A randomized Phase II obesity trial showed dose-dependent weight loss, and smaller physiology studies suggest appetite/satiety effects are more prominent than a large 24-hour energy-expenditure increase. Tesomet combination data exist in hypothalamic obesity.
Regulatory status
Not FDA-approved; FDA has cited tesofensine as ineligible for use in US 503A compounding in enforcement material.
Main limitations
Marketing approval, long-term cardiovascular outcomes, routine-use dosing or superiority to current approved obesity medicines.
Safety
Increased heart rate/blood pressure, dry mouth, nausea, insomnia and neuropsychiatric effects are key concerns.
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A randomized Phase II obesity trial showed dose-dependent weight loss, and smaller physiology studies suggest appetite/satiety effects are more prominent than a large 24-hour energy-expenditure increase. Tesomet combination data exist in hypothalamic obesity.
What the evidence actually supports
✓Evidence is human and meaningful but not equivalent to approval or long-term established use.
✓Evidence is stronger than many research chemicals but weaker than currently approved obesity medicines.
✓Useful mechanistic correction for weight-loss pages.
✓Do not transfer combination tolerability directly to tesofensine alone.
What is not established / key limitations
×Heart rate increased at 0.5 mg and CNS/GI adverse effects were common; Phase III confirmation was explicitly required.
×Heart-rate and tolerability effects constrained interpretation / development.
×No evidence this is primarily a 'metabolic burner'.
×One treatment-related serious adverse event was exacerbation of pre-existing anxiety.
Increased heart rate/blood pressure, dry mouth, nausea, insomnia and neuropsychiatric effects are key concerns.
Dry mouth, nausea, constipation, insomnia and heart-rate increases were notable in obesity trials; combination tolerability cannot be transferred to monotherapy.
Technical details
Mechanism / biologyInhibits reuptake of noradrenaline, dopamine and serotonin, affecting appetite and energy intake.
Route / formulation boundaryThis is not a peptide. Research results do not validate unregulated oral capsules.
Identity / data-quality noteUse the canonical compound identity and studied formulation when interpreting evidence.
Dosing evidence statusPhase 2 human dosing verified. A Phase 2 obesity trial studied oral tesofensine 0.25 mg, 0.5 mg and 1.0 mg once daily for 24 weeks. Tesofensine remains investigational.
Identifiers & alternate namesTeso · TESOFENSINE
Evidence rule: WhichPeps keeps human, animal, laboratory, regulatory and product/formulation evidence distinct. Common names help people find the page; they do not change the underlying scientific identity.
