Therapeutics
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Valganciclovir for congenital CMV-associated hearing loss

Also known as: Valganciclovir, Valcyte, Valganciclovirhydrochloride, Rovalcyte, Oral valganciclovir, Simple Syrup placebo comparator, Simple Syrup, simple-syrup, Sucrose Water, ValEAR Trial, CONCERT, CONCERT 2, GANCIMVEAR, NCT02005822, NCT02606266, NCT03107871, NCT01649869, NCT01655212

Multiple non-industry cCMV hearing-loss study sponsors

Primary source
Sponsor / Institution
Multiple non-industry cCMV hearing-loss study sponsors
Program Type
Therapeutic
Modality
Small Molecule
Stage
Phase 3
Status
Active
Target Gene
Route / Mode
Oral solution
Confidence
83%
Status Confidence
Status needs checking
Evidence Strength
Needs more support
Last Reviewed
2026-06-09
Geography
France, Netherlands, United Kingdom, United States
Population
pediatric, congenital, sensorineural, cmv, infant
Trial IDs
5
Mechanism

Oral valganciclovir, a ganciclovir prodrug antiviral, evaluated to suppress congenital cytomegalovirus replication and reduce or stabilize CMV-associated sensorineural hearing-loss progression in infants and young children.

Indications
Notes

Normalized a generated generic-drug cluster covering non-industry/NIH/academic studies of oral valganciclovir for congenital cytomegalovirus-associated sensorineural hearing loss. Genentech is listed as an industry collaborator in ValEAR, but the hearing-loss studies are not Genentech-sponsored pipeline programs, so this record is not marked industry-sponsored. The generated Simple Syrup row was collapsed because it is the placebo comparator arm in ValEAR, not a separate therapeutic program. Most linked studies are completed or terminated; ValEAR remains listed as active-not-recruiting in the public registry despite stale anticipated completion dates, so the public status is retained as Active with a QA caveat.

Evidence & Sources
7 structured sources
clinicaltrials
Supports: canonicalName, aliases, company, allCompanies, programType, modality, mechanism, indications...
IDs: NCT03107871, ValEAR, Valganciclovir, Simple Syrup
Open
registry mirror
Supports: canonicalName, aliases, company, allCompanies, mechanism, indications, stage, status...
IDs: NCT03107871, ValEAR, Valganciclovir, Simple Syrup
Open
clinicaltrials
Supports: aliases, allCompanies, indications, stage, status, route, populationTags, geography...
IDs: NCT02005822, CONCERT 2, Valganciclovir
Open
registry mirror
Supports: aliases, allCompanies, indications, stage, status, route, populationTags, geography...
IDs: NCT02005822, CONCERT 2, Valganciclovir
Open
clinicaltrials
Supports: allCompanies, indications, stage, status, route, populationTags, geography, trialIds
IDs: NCT01649869, Valganciclovir
Open
clinicaltrials
Supports: aliases, allCompanies, indications, stage, status, route, populationTags, geography...
IDs: NCT02606266, GANCIMVEAR, Valganciclovir
Open
clinicaltrials
Supports: aliases, allCompanies, indications, stage, status, route, populationTags, geography...
IDs: NCT01655212, CONCERT, Valganciclovir
Open
Key Events
Clinical Trials (5)
Data Checks
generic-drug-study-clusternot-industry-sponsored-pipeline-programplacebo-arm-collapsedindustry-collaborator-not-primary-sponsorregistry-status-may-be-stale
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