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Levoleucovorin

  • Prescription medicine
  • Given by a clinician
  • 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 Levoleucovorin does in the body

Cerebral folate transport deficiency

From the FDA-approved label: High-Dose Methotrexate Therapy Leucovorin is a mixture of the diastereoisomers of the 5-formyl derivative of tetrahydrofolic acid (THF). The biologically active compound of the mixture is the (-)- l isomer, known as Citrovorum factor or (-)-folinic acid. Leucovorin does not require reduction by the enzyme dihydrofolate reductase in order to participate in reactions utilizing folates as a source of "one-carbon" moieties. l -Leucovorin (l-5 formyltetrahydrofolate) is rapidly metabolized (via 5, 10-methenyltetrahydrofolate then 5, 10-methylenetetrahydrofolate) to l -5-methyltetrahydrofolate.

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
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • The supplement label database classes it as botanical, under the name Leucovorin.

    NIH Dietary Supplement Label Database · 1397 · read 2026-08-29

  • 6 registered substances share the start of this name, which is why a search for it can return more than one thing.

    FDA substance registry · 990S25980Y · 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 97 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.

Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization

The study did not show it

Who was studied
NCT01190930
How many people
9350
Study design
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. Intramuscular, intravenous

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

Disease free survival (DFS) in randomization eligible patients with higher risk features (SR-High) or standard risk average (SR-Avg) B-ALL patients based on randomization with addition of blinatumomab

The study did not show it

Who was studied
NCT03914625
How many people
6720
Study design
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. Intramuscular, intravenous

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

Post-induction 5-year event-free survival (EFS)

The study did not show it

Who was studied
NCT03959085
How many people
5951
Study design
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. Intramuscular, intravenous

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

DFS of Non-DS HR Post-induction Patients Receiving Intrathecal (IT) Methotrexate (MTX) Compared With Patients Receiving Intrathecal Triple Therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) Interim Maintenance High-dose Methotrexate Backbone

The study did not show it

Who was studied
NCT02883049
How many people
5949
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. Intramuscular, intravenous

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

Event-free Survival (EFS) for SR-Average ALL Patients

The study did not show it

Who was studied
NCT00103285
How many people
5377
Study design
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. Intramuscular, intravenous

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

Disease-free survival

The study did not show it

Who was studied
NCT00764907
How many people
4000
Study design
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. Intramuscular, intravenous

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.

  • Leucovorin is a folate analog indicated: To reduce the toxicity of: Methotrexate in adult patients with impaired methotrexate elimination, and Folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients.

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 effectiveness of leucovorin have not been established to reduce the toxicity of methotrexate in pediatric patients with impaired methotrexate elimination or in pediatric patients to reduce the toxicity of folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose.”

    US prescribing information · c8102043-79f2-421a-b849-94bac19007a6 · read 2026-08-30

  • On older people, the label states: “There is insufficient information in patients 65 years of age and older on the use of leucovorin to reduce the toxicity of methotrexate, other folic acid antagonists, or DHFR inhibitors, and there is no information on the use of leucovorin to treat FOLR1-CFTD in patients 65 years of age and older to determine whether they respond differently from younger patients [see Clinical Studies (14.1) ] .”

    US prescribing information · c8102043-79f2-421a-b849-94bac19007a6 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Available data on the intermittent use of leucovorin for the treatment of folic acid antagonist or DHFR inhibitor toxicity during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.”

    US prescribing information · c8102043-79f2-421a-b849-94bac19007a6 · read 2026-08-30

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

    US prescribing information · c8102043-79f2-421a-b849-94bac19007a6 · 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

Given by a clinician

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

Intramuscular, intravenous

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

RNAWiki has not recorded a supervision or regulatory status for this substance.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

No register row and no identity class settled the question.

No source is stored against this line.

What is in the pack

Sold as solution, injectable, injectable, tablet, given by the intramuscular, intravenous, injection, injection 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

Intramuscular, intravenous

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

  • 83 products list this as an active ingredient in the United States drug directory. 81 of them contain it and nothing else.

    FDA National Drug Code directory · 83831-149 · read 2026-08-29

  • They are sold as capsule, capsule, delayed release pellets, injection, injection, powder, lyophilized, for solution, injection, powder, lyophilized, for suspension and powder, taken intramuscular, intravenous and oral.

    FDA National Drug Code directory · 83831-149 · read 2026-08-29

  • The regulator's established pharmacologic class for it is folate analog [epc] and folic acid [cs].

    FDA National Drug Code directory · 83831-149 · read 2026-08-29

  • 28 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 · ab691d4e-e0d1-4ba1-9c7a-1cdcfcc3c17c · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · ab691d4e-e0d1-4ba1-9c7a-1cdcfcc3c17c · read 2026-08-29

  • 480 marketed supplement labels list this ingredient, classed as botanical with nutrients, multi-vitamin and mineral (mvm) and other combinations.

    NIH Dietary Supplement Label Database · 15601 · read 2026-08-29

  • Those labels carry all other, nutrient and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.

    NIH Dietary Supplement Label Database · 15601 · read 2026-08-29

  • LEUCOVORIN CALCIUM is oral at 3 DOSAGE FORMS AND STRENGTHS Leucovorin calcium tablets: 5 mg tablets are supplied as a white to off-white to pale yellow, round tablet; scored on one side and "LP" over "184" debossed on the other side; bottles of 30 (…, recorded as fda label in effect 2026-03-27 in the United States.

    US prescribing information · c8102043-79f2-421a-b849-94bac19007a6 · read 2026-08-30

  • Recorded price in US: 0.34304–2.0009 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 31 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 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.

RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.

Questions worth asking

  • Which of the trials of Levoleucovorin 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 Levoleucovorin 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.

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

  • 24 documents were read for this substance.

    RNAWiki source record

  • 23 of them state the same bioavailability, 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

  • Not passed

    Safety mode resolved

    No register row and no identity class settled the question.

  • 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.

What the approval register records

  • 59 approved applications cover products containing this substance. The earliest was NDA008107, approved 19520620 to HOSPIRA.

    Drugs@FDA application register · NDA008107 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA008107 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19830601.

    FDA National Drug Code directory · 83831-149 · 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 Levoleucovorin label: indicated for what?


"Leucovorin calcium tablets are a folate analog indicated: To reduce the toxicity of: Methotrexate in adult patients with impaired methotrexate elimination, and Folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. ( 1.1 ) For the treatment of cerebral folate…": indications and usage on Levoleucovorin's label. DailyMed label · 94669fc8-3c1c-4228-be27-09a1cd468c36 · 2026-03-31

958 registered trials of Levoleucovorin — at which phases?


Registered studies posting no result
707 of 958

958 registered studies of Levoleucovorin: 539 phase2, 245 phase1, 229 phase3, 31 na, 8 early phase1, 5 phase4, 4 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

2372 with a PubMed record

Show the evidence
  • phase2
    539
  • phase1
    245
  • phase3
    229
  • na
    31
  • early phase1
    8
  • phase4
    5
11 more recorded rows
  • na or unstated
    4
  • completed
    481
  • terminated
    121
  • recruiting
    103
  • unknown
    100
  • active not recruiting
    78
  • withdrawn
    50
  • not yet recruiting
    22
  • approved for marketing
    1
  • enrolling by invitation
    1
  • suspended
    1

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

143 of Levoleucovorin's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (7), futility/efficacy (7), accrual/recruitment (52), funding/business (12), sponsor decision unspecified (8) and other (57): Levoleucovorin's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"The study was stopped before reaching its accrual goal due to slow accrual"; 143 of 958 registered studies

Show the evidence

Trial

  • NCT00002525
    terminated; "The study was stopped before reaching its accrual goal due to slow accrual"
  • NCT00004099
    terminated; "low accrual"
  • NCT00004897
    terminated; "Institutional Review Board requested termination - all patients deceased and no new accrual."
  • NCT00005608
    terminated; "Drug was pulled from the market."
  • NCT00005641
    terminated; "low study accrual"
  • NCT00005944
    terminated; "insuffisient recruitment"
14 further recorded trials
  • NCT00006015
    terminated; "lack of sufficient accrual"
  • NCT00023868
    terminated; "redesign"
  • NCT00043004
    terminated; "low accrual"
  • NCT00052585
    terminated; "Administratively complete."
  • NCT00070122
    terminated; "Administratively complete."
  • NCT00070434
    withdrawn; "poor accrual"
  • NCT00077233
    terminated; "Poor accrual"
  • NCT00126191
    terminated; "closed due to slow accrual"
  • NCT00155883
    terminated; "slow a accrul due to many competitive trials."
  • NCT00227617
    terminated; "Low accrual"
  • NCT00262925
    terminated; "slow accrual"
  • NCT00275106
    terminated; "Withdrawn due to an excess of toxic deaths"
  • NCT00303628
    terminated; "The study was terminated before reaching its accrual goal due to slow accrual."
  • NCT00335140
    terminated; "slow accrual"

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

Levoleucovorin's half-life is 0.5-1.3 hours — which schedules were studied?


0.5-1.3 hours, the half-life Levoleucovorin's label states: "Elimination After intravenous administration of leucovorin in adults, the reported mean plasma elimination half-life in the literature was 0.5-1.3 hours for levoleucovorin and 3-7 hours for 5-MTHF." DailyMed label · 94669fc8-3c1c-4228-be27-09a1cd468c36 · 2026-03-31

bioavailability 97 %.

Show the evidence
  • half life pharmacokinetics
    0.5-1.3 hours; Elimination After intravenous administration of leucovorin in adults, the reported mean plasma elimination half-life in the literature was 0.5-1.3 hours for levoleucovorin and 3-7 hours for 5-MTHF.
  • bioavailability pharmacokinetics
    97 %; Absorption Following oral administration of leucovorin in adults, the apparent bioavailability of levoleucovorin is 97% for 25 mg, 75% for 50 mg, and 37% for 100 mg, and dextroleucovorin is approximately 19% for 25 mg, 20% for 50 mg, and 7% for 100 mg.
  • metabolism pharmacokinetics
    Metabolism: Following administration of oral leucovorin, levoleucovorin undergoes metabolism in intestinal cells via methenyltetrahydrofolate synthetase (MTHFS) and methylenetetrahydrofolate reductase (MTHFR) to its active metabolite, 5-MTHF.

recorded 2026-03-31 · last checked 2026-09-04

Which running trial of Levoleucovorin could settle lifespan?


NCT04821284 measures Progression-free survival, reading out 2026-02-28.

69 open trials; n 120; "Sonoporation and Chemotherapy for the Treatment of Pancreatic Cancer"

Show the evidence

Trial

  • NCT04821284
    "Sonoporation and Chemotherapy for the Treatment of Pancreatic Cancer"; n 120; "Progression-free survival"; 2026-02-28
  • NCT04390399
    "Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer"; n 328; "Progression Free Survival (PFS)"; 2026-05-31
  • NCT04094688
    "Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer"; n 455; "Progression-free Survival (PFS)"; 2026-07-01
  • NCT05568095
    "A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body"; n 1040; "Overall survival"; 2026-08
  • NCT02101853
    "Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia"; n 669; "Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients"; 2026-09-16
  • NCT02112916
    "Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma"; n 847; "Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients"; 2026-09-16
14 further recorded trials
  • NCT05564403
    "Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)"; n 66; "Overall survival (OS)"; 2026-10-01
  • NCT02008656
    "Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management"; n 358; "disease-free survival (DFS)"; 2026-11
  • NCT04762953
    "Study of Sequential Systemic Therapy + Intraperitoneal Paclitaxel in Gastric/GEJ Peritoneal Carcinomatosis"; n 40; "Participants with Progression Free Survival at 1-Year"; 2026-12
  • NCT04776655
    "Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB"; n 280; "Progression free survival (PFS) in patients with RASmut at liquid biopsy and RASwt on tissue."; 2026-12
  • NCT03764553
    "Liposomal iRInotecan, Carboplatin or oXaliplatin for Esophagogastric Cancer"; n 320; "Progression free survival"; 2026-12-01
  • NCT02912559
    "Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair"; n 712; "Disease Free Survival (DFS)"; 2026-12-18
  • NCT03303495
    "A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC"; n 280; "Progression-free survival (PFS)"; 2026-12-31
  • NCT04233866
    "Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread"; n 176; "Overall survival (OS)"; 2026-12-31
  • NCT00792948
    "Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia"; n 97; "Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation"; 2027-01-06
  • NCT02003222
    "Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia"; n 488; "Overall Survival (OS) Among Patients Who Were MRD Negative After Induction and Intensification Chemotherapy"; 2027-02-25
  • NCT05062317
    "ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases"; n 120; "To establish the 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy"; 2027-02-28
  • NCT04008030
    "A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)"; n 839; "Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm A All Lines Centrally Confirmed MSI-H/dMMR"; 2027-03-23
  • NCT06210360
    "Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX"; n 134; "2-year Overall Survival Rate"; 2027-04-01
  • NCT04447352
    "HIPEC + FLOT vs. FLOT Alone in Patients With Gastric Cancer and GEJ (PREVENT)"; n 200; "Comparison of progression-/disease-free survival (PFS/DFS) between arms"; 2027-05-01

Which 239 trials of Levoleucovorin posted no result?


Posted no result
239 of 239 completed trials
Registrations
NCT00000998, NCT00000703, NCT00000689, NCT00001013, NCT00001014 and NCT00000674, and 233 more
Completion dates
oldest 1989-04; newest 2024-08-27
Show the evidence

Trial

  • NCT00000998
    1989-04
  • NCT00000703
    1990-03
  • NCT00000689
    1991-03
  • NCT00001013
    1991-09
  • NCT00001014
    1991-09
  • NCT00000674
    1992-08
14 further recorded trials
  • NCT00000643
    1994-05
  • NCT00000973
    1995-03
  • NCT00000658
    1996-02
  • NCT00000794
    1998-04
  • NCT00003776
    2000-03
  • NCT00001449
    2000-04
  • NCT00002691
    2000-06
  • NCT00001498
    2000-12
  • NCT00002783
    2001-01
  • NCT00001579
    2001-03
  • NCT00002865
    2001-08
  • NCT00001576
    2002-03
  • NCT00019760
    2002-03
  • NCT00005988
    2002-03-08

At the median, Levoleucovorin's trials enrolled 66 people — anything larger?


Median enrolment
66
Largest enrolment
9350
Registered trials counted
885

What do 5675 spontaneous reports say about Levoleucovorin — 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.

Levoleucovorin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 5675 reaction mentions were counted: diarrhoea 1089; neutropenia 890; vomiting 679; pyrexia 571. FAERS via Open Targets · CHEMBL1908361 · 2026-06-24

Show the evidence
  • diarrhoea
    1089
  • neutropenia
    890
  • vomiting
    679
  • pyrexia
    571
  • febrile neutropenia
    544
  • neuropathy peripheral
    423
4 more recorded rows
  • thrombocytopenia
    410
  • abdominal pain
    377
  • disease progression
    357
  • dehydration
    335

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

Which 10 reactions does Levoleucovorin's label not list?


abdominal pain, dehydration and diarrhoea and 7 more reported for Levoleucovorin, absent from its label. FAERS via Open Targets · CHEMBL1908361 · 2026-06-24

3 label terms; 10 reported and unlisted; 54f01988-aac2-4b0e-9d20-b7f621a0cd50

Show the evidence
  • abdominal pain
    count not stated
  • dehydration
    count not stated
  • diarrhoea
    count not stated
  • disease progression
    count not stated
  • febrile neutropenia
    count not stated
  • neuropathy peripheral
    count not stated
4 more recorded rows
  • neutropenia
    count not stated
  • pyrexia
    count not stated
  • thrombocytopenia
    count not stated
  • vomiting
    count not stated

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1908361
PubChem CID
101641675
CAS number
80433-71-2
RxCUI
979509
InChIKey
VVIAGPKUTFNRDU-STQMWFEESA-N
Also called
Levofolinato de calcio, l-lv, leucovorin, Levofolene, LEVOLEUCOVORIN CALCIUM, Elvorine, Isovorin, Levofolinic acid, L-folinic acid, folinic acid, (-)-5-FORMYL-(6S)-TETRAHYDROFOLATE CALCIUM SALT, CALCIUM LEVOFOLINATE [MART.]
Salt form
leucovorin calcium, Calcium (6s)-folinate, Calcium levofolinate hydrate, Calcium levofolinate pentahydrate, Folinic acid l-form calcium salt, Levofolinate calcium, Levofolinate de calcium, Leucovorin Calcium Preservative Free, Leucovorin Calcium Preservative Free / Wellcovorin / Vykoura / Lederle Leucovorin, Levoleucovorin Disodium, LEVOLEUCOVORIN INJECTION
Trade name
Khapzory, Fusilev, Wellcovorin, Vykoura, Lederle Leucovorin, Khapzory / Fusilev
Also called
Calcium levofolinate
Development code
CL 307,782, CL-307782, LFP-754
Component
Calcium levofolinate
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · 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

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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