROTOPAM CHLORIDE FDA Label Details

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Indications & Usage

FDA Label (PDF)

PROTOPAM Chloride is indicated as an antidote: 1. In the treatment of poisoning due to those pesticides and chemicals (e.g., nerve agents) of the organophosphate class which have anticholinesterase activity and 2. In the control of overdosage by anticholinesterase drugs used in the treatment of myasthenia gravis. The principal indications for the use of PROTOPAM Chloride are muscle weakness and respiratory depression. In severe poisoning, respiratory depression may be due to muscle weakness.

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Data Sources

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