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Data updated: Mar 10, 2026

SODIUM THIOSULFATE

SODIUM THIOSULFATE
Approved 1992-02-14
2
Indications
--
Phase 3 Trials
34
Years on Market

Details

Status
Prescription
First Approved
1992-02-14
Routes
INTRAVENOUS, INJECTION
Dosage Forms
SOLUTION, INJECTABLE

Companies

Active Ingredient: SODIUM THIOSULFATE

SODIUM THIOSULFATE Approval History

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What SODIUM THIOSULFATE Treats

1 indications

SODIUM THIOSULFATE is approved for 1 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Cyanide Poisoning
Source: FDA Label
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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.

SODIUM THIOSULFATE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Sodium Thiosulfate Injection is indicated for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potential risks associated with Sodium Thiosulfate Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis. Sodium Thiosulfate Injection, an antidote, is indicated for sequential use with sodium nitrite for treatment of acute cyanide poisoning that is judged to be serious or life-threatening. Use with caut...

SODIUM THIOSULFATE Patents & Exclusivity

Latest Patent: Mar 2031

Patents (6 active)

US8496973 Expires Mar 29, 2031
US9345724 Expires Jul 7, 2030
US10479686 Expires Jul 7, 2030
US9585912 Expires Jul 7, 2030
US11753301 Expires Feb 10, 2030
US12304813 Expires Feb 10, 2030
Source: FDA Orange Book

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Data Sources

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