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Congenital Cytomegalovirus Infection

2
Pipeline Programs
6
Companies
3
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
1
0
0
0
1
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1100%
+ 2 programs with unclassified modality

Competitive Landscape

3 companies ranked by most advanced pipeline stage

Human BioSciences
Human BioSciencesWV - Martinsburg
1 program
1
CMV hyperimmune globulinPhase 31 trial
Active Trials
NCT01376778Completed399Est. Jun 2021
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
1
LetermovirPhase 1Small Molecule1 trial
Active Trials
NCT06118515Recruiting12Est. Aug 2026
Biotest Pharmaceuticals
Biotest PharmaceuticalsGermany - Dreieich
1 program
BT097PHASE_31 trial
Active Trials
NCT05170269Terminated48Est. Mar 2024

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Biotest PharmaceuticalsBT097
Human BioSciencesCMV hyperimmune globulin
Allergy TherapeuticsLetermovir

Clinical Trials (3)

Total enrollment: 459 patients across 3 trials

Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)

Start: Nov 2021Est. completion: Mar 202448 patients
Phase 3Terminated
NCT01376778Human BioSciencesCMV hyperimmune globulin

A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)

Start: Apr 2012Est. completion: Jun 2021399 patients
Phase 3Completed

A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus

Start: Feb 2025Est. completion: Aug 202612 patients
Phase 1Recruiting

Phase Legend

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

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 459 patients
6 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.