Tesofensine

What Tesofensine does

Tesofensine is a small-molecule drug, not a peptide. Obesity trials found weight loss with daily oral doses. It has no FDA approval, and Mexican approval was not confirmed as of this review. Heart-rate increases and mental health effects are key concerns. The main 2008 trial later received an expression of concern about safety reporting.

• A phase 2 trial reported weight loss, but its safety reporting raised concerns. (Studied in a trial)
• A larger trial in Mexico also points to weight loss, though its full safety data were never published. (Studied in a trial)
• In a study, people felt full sooner at first, but this faded with continued use. (Studied in a trial)
• Some users report less appetite, and changes in mood, focus or motivation. (Reported by users)

Uses in the sources

• A phase 2 obesity trial found more weight loss than placebo, but the journal later raised concerns about safety reporting. (Studied in a trial) (source)
• Tesomet combines tesofensine with metoprolol. Small trials studied hypothalamic obesity, Prader–Willi syndrome and type 2 diabetes. (Studied in a trial) (source)
• Alzheimer’s and Parkinson’s studies did not establish useful clinical benefit. (Studied in a trial) (source)
• Some users report focus or mood effects. These are anecdotes, not evidence for ADHD or depression care. (Reported by users) (source)

Tesofensine dosage

Typical reported dose: 0.5 mg by mouth once a day

• TIPO-1: 0.25 mg: 0.25 mg daily once daily, by mouth. Studied in a trial. Studied in: Adults with obesity. (source)
• TIPO-1: 0.5 mg: 0.5 mg daily once daily, by mouth. Studied in a trial. Studied in: Adults with obesity. (source)
• TIPO-1: 1 mg: 1 mg daily once daily, by mouth. Studied in a trial. Studied in: Adults with obesity. (source)
• Mexico phase 3: 0.25 mg: 0.25 mg daily once daily, by mouth. Studied in a trial. Studied in: Adults with obesity. (source)
• Mexico phase 3: 0.5 mg: 0.5 mg daily once daily, by mouth. Studied in a trial. Studied in: Adults with obesity. (source)
• Two-week energy study: 2 mg daily, days 1–7, then 1 mg daily, days 8–14 once daily, by mouth. Studied in a trial. Studied in: Overweight or moderately obese men. (source)

These are doses reported in labels, trials or user reports, not a personal plan. Check the source behind each one.

Work out syringe units with the dosing calculator

How to store Tesofensine

Comes as: Oral trial tablets, Capsules reported in community use and assayed in one study, Oral liquid reported in forums.

Mixed with: No home reconstitution diluent established; oral trials used finished tablets..

• No established vial size or water volume applies to the oral trial tablets.
• Subcutaneous use is an isolated anecdote; no human regimen or sterile preparation standard was found.
• Do not use laboratory extraction solvents as a human preparation recipe.

Before mixing: Trial tablets followed manufacturer instructions in monitored storage. No validated universal storage temperature for unregulated products was found.

After mixing: No validated home-mixed liquid stability or beyond-use time found.

Tesofensine side effects and risks

Reported side effects

• Dry mouth: Originally reported at 0.5 mg: 42.0% versus 11.5% placebo. Safety events were later found under reported., moderate (source)
• Nausea: Originally reported at 0.5 mg: 20.0% versus 9.6% placebo., moderate (source)
• Insomnia: Originally reported at 0.5 mg: 12.0% versus 1.9% placebo., moderate (source)
• Hard stools: Originally reported at 0.5 mg: 14.0% versus 3.8% placebo., moderate (source)
• Constipation: Originally reported at 1 mg: 16.3%; 0.5 mg: 2.0%; placebo: 7.7%. Frequency varies with dose., moderate (source)
• Diarrhea: Originally reported at 0.5 mg: 8.0% versus 5.8% placebo., moderate (source)
• Headache: Originally reported at 0.5 mg: 34.0% versus 40.4% placebo., moderate (source)
• Dizziness: Originally reported at 0.5 mg: 10.0% versus 3.8% placebo., moderate (source)
• Vomiting: Originally reported at 0.5 mg: 6.0% versus 1.9% placebo., moderate (source)
• Raised heart rate or palpitations: 0.5 mg increased mean heart rate by 7.4 beats/min versus placebo. Palpitations were reported., serious (source)
• High blood pressure: 1 mg increased blood pressure in TIPO 1; individual risk cannot be estimated reliably., serious (source)
• Anxiety, mania, depression or unusual behavior: Serious psychiatric events occurred in small Tesomet studies. A population rate is unknown., serious (source)

Stop and get help if

• Chest pain, fainting or a racing/irregular heartbeat: Stop exposure and get urgent medical care.
• Fever with confusion, sweating, shaking or muscle twitching: Seek emergency care for possible serotonin toxicity.
• Hallucinations, mania, severe agitation or suicidal thoughts: Stop exposure and seek urgent assessment; immediate danger needs emergency care.
• Swollen tongue or throat, or trouble breathing: Seek emergency care for a possible severe allergic reaction.
• Confusion, severe headache or seizures while taking desmopressin: Seek urgent care; low blood sodium is possible.
• Persistent low glucose, confusion or inability to swallow safely: Use the prescribed hypoglycemia plan and seek urgent care.

Who should avoid it

• pregnant: Pregnancy was excluded from obesity trials; fetal safety has not been established.
• breastfeeding: Breastfeeding was excluded; milk transfer and infant safety are unknown.
• tryingToConceive: Trials required contraception. No evidence-based preconception washout is established.
• under18: General obesity dosing is not established under 18. A small PWS trial does not validate general pediatric use.
• eatingDisorderHistory: Appetite suppression can worsen restrictive eating; obesity trials excluded eating disorders.
• heartCondition: Heart rate can rise. Trials excluded major heart disease, arrhythmias and recent heart attack or stroke.
• uncontrolledBloodPressure: Tesofensine can raise blood pressure; uncontrolled hypertension was excluded from trials.
• psychiatricCondition: Anxiety, mania, paranoia and mood changes occurred. Bipolar illness or psychosis requires particular review.
• depressionOrSuicidalThoughts: Trials screened mood and suicidality; serious depression was reported in a short Tesomet study.
• kidneyDisease: Kidney function affected modeled exposure; significant impairment was excluded. No validated dose adjustment exists.
• liverDisease: Significant liver disease was excluded; metabolism involves CYP3A4. No validated adjustment is available.
• seizureDisorder: Epilepsy was excluded from TIPO-1; seizure risk has not been defined.
• diabetes: Reduced intake may change glucose medicine needs. Diabetes trials used additional glucose monitoring.
• other: Known allergy to tesofensine or its tablet ingredients should stop use.
• other: Uncontrolled thyroid disease was excluded; it may compound heart-rate and weight effects.
• other: Uncontrolled glaucoma and significant eye disease were excluded from the obesity trial.
• surgeryPlanned: Tell the anesthesia team about exposure; the drug clears over weeks. No validated stop interval was found.
• testedAthlete: Tesofensine is named in WADA 2026 S6.B and prohibited in competition.
• other: Metoprolol protocols only: the label blocks severe bradycardia. TM005 also excluded resting heart rate <50 beats/min.
• other: Metoprolol protocols only: the label contraindicates metoprolol with second- or third-degree heart block.
• other: Metoprolol protocols only: sick sinus syndrome is a label contraindication unless a permanent pacemaker is in place.
• other: Metoprolol protocols only: the label contraindicates metoprolol during cardiogenic shock.
• other: Metoprolol protocols only: the label blocks use in decompensated heart failure. TM005 also excluded this condition.
• other: Metoprolol protocols only: allergy to metoprolol or any component of its tablet is a label contraindication and a TM005 exclusion.

Interactions

• MAO inhibitors: Avoid combining monoamine reuptake blockade with MAO inhibition: predicted serotonin toxicity or dangerous blood-pressure changes. MAOIs were excluded.
• Serotonergic medicines and supplements: Predicted serotonin-toxicity risk; SSRIs/SNRIs were prohibited in Tesomet trials. Direct interaction rates are unknown.
• Stimulants and other appetite suppressants: Overlapping stimulant effects may worsen heart rate, pressure, anxiety and sleep. Other appetite suppressants were excluded from trials.
• Strong CYP3A4 inhibitors: Itraconazole increased exposure; effects with other strong CYP3A4 inhibitors are predicted, not directly measured.
• Insulin and sulfonylureas: Reduced food intake and weight loss can lower glucose medicine needs. Hypoglycemia risk is inferred; combination data are limited.
• Metoprolol and other beta blockers: Metoprolol was studied with tesofensine. It can slow the heart or lower pressure; it does not remove psychiatric risk.
• Desmopressin: The trial protocol flags possible additive water retention and low sodium. The interaction is theoretical.
• GLP-1 drugs and experimental appetite drugs: Formal stack trials are lacking. Reduced intake, nausea and heart-rate effects may overlap; community results cannot establish safety.

Product quality risks

• A 2026 study measured 483 mcg in one capsule labeled 500 mcg. One product cannot establish market-wide quality.
• No independent market-wide tesofensine purity, contamination or counterfeit survey was located.
• FDA documented manufacturing-quality failures at an API distributor and identified tesofensine as ineligible for 503A compounding.
• Oral product purity does not establish sterility or safety for injection.

What to expect

At least 22 distinct human studies identified. The sponsor reports 34 development trials; many lack public detail. Phase 3 registry results exist; long-term safety is unsettled.

Key studies

• TIPO-1: obesity dose finding: Weight loss increased with dose; the safety record has reporting concerns. (source)
• Mexico: phase 3 obesity trial: Registry results support weight loss; the full published safety dataset is missing. (source)
• TIPO-4: long-term extension: Longer exposure occurred, but a complete final safety report was not found. (source)
• TIPO appetite follow-up: Early satiety gains faded during continued use and returned after restarting. (source)
• Two-week appetite and energy trial: Appetite changed clearly; total daily energy use did not significantly increase. (source)
• Four neurology trials: pooled weight data: Unplanned weight loss led to obesity development. (source)

Tesofensine FAQ

• Is Tesofensine FDA-approved? No FDA-approved product or label found. No tesofensine PCAC decision found. No 503B inclusion found; orphan designation is not approval.
• How do people take it? By mouth, once daily. 24 weeks. Source: studied in a trial.
• What's the difference between Tesofensine and Retatrutide? Tesofensine: an oral appetite drug with weight-loss trial results and heart-rate and psychiatric risks. Retatrutide: an experimental weekly injection with phase 3 weight-loss results. Why people pair them: users seek stronger appetite suppression or less food noise. No controlled stack trial was found.
• Can I take it with Retatrutide? Users seek stronger appetite suppression or less food noise. No controlled stack trial was found. Combined heart-rate and poor-intake risks are not quantified. Source: reported by users. Ask a doctor before combining anything.
• Is it banned in sport? Yes, in competition (WADA 2026). Named on page 16. A long detection window does not define an athlete’s safe washout time.
• How do I store it once opened? No validated home-mixed liquid stability or beyond-use time found.