Naloxone Hydrochloride

ApprovedSmall molecule

PPurdue Pharma LP

Naloxone Hydrochloride is one of 79 small molecule programs targeting Stroke. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

StrokeActive, not recruiting

Respiratory DepressionActive, not recruiting

Chronic PainActive, not recruiting

FentanylRecruiting

StrokeApproved

Active, not recruiting

Respiratory DepressionPhase 1

Active, not recruiting

Chronic PainPhase 3

Active, not recruiting

FentanylPhase 2

Recruiting

Competition

Competitive Landscape

461 competitors in Stroke

#DrugCompanyPhaseTrials

Naloxone Hydrochloride

PPurdue Pharma LP

Approved

1 2

Proamatine

Repatha

Pradaxa

3 5

Botox

RRevance Therapeutics, Inc.

Preclinical

2 6

Periactin

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 7

Zantac 150

CChattem

Preclinical

1 8

Direct Anticoagulant

Bayer

Preclinical

3 9

Carbidopa-Levodopa

Neurocrine Biosciences

Preclinical

1 10

Inderal

Mylan Pharmaceuticals Inc

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Respiratory Depression

NCT05338632

Phase 2Recruiting

Fentanyl

NCT07459166

Clinical

Trials by Indication[1]

Chronic pain2 trials

The Effect of Chronic Pain on Delay Discounting in Methadone Patients

Terminated·UUniversity of California, San Francisco·Phase 1·NCT04473950·10 enrolled

Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain

Unknown status·—·Phase 3·NCT00020605

Stroke1 trial

A Phase 4 Clinical Study to Investigate the Efficacy and Safety of Naloxone HCI IV in Patients With Stroke

Completed·SSamjin Pharmaceutical Co., Ltd.·Phase 4·NCT05301712·446 enrolled

Outcome1 trial

Clinical Outcomes From Nalmefene

Withdrawn·PPurdue Pharma LP·Phase 4·NCT05808881

Respiratory Depression1 trial

Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists

Recruiting·LLeiden University Medical Center·Phase 1·NCT05338632·24 enrolled

Gambling Disorder1 trial

Effects of Intranasal Naloxone on Gambling Urges and Craving in Gambling Disorder

Unknown status·FFinnish Institute for Health and Welfare·Phase 2·NCT03430180·126 enrolled

2 more indications

Fentanyl1 trial

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Single Dose of Intravenous CS 1103 Following a Single Intravenous Dose of Fentanyl in Healthy Subjects With Naloxone Blockade

Recruiting·CClear Scientific, Inc.·Phase 2·NCT07459166·16 enrolled

Unspecified1 trial

Pharmacodynamic Evaluation of Intranasal Nalmefene

Completed·OOpiant Pharmaceuticals Inc·Phase 1·NCT04828005·84 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Naloxone Hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Naloxone Hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Naloxone Hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Purdue Pharma LP company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: PPurdue Pharma LP

Naloxone Hydrochloride

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Chronic pain2 trials

Stroke1 trial

Outcome1 trial

Respiratory Depression1 trial

Gambling Disorder1 trial

Fentanyl1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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