This page shows what was measured, who it was measured in, and what that does not settle.
What Valganciclovir does in the body
CMV retinitis
4) ] . Mechanism of Action: Valganciclovir is an L-valyl ester (prodrug) of ganciclovir that exists as a mixture of two diastereomers. After oral administration, both diastereomers are rapidly converted to ganciclovir by intestinal and hepatic esterases. Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, which inhibits replication of human CMV in cell culture and in vivo. In CMV-infected cells, ganciclovir is initially phosphorylated to ganciclovir monophosphate by the viral protein kinase, pUL97.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
Its recorded molecular formula is C14H22N6O5·HCl.
US prescribing information · 2e8a4d62-2098-4ffe-a154-e45cfdfe6c4c · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 86 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Percentage of Participants With Adjudicated Cytomegalovirus (CMV) Disease Through 52 Weeks Post-transplant
✗ The study did not show it
Who was studied
NCT03443869
How many people
601
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Mortality
✗ The study did not show it
Who was studied
NCT03915366
How many people
563
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Number of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribose Nucleic Acid (DNA) at the End of Study Week 8
✗ The study did not show it
Who was studied
NCT02927067
How many people
553
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Valganciclovir in Patients With CMV Retinitis and AIDS Who Cannot Take Drugs by Injection
✗ The study did not show it
Who was studied
NCT00017784
How many people
500
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Incidence of endpoint committee (EC)-confirmed CMV disease (either syndrome or end-organ) by 1-year post-transplant.
✗ The study did not show it
Who was studied
NCT06798909
How many people
360
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Percentage of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (CMV Viremia Clearance) at End of Week 8
✗ The study did not show it
Who was studied
NCT02931539
How many people
352
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
& USAGE Valganciclovir tablets, USP are a cytomegalovirus (CMV) nucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients ( 1.1 ) • Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). • Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and efficacy of valganciclovir for oral solution and tablets have not been established in children for prevention of CMV disease in pediatric liver transplant patients, in kidney transplant patients less than 4 months of age, in heart transplant patients less than 1 month of age, in pediatric AIDS patients with CMV retinitis, and in infants with congenital CMV infection.”
US prescribing information · 2e8a4d62-2098-4ffe-a154-e45cfdfe6c4c · read 2026-08-30
On older people, the label states: “Clinical studies of valganciclovir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”
US prescribing information · 2e8a4d62-2098-4ffe-a154-e45cfdfe6c4c · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary After oral administration, valganciclovir (prodrug) is converted to ganciclovir (active drug) and, therefore, valganciclovir is expected to have reproductive toxicity effects similar to ganciclovir.”
US prescribing information · 2e8a4d62-2098-4ffe-a154-e45cfdfe6c4c · read 2026-08-30
On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential Pregnancy Testing Females of reproductive potential should undergo pregnancy testing before initiation of valganciclovir [see Use in Specific Populations ( 8.1 )] .”
US prescribing information · 2e8a4d62-2098-4ffe-a154-e45cfdfe6c4c · read 2026-08-30
On people with reduced liver function, the label states: “The safety and efficacy of valganciclovir have not been studied in patients with hepatic impairment.”
US prescribing information · 2e8a4d62-2098-4ffe-a154-e45cfdfe6c4c · read 2026-08-30
On people with reduced kidney function, the label states: “Dose reduction is recommended when administering valganciclovir to patients with renal impairment [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.2 ), Clinical Pharmacology ( 12.3 )] .”
US prescribing information · 2e8a4d62-2098-4ffe-a154-e45cfdfe6c4c · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S3, S6.
No source is stored against this line.
What is in the pack
Sold as tablet, for solution, tablet, film coated, powder, for solution, given by the oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
45 products list this as an active ingredient in the United States drug directory. 45 of them contain it and nothing else.
FDA National Drug Code directory · 50268-787 · read 2026-08-29
They are sold as for solution, powder, powder, for solution, tablet and tablet, film coated, taken oral.
FDA National Drug Code directory · 50268-787 · read 2026-08-29
The regulator's established pharmacologic class for it is cytomegalovirus nucleoside analog dna polymerase inhibitor [epc], dna polymerase inhibitors [moa] and nucleoside analog antiviral [epc].
FDA National Drug Code directory · 50268-787 · read 2026-08-29
26 published labels name it as an active ingredient. 26 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 2e8a4d62-2098-4ffe-a154-e45cfdfe6c4c · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 2e8a4d62-2098-4ffe-a154-e45cfdfe6c4c · read 2026-08-29
VALGANCICLOVIR is oral at 3 DOSAGE FORMS AND STRENGTHS • Valganciclovir for oral solution: 50 mg per mL, supplied as a white to slightly yellow powder for constitution, forming a colorless to brownish yellow tutti-frutti flavored solution., recorded as fda label in effect 2024-04-11 in the United States.
US prescribing information · 2e8a4d62-2098-4ffe-a154-e45cfdfe6c4c · read 2026-08-30
Recorded price in US: 0.98978 USD per one millilitre, across 10 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Recorded price in US: 2.01508 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 15 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Valganciclovir studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Valganciclovir are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
◇Read from sources, not yet reviewed
No traced study record is stored for this substance.
Built from stored sources by fixed rules. No reviewer has signed it off.
How many documents were read
25 documents were read for this substance.
RNAWiki source record
25 of them state the same halfLife, and they agree.
RNAWiki source record
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S3, S6.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
20 approved applications cover products containing this substance. The earliest was NDA021304, approved 20010329 to CHEPLAPHARM.
This order is fixed in code and does not count clicks or time on the page.
What is not here
9 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (10)
Q2
On the Valganciclovir label: indicated for what?
"Valganciclovir tablet is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients (1.1) Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.": indications and usage on Valganciclovir's label. DailyMed label · 4db6dd63-e56b-45a4-86b2-ee125a1854a0 · 2026-06-24
Q3
91 registered trials of Valganciclovir — at which phases?
Registered studies posting no result
62 of 91
91 registered studies of Valganciclovir: 31 phase2, 28 phase3, 14 phase4, 11 phase1, 8 na, 7 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"difficulty to include patients"; 15 of 91 registered studies
Show the evidence
Trial
NCT00237653
terminated; "difficulty to include patients"
NCT00241345
terminated; "Due to low accrual"
NCT00275314
terminated; "Study never started at our site Funding issue"
NCT00361933
withdrawn; "Research never begun."
NCT01655212
terminated; "1 Indication for further investigations (brain ultrasound). 2 Change of study design to efficacy study with historical control group."
NCT02188719
terminated; "The trial could not be completed within the grant timeline."
9 further recorded trials
NCT02409147
withdrawn; "Lack of funding"
NCT02439957
terminated; "Study terminated early due to results from another CMX001 study."
NCT02439970
terminated; "Study was terminated early due to results from another CMX001 study"
NCT02606266
terminated; "No eligibles patients"
NCT03107871
terminated; "Study sponsor closed trial due to slow enrollment."
NCT03301415
terminated; "Safety signal"
NCT03586284
terminated; "Funding discontinued."
NCT04064697
terminated; "low of inclusions"
NCT05166577
terminated; "Sponsor Decision"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Valganciclovir used Oral valganciclovir (Rovalcyte 50 mg/ml, powder for oral suspension) — over how long?
studies of Valganciclovir used the recorded amount. ClinicalTrials.gov · 2026-09-01
2 recorded entries; human; oral; also "Oral valganciclovir (Rovalcyte 50 mg/ml, powder for oral suspension)", "Valganciclovir 450 mg"
Show the evidence
human
NCT02606266
oral; Oral valganciclovir (Rovalcyte 50 mg/ml, powder for oral suspension)
NCT04116411
Valganciclovir 450 mg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Valganciclovir's half-life is 0-24 h — which schedules were studied?
0-24 h, the half-life Valganciclovir's label states: "PK parameter N Value (Mean ± SD) AUC 0-24h (mcg∙h/mL) 57 29.1 ± 9.7 C max (mcg/mL) 58 5.61 ± 1.52 Absolute oral bioavailability (%) 32 59.4 ± 6.1 Elimination half-life (hr) 73 4.08 ± 0.76 Renal clearance (mL/min/kg) 20 3.21 ± 0.75 (1 study, n=20) The systemic ganciclovir exposures attained following administration of…" DailyMed label · 4db6dd63-e56b-45a4-86b2-ee125a1854a0 · 2026-06-24
tmax 1.7 h.
Show the evidence
half lifepharmacokinetics
0-24 h; PK parameter N Value (Mean ± SD) AUC 0-24h (mcg∙h/mL) 57 29.1 ± 9.7 C max (mcg/mL) 58 5.61 ± 1.52 Absolute oral bioavailability (%) 32 59.4 ± 6.1 Elimination half-life (hr) 73 4.08 ± 0.76 Renal clearance (mL/min/kg) 20 3.21 ± 0.75 (1 study, n=20) The systemic ganciclovir exposures attained following administration of 900 mg valganciclovir tablets once daily were comparable across kidney, heart…
tmaxpharmacokinetics
1.7 h; Valganciclovir Ganciclovir Absorption T max (h) median (min-max) (fed conditions) 2.18 1.7h to 3.0h Food effect (high fat meal/fasting): PK parameter ratio and 90% confidence interval Steady state ganciclovir PK was assessed after administration of valganciclovir tablets (875 mg once daily) were administered with a high fat meal containing approximately 600 total calories (31.1 g fat, 51.6 g…
metabolismpharmacokinetics
Absorption, Distribution, Metabolism, and Excretion The pharmacokinetic (PK) properties of valganciclovir are provided in Table 12.
recorded 2026-06-24 · last checked 2026-09-04
Q7
Which running trial of Valganciclovir could settle lifespan?
NCT04116411 measures Impact of valganciclovir on median overall survival of glioblastoma patients, reading out 2027-09-16.
2 open trials; n 220; "A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients"
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Trial
NCT04116411
"A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients"; n 220; "Impact of valganciclovir on median overall survival of glioblastoma patients"; 2027-09-16
NCT05708755
"CMV Immunity Monitoring in Lung Transplant Recipients"; n 50; "CMV Viremia-Free Survival"; 2028-05
Q8
Which 25 trials of Valganciclovir posted no result?
Posted no result
25 of 25 completed trials
Registrations
NCT00002377, NCT00194467, NCT00374686, NCT00006145, NCT00562770 and NCT00217503, and 19 more
Completion dates
oldest 2002-12; newest 2023-05-29
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Trial
NCT00002377
2002-12
NCT00194467
2005-03
NCT00374686
2005-09
NCT00006145
2006-02
NCT00562770
2006-07
NCT00217503
2007-06
14 further recorded trials
NCT00031434
2007-07
NCT00275665
2007-07
NCT00189150
2007-08
NCT00478465
2007-08
NCT00016068
2007-09
NCT00400322
2008-06
NCT00730769
2008-07
NCT00386412
2009-09
NCT00034385
2009-10-30
NCT00330018
2010-04
NCT02296723
2011-08
NCT02297854
2011-08
NCT00947141
2013-02
NCT01255644
2015-07
Q9
At the median, Valganciclovir's trials enrolled 42 people — anything larger?
Median enrolment
42
Largest enrolment
5000
Registered trials counted
89
Q10
What do 2189 spontaneous reports say about Valganciclovir — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Valganciclovir appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2189 reaction mentions were counted: cytomegalovirus infection 464; neutropenia 359; leukopenia 257; drug resistance 249. FAERS via Open Targets · CHEMBL1200454 · 2026-06-24
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cytomegalovirus infection
464
neutropenia
359
leukopenia
257
drug resistance
249
cytomegalovirus viraemia
204
pathogen resistance
151
4 more recorded rows
pancytopenia
149
thrombocytopenia
137
anaemia
121
acute kidney injury
98
recorded 2026-06-24 · last checked 2026-09-04
Q11
Which 10 reactions does Valganciclovir's label not list?
ChEMBL 37 — CC BY-SA 3.0 Unported · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
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