KLOXXADO (naloxone hydrochloride)
KLOXXADO is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose in adult and pediatric patients. It is used to treat manifestations of overdose such as respiratory and central nervous system depression. The drug is intended for immediate administration in settings where opioids may be present, though it is not a substitute for professional emergency medical care.
How KLOXXADO Works
Naloxone hydrochloride acts as an opioid antagonist by competing for the same receptor sites as opioid drugs. By binding to these receptors, it reverses the physiological effects of opioids, including respiratory depression, sedation, and hypotension. It is also capable of reversing the psychotomimetic and dysphoric effects associated with agonist-antagonist substances.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-04-29
- Patent Cliff
- 2034
- Routes
- NASAL
- Dosage Forms
- SPRAY
KLOXXADO Approval History
What KLOXXADO Treats
3 indicationsKLOXXADO is approved for 3 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Opioid Overdose
- Respiratory Depression
- Central Nervous System Depression
KLOXXADO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 KLOXXADO
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07459166 | CS-1103-03 5UG3DA059286 | Ph 2 | not yet recruiting | A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade |
| NCT04828005 results posted | OPNT003-PD-001 | Ph 1 | completed | Pharmacodynamic Evaluation of Intranasal Nalmefene |
| NCT04473950 results posted | Z-1902 R21DA047520 | Ph 1 | terminated | The Effect of Chronic Pain on Delay Discounting in Methadone Patients |
| NCT05338632 ROAR | P21.112 | Ph 1 | recruiting | Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists |
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.
KLOXXADO FDA Label Details
Indications & Usage
FDA Label (PDF)KLOXXADO is indicated for the treatment of Opioid Overdose; Respiratory Depression; Central Nervous System Depression.
KLOXXADO Patents & Exclusivity
Patents (7 active)
Pro Intelligence Preview
Deep insights for KLOXXADO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 14 active patents
Trial Analysis
- • 26 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