Skip to main content

Neonatal Encephalopathy

3
Pipeline Programs
7
Companies
7
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
0
0
3
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

7 companies ranked by most advanced pipeline stage

Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
1 program
1
Normal saline placeboPhase 31 trial
Active Trials
NCT02811263Completed500Est. Apr 2022
Utah Medical
Utah MedicalIreland - Dublin
1 program
1
Normal saline placeboPhase 3
Pediatrix Therapeutics
Pediatrix TherapeuticsChina - Shanghai
1 program
1
Normal saline placeboPhase 3
Sudhin Biopharma
Sudhin BiopharmaCO - Superior
4 programs
Intra-partum care bundle invoking 4 elementsN/A1 trial
Tecotherm-HELIXN/A1 trial
Therapeutic hypothermiaN/A1 trial
Whole body coolingN/A1 trial
Active Trials
NCT04054453Unknown2,000Est. Oct 2024
NCT01760629Completed62Est. Dec 2014
NCT03409770Unknown140Est. Aug 2024
+1 more trials
Autonomous Therapeutics
1 program
Database Entry/Biospecimen CollectionN/A1 trial
Active Trials
NCT02544100Recruiting2,000Est. Dec 2025
Medtronic
MedtronicNJ - Phillipsburg
1 program
Transcutaneous Carbon Dioxide MonitoringN/A1 trial
Active Trials
NCT04603547Active Not Recruiting53Est. Dec 2027
Cook Medical
Cook MedicalIN - Bloomington
1 program
Normal saline placeboPHASE_3

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Angeles TherapeuticsNormal saline placebo
Sudhin BiopharmaIntra-partum care bundle invoking 4 elements
Sudhin BiopharmaTherapeutic hypothermia
MedtronicTranscutaneous Carbon Dioxide Monitoring
Autonomous TherapeuticsDatabase Entry/Biospecimen Collection
Sudhin BiopharmaWhole body cooling
Sudhin BiopharmaTecotherm-HELIX

Clinical Trials (7)

Total enrollment: 5,163 patients across 7 trials

NCT02811263Angeles TherapeuticsNormal saline placebo

High-dose Erythropoietin for Asphyxia and Encephalopathy

Start: Jan 2017Est. completion: Apr 2022500 patients
Phase 3Completed
NCT04054453Sudhin BiopharmaIntra-partum care bundle invoking 4 elements

Prevention of Epilepsy by Reducing Neonatal Encephalopathy

Start: Mar 2020Est. completion: Oct 20242,000 patients
N/AUnknown
NCT03409770Sudhin BiopharmaTherapeutic hypothermia

Optimising the Duration of Cooling in Mild Encephalopathy

Start: Oct 2019Est. completion: Aug 2024140 patients
N/AUnknown
NCT04603547MedtronicTranscutaneous Carbon Dioxide Monitoring

Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy

Start: Sep 2019Est. completion: Dec 202753 patients
N/AActive Not Recruiting
NCT02544100Autonomous TherapeuticsDatabase Entry/Biospecimen Collection

Neonatal Neurologic Intensive Care Network of China

Start: Sep 2015Est. completion: Dec 20252,000 patients
N/ARecruiting
NCT02387385Sudhin BiopharmaWhole body cooling

Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial

Start: Aug 2015Est. completion: Dec 2020408 patients
N/ACompleted
NCT01760629Sudhin BiopharmaTecotherm-HELIX

Hypothermia for Encephalopathy in Low Income Countries-Feasibilty

Start: Apr 2013Est. completion: Dec 201462 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

3 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 5,163 patients
7 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.