SODIUM THIOSULFATE
Sodium thiosulfate is an antidote used for patients experiencing serious or life-threatening acute cyanide poisoning. It is administered sequentially with sodium nitrite to counteract the rapid and dangerous effects of cyanide on the body's cells. This medication helps patients by facilitating the detoxification of cyanide, especially when the poisoning is severe enough to stop cellular respiration.
How SODIUM THIOSULFATE Works
Sodium thiosulfate works by enhancing the body's natural detoxification process, which converts cyanide into thiocyanate through enzymatic transulfuration. This resulting thiocyanate is relatively nontoxic and is easily cleared from the body through the urine. By neutralizing the poison, the drug helps restore the cells' ability to use oxygen and prevents metabolic acidosis.
Details
- Status
- Discontinued
- First Approved
- 1992-02-14
- Patent Cliff
- 2031
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE, SOLUTION
SODIUM THIOSULFATE Approval History
What SODIUM THIOSULFATE Treats
1 indicationsSODIUM 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
SODIUM THIOSULFATE Competitive Set
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Same target(s) AND same indication — head-to-head.
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 SODIUM THIOSULFATE
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03127774 | AAAQ9194 | Ph 2 | active not recruiting | Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma |
| NCT05382338 | ACNS2031 NCI-2022-04866, ACNS2031 | Ph 3 | recruiting | A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss |
| NCT04847063 | 210012 21-C-0012 | Ph 1 | recruiting | Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies |
| NCT05018221 BEAT-Calci | BEAT-Calci | Ph 3 | recruiting | Better Evidence and Translation for Calciphylaxis |
| NCT02527213 | 1STS12001 | Ph 3 | withdrawn | Double-blind Trial of Sodium Thiosulfate for the Treatment of Pain Associated With Calcific Uremic Arteriolopathy |
| NCT03092518 results posted | 170070 17-C-0070 | Ph 2 | completed | Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology |
| NCT03267277 results posted | 170161 17-E-0161 | Ph 2, Ph 3 | completed | Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis |
| NCT04541355 results posted | 20208 NCI-2020-05752 | Ph 2 | completed | Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin |
| NCT00716976 results posted | ACCL0431 COG-ACCL0431, CDR0000588655 | Ph 3 | completed | Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy |
| NCT02624479 TSTS | 009_15 | Ph 1 | withdrawn | Pharmacokinetic Study to Investigate the Bioavailability and Tolerability of 3 Oral Formulations of Sodium Thiosulfate |
| NCT03639779 results posted | BIO-18-14095 | Ph 4 | terminated | Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Saline for Dystrophic and Idiopathic Calcinosis Cutis |
| NCT02092298 results posted | 2013-0989 NCI-2014-01105 | Ph 2 | completed | Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) for Metastatic Gastric Cancer |
| NCT03150420 CALISTA | ST-001 | Ph 3 | terminated | A Phase 3 Clinical Trial of Intravenous Sodium Thiosulfate in Acute Calciphylaxis Patients |
| NCT01833832 results posted | 130114 13-C-0114 | Ph 2 | completed | Surgery and Heated Chemotherapy for Adrenocortical Carcinoma |
| NCT02538939 THIOCAL | RC14_0394 | Ph 2 | completed | Efficacy and Tolerance of Sodium Thiosulfate Injection After Ultrasound-guided Percutaneous Irrigation of Calcific Tendinopathy of the Rotator Cuff |
| NCT01572844 results posted | 121131 | Ph 2 | completed | Topical Sodium Thiosulfate and Fractional Carbon Dioxide Laser in Treating Dermatomyositis Associated Calcinosis |
| NCT00397501 | IRB00002188 2188, SOL-06015 | Ph 1, Ph 2 | withdrawn | BBBD Followed By Methotrexate and Carboplatin With or Without Trastuzumab in Treating Women With Breast Cancer That Has Spread to the Brain |
| NCT01918904 STS-CALC | 205683 | Ph 2 | withdrawn | A Pilot Study to Evaluate Topical Sodium Thiosulfate Therapy for Calcinosis Cutis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
Indications & Usage
FDA Label (PDF)SODIUM THIOSULFATE is indicated for the treatment of Cyanide Poisoning.
SODIUM THIOSULFATE Patents & Exclusivity
Patents (6 active)
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 6 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 3 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.