N-PEP-12

Clinically accepted and researched uses:

• Age-related cognitive decline (Mild memory impairment in older adults):
  Used as a neurotrophic supplement to enhance memory and cognitive performance in adults over 50 years old with age-related memory complaints. Improvement observed in short-term and long-term memory after 30–90 days of treatment.
• Post-stroke cognitive recovery:
  Investigated for use in improving cognitive function in patients aged 18–80 years, 30–120 days after a supratentorial ischemic stroke. Used as supportive therapy for neurorecovery.

Note: N-PEP-12 is not officially approved as a drug by regulatory agencies like the FDA or EMA. It is marketed as a dietary supplement with neurotrophic activity.

Adults (Age-related memory impairment):

• Dosage: 90 mg orally once daily
• Duration: 30 to 90 consecutive days
• Administration: With or without food. Swallow whole with water.

Post-stroke cognitive rehabilitation:

• Dosage: 90 mg orally once daily
• Duration: Up to 360 days as per clinical trials
• Administration: No titration required; consistent daily intake is advised.

Pediatric Use:

• Not recommended. Safety and efficacy not established.

Elderly (≥65 years):

• Same as adult dose; no specific adjustment needed unless comorbidities exist.

Renal or Hepatic Impairment:

• No dose adjustment data available. Use with caution due to lack of pharmacokinetic studies in these populations.

N-PEP-12 is an orally bioavailable peptide preparation derived from enzymatically digested proteins of porcine brain tissue (similar to cerebrolysin). It contains biologically active neuropeptides and amino acids. The compound acts by promoting neuronal survival, enhancing synaptic plasticity, and stimulating the formation of dendritic spines in the hippocampus and cortex. These neurotrophic effects result in improved memory and cognitive functions. Preclinical models show that N-PEP-12 protects against oxidative stress, excitotoxicity, and ischemic neuronal damage, thereby supporting neuroregeneration and recovery of cognitive performance.

• Absorption:
  Orally absorbed; bioavailability confirmed by neurobehavioral effects and cognitive response. Crosses the blood-brain barrier unlike its parenteral counterpart cerebrolysin.
• Distribution:
  Active peptides reach cerebral tissues including the hippocampus and prefrontal cortex in animal studies.
• Metabolism:
  Specific hepatic or enzymatic metabolism is not characterized. Likely undergoes proteolytic degradation similar to other peptides.
• Excretion:
  Presumed renal clearance of degraded peptide fragments; not specifically studied.
• Half-life & Onset:
  Not formally established. Onset of cognitive effects typically observed after 14–30 days.
• Active Metabolites:
  Not identified.

• Pregnancy:
  No FDA pregnancy category assigned. No animal or human reproductive studies available. Use is not recommended during pregnancy due to unknown fetal effects.
• Lactation:
  Unknown if excreted into human breast milk. Safety in breastfeeding has not been established. Avoid use in lactating women.
• Recommendation:
  Use only if clearly necessary and under medical supervision. Consider safer alternatives for pregnant or breastfeeding individuals.

• Primary Class: Neurotrophic Cognitive Enhancer
• Subclass: Peptide-based dietary supplement derived from cerebrolysin
• Regulatory Status: Classified as a nutraceutical or supplement in most countries

• Known hypersensitivity to porcine-derived peptides or excipients
• Use in children under 18 years
• Pregnancy and lactation (due to lack of safety data)
• Severe hepatic or renal dysfunction (precaution due to unknown metabolism/excretion)

• High-risk groups:
  Pregnant or breastfeeding women, pediatric patients, individuals with severe liver or kidney disease
• Serious risks:
  No black box warnings or serious adverse effects documented to date.
• Monitoring:
  Not required under normal use. In clinical trials, no laboratory monitoring was mandated.
• Early signs of intolerance:
  Dizziness, nausea, or headache may indicate sensitivity; discontinue if persistent.

Common side effects (incidence ~10–20%, similar to placebo):

• Central Nervous System:
  Headache, dizziness, fatigue
• Gastrointestinal:
  Nausea, abdominal discomfort, flatulence
• Cardiovascular:
  Mild hypotension

Rare or serious side effects:
None reported in clinical trials; no known dose-dependent toxicities

Onset:
Most side effects occur within the first 1–2 weeks of use

Severity:
Mild, self-limiting; no discontinuations due to adverse events in published trials

• Drug–Drug:
  No known interactions with prescription medications
• Drug–Food:
  Safe with or without meals
• Drug–Alcohol:
  No data; advisable to limit alcohol due to possible interference with neurocognitive recovery
• Enzyme systems involved:
  No CYP450 interactions known or expected

• A 2024 open-label trial (ISRCTN10702895) confirmed the long-term safety and potential cognitive benefit of N-PEP-12 over 360 days in post-stroke adults.
• No changes in approval status from the FDA, EMA, WHO, or other regulatory bodies.
• No new safety warnings issued as of 2025.

• Storage temperature: 20°C to 25°C (room temperature)
• Humidity: Store in a dry place; avoid exAAposure to high moisture
• Light protection: Keep away from direct sunlight
• Handling: Do not freeze; do not crush or chew capsules
• Reconstitution: Not required