▶ TESOFENSINE · SUBTOPIC · SAFETY PROFILE
TESOFENSINE Safety Profile
For Laboratory Research Use Only. This page summarises observed adverse events and regulatory status reported in the peer- reviewed literature. It is not medical advice and does not recommend any human use of TESOFENSINE.
OBSERVED ADVERSE EVENTS IN LITERATURE
The following adverse events have been observed in trials or animal studies of TESOFENSINE. Severity, frequency, and attribution depend on the source publication.
- Dry mouth
- Nausea
- Constipation
- Insomnia
- Dose-dependent heart rate increase
- Mild blood pressure increase
DRUG INTERACTIONS
The following interactions are reported in or theorised from the published mechanism for TESOFENSINE.
- MAO inhibitors (contraindicated)
- Serotonergic agents (serotonin syndrome risk)
- Stimulants (additive cardiovascular effects)
CONTRAINDICATIONS REPORTED IN LITERATURE
Contraindications recorded for TESOFENSINE in the published record:
- Recent MAO inhibitor use
- Severe cardiovascular disease
- Pheochromocytoma
- Pregnancy/lactation
FDA REGULATORY STATUS
Not FDA-approved. Saniona Phase 3 obesity programs ongoing.
WADA REGULATORY STATUS
Not currently listed on the WADA Prohibited List (2026).
SAFETY Q+A FROM LITERATURE
▶ Is tesofensine FDA-approved?
No. Saniona is conducting Phase 3 programs in Prader-Willi syndrome (TES-PWS) and hypothalamic obesity (TES-HO). FDA approval is pending Phase 3 readout.
▶ Is tesofensine WADA-prohibited?
Tesofensine is not currently listed on the WADA Prohibited List as of 2026. Some triple reuptake inhibitors are listed under stimulant categories; tesofensine specifically is not.
CITED LITERATURE
The safety statements above are drawn from the following peer-reviewed sources. Refer to the originals for adverse- event tables, attribution, and full context.
- Astrup A, Madsbad S, Breum L, Jensen TJ, Kroustrup JP, Larsen TM. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet 2008. PMID 18950853. link
- Bello NT, Zahner MR. Tesofensine: A novel weight-loss agent for obesity treatment. Drug Discov Today Ther Strateg 2009. link
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▶ LAST UPDATED · 2026-05-25