Prematurity

Pipeline Programs

Companies

Clinical Trials

1 recruiting

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Vaccine

2100%

+ 12 programs with unclassified modality

Competitive Landscape

9 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

ViiV HealthcareNC - Durham

1 program

4CMenB VaccinePhase 4Vaccine

BayerLEVERKUSEN, Germany

1 program

JosamycinPhase 31 trial

Active Trials

NCT00718705Completed3,200Est. Sep 2011

Human BioSciencesWV - Martinsburg

4 programs

Aerosolized Normal SalinePhase 21 trial

Darbepoetin AlfaPhase 21 trial

Infant Immune Response to Bacterial InfectionN/A1 trial

Neutrophil Extracellular Trap Formation in Newborn Infants at Risk for Inflammatory SyndromesN/A1 trial

Active Trials

NCT00546195Completed45Est. Mar 2011

NCT01106209Terminated14Est. Jun 2020

NCT01467076Terminated7Est. Jun 2012

+1 more trials

Pediatrix TherapeuticsChina - Shanghai

2 programs

Amino Acid and Acylcarnitine Profiles in Premature NeonatesN/A1 trial

Nutritional Content of Breast Milk From Mothers of PremiesN/A1 trial

Active Trials

NCT00865150Completed1,003Est. Feb 2012

NCT01050192Withdrawn0Est. Sep 2010

MasimoIRVINE, CA

2 programs

titration of oxygen during resuscitationN/A1 trial

Active Trials

NCT00356902Completed215Est. Sep 2007

NCT00355875Completed30Est. Oct 2006

MeissnerCA - Camarillo

1 program

Defects in Opsonophagocytosis in Premature InfantsN/A1 trial

Active Trials

NCT00866567Completed80Est. Sep 2009

Johnson & JohnsonNEW BRUNSWICK, NJ

1 program

Early HMFN/A1 trial

Active Trials

NCT05525585Active Not Recruiting80Est. May 2026

NFANT Labs-

1 program

nfantN/A1 trial

Active Trials

NCT04256889Completed23Est. Mar 2024

GSKLONDON, United Kingdom

1 program

4CMenB VaccinePHASE_4Vaccine1 trial

Active Trials

NCT03125616Completed136Est. Aug 2020

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

2027

GSK4CMenB Vaccine

BayerJosamycin

Human BioSciencesDarbepoetin Alfa

Human BioSciencesAerosolized Normal Saline

Johnson & JohnsonEarly HMF

NFANT Labsnfant

Human BioSciencesNeutrophil Extracellular Trap Formation in Newborn Infants at Risk for Inflammatory Syndromes

Pediatrix TherapeuticsNutritional Content of Breast Milk From Mothers of Premies

Pediatrix TherapeuticsAmino Acid and Acylcarnitine Profiles in Premature Neonates

MeissnerDefects in Opsonophagocytosis in Premature Infants

Human BioSciencesInfant Immune Response to Bacterial Infection

Masimotitration of oxygen during resuscitation

Clinical Trials (13)

Total enrollment: 4,953 patients across 13 trials

NCT03125616 GSK4CMenB Vaccine

Babies Born Early Antibody Response to Men B Vaccination: BEAR Men B

Start: Aug 2017Est. completion: Aug 2020136 patients

Phase 4Completed

NCT00718705 BayerJosamycin

Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin)

Start: Jul 2008Est. completion: Sep 20113,200 patients

Phase 3Completed

NCT05340465 Human BioSciencesDarbepoetin Alfa

Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants

Start: Nov 2022Est. completion: Jun 2027120 patients

Phase 2Recruiting

NCT01467076 Human BioSciencesAerosolized Normal Saline

Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF)

Start: Nov 2011Est. completion: Jun 20127 patients

Phase 2Terminated

NCT05525585 Johnson & JohnsonEarly HMF

Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants

Start: Nov 2022Est. completion: May 202680 patients

N/AActive Not Recruiting

NCT04256889 NFANT Labsnfant

Use Of Nfant(R) Technology Feeding System For Infants Less Than 30 Weeks GA

Start: Jan 2020Est. completion: Mar 202423 patients

N/ACompleted

NCT01106209 Human BioSciencesNeutrophil Extracellular Trap Formation in Newborn Infants at Risk for Inflammatory Syndromes

Neutrophil Extracellular Trap Formation in Newborn Infants at Risk for Inflammatory Syndromes

Start: Apr 2010Est. completion: Jun 202014 patients

N/ATerminated

NCT01050192 Pediatrix TherapeuticsNutritional Content of Breast Milk From Mothers of Premies

Nutritional Content of Breast Milk From Mothers of Premies

Start: Dec 2009Est. completion: Sep 20100

N/AWithdrawn

NCT00865150 Pediatrix TherapeuticsAmino Acid and Acylcarnitine Profiles in Premature Neonates

Amino Acid and Acylcarnitine Profiles in Premature Neonates

Start: Apr 2009Est. completion: Feb 20121,003 patients

N/ACompleted

NCT00866567 MeissnerDefects in Opsonophagocytosis in Premature Infants

Defects in Opsonophagocytosis in Premature Infants

Start: Oct 2008Est. completion: Sep 200980 patients

N/ACompleted

NCT00546195 Human BioSciencesInfant Immune Response to Bacterial Infection

Infant Immune Response to Bacterial Infection

Start: Oct 2007Est. completion: Mar 201145 patients

N/ACompleted

NCT00356902 Masimotitration of oxygen during resuscitation

Comparison of Different Oxygen Delivery Strategies During Resuscitation of Babies

Start: Jul 2005Est. completion: Sep 2007215 patients

N/ACompleted

NCT00355875 Masimotitration of oxygen during resuscitation

The Effect of Oxygen Exposure During Newborn Resuscitation on Lung Injury

Start: Jul 2005Est. completion: Oct 200630 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

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

1 actively recruiting trials targeting 4,953 patients

9 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.