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Retinopathy of Prematurity (ROP)

2
Pipeline Programs
7
Companies
4
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
2
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
2100%
+ 4 programs with unclassified modality

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Sandoz
SandozAustria - Kundl
1 program
1
RanibizumabPhase 3Monoclonal Antibody
Human BioSciences
Human BioSciencesWV - Martinsburg
1 program
1
myo-Inositol 5% InjectionPhase 31 trial
Active Trials
NCT01954082Terminated638Est. Dec 2016
Takeda
TakedaTOKYO, Japan
2 programs
rhIGF-1/rhIGFBP-3PHASE_21 trial
rhIGF-I/rhIGFBP-3PHASE_21 trial
Active Trials
NCT02386839Completed76Est. Sep 2021
NCT01096784Completed121Est. Mar 2016
Regeneron
RegeneronTARRYTOWN, NY
1 program
EyleaPHASE_3
Novartis
NovartisBASEL, Switzerland
1 program
RanibizumabPHASE_3Monoclonal Antibody1 trial
Active Trials
NCT02640664Completed180Est. Apr 2022

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
NovartisRanibizumab
Human BioSciencesmyo-Inositol 5% Injection
TakedarhIGF-1/rhIGFBP-3
TakedarhIGF-I/rhIGFBP-3

Clinical Trials (4)

Total enrollment: 1,015 patients across 4 trials

NCT02640664NovartisRanibizumab

Rainbow Extension Study

Start: Jun 2016Est. completion: Apr 2022180 patients
Phase 3Completed
NCT01954082Human BioSciencesmyo-Inositol 5% Injection

Inositol to Reduce Retinopathy of Prematurity

Start: Apr 2014Est. completion: Dec 2016638 patients
Phase 3Terminated
NCT02386839TakedarhIGF-1/rhIGFBP-3

Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)

Start: Mar 2015Est. completion: Sep 202176 patients
Phase 2Completed
NCT01096784TakedarhIGF-I/rhIGFBP-3

IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity

Start: Jun 2010Est. completion: Mar 2016121 patients
Phase 2Completed

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

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