Aniracetam

Aniracetam is a fat-soluble racetam developed by Hoffmann-La Roche as Ro 13-5057 and later sold in Italy and Japan for dementia symptoms.

Human trialsNon-peptide compound reference

Also known as: Ro 13-5057, Draganon, Sarpul, Ampamet, 1-p-Anisoyl-2-pyrrolidinone, 1-(4-Methoxybenzoyl)-2-pyrrolidinone, UNII 5L16LKN964, CHEBI:47943

(how we review)

Dosing & scaling, explained

Amounts reported for Aniracetam are listed under Reported protocols, each with its source and study kind. No amount ladder is inferred from them. This is educational source context, not a protocol or recommendation.

No source-supported amount ladder is shown

Enter a target amount only from your own reviewed source. The calculator can convert it into concentration, volume and device markings, but it will not infer an amount from product availability or another compound.

Only mcg or mg amounts are retained. The calculator derives mL, syringe units or pen clicks from the current vial strength, water volume and device.

No independently verified schedule

Clinical context

Human study rows are described per source under Reported protocols; they belong to their trial populations and are not a general amount.

Storage, handling and interpretation

Product identity

Verify the exact compound, formulation and amount against the product label or certificate before calculation.

Storage & handling

Follow the product label, certificate and validated laboratory SOP; no universal storage assumption is applied here.

Prepared solutions

Label concentration and preparation date, use sterile technique where applicable, and follow a validated stability protocol.

Reported protocols for Aniracetam

What published studies and recent community write-ups report about amounts, timing and course length. 4 clinical, 3 preclinical and 3 community-reported rows, each linked to its source. These are descriptions of what others report, not instructions, and nothing here is medical advice.

ContextDoseFrequencyRouteCourseSource
Clinical4 rows
Registered dose in dementia trials (review of human data)Elderly patients with mild to moderate senile dementia of the Alzheimer type1500 mg per dayDaily, divided into two or three doses in the registered productOral4-6 months in the placebo-controlled trialsNone describedDrugs and Aging (PubMed)1994
This Drugs and Aging review records that 1500 mg a day beat placebo on all tests at 4 and 6 months, and beat piracetam 2400 mg a day on 8 of 18 tests in a further 6-month trial. The underlying placebo-controlled trial enrolled 109 patients for 6 months. The reviewers called for confirmatory trials that never appeared in Western journals, and the figure is a dose for dementia patients, not for healthy adults.
Open comparison against cholinesterase inhibitors276 patients with cognitive disorders (mean age 71), of whom 58 received aniracetam alone1500 mg per day (fixed dose from the prescribing information)DailyOral12 months, with assessments at 3, 6 and 12 monthsNone describedCNS Neuroscience and Therapeutics (PubMed Central)2012
In this prospective open-label Greek study, patients on aniracetam held their neuropsychological scores at 6 and 12 months while patients on cholinesterase inhibitors declined at 12 months, and aniracetam did better on cognition at 6 months in those with milder dementia. The study was not randomised or blinded, so the comparison is suggestive rather than conclusive.
Human pharmacokinetics (bioequivalence study)20 healthy Chinese men400 mg single dose (two 200 mg capsules)Single dose, two formulations with a 3-day washoutOral, fastingSingle doseNot applicableArzneimittelforschung (PubMed)2008
Plasma aniracetam peaked at about 0.4 hours and disappeared with a half-life of roughly 0.47-0.49 hours, with peak concentrations under 10 ng/mL. The parent compound is therefore almost gone within a couple of hours, and its longer-lived metabolites are thought to carry most of the activity, which is why every protocol splits the daily total.
Supplement market analysis10 over-the-counter cognitive enhancement products bought online in the United StatesUp to 502 mg of aniracetam per recommended serving; the paper quotes 200-750 mg as the typical pharmacologic doseAs labelled on the productsOral capsules and tabletsNot applicableNot applicableNeurology: Clinical Practice (PubMed)2021
Mass spectrometry found aniracetam and omberacetam in the products along with three undeclared unapproved drugs (phenibut, vinpocetine and picamilon); some declared drugs were absent and 9 of 12 stated quantities were wrong. The authors stress that none of these four racetam-class drugs is approved for human use in the United States.
Preclinical3 rows
Healthy adult miceNaive adult C57BL/6J mice50 mg/kgOnce dailyOralDaily dosing through a battery of behavioural testsNot applicablePLoS One (PubMed)2014
Spatial learning, fear conditioning, motor learning, odour discrimination, locomotion, anxiety and repetitive behaviour were all unchanged against placebo. The authors wrote the study with self-administering healthy humans in mind and concluded that aniracetam does not alter behaviour in normal mice.
Traumatic brain injury in ratsRats with moderate fluid percussion brain injury25 or 50 mg/kgOnce dailySystemic injection15 days, including a course started 11 days after injuryBenefit was lost when dosing stopped before water-maze testingJournal of Neurotrauma (PubMed)2006
Both doses reduced injury-induced water-maze deficits, and treatment that began on day 11 after injury still brought performance to sham levels. Rats whose treatment ended before testing performed no better than controls, which suggests the effect depends on ongoing exposure rather than lasting repair.

How a course is commonly described

  1. Weeks 1-2Community-reported

    Community guides start at 400-750 mg once in the morning with a fatty meal to check tolerance, adding a choline source from the first dose to head off the headache that users most often report.

  2. Weeks 2-8Community-reported

    The common pattern is 750 mg twice a day, morning and early afternoon, which adds up to the 1500 mg a day used in the dementia trials. Effects are described as immediate rather than cumulative because the parent compound clears within hours.

  3. Clinical comparisonClinical

    The trials behind the 1500 mg figure ran 4-6 months in elderly dementia patients, and the 2012 open study followed patients for 12 months on the same fixed dose. No study has tested any schedule in healthy adults, and the one healthy-animal study found no effect.

  • Every human dose figure for aniracetam traces back to 1500 mg a day in elderly dementia patients. Community ranges of 750-1500 mg a day copy that number; there is no trial of any dose in healthy adults, and the only healthy-animal study found nothing.
  • Aniracetam is fat-soluble with a parent half-life of about 30 minutes in people, which is why guides insist on taking it with food and splitting the day's amount. It is an oral small molecule, so nothing is reconstituted or injected.
  • It is not approved for human use in the United States and has turned up in supplements at unlabelled or inaccurate amounts alongside undeclared drugs. The rows above record what sources report, not endorsements.
Sources for this section (11)
  1. Aniracetam. An overview of its pharmacodynamic and pharmacokinetic properties, and a review of its therapeutic potential in senile cognitive disordersDrugs and Aging (PubMed)1994Clinical
  2. Aniracetam (Ro 13-5057) in the treatment of senile dementia of Alzheimer type (SDAT): results of a placebo controlled multicentre clinical studyEuropean Neuropsychopharmacology (PubMed)1991Clinical
  3. Clinical efficacy of aniracetam, either as monotherapy or combined with cholinesterase inhibitors, in patients with cognitive impairment: a comparative open studyCNS Neuroscience and Therapeutics (PubMed Central)2012Clinical
  4. Pharmacokinetics and bioequivalence study of aniracetam after single-dose administration in healthy Chinese male volunteersArzneimittelforschung (PubMed)2008Clinical
  5. Five Unapproved Drugs Found in Cognitive Enhancement SupplementsNeurology: Clinical Practice (PubMed)2021Clinical
  6. Aniracetam does not alter cognitive and affective behavior in adult C57BL/6J micePLoS One (PubMed)2014Preclinical
  7. Delayed, post-injury treatment with aniracetam improves cognitive performance after traumatic brain injury in ratsJournal of Neurotrauma (PubMed)2006Preclinical
  8. Anxiolytic effects of aniracetam in three different mouse models of anxiety and the underlying mechanismEuropean Journal of Pharmacology (PubMed)2001Preclinical

Plus 3 community resources (dosing guides, forum threads and vendor write-ups), reported above but not linked.

Overview

Aniracetam is a fat-soluble racetam developed by Hoffmann-La Roche as Ro 13-5057 and later sold in Italy and Japan for dementia symptoms. Its human evidence comes from 1990s trials in elderly patients with Alzheimer-type or cerebrovascular cognitive impairment at a fixed 1500 mg a day, plus a 2012 open comparison in 276 patients, while a 2014 mouse study found no effect at all in healthy animals. It has a parent half-life of about half an hour in people, is not approved in the United States, and has been found in over-the-counter supplements at up to 502 mg per serving.

What researchers are exploring

These themes describe recurring questions in published research. They are not claims of effectiveness or recommendations for use.

  • 1

    Cognitive & neural

    Neuroplasticity, cognition, stress and sleep models.

  • 2

    Registered dose in dementia trials (review of human data)

    This Drugs and Aging review records that 1500 mg a day beat placebo on all tests at 4 and 6 months, and beat piracetam 2400 mg a day on 8 of 18 tests in a further 6-month trial. The underlying placebo-controlled trial.

  • 3

    Open comparison against cholinesterase inhibitors

    In this prospective open-label Greek study, patients on aniracetam held their neuropsychological scores at 6 and 12 months while patients on cholinesterase inhibitors declined at 12 months, and aniracetam did better on.

  • 4

    Human pharmacokinetics (bioequivalence study)

    Plasma aniracetam peaked at about 0.4 hours and disappeared with a half-life of roughly 0.47-0.49 hours, with peak concentrations under 10 ng/mL. The parent compound is therefore almost gone within a couple of hours.

  • 5

    Supplement market analysis

    Mass spectrometry found aniracetam and omberacetam in the products along with three undeclared unapproved drugs (phenibut, vinpocetine and picamilon); some declared drugs were absent and 9 of 12 stated quantities were.

  • 6

    Healthy adult mice

    Spatial learning, fear conditioning, motor learning, odour discrimination, locomotion, anxiety and repetitive behaviour were all unchanged against placebo. The authors wrote the study with self-administering healthy.

What the current evidence can support

Study models remain visible so laboratory and animal findings are not mistaken for established human outcomes.

  • Human

    Human studies and registrations

    4 protocol rows on this page come from human trials, trial registrations, regulator labels or reviews of human data. Approval status and populations are stated per row.

  • Animal

    Preclinical models

    3 protocol rows describe animal, cell or toxicology work. Amounts from these rows do not translate to people.

  • Not graded

    Community-reported use

    3 rows record what blogs, vendor write-ups or forums describe for Aniracetam. None has been verified against primary literature.

Chemistry identifiers

Sequence, synonyms and registry identifiers as recorded in PubChem, the National Library of Medicine's open chemistry database. Formula, mass and CAS number are summarized at the top of the page.

Also listed as

Ro 13-5057, Draganon, Sarpul, Ampamet, 1-p-Anisoyl-2-pyrrolidinone, 1-(4-Methoxybenzoyl)-2-pyrrolidinone, UNII 5L16LKN964, CHEBI:47943

InChIKey

ZXNRTKGTQJPIJK-UHFFFAOYSA-N

IUPAC name

1-(4-methoxybenzoyl)pyrrolidin-2-one

Limitations and unknowns

Important limitations

  • Every amount on this page is a report of what a source describes, not a protocol to follow.
  • Preclinical and community rows do not establish a human amount, schedule or route.
  • Formulation, purity and presentation vary by supplier and are not covered by the dossier.

Sources

8 curated references, each with its journal, year and study model, plus 3 community resources reported but not linked.

  1. Aniracetam (PubChem CID 2196)PubChem, National Library of Medicine2026Not graded
  2. Aniracetam. An overview of its pharmacodynamic and pharmacokinetic properties, and a review of its therapeutic potential in senile cognitive disordersDrugs and Aging (PubMed)1994Human
  3. Aniracetam (Ro 13-5057) in the treatment of senile dementia of Alzheimer type (SDAT): results of a placebo controlled multicentre clinical studyEuropean Neuropsychopharmacology (PubMed)1991Human
  4. Clinical efficacy of aniracetam, either as monotherapy or combined with cholinesterase inhibitors, in patients with cognitive impairment: a comparative open studyCNS Neuroscience and Therapeutics (PubMed Central)2012Human
  5. Pharmacokinetics and bioequivalence study of aniracetam after single-dose administration in healthy Chinese male volunteersArzneimittelforschung (PubMed)2008Human
  6. Five Unapproved Drugs Found in Cognitive Enhancement SupplementsNeurology: Clinical Practice (PubMed)2021Human
  7. Aniracetam does not alter cognitive and affective behavior in adult C57BL/6J micePLoS One (PubMed)2014Animal
  8. Delayed, post-injury treatment with aniracetam improves cognitive performance after traumatic brain injury in ratsJournal of Neurotrauma (PubMed)2006Animal