SODIUM NITRITE
Sodium nitrite is an antidote used for patients experiencing serious or life-threatening acute cyanide poisoning. It is administered as part of a sequential regimen with sodium thiosulfate to counteract the rapid cellular damage caused by the toxin. Healthcare providers use this medication with caution when a diagnosis is not certain, weighing the risks of the treatment against the severity of the patient's condition.
How SODIUM NITRITE Works
This medication works by reacting with hemoglobin to create methemoglobin, which has a high affinity for cyanide and pulls it away from the mitochondria. By displacing cyanide from cytochrome oxidase, the drug allows cells to resume normal oxygen use and aerobic metabolism. The resulting combination forms cyanomethemoglobin, a non-toxic substance that helps neutralize the poison's effects.
Details
- Status
- Prescription
- First Approved
- 2012-02-14
- Patent Cliff
- 2031
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
SODIUM NITRITE Approval History
What SODIUM NITRITE Treats
1 indicationsSODIUM NITRITE is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cyanide Poisoning
SODIUM NITRITE Boxed Warning
LIFE THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION Sodium nitrite can cause serious adverse reactions and death in humans, even at doses less than twice the recommended therapeutic dose. Sodium nitrite causes hypotension and methemoglobin formation, which diminishes oxygen carrying capacity. Hypotension and methemoglobin formation can occur concurrently or separately. Because of these risks, sodium nitrite should be used to treat acute life-threatening cyanide poisoning and be used with ca...
WARNING: LIFE THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION Sodium nitrite can cause serious adverse reactions and death in humans, even at doses less than twice the recommended therapeutic dose. Sodium nitrite causes hypotension and methemoglobin formation, which diminishes oxygen carrying capacity. Hypotension and methemoglobin formation can occur concurrently or separately. Because of these risks, sodium nitrite should be used to treat acute life-threatening cyanide poisoning and be used with caution in patients where the diagnosis of cyanide poisoning is uncertain . Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with sodium nitrite. Alternative therapeutic approaches should be considered in patients known to have diminished oxygen or cardiovascular reserve (e.g., smoke inhalation victims, pre-existing anemia, cardiac or respiratory compromise), and those at higher risk of developing methemoglobinemia (e.g., congenital methemoglobin reductase deficiency) as they are at greater risk for potentially life-threatening adverse events related to the use of sodium nitrite . [see Warnings and Precautions (5.1 and 5.2) ] WARNING: LIFE-THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION See full prescribing information for complete boxed warning . Sodium nitrite can cause serious adverse reactions and death from: Hypotension ( 5.1 ) Methemoglobin formation ( 5.2 ) Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with sodium nitrite.
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Clinical Trial Registry
19 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02694393 results posted | PRO15040062 | Ph 1, Ph 2 | terminated | Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis |
| NCT03015402 PH-HFpEF results posted | STUDY20010014 5P01HL103455 | Ph 2 | completed | Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction |
| NCT02713126 INABLE results posted | 16-001467 R01HL128526 | Ph 2 | completed | Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF) (INABLE-Training) |
| NCT02433977 NICLA results posted | PRO14110207 | Ph 2 | completed | The Effects of NOx and Conjugated Linoleic Acid on Asthmatics |
| NCT04289558 | Pro00100364 R01HL130763 | Ph 1 | withdrawn | Nitrite Infusion in Children With Malaria |
| NCT04401527 | SN02-01 | Ph 2 | withdrawn | Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite |
| NCT00873015 results posted | 14024 1R44NS063485-01 | Ph 2 | completed | Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm |
| NCT02412852 results posted | TheraVasc-TV1001-003 | Ph 2 | completed | A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain |
| NCT04354051 | 228798 | Ph 1, Ph 2 | completed | The Nitrite and Coronary Flow Study |
| NCT01401517 results posted | TheraVasc-TV1001-002 | Ph 2 | completed | Phase IIa: Safety, PK, & Tolerability of Sodium Nitrite in Patients With Peripheral Arterial Disease-SONIC |
| NCT02918552 ONOH results posted | STUDY19070450 1R56AG051637-01A1 | Ph 2 | completed | Oral Nitrite for Older Heart Failure With Preserved Ejection Fraction |
| NCT03331146 | 1709284471 | Ph 3 | withdrawn | Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass |
| NCT01715883 results posted | PRO11030251 | Ph 2 | terminated | Sodium Nitrite in Lung Transplant Patients to Minimize the Risk of Pulmonary Graft Dysfunction |
| NCT00924118 results posted | NA_00023049 | Ph 2 | completed | Sodium Nitrite in Acute Myocardial Infarction |
| NCT02987088 | 51605-A | Ph 1 | completed | Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest |
| NCT02176837 results posted | SN-03-01 | Ph 2 | terminated | Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage |
| NCT01584453 NITRITE-AMI | 11/LO/1500 | Ph 2 | completed | Safety and Effectiveness of Intra-coronary Nitrite in Acute Myocardial Infarction |
| NCT01388504 NIAMI | 3/030/10 | Ph 2, Ph 3 | completed | Nitrites in Acute Myocardial Infarction |
| NCT02022670 results posted | R21HL107105 | Ph 1, Ph 2 | completed | Sodium Nitrite to Treat Arterial Aging |
Active Pipeline
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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 NITRITE FDA Label Details
Indications & Usage
FDA Label (PDF)SODIUM NITRITE is indicated for the treatment of Cyanide Poisoning.
WARNING: LIFE THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION Sodium nitrite can cause serious adverse reactions and death in humans, even at doses less than twice the recommended therapeutic dose. Sodium nitrite causes hypotension and methemoglobin formation, which diminishes oxygen carrying ca...
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Revenue Insights
- • Quarterly revenue tracking
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Patent Timeline
- • Cliff: 2031
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 3 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.