ZURNAI (AUTOINJECTOR) (nalmefene hydrochloride)
Zurnai (nalmefene hydrochloride) is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, manifested by respiratory and/or central nervous system depression. It is used for the complete or partial reversal of effects induced by natural or synthetic opioids in adult and pediatric patients.
How ZURNAI (AUTOINJECTOR) Works
Nalmefene hydrochloride functions as a long-acting opioid antagonist. It competitively binds to mu ($\mu$), kappa ($\kappa$), and delta ($\delta$) opioid receptors in the central nervous system, with the highest affinity for mu receptors. By displacing opioid agonists from these sites, it reverses their pharmacological effects, including respiratory depression, sedation, and hypotension. Unlike naloxone, nalmefene has a significantly longer half-life, providing a more prolonged duration of antagonism.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-08-07
- Patent Cliff
- 2039
- Routes
- INTRAMUSCULAR, SUBCUTANEOUS
- Dosage Forms
- SOLUTION
ZURNAI (AUTOINJECTOR) Approval History
What ZURNAI (AUTOINJECTOR) Treats
2 indicationsZURNAI (AUTOINJECTOR) is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Opioid Overdose
- Respiratory Depression
ZURNAI (AUTOINJECTOR) Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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 ZURNAI (AUTOINJECTOR)
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04828005 results posted | OPNT003-PD-001 | Ph 1 | completed | Pharmacodynamic Evaluation of Intranasal Nalmefene |
| NCT04759768 results posted | OPNT003-PK-001 | Ph 1 | completed | Pharmacokinetic Evaluation of Intranasal Nalmefene |
| NCT05219669 results posted | OPNT003-PK-002 | Ph 1 | completed | Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens |
| NCT02382276 results posted | 339-14-002 JapicCTI-152806 | Ph 3 | completed | A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence |
| NCT02364947 results posted | 339-14-001 JapicCTI-152804 | Ph 3 | completed | A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-parallel-group Comparison Trial to Investigate the Effect of Nalmefene on Alcohol Consumption Reduction in Patients With Alcohol Dependence (Phase 3 Trial) |
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.
ZURNAI (AUTOINJECTOR) FDA Label Details
Indications & Usage
FDA Label (PDF)ZURNAI (AUTOINJECTOR) is indicated for the treatment of Opioid Overdose; Respiratory Depression.
ZURNAI (AUTOINJECTOR) Patents & Exclusivity
Patents (2 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ZURNAI (AUTOINJECTOR)
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 2 active patents
Trial Analysis
- • 5 total trials
- • Stage: Declining
Competitive Landscape
- • 7 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