NDAINTRAVENOUS, INTRAVENOUSSOLUTION, SOLUTIONPriority Review
Approved
Jan 2011
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
Priority Review
NITHIODOTE (sodium nitrite and sodium thiosulfate) by Hope Pharmaceuticals is poison. Approved for acute cyanide poisoning, life-threatening. First approved in 2011.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NITHIODOTE is a fixed-dose combination of sodium nitrite and sodium thiosulfate administered intravenously to treat acute cyanide poisoning. Sodium nitrite converts hemoglobin to methemoglobin, which sequesters cyanide away from cytochrome oxidase, while sodium thiosulfate enhances enzymatic conversion of cyanide to the non-toxic thiocyanate. This synergistic two-agent approach rapidly restores cellular aerobic metabolism in life-threatening poisoning cases.
Peak5.6 years to LOE
Peak-stage product with stable market position in a niche critical-care indication; limited commercial growth but stable staffing.
Mechanism of Action
poison. In the absence of rapid and adequate treatment, exposure to a high dose of cyanide can result in death within minutes due to the inhibition of cytochrome oxidase resulting in arrest of cellular respiration. Specifically, cyanide binds rapidly with cytochrome a3, a component of the…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.