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Opioid Overdose

4
Pipeline Programs
5
Companies
7
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
0
0
0
0
1
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Purdue Pharma
Purdue PharmaCT - Stamford
2 programs
1
1
Nalmefene Hydrochloride InjectionPhase 42 trials
Nalmefene HCl injectionPhase 11 trial
Active Trials
NCT06719986Completed24Est. Dec 2022
NCT07543276Completed13Est. Apr 2026
NCT05808881Withdrawn0Est. May 2024
Emergent BioSolutions
1 program
1
16 mg naloxone AP003Phase 11 trial
Active Trials
NCT05377255Completed24Est. May 2022
Cessation Therapeutics
1 program
1
CSX-1004Phase 11 trial
Active Trials
NCT06005402Completed32Est. May 2024
Indivior
IndiviorUK - Slough
1 program
Extensive trainingN/A1 trial
Active Trials
NCT02535494Completed405Est. Dec 2021
Deka Biosciences
Deka BiosciencesMD - Germantown
1 program
intradermal naloxonePHASE_41 trial
Active Trials
NCT05876572WithdrawnEst. Dec 2024

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Deka Biosciencesintradermal naloxone
Purdue PharmaNalmefene Hydrochloride Injection
Purdue PharmaNalmefene Hydrochloride Injection
Cessation TherapeuticsCSX-1004
Purdue PharmaNalmefene HCl injection
Emergent BioSolutions16 mg naloxone AP003
IndiviorExtensive training

Clinical Trials (7)

Total enrollment: 498 patients across 7 trials

NCT05876572Deka Biosciencesintradermal naloxone

Blood Naloxone Levels Following Intradermal Injection in Humans

Start: Aug 2024Est. completion: Dec 2024
Phase 4Withdrawn
NCT05808881Purdue PharmaNalmefene Hydrochloride Injection

Clinical Outcomes From Nalmefene

Start: Jun 2023Est. completion: May 20240
Phase 4Withdrawn
NCT07543276Purdue PharmaNalmefene Hydrochloride Injection

Pharmacokinetic (PK) Evaluation of Nalmefene Formulations

Start: Feb 2026Est. completion: Apr 202613 patients
Phase 1Completed
NCT06005402Cessation TherapeuticsCSX-1004

Safety, Tolerability, and Pharmacokinetics of CSX-1004

Start: Aug 2023Est. completion: May 202432 patients
Phase 1Completed
NCT06719986Purdue PharmaNalmefene HCl injection

Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg

Start: Oct 2022Est. completion: Dec 202224 patients
Phase 1Completed
NCT05377255Emergent BioSolutions16 mg naloxone AP003

Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults

Start: Mar 2022Est. completion: May 202224 patients
Phase 1Completed
NCT02535494IndiviorExtensive training

Risks and Benefits of Naloxone Prescribing

Start: Jul 2014Est. completion: Dec 2021405 patients
N/ACompleted

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

5 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.