500mcg
500mcg oral capsule
Potential For
Patients who prefer oral medications over injections, or those seeking an alternative mechanism to GLP-1 therapies for appetite control.
Triple Reuptake Inhibitor • Coming Soon
A Different Approach to Appetite Control
Tesofensine is a novel triple monoamine reuptake inhibitor that works on serotonin, norepinephrine, and dopamine pathways—completely different from GLP-1 medications. Phase 2 trials showed up to 10.6% weight loss in 24 weeks, with effects on both appetite suppression and resting energy expenditure. Join our waitlist to be notified when available.
10.6%
Weight Loss (0.5mg)*
24
Week Phase 2 Trial
1x
Daily Oral Dose
TBD
FDA Status Pending
Coming Soon
A novel oral weight loss medication that works through brain neurotransmitter pathways rather than gut hormones—offering an alternative approach for patients who prefer pills over injections.
500mcg oral capsule
Potential For
Patients who prefer oral medications over injections, or those seeking an alternative mechanism to GLP-1 therapies for appetite control.
The Science
Tesofensine is a triple monoamine reuptake inhibitor—it blocks the reabsorption of serotonin, norepinephrine, and dopamine in the brain. This is a completely different mechanism from GLP-1 medications, working directly on brain neurotransmitter systems that regulate appetite, satiety, and energy expenditure.
Originally developed for Parkinson’s and Alzheimer’s disease, tesofensine was repurposed for obesity after clinical trials consistently showed significant weight loss as a “side effect.” By modulating dopamine and serotonin pathways, it reduces food cravings and enhances feelings of fullness while potentially increasing resting metabolic rate.
In Phase 2 trials published in The Lancet, patients on 0.5mg tesofensine lost an average of 11.3kg (about 10.6% body weight) over 24 weeks—roughly double what was achieved with obesity medications available at that time. Phase 3 trials are ongoing.
Join the Waitlist
How It Works
Tesofensine works by blocking the reabsorption of three key neurotransmitters involved in appetite and energy regulation.
Increases serotonin availability in the brain, enhancing satiety signals and reducing cravings—similar to how SSRIs work but with additional pathways.
Boosts norepinephrine levels, potentially increasing resting energy expenditure and fat oxidation while suppressing appetite.
Modulates the reward pathway to reduce the pleasure drive for food consumption, making it easier to resist cravings and emotional eating.
Different Approaches
Tesofensine represents a fundamentally different approach to weight loss—working on brain neurotransmitters rather than gut hormones.
*Phase 2 trial data. Phase 3 trials ongoing. Not yet FDA approved.
Potential Benefits
A daily pill instead of weekly injections—ideal for patients who prefer not to self-inject or have needle aversion.
Works on brain neurotransmitter systems (serotonin, dopamine, norepinephrine) rather than gut hormones—a completely distinct pathway from GLP-1 medications.
Both suppresses appetite and potentially increases resting energy expenditure—addressing weight from both calorie intake and metabolic rate angles.
Unlike GLP-1 therapies, the primary side effects are dry mouth, headache, and insomnia rather than nausea and vomiting.
Dopamine pathway modulation may help reduce food cravings and emotional eating—addressing the psychological aspects of overeating.
Increased BDNF levels and serotonin/dopamine activity may provide mild mood-enhancing effects alongside weight loss.
What to Do Now
Tesofensine isn’t available yet, but you don’t have to wait to start your weight loss journey. Here’s how we can help today.
Sign up to be notified when tesofensine receives FDA approval and becomes available at BHRC.
Meet with our physicians to discuss FDA-approved options like semaglutide or tirzepatide that are available now.
Begin your weight loss journey with proven therapies while monitoring tesofensine’s progress through approval.
When tesofensine becomes available, discuss with your physician whether its oral, neurotransmitter-based approach is right for you.
Clinical Trial Status
Tesofensine has completed Phase 2 clinical trials with Phase 3 trials ongoing. While results are promising, it has not yet received FDA approval for commercial use.
TIPO
Clinical trial program evaluating tesofensine for obesity treatment
203
Participants in the pivotal Phase 2b trial (TIPO-1)
Questions
No, tesofensine is not yet FDA approved. It has completed Phase 2 clinical trials with Phase 3 trials ongoing. The timeline for FDA approval remains uncertain. Until approved, tesofensine is not available for commercial sale.
Tesofensine works on completely different pathways. While GLP-1 medications (semaglutide, tirzepatide) work through gut hormones and affect gastric emptying, tesofensine is a triple reuptake inhibitor that blocks reabsorption of serotonin, norepinephrine, and dopamine in the brain. It’s taken as a daily oral pill rather than a weekly injection.
The most common side effects in clinical trials were dry mouth, headache, nausea, insomnia, constipation, and diarrhea. Unlike GLP-1 medications, nausea and vomiting are less prominent. Higher doses showed some increase in heart rate, which is being carefully evaluated in Phase 3 trials.
Yes, tesofensine is taken as a once-daily oral capsule—no injections required. This makes it an attractive option for patients who prefer pills over self-injection or have needle aversion.
In Phase 2 trials, the 0.5mg dose produced approximately 10.6% body weight loss over 24 weeks (average 11.3kg or about 25 pounds). Extended studies showed continued weight loss, with some patients losing 13-14kg over 48 weeks. Phase 3 trials will provide more definitive data.
Tesofensine is not available outside of clinical trials. Be cautious of any source claiming to sell tesofensine—these products are unregulated and potentially dangerous. If you’re interested in weight loss treatment now, we offer FDA-approved options like semaglutide and tirzepatide.
Once available, tesofensine may be particularly suitable for patients who prefer oral medications over injections, those who experience significant GI side effects with GLP-1 therapies, or those who struggle with food cravings and emotional eating (due to its dopamine pathway effects). Our physicians can help determine the best approach for your needs.
Stay Updated
Be the first to know when tesofensine becomes available. In the meantime, our team can discuss FDA-approved options like semaglutide and tirzepatide.
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*Tesofensine is an investigational medication that has completed Phase 2 clinical trials with Phase 3 trials ongoing. It is NOT FDA approved for commercial sale. The weight loss figures cited (10.6%) are from Phase 2 trials at the 0.5mg dose; final Phase 3 results may differ. Tesofensine may increase heart rate and has other cardiovascular considerations under evaluation. Any source claiming to sell tesofensine outside of clinical trials is unregulated and potentially dangerous. BHRC does not currently offer tesofensine. This page is for informational purposes only. Consult with our medical team about FDA-approved weight loss options available today.