NITHIODOTE (sodium nitrite)
NITHIODOTE is indicated for the treatment of Cyanide Poisoning.
How NITHIODOTE Works
Nithiodote works through the synergistic action of two components. Sodium Nitrite reacts with hemoglobin to form methemoglobin, which has a high affinity for cyanide. This displaces cyanide from cytochrome c oxidase in the mitochondria, forming cyanomethemoglobin and restoring aerobic metabolism. Sodium Thiosulfate then acts as a sulfur donor for the enzyme rhodanese, which facilitates the conversion of cyanide into thiocyanate, a relatively non-toxic derivative that is excreted in the urine.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2011-01-14
- Patent Cliff
- 2031
- Routes
- INTRAVENOUS, INTRAVENOUS
- Dosage Forms
- SOLUTION, SOLUTION
NITHIODOTE Approval History
What NITHIODOTE Treats
1 indicationsNITHIODOTE is approved for 1 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cyanide Poisoning
NITHIODOTE 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.
NITHIODOTE 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.
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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
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.
NITHIODOTE FDA Label Details
Indications & Usage
FDA Label (PDF)NITHIODOTE 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...
NITHIODOTE Patents & Exclusivity
Patents (8 active)
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Deep insights for NITHIODOTE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 9 active patents
Trial Analysis
- • 19 total trials
- • Stage: Declining
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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment