What is it?
What Coluracetam is
5The research names MKC-231 and BCI-540 refer to Coluracetam. Its proposed action concerns choline transport into nerve terminals, rather than supplying choline as a nutrient. A research listing is not evidence of a human cognitive effect.
Names, aliases and forms
Mechanisms of action
Choline transporter mechanism
5Preclinical experiments suggest MKC-231 affects movement of choline transporter 1 (CHT1) to the nerve-terminal membrane. This can alter high-affinity choline uptake, the transport step supplying choline for acetylcholine synthesis. The mechanism is not a demonstrated cognitive benefit in people.
Animal learning signal
3The memory experiments used rodents with chemically induced cholinergic impairment. Results in this model do not predict a useful dose or effect in healthy adults.
Potential effects and evidence map
Evidence for Coluracetam remains predominantly preclinical. Rodent experiments examined learning in chemically induced cholinergic impairment models; these cannot establish a benefit in healthy people. A completed Phase 2 registry record has no posted results as checked on 14 October 2026. A 2023 uncontrolled single-person report cannot establish efficacy or a human safety profile.
MKC-231 improved maze-learning measures in chemically impaired rodents; a reliable human memory benefit is unproven.
An uncontrolled single-person report does not establish a reproducible focus or attention benefit.
The completed BCI-540 trial registry has no posted results. Registration alone is not evidence of a mood benefit.
Experiments in rat neuron cultures examined glutamate-related cell injury; they do not demonstrate human brain protection.
Typical dosages and timing
The registry specifies two discrete schedules: 80 mg once daily or three times daily, with a week-6 endpoint in adults with depression and anxiety. These are trial-design doses, not a validated healthy-adult nootropic regimen. Results are not posted in the registry.
Timing & effect horizon
The featured study window describes the trial design. It does not establish when effects start, how long a single dose lasts, or a recommended cycle.
No source-verified human onset, The time for blood levels to fall by half during the final elimination phase.Source or single-dose effect duration was identified. The often-cited prolonged maze-learning finding followed repeated dosing in rats; it is not a human duration estimate. No evidence-based cycling schedule is established.
Safety, side effects and risk profile
Human adverse-event frequency, serious-harm risk and long-term safety cannot be estimated from these sources.
United States, as of 14 October 2026: a 2019 DOJ/FDA case included Coluracetam products unlawfully imported and sold under that case's circumstances.
Compatibility with cholinergic or other CNS-active compounds has not been established in controlled human interaction studies in the reviewed sources.
Pregnant and lactating participants were excluded from the registered trial; reproductive safety is unestablished.
One uncontrolled report described brief mild headaches in the initial weeks, later diminishing; incidence and causality are unknown.
Interactions and cautions
The trial excluded recent antidepressants, anxiolytics and other CNS-active medicines. These design restrictions do not demonstrate specific drug interactions. Human compatibility with medicines, alcohol or multi-nootropic stacks is unestablished.
Legal and regulatory status
United States, as of 14 October 2026: a 2019 DOJ/FDA case expressly included Coluracetam among products unlawfully imported and sold, citing approval, labeling and manufacturing circumstances. This historical case is not a worldwide possession rule or a legal determination for every current listing. Current sale and import requirements depend on the destination and product category.
Practical buying and quality notes
- For a Coluracetam powder labeled 1 g, 1,000 mg is the total labeled package mass, not a suggested dose. For capsules, multiply labeled Coluracetam mg per capsule by capsule count; for liquids, multiply mg/mL by bottle volume. Compare only clearly disclosed Coluracetam mass.12
- Check that a lot-specific certificate of analysis (COA) identifies Coluracetam, MKC-231 or BCI-540, and distinguishes an identity test from a purity percentage. The Coluracetam InChIKey is PSPGQHXMUKWNDI-UHFFFAOYSA-N. A matching identifier alone does not independently verify the contents of a bottle.11
- Divide package price by clearly labeled Coluracetam grams, then compare currency, form, stock status and delivered cost. Check the COA lot, test methods, actual results and contaminant coverage separately. A cheaper gram or a high purity claim does not establish human safety, efficacy or lawful sale.12
FAQ
Is Coluracetam proven to improve memory or focus?
9No reliable human benefit is established by the reviewed evidence. Animal experiments and one uncontrolled case report cannot show that it improves cognitive performance in healthy adults.
Is there an established Coluracetam nootropic dose?
7No validated healthy-adult nootropic regimen is established. The trial-dose context above and a self-selected dose in one case report do not establish an effective or safe serving size.
Does the six-week study define a Coluracetam cycle?
7No. A trial observation window is not a recommended cycle or evidence of tolerance prevention. Human onset, half-life and practical effect duration remain unresolved in the reviewed sources.
Does an FDA substance identifier mean Coluracetam is approved?
11No. As checked on 14 October 2026, the U.S. FDA substance record explicitly says that a UNII identifies a substance and does not imply regulatory review or approval. A chemical database entry is not a clearance to sell or import a product.
What can a Coluracetam COA actually verify?
12A COA reports the tests performed on an identified sample or lot. Look for the method, limits and actual result for each test. Identity, assay and contaminant coverage are different checks; a purity percentage alone is not a complete quality assessment.
References
- PubChem Compound Summary for Coluracetam, CID 214346.
- Murai S, Saito H, Abe E, Masuda Y, Odashima J, Itoh T. MKC-231, a choline uptake enhancer, ameliorates working memory deficits and decreased hippocampal acetylcholine induced by ethylcholine aziridinium ion in mice. Journal of Neural Transmission. General Section. 1994;98(1):1-13.
- Bessho T, Takashina K, Eguchi J, Komatsu T, Saito K. MKC-231, a choline-uptake enhancer: (1) long-lasting cognitive improvement after repeated administration in AF64A-treated rats. Journal of Neural Transmission. 2008;115(7):1019-1025.
- Takashina K, Bessho T, Mori R, Eguchi J, Saito K. MKC-231, a choline uptake enhancer: (2) Effect on synthesis and release of acetylcholine in AF64A-treated rats. Journal of Neural Transmission. 2008;115(7):1027-1035.
- Takashina K, Bessho T, Mori R, Kawai K, Eguchi J, Saito K. MKC-231, a choline uptake enhancer: (3) Mode of action of MKC-231 in the enhancement of high-affinity choline uptake. Journal of Neural Transmission. 2008;115(7):1037-1046.
- Akaike A, Maeda T, Kaneko S, Tamura Y. Protective effect of MKC-231, a novel high affinity choline uptake enhancer, on glutamate cytotoxicity in cultured cortical neurons. Japanese Journal of Pharmacology. 1998;76(2):219-222.
- ClinicalTrials.gov. NCT00621270: Safety and Effectiveness Study of BCI-540 Versus Placebo in Major Depressive Disorder With Concomitant Anxiety.
- U.S. Food and Drug Administration. New Dietary Ingredients in Dietary Supplements - Background for Industry.
- Villarino ML, Villarino RT. The Effects of Cognitive Enhancement Drug (Coluracetam) on Visual Perception, Abstract Reasoning, Pattern Recognition, Spatial Orientation, and Analytical Thinking: A Case Study. International Journal of Cognition and Behaviour. 2023;6:016.
- U.S. Department of Justice, Western District of Pennsylvania. Hermitage Company and Its Owner Plead Guilty to Illegally Importing and Selling Brain Drugs Not Approved for Sale by FDA. June 3, 2019.
- U.S. Food and Drug Administration Substance Registration System. COLURACETAM, UNII V6FL6O5GR7.
- U.S. Food and Drug Administration. Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.