At a glance
- Tesofensine is not an FDA-approved drug: Drugs@FDA has no record of it.
- PubMed lists 56 publications mentioning it, including 11 randomized controlled trials and 9 animal-only studies.
- ClinicalTrials.gov lists 14 registered studies testing it (0 active).
- FDA's adverse event system (FAERS) holds 3 reports mentioning it; 2 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Investigations Into the Metabolism and Elimination of Tesofensine in Human Urine.
- Structural basis for pharmacotherapeutic action of triple reuptake inhibitors.
- Sex-specific effects of appetite suppressants on stereotypy in rats.
- Tesofensine, a novel antiobesity drug, silences GABAergic hypothalamic neurons.
- Randomized controlled trial of Tesomet for weight loss in hypothalamic obesity.
- New insights into potential nutritional effects of dietary saponins in protecting against the development of obesity.
- Anorectic state of obesity medications in the United States. Are leaner times ahead?
- Centrally Acting Agents for Obesity: Past, Present, and Future.
- Future Pharmacotherapy for Obesity: New Anti-obesity Drugs on the Horizon.
- Approaches for the Development of Drugs for Treatment of Obesity and Metabolic Syndrome.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 14
- Active
- 0
- With posted results
- 5
Conditions studied
Show 4 more studies
All 14 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 3
- Serious
- 2
- With death outcome
- 0
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
Change history
No changes since monitoring began on October 30, 2026.