TheraRadar
Data updated: May 26, 2026

EVZIO (naloxone hydrochloride)

Trial Activity: Declining 2 active trials
CNS Approved 2014-04-03
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

National Institute on Drug Abuse (NIDA) conducting 3 trials (12%)
39 indications explored (Broad Platform)
→ pain (2 trials)
→ virtual reality (2 trials)
→ placebo (2 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
12
Years on Market

Details

Status
Discontinued
First Approved
2014-04-03
Patent Cliff
2035

Pro Metrics

Patent cliff and revenue data

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Routes
INTRAMUSCULAR, SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

KALEO INC
Active Ingredient: NALOXONE HYDROCHLORIDE

EVZIO Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2014 to 2016
Jun 2016 SUPPL Priority
Mfg · Manufacturing (CMC)
Jun 2016 SUPPL Priority
Mfg · Manufacturing (CMC)
May 2015 SUPPL Priority
Mfg · Manufacturing (CMC)

What EVZIO Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

  • Other (1)
📋

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

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

EVZIO FDA Label Details

View full patent landscape →
21 OB patents · 12 families · 141 international docs across 15 countries

EVZIO Patents & Exclusivity

Latest Patent: Mar 2035

Patents (21 active)

US10220158 Expires Mar 20, 2035
US9517307 Expires Jul 18, 2034
US8627816 Expires Feb 4, 2032
US10143972 Expires May 24, 2031
US9474869 Expires Feb 28, 2031
US10322239 Expires Feb 28, 2031
US8939943 Expires Feb 28, 2031
US9022022 Expires Feb 28, 2031
US8021344 Expires Nov 2, 2029
US8226610 Expires Apr 10, 2029
US8231573 Expires Nov 25, 2028
US7749194 Expires Oct 30, 2028
US7947017 Expires Mar 12, 2028
US9724471 Expires May 23, 2027
US8206360 Expires Feb 27, 2027
US9238108 Expires Feb 20, 2027
US11590286 Expires Dec 12, 2026
US10960155 Expires Jun 25, 2026
US7731686 Expires Jun 10, 2026
US8926594 Expires Mar 31, 2026
US9278182 Expires Feb 1, 2026
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for EVZIO

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2035
  • • 21 active patents

Trial Analysis

  • • 26 total trials
  • • Stage: Declining

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA205787 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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