TheraRadar
Data updated: May 26, 2026

PROTOPAM CHLORIDE (pralidoxime chloride)

Other Approved 1964-03-11

PROTOPAM CHLORIDE is indicated for the treatment of Organophosphate Poisoning; Anticholinesterase Overdose; Myasthenia Gravis.

Source: FDA Label • Baxter

How PROTOPAM CHLORIDE Works

Pralidoxime chloride is a cholinesterase reactivator. It works by displacing the phosphate group from the active site of the acetylcholinesterase enzyme that has been inhibited by an organophosphate pesticide or nerve agent. This restores the enzyme's ability to hydrolyze acetylcholine, thereby reversing the neuromuscular blockade and cholinergic crisis. The drug is most effective when administered before the enzyme-inhibitor complex undergoes "aging," a chemical process that renders the enzyme-inhibitor bond permanent.

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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Original
New Indication
New Form
Label Update
35 FDA actions from 1964 to 2014
Jan 2014 SUPPL Priority
Mfg · Manufacturing (CMC)
May 2013 SUPPL Priority
Mfg · Manufacturing (CMC)
Nov 2012 SUPPL Priority
Mfg · Manufacturing (CMC)

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

PROTOPAM CHLORIDE Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to PROTOPAM CHLORIDE

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Active Pipeline

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Key Completed Trials

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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

Indications & Usage

FDA Label (PDF)

PROTOPAM CHLORIDE is indicated for the treatment of Organophosphate Poisoning; Anticholinesterase Overdose; Myasthenia Gravis.

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Data Sources

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