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Neonatal Opiate Withdrawal Syndrome

1
Pipeline Programs
2
Companies
1
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
0
0
0
0
1
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Human BioSciences
Human BioSciencesWV - Martinsburg
1 program
1
Symptom-based Dosing ApproachPhase 31 trial
Active Trials
NCT05980260Completed626Est. Jul 2025
HELP Therapeutics
HELP TherapeuticsChina - Nanjing
1 program
Symptom-based Dosing ApproachPHASE_3

Trial Timeline

Clinical trial activity over time

2024
2025
2026
Human BioSciencesSymptom-based Dosing Approach

Clinical Trials (1)

Total enrollment: 626 patients across 1 trials

NCT05980260Human BioSciencesSymptom-based Dosing Approach

Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach

Start: Mar 2024Est. completion: Jul 2025626 patients
Phase 3Completed

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
2 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.