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Neonatal Opioid Withdrawal Syndrome

2
Pipeline Programs
5
Companies
5
Clinical Trials
1 recruiting
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
1
0
1
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Human BioSciences
Human BioSciencesWV - Martinsburg
3 programs
1
MorphinePhase 31 trial
ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure StudyN/A1 trial
Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal SyndromeN/A1 trial
Active Trials
NCT04149509Active Not Recruiting300Est. Dec 2026
NCT07278375Recruiting796Est. Aug 2026
NCT04214834Active Not Recruiting189Est. Jun 2026
Chiesi
ChiesiBrazil - Santana de Parnaíba
1 program
1
CHF6563Phase 21 trial
Active Trials
NCT04104646Terminated7Est. Dec 2021
SPARK Biopharma
SPARK BiopharmaKorea - Seoul
1 program
Sparrow Fledging Therapy SystemN/A1 trial
Active Trials
NCT05129020Active Not Recruiting52Est. Jan 2027
Spark Biomedical
Spark BiomedicalTX - Dallas
1 program
Sparrow Fledging Therapy SystemN/A
HELP Therapeutics
HELP TherapeuticsChina - Nanjing
1 program
Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal SyndromeN/A

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Human BioSciencesMorphine
ChiesiCHF6563
Human BioSciencesTarget Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome
SPARK BiopharmaSparrow Fledging Therapy System
Human BioSciencesACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study

Clinical Trials (5)

Total enrollment: 1,344 patients across 5 trials

NCT04214834Human BioSciencesMorphine

Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)

Start: Sep 2020Est. completion: Jun 2026189 patients
Phase 3Active Not Recruiting
NCT04104646ChiesiCHF6563

CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome

Start: Dec 2020Est. completion: Dec 20217 patients
Phase 2Terminated
NCT07278375Human BioSciencesTarget Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome

Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome

Start: Dec 2025Est. completion: Aug 2026796 patients
N/ARecruiting
NCT05129020SPARK BiopharmaSparrow Fledging Therapy System

Neurostimulation to Improve NOWS Outcomes

Start: Jul 2022Est. completion: Jan 202752 patients
N/AActive Not Recruiting
NCT04149509Human BioSciencesACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study

ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study

Start: Aug 2020Est. completion: Dec 2026300 patients
N/AActive Not Recruiting

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

1 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 1,344 patients
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.