TheraRadar
Data updated: May 26, 2026

TARGINIQ (naloxone hydrochloride)

Trial Activity: Declining 2 active trials
Pain Approved 2014-07-23
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
11
Years on Market

Details

Status
Discontinued
First Approved
2014-07-23
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

PURDUE PHARMA LP
Active Ingredient: NALOXONE HYDROCHLORIDE , OXYCODONE HYDROCHLORIDE

TARGINIQ Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
27 FDA actions from 2014 to 2018
Sep 2018 SUPPL
Update · REMS
FDA Letter Label
May 2017 SUPPL
Update · REMS
FDA Letter
Dec 2016 SUPPL
Label · Labeling
FDA Letter Label

What TARGINIQ 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

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

TARGINIQ FDA Label Details

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Data Sources

FDA Approval: NDA205777 → 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