Omberacetam
Also known as: GVS-111, N-phenylacetyl-L-prolylglycine ethyl ester, Noopept, Noopeptide
Summary
Omberacetam (brand name Noopept) is a synthetic dipeptide nootropic and neuroprotective compound approved in Russia for cognitive impairment and mild cognitive disorders. It is a prodrug that is metabolized to cycloprolylglycine, an endogenous neuropeptide. It enhances memory, learning, and attention while exhibiting neuroprotective properties. It is widely used as a research and self-administered nootropic compound in Western countries.
Mechanism of Action
Cycloprolylglycine mimetic and AMPA receptor positive modulator; also mimics nerve growth factor (NGF) effects by activating TrkA receptors and downstream signaling (MAPK/ERK, PI3K/Akt pathways); enhances glutamatergic neurotransmission and promotes neuroplasticity
Routes of Administration
Goals & Uses
- Memory consolidationCognitiveModerate
- NeuroprotectionNeurologyModerate
- Alzheimer's disease symptomatic treatmentNeurodegenerationLow
- Anxiety reductionNeuropsychiatricLow
- Post-traumatic cognitive recoveryRehabilitationModerate
- Cognitive enhancementNootropicModerate
Contraindications
- Hypersensitivity to omberacetam or excipientsAllergyHigh
- Severe hepatic impairmentOrganModerateLiver function concerns
- Age under 18PediatricModerate
- Severe renal impairmentOrganModerateKidney function concerns
- PregnancyPopulationHighPotential fetal risk or insufficient safety data
- LactationReproductiveHigh
Adverse Effects
- HeadacheNeurologicUncommonPain in the head or upper neck
- InsomniaPsychiatricUncommonDifficulty sleeping
- Increased blood pressureCardiovascularUncommon
- NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
- Psychomotor agitationNeuropsychiatricRare
- IrritabilityPsychiatricUncommonIncreased agitation or short temper
Drug Interactions
- Psychostimulants (amphetamine, modafinil)Moderate
- Cholinergic agentsLow
- AlcoholModerate
- AntihypertensivesLowMay potentiate hypotensive effects in some contexts
Population Constraints
- Patients with hypertensionCardiovascularRelative
- Patients with epilepsyNeurologicalRelative
- Elderly patientsAgeRelative
- Pediatric population (<18 years)PediatricAbsolute
Regulatory Status
- European UnionUnapprovedNot approved by EMA; regulatory status varies by member state; generally sold as a supplement or research compound
- United StatesUnapprovedNot FDA approved; sold as a research chemical or unscheduled dietary supplement; no IND or NDA on record
- United KingdomUnapprovedNot MHRA approved; sold as unregulated supplement; not a controlled substance under UK law as of last review
Approved as a pharmaceutical drug in Russia (Novartis/Grunethal licensed to JSC Lekko Pharmaceuticals) for cognitive impairment associated with organic brain diseases and post-traumatic stress. Not approved by the FDA, EMA, or MHRA. Sold as an unregulated dietary supplement or research chemical in many Western markets.
Evidence & Sources
No sources recorded yet.