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Naloxone Hydrochloride Injection, USP
Naloxone competitively blocks opioid receptors to rapidly reverse opioid overdose and restore normal breathing.
Naloxone competitively blocks opioid receptors in the central nervous system, rapidly reversing the effects of opioid overdose. Used for Reversal of opioid overdose and opioid-induced respiratory depression, Emergency treatment of known or suspected opioid poisoning.
At a glance
| Generic name | Naloxone Hydrochloride Injection, USP |
|---|---|
| Sponsor | Pfizer |
| Drug class | Opioid antagonist |
| Target | Opioid receptors (mu, delta, kappa) |
| Modality | Small molecule |
| Therapeutic area | Emergency Medicine / Toxicology |
| Phase | FDA-approved |
Mechanism of action
Naloxone is a non-selective opioid antagonist that binds with high affinity to mu, delta, and kappa opioid receptors, displacing opioid agonists and preventing their effects. By blocking opioid receptor activation, it reverses respiratory depression, sedation, and other life-threatening effects of opioid overdose. Its rapid onset and short duration make it ideal for emergency reversal of acute opioid toxicity.
Approved indications
- Reversal of opioid overdose (acute opioid toxicity)
- Reversal of opioid-induced respiratory depression
Common side effects
- Acute withdrawal syndrome (agitation, body aches, sweating)
- Hypertension
- Tachycardia
- Tremor
- Anxiety
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Naloxone Hydrochloride Injection, USP CI brief — competitive landscape report
- Naloxone Hydrochloride Injection, USP updates RSS · CI watch RSS
- Pfizer portfolio CI