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Levomefolic acid

  • 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 Levomefolic acid does in the body

Symptoms of premenstrual dysphoric disorder

From the FDA-approved label: VITAMIN B 12 [TREATMENT]; FOLATE [PREVENTION]; OTHER [SUPPLEMENTATION]; Vitamin B 12 is essential for the synthesis of methionine from homocysteine - a reaction which also requires l-methylfolate as a necessary cofactor.

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 substance registry classes this as chemical.

    FDA substance registry · 8S95DH25XC · read 2026-08-29

  • The supplement label database classes it as vitamin, under the name Vitamin B9.

    NIH Dietary Supplement Label Database · 9726 · 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 52 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.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

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.

First ischemic stroke

The study did not show it

Who was studied
NCT04974151
How many people
24000
Study design
Phase 4
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

Maternal Blood Pressure

The study did not show it

Who was studied
NCT04723836
How many people
2250
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. 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

Lipid profile

The study did not show it

Who was studied
NCT02837367
How many people
600
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. 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

ongoing intact pregnancy at 24 weeks of gestation

The study did not show it

Who was studied
NCT00400387
How many people
449
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

Red Blood Cell (RBC) Folate Level at 24 Weeks

The study did not show it

Who was studied
NCT00468481
How many people
385
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

weight gain (gram/day)

The study did not show it

Who was studied
NCT02437721
How many people
360
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. 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 happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.1 registered measure of this kind. No reviewed result.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.2 registered measures of this kind.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.5 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

  • adult adhd investigator symptom rating scale
  • health questionnaire

Measured

Things only a test, a scale or a device shows.

  • hemoglobin
  • concentration of red blood cell folate levels
  • concentration of serum folate levels
  • concentration of unmetabolized folic acid
  • maternal blood pressure

Meaningful

Things that change how a life goes, not only a number.

  • first ischemic stroke

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (5)
  • folate status
  • homocysteine status
  • ongoing pregnancy on the 20th week of gestational age
  • benefit of nutritional supplement
  • incidence of treatment emergent adverse events

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

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.

  • Beyaz is a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to: • Prevent pregnancy. ( 1.1 ) • Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception.

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.

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 for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

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 (10)
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

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

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 tablet, capsule, gelatin coated, liquid, capsule, delayed release pellets, 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 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.

Reports sent to a regulator

  • 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.

Levomefolic acid appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 79 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • dehydration — 12 reaction mentions
  • drug interaction — 11 reaction mentions
  • dysphagia — 9 reaction mentions
  • condition aggravated — 9 reaction mentions
  • mental disorder — 8 reaction mentions
  • muscle spasms — 7 reaction mentions
  • urinary tract infection — 7 reaction mentions
  • muscular weakness — 6 reaction mentions
  • normal newborn — 5 reaction mentions
  • systemic lupus erythematosus — 5 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

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

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

  • 28 products list this as an active ingredient in the United States drug directory. 5 of them contain it and nothing else.

    FDA National Drug Code directory · 54239-008 · read 2026-08-29

  • They are sold as capsule, capsule, gelatin coated, capsule, liquid filled, liquid, powder and tablet, taken oral.

    FDA National Drug Code directory · 54239-008 · read 2026-08-29

  • 23 published labels name it as an active ingredient. None of them describes this substance alone, so no label text on this page can be attributed to it rather than to a combination.

    US prescribing information · 8f2eca71-9a82-4a19-9206-36a04b865fe1 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 8f2eca71-9a82-4a19-9206-36a04b865fe1 · read 2026-08-29

  • 1389 marketed supplement labels list this ingredient, classed as botanical with nutrients, other combinations and vitamin.

    NIH Dietary Supplement Label Database · 243621 · 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 · 243621 · read 2026-08-29

  • Menatrol is oral at How Supplied: Menatrol™ Capsules are light yellow powder with black specks, encased in a hard shell capsule., recorded as fda label in effect 2023-12-18 in the United States.

    US prescribing information · 0a100e7d-3a8d-2d8b-e063-6394a90a3203 · 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.

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

Questions worth asking

  • Which of the trials of Levomefolic acid 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 fast does the body clear it?

The sources RNAWiki checked hold nothing for this field.

Why it matters. Without this, nothing on this page can say how long anything lasts.

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 Levomefolic acid 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.

Where else this substance is registered

FDA substance identifier (UNII)
8S95DH25XC
CAS registry number
31690-09-2
PubChem compound
135398561
ChEMBL
CHEMBL1231574
ChEBI
18608
WHO international nonproprietary name list entry
8917
RxNorm concept
1025342
EMA substance identifier
100000127631
DrugBank
DB11256

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

  • 6 approved applications cover products containing this substance. The earliest was NDA022532, approved 20100924 to BAYER HLTHCARE.

    Drugs@FDA application register · NDA022532 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA022532 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20120101.

    FDA National Drug Code directory · 54239-008 · 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

7 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.
  • The path through the body — 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)

What did Levomefolic acid's largest trial (24000 people) and its longest (8.8 years) measure?


24000 people in Levomefolic acid's largest registered study, 8.8 years in its longest registered window, measuring Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study. ClinicalTrials.gov · 2026-09-01

11 na, 6 phase4, 3 phase2, 2 phase1, 2 phase3, 1 na or unstated; NCT04723836; 2025-12-31; no ageing endpoint recorded. Last human test completed 2023, NCT05931965.

Interpretation These counts include studies where Levomefolic acid was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • na
    11
  • phase4
    6
  • phase2
    3
  • phase1
    2
  • phase3
    2
  • na or unstated
    1
1 more recorded row
  • Last recorded human test NCT05931965
    2023-08-31

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

Levomefolic acid was tested only in human — what did it show?


human: biomarker (22): the rungs where Levomefolic acid has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human biomarker
Show the evidence
  • human NCT00511901
    biomarker; Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study; 22

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

2 of Levomefolic acid's trials stopped: accrual/recruitment, other?


accrual/recruitment (1) and other (1): Levomefolic acid's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Study enrollment was suspended in response to an FDA alert regarding the study drug. The study was subsequently terminated"; 2 of 22 registered studies

Show the evidence

Trial

  • NCT00511901
    terminated; "Study enrollment was suspended in response to an FDA alert regarding the study drug. The study was subsequently terminated"
  • NCT02223299
    withdrawn; "The study was never approved by the IRB and the PI left the VA"

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

Human studies of Levomefolic acid used 5-methyltetrahydrofolate (400µg) — over how long?


Human studies of Levomefolic acid used "5-methyltetrahydrofolate (400µg)". ClinicalTrials.gov · 2026-09-01

Show the evidence
  • human NCT04723836
    5-methyltetrahydrofolate (400µg)

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

Could one person measure Levomefolic acid's effect on folate status?


Folate status: measured in Levomefolic acid's trials.

Interpretation folate status is the recorded endpoint.

Show the evidence

biomarkers

  • folate status; 2026-09-01
  • homocysteine status; 2026-09-01
  • adult adhd investigator symptom rating scale; 2026-09-01
  • ongoing pregnancy on the 20th week of gestational age; 2026-09-01
  • benefit of nutritional supplement; 2026-09-01
  • hemoglobin; 2026-09-01
7 more recorded rows
  • biomarkers
    concentration of red blood cell folate levels; 2026-09-01
  • biomarkers
    concentration of serum folate levels; 2026-09-01
  • biomarkers
    concentration of unmetabolized folic acid; 2026-09-01
  • biomarkers
    maternal blood pressure; 2026-09-01
  • biomarkers
    first ischemic stroke; 2026-09-01
  • biomarkers
    health questionnaire; 2026-09-01
  • biomarkers
    incidence of treatment emergent adverse events; 2026-09-01
  • human trials at or under30
    4
  • Not recorded for this substance
    a recorded half-life
  • smallest human trial
    0; NCT02223299; NA; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN

Which of adult adhd investigator symptom rating scale, benefit of nutritional supplement and concentration of red blood cell folate levels did Levomefolic acid's trials measure?


adult adhd investigator symptom rating scale, benefit of nutritional supplement and concentration of red blood cell folate levels lead 13 outcome terms across Levomefolic acid's trials. ClinicalTrials.gov · 2026-09-01

ongoing pregnancy on the 20th week of gestational age, benefit of nutritional supplement, hemoglobin, concentration of red blood cell folate levels, concentration of serum folate levels and concentration of unmetabolized folic acid follow.

Show the evidence
  • folate status
    1
  • homocysteine status
    1
  • adult adhd investigator symptom rating scale
    1
  • ongoing pregnancy on the 20th week of gestational age
    1
  • benefit of nutritional supplement
    1
  • hemoglobin
    1
7 more recorded rows
  • concentration of red blood cell folate levels
    1
  • concentration of serum folate levels
    1
  • concentration of unmetabolized folic acid
    1
  • maternal blood pressure
    1
  • first ischemic stroke
    1
  • health questionnaire
    1
  • incidence of treatment emergent adverse events
    1

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

Which of Levomefolic acid's 6 ongoing trials reports first?


6 registered trials of Levomefolic acid are open; earliest completion 2025-12-31. ClinicalTrials.gov · 2026-09-01

Plateau enrichment of infused amino acid tracers and related metabolites to quantify turnover rates of folate dependent pathways; Maternal Blood Pressure; latest 2029-06-30

Show the evidence

Trial

  • NCT01687127
    "Impact of High-dose Folic Acid Supplementation on Pathways Linked to DNA Formation"; n 25; "Plateau enrichment of infused amino acid tracers and related metabolites to quantify turnover rates of folate dependent pathways"; 2026-12-31
  • NCT04723836
    "Optimal Nutrition for Prevention of Hypertension in Pregnancy"; n 2250; "Maternal Blood Pressure"; 2025-12-31
  • NCT04974151
    "China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype"; n 24000; "First ischemic stroke"; 2029-06-30
  • NCT06218030
    "Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder: a Pilot Study"; n 10; "Incidence of treatment-emergent adverse events"; 2026-05-01
  • NCT06930144
    "5-MTHF Supplementation for Treatment of Type 1 Diabetes Patients"; n 34; "Islet β cell function"; 2027-04
  • NCT07740109
    "The Effects of 5-methyltetrahydrofolate Supplementation in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease"; n 44; "Serum folate level"; 2027-08-30

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

Which 7 trials of Levomefolic acid posted no result?


Posted no result
7 of 7 completed trials
Registrations
NCT01031355, NCT00372645, NCT01091506, NCT01976676, NCT04022135 and NCT02133898, and 1 more
Completion dates
oldest 2010-03; newest 2023-08-31
Show the evidence

Trial

  • NCT01031355
    2010-03
  • NCT00372645
    2012-01
  • NCT01091506
    2014-06
  • NCT01976676
    2014-09
  • NCT04022135
    2021-09-08
  • NCT02133898
    2023-04-04
  • 1 further recorded trial NCT05931965
    2023-08-31

At the median, Levomefolic acid's trials enrolled 62 people — anything larger?


Median enrolment
62
Largest enrolment
24000
Registered trials counted
22

What do 79 spontaneous reports say about Levomefolic acid — 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.

Levomefolic acid appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 79 reaction mentions were counted: dehydration 12; drug interaction 11; dysphagia 9; condition aggravated 9. open-targets-adr · CHEMBL1231574 · 2026-06-24

Show the evidence
  • dehydration
    12
  • drug interaction
    11
  • dysphagia
    9
  • condition aggravated
    9
  • mental disorder
    8
  • muscle spasms
    7
4 more recorded rows
  • urinary tract infection
    7
  • muscular weakness
    6
  • normal newborn
    5
  • systemic lupus erythematosus
    5

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1231574
PubChem CID
135398561
CAS number
31690-09-2
RxCUI
1025342
InChIKey
ZNOVTXRBGFNYRX-STQMWFEESA-N
Also called
5- methyltetrahydrofolate, 5-mthf, Acide levomefolique, Acido levomefolico, L-5-mthf, Levomefolate, Levomefolinic acid, L-methylfolate, deplin, LEVOMEFOLATE CALCIUM, Extrafolate-s, L-5-mthf-ca
Trade name
Bodyfolin, Metafolin, Nutrifolin, Tydemy, Safyral, Beyaz, Prenate Mini, Davimet with Iron, Livita Children, Tydemy / Safyral / Beyaz / Prenate Mini / Davimet with Iron / Livita Children, Floriva, Chromagen
Development code
LMSR, LMC-A, LMCA, NDI 638
Salt form
Calcium-5-methyltetrahydrofolate, Calcium levomefolate, Calcium l-methylfolate, Levomefolate calcium component of beyaz, Levomefolate calcium component of safyral, Levomefolinate calcium, L-methylfolate-calcium, Levomefolate Magnesium
Sources (7)

Sources

1 more source

ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 7 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

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.