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Hypoxic-Ischemic Encephalopathy

2
Pipeline Programs
7
Companies
9
Clinical Trials
4 recruiting
0
Approved Products

Pipeline by Development Stage

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

Competitive Landscape

7 companies ranked by most advanced pipeline stage

ReAlta Life Sciences
1 program
1
RLS-0071Phase 21 trial
Active Trials
NCT05778188Recruiting70Est. Dec 2028
Human BioSciences
Human BioSciencesWV - Martinsburg
3 programs
1
Caffeine citrate 20 mg/kgPhase 11 trial
Umbilical Cord MilkingN/A1 trial
Umbilical cord milkingN/A1 trial
Active Trials
NCT03682042Recruiting3,442Est. Oct 2027
NCT03657394Active Not Recruiting3,442Est. Jun 2026
NCT06448780Recruiting16Est. Nov 2028
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
3 programs
Umbilical Cord MilkingN/A
Umbilical Cord MilkingN/A1 trial
Umbilical cord milkingN/A
Active Trials
NCT03681314Withdrawn0Est. Aug 2026
Mission Therapeutics
Mission TherapeuticsUK - Cambridge
1 program
Umbilical Cord MilkingN/A1 trial
Active Trials
NCT03123081Unknown400Est. Jul 2022
Mononuclear Therapeutics
Mononuclear TherapeuticsChina - Hong Kong
1 program
autologous umbilical cord bloodPHASE_11 trial
Active Trials
NCT03352310Unknown40Est. Dec 2020
Pharmazz
PharmazzIndia - Greater Noida
1 program
Normal Saline along with standard treatmentPHASE_21 trial
Active Trials
NCT05514340Recruiting40Est. Dec 2026
Bracco
BraccoItaly - Milan
1 program
Sulfur hexafluoride lipid-type A microspheresPHASE_31 trial
Active Trials
NCT03549520Completed1Est. May 2024

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
BraccoSulfur hexafluoride lipid-type A microspheres
PharmazzNormal Saline along with standard treatment
ReAlta Life SciencesRLS-0071
Human BioSciencesCaffeine citrate 20 mg/kg
Mononuclear Therapeuticsautologous umbilical cord blood
Human BioSciencesUmbilical Cord Milking
Sharp TherapeuticsUmbilical Cord Milking
Human BioSciencesUmbilical cord milking
Mission TherapeuticsUmbilical Cord Milking

Clinical Trials (9)

Total enrollment: 7,451 patients across 9 trials

NCT03549520BraccoSulfur hexafluoride lipid-type A microspheres

CEUS Evaluation of Hypoxic Ischemic Injury

Start: Dec 2020Est. completion: May 20241 patients
Phase 3Completed
NCT05514340PharmazzNormal Saline along with standard treatment

Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy

Start: Sep 2023Est. completion: Dec 202640 patients
Phase 2Recruiting

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia

Start: Jul 2023Est. completion: Dec 202870 patients
Phase 2Recruiting
NCT06448780Human BioSciencesCaffeine citrate 20 mg/kg

Dose Optimization of Caffeine for HIE

Start: Jul 2024Est. completion: Nov 202816 patients
Phase 1Recruiting
NCT03352310Mononuclear Therapeuticsautologous umbilical cord blood

Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia

Start: Apr 2018Est. completion: Dec 202040 patients
Phase 1Unknown
NCT03682042Human BioSciencesUmbilical Cord Milking

Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up

Start: Oct 2022Est. completion: Oct 20273,442 patients
N/ARecruiting
NCT03681314Sharp TherapeuticsUmbilical Cord Milking

Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)

Start: Oct 2022Est. completion: Aug 20260
N/AWithdrawn
NCT03657394Human BioSciencesUmbilical cord milking

Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries

Start: Oct 2022Est. completion: Jun 20263,442 patients
N/AActive Not Recruiting
NCT03123081Mission TherapeuticsUmbilical Cord Milking

Role of Umbilical Cord Milking in the Management of Hypoxic-ischemic Encephalopathy in Neonates

Start: Jan 2018Est. completion: Jul 2022400 patients
N/AUnknown

Phase Legend

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

Key Insights

4 actively recruiting trials targeting 7,451 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.