Tesofensine has randomized human Phase 2 evidence showing weight-loss effects, but it is not an approved obesity medicine. Long-term cardiovascular outcomes and its place compared with current approved treatments remain uncertain.
Still uncertain: Marketing approval, long-term cardiovascular outcomes, routine-use dosing or superiority to current approved obesity medicines.
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What does the evidence mean in simple terms? table
What is it?
Small-molecule monoamine reuptake inhibitor
Entity type
Small molecule
Research focus
Obesity/weight-management research
Human evidence
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.
Evidence reviewed
2026-09-18
i
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.
Outcome-level evidence
Evidence is not one score.
Each record below answers a narrower question about an outcome, population or context. Evidence status and the study finding are shown separately so strong evidence is not mistaken for a positive effect.
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.
Study / label regimen evidencePhase 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.
WhichPeps does not rely on a single headline study when the evidence base is broader. Primary research, registries, regulators and supporting records are kept distinct.
2structured study records
4outcome records
6linked source records
How to read these counts: they show evidence coverage, not evidence strength. One large, well-designed study can be more informative than several weak or indirect records.
Show supporting and discovery sources
Study pages above contain the records used for public evidence summaries. The links below include supporting, regulatory and literature-discovery sources; a registry or search result is not treated as proof of benefit.
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.
