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Ganciclovir

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Ganciclovir does in the body

Cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) [see

4) ] . Mechanism of Action 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. Further phosphorylation occurs by cellular kinases to produce ganciclovir triphosphate, which is then slowly metabolized intracellularly. As the phosphorylation is largely dependent on the viral kinase, phosphorylation of ganciclovir occurs preferentially in virus-infected cells.

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

  • The substance registry classes this as chemical.

    FDA substance registry · P9G3CKZ4P5 · read 2026-08-29

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 102 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 peopleRead 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.

The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV

The study did not show it

Who was studied
NCT00001034
How many people
850
Study design
Phase 2
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. Injection

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

A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus

The study did not show it

Who was studied
NCT00002095
How many people
700
Study design
Not applicable
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. Injection

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 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. Injection

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. Injection

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. Injection

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

Morbidity

The study did not show it

Who was studied
NCT00001082
How many people
505
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. Injection

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 unclearRead 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.

  • Ganciclovir for Injection, USP is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the: treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). ( 1.1 ) prevention of CMV disease in adult transplant recipients at risk for CMV disease.

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: “Safety and efficacy of Ganciclovir Injection Safety and efficacy of Ganciclovir Injection have not been established in pediatric patients.”

    US prescribing information · 3059c2da-d4a7-4aea-828c-20e671cb875c · read 2026-08-30

  • On older people, the label states: “Clinical studies of Ganciclovir Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”

    US prescribing information · 3059c2da-d4a7-4aea-828c-20e671cb875c · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary In animal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures two times the exposure at the recommended human dose (RHD) [see Data] .”

    US prescribing information · 3059c2da-d4a7-4aea-828c-20e671cb875c · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary No data are available regarding the presence of ganciclovir in human milk, the effects on the breastfed infant, or the effects on milk production.”

    US prescribing information · 3059c2da-d4a7-4aea-828c-20e671cb875c · read 2026-08-30

  • On people with reduced liver function, the label states: “The safety and efficacy of Ganciclovir Injection have not been studied in patients with hepatic impairment.”

    US prescribing information · 3059c2da-d4a7-4aea-828c-20e671cb875c · read 2026-08-30

  • On people with reduced kidney function, the label states: “Dose reduction is recommended when administering Ganciclovir Injection to patients with renal impairment Dose reduction is recommended when administering Ganciclovir Injection to patients with renal impairment [see Dosage and Administration (2.5) , and Warnings and Precautions (5.2) ] .”

    US prescribing information · 3059c2da-d4a7-4aea-828c-20e671cb875c · 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 takeRead 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 takeRead 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

Injection

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 injectable, capsule, gel, solution, given by the injection, oral, ophthalmic 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 takeNothing 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 unclearRead 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

Injection

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

  • 12 products list this as an active ingredient in the United States drug directory. 12 of them contain it and nothing else.

    FDA National Drug Code directory · 12869-803 · read 2026-08-29

  • They are sold as gel, injection, injection, powder, lyophilized, for solution, injection, solution and powder, taken intravenous and ophthalmic.

    FDA National Drug Code directory · 12869-803 · 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 · 12869-803 · read 2026-08-29

  • 9 published labels name it as an active ingredient. 9 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · ea25e7ac-7a93-4ec8-975b-2cec197e1c27 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · ea25e7ac-7a93-4ec8-975b-2cec197e1c27 · read 2026-08-29

  • Ganciclovir is intravenous at 3 DOSAGE FORMS AND STRENGTHS For injection: Single-dose vial containing 500 mg of ganciclovir as a sterile solution for intravenous use For injection: Single dose vial containing 500 mg of ganciclovir as a sterile solut…, recorded as fda label in effect 2022-12-21 in the United States.

    US prescribing information · 3059c2da-d4a7-4aea-828c-20e671cb875c · read 2026-08-30

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 takeRead 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 Ganciclovir 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 unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

How much did people take in the studies?

The sources RNAWiki checked hold nothing for this field.

Why it matters. A result belongs to an amount. Without the amount the result floats free.

What would answer it

A stored source that records 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 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 Ganciclovir 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 peopleRead 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.

How many documents were read

  • 9 documents were read for this substance.

    RNAWiki source record

  • 8 of them state the same halfLife, and they agree.

    RNAWiki source record

  • 8 of them state the same volumeOfDistribution, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
P9G3CKZ4P5
CAS registry number
82410-32-0
PubChem compound
135398740
ChEMBL
CHEMBL182
ChEBI
465284
WHO international nonproprietary name list entry
6023
RxNorm concept
4678
EMA substance identifier
100000085455
DrugBank
DB01004

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 unclearRead 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.

  1. Withdrawn, in European Union; no reason is published (EMA Medicine.csv)

What the approval register records

  • 14 approved applications cover products containing this substance. The earliest was NDA019661, approved 19890623 to CHEPLAPHARM.

    Drugs@FDA application register · NDA019661 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA019661 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20030422.

    FDA National Drug Code directory · 12869-803 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

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 (9)

On the Ganciclovir label: indicated for what?


"Ganciclovir for Injection is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the: • treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). ( 1.1 ) • prevention of CMV disease in adult transplant…": indications and usage on Ganciclovir's label. DailyMed label · 35addab5-09db-4f8a-9c69-6fbce33ecc37 · 2026-01-09

96 registered trials of Ganciclovir — at which phases?


Registered studies posting no result
83 of 96

96 registered studies of Ganciclovir: 26 na, 20 phase1, 20 phase2, 19 phase3, 8 phase4, 7 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

520 with a PubMed record

Show the evidence
  • na
    26
  • phase1
    20
  • phase2
    20
  • phase3
    19
  • phase4
    8
  • na or unstated
    7
7 more recorded rows
  • completed
    71
  • unknown
    11
  • terminated
    7
  • recruiting
    3
  • not yet recruiting
    2
  • active not recruiting
    1
  • withdrawn
    1

recorded 2026-09-01 · last checked 2026-09-04

5 of Ganciclovir's trials stopped: futility/efficacy, accrual/recruitment, funding/business, other?


futility/efficacy (1), accrual/recruitment (2), funding/business (1) and other (1): Ganciclovir's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Due to low accrual"; 5 of 96 registered studies

Show the evidence

Trial

  • NCT00241345
    terminated; "Due to low accrual"
  • NCT02188719
    terminated; "The trial could not be completed within the grant timeline."
  • NCT02382588
    terminated; "There were difficulties meeting the enrollment goal within stipulated time frames."
  • NCT03586284
    terminated; "Funding discontinued."
  • NCT04706507
    terminated; "due to increased mortality and futility analyses"

recorded 2026-09-01 · last checked 2026-09-04

Ganciclovir's half-life is 3.5 ± 0.9 hours — which schedules were studied?


3.5 ± 0.9 hours, the half-life Ganciclovir's label states: "Half-life was 3.5 ± 0.9 hours (n=98) following intravenous administration." DailyMed label · 35addab5-09db-4f8a-9c69-6fbce33ecc37 · 2026-01-09

Show the evidence
  • half life pharmacokinetics
    3.5 ± 0.9 hours; Half-life was 3.5 ± 0.9 hours (n=98) following intravenous administration.
  • metabolism clinical_pharmacology
    Further phosphorylation occurs by cellular kinases to produce ganciclovir triphosphate, which is then slowly metabolized intracellularly.

recorded 2026-01-09 · last checked 2026-09-04

Which 37 trials of Ganciclovir posted no result?


Posted no result
37 of 37 completed trials
Registrations
NCT00000995, NCT00000989, NCT00000673, NCT00000970, NCT00000668 and NCT00001034, and 31 more
Completion dates
oldest 1990-02; newest 2024-04-11
Show the evidence

Trial

  • NCT00000995
    1990-02
  • NCT00000989
    1992-07
  • NCT00000673
    1993-05
  • NCT00000970
    1993-06
  • NCT00000668
    1995-02
  • NCT00001034
    1995-08
14 further recorded trials
  • NCT00001062
    1998-01
  • NCT00000805
    1998-03
  • NCT00001061
    1998-03
  • NCT00000768
    1998-08
  • NCT00006340
    2000-07
  • NCT00002377
    2002-12
  • NCT00006264
    2003-07
  • NCT00373165
    2003-10
  • NCT00006480
    2005-03
  • NCT00001100
    2005-11
  • NCT00023231
    2006-08
  • NCT00217503
    2007-06
  • NCT00031434
    2007-07
  • NCT00716911
    2007-07

At the median, Ganciclovir's trials enrolled 100 people — anything larger?


Median enrolment
100
Largest enrolment
5000
Registered trials counted
79

What do 1408 spontaneous reports say about Ganciclovir — 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.

Ganciclovir appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1408 reaction mentions were counted: drug resistance 293; cytomegalovirus infection 270; neutropenia 166; pathogen resistance 150. FAERS via Open Targets · CHEMBL1200850 · 2026-06-24

Show the evidence
  • drug resistance
    293
  • cytomegalovirus infection
    270
  • neutropenia
    166
  • pathogen resistance
    150
  • cytomegalovirus viraemia
    124
  • pancytopenia
    98
4 more recorded rows
  • renal impairment
    86
  • thrombocytopenia
    76
  • end stage renal disease
    75
  • leukopenia
    70

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Ganciclovir's label not list?


cytomegalovirus infection, cytomegalovirus viraemia and drug resistance and 7 more reported for Ganciclovir, absent from its label. FAERS via Open Targets · CHEMBL1200850 · 2026-06-24

2 label terms; 10 reported and unlisted; 35addab5-09db-4f8a-9c69-6fbce33ecc37

Show the evidence
  • cytomegalovirus infection
    count not stated
  • cytomegalovirus viraemia
    count not stated
  • drug resistance
    count not stated
  • end stage renal disease
    count not stated
  • leukopenia
    count not stated
  • neutropenia
    count not stated
4 more recorded rows
  • pancytopenia
    count not stated
  • pathogen resistance
    count not stated
  • renal impairment
    count not stated
  • thrombocytopenia
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Where do the label and the trials disagree about Ganciclovir?


"withdrawn" against "approved": withdrawal status vs register status for Ganciclovir.

EMA_MEDICINE_REGISTER, Drugs@FDA; 1 recorded pair

Show the evidence
  • EMA_MEDICINE_REGISTER EMEA/H/C/000120
    withdrawn; 2026-09-04
  • Drugs@FDA ANDA076222
    approved; 2026-08-28
Where it is registered

Where it’s registered

Withdrawn, in European Union; no reason is published (EMA Medicine.csv)

Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1200850
PubChem CID
23700083
CAS number
107910-75-8
RxCUI
82131
InChIKey
IRSCQMHQWWYFCW-UHFFFAOYSA-N
Also called
GANCICLOVIR SODIUM, Cytovene iv, Gancyclovir, dhpg, gcv, valganciclovir, 6H-PURIN-6-ONE, 2-AMINO-1,9-DIHYDRO-9-((2-HYDROXY-1-(HYDROXYMETHYL)ETHOXY)METHYL)-, MONOSODIUM SALT, 9-[[2-Hydroxy-1-(hydroxymethyl)ethoxy]methyl]guanine, monosodium salt, GANCICLOVIR (AS SODIUM) [VANDF], GANCICLOVIR SODIUM SALT [MI], GANCICLOVIR SODIUM [MART.], GANCICLOVIR SODIUM [ORANGE BOOK]
Trade name
Cytovene, Cymevene, Ganzyk-rtu, Virgan, Vitrasert, Vitrasert implant, Zirgan, Cytovene / Zirgan / Ganzyk-Rtu / Vitrasert
Salt form
Ganciclovir sodium salt, RS-21592 SODIUM, Valganciclovir hydrochloride impurity a
Development code
BW 759U, NSC-759656, RS-21592
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ClinicalTrials.gov — US Government work · EMA medicine register · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • 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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