Regulatory Status
Tesofensine has no approved medical use and carries no FDA-approved label. It remains classified as an investigational compound under research, with no marketed brand name or authorized indication in any country referenced by this data.
Key Takeaways
- Tesofensine is an unapproved, investigational chemical entity with no FDA label.
- Thirteen clinical trials have been registered for tesofensine to date.
- Sampled trials span pharmacokinetic, dementia-related, and obesity-related research contexts.
- No adverse event report data is available for this compound in this dataset.
What Tesofensine Is
Tesofensine is a small molecule chemical compound with the molecular formula C17H23Cl2NO and a molecular weight of about 328.3. It has no approved drug label, meaning no FDA-sanctioned indication, dosing information, or official mechanism-of-action statement exists for it. Any use of tesofensine outside registered research settings falls outside approved medical practice.
Trial Footprint
Thirteen clinical trials referencing tesofensine are registered. Among the sampled studies, one Phase 2 trial evaluated the safety and tolerability of co-administering tesofensine with metoprolol in subjects with hypothalamic injury-induced obesity over 48 weeks, and it has completed. A separate completed Phase 2 trial examined three doses of tesofensine (referred to as NS 2330) in patients with mild to moderate Alzheimer's type dementia. A completed Phase 1 study also investigated the compound's pharmacokinetic profile.