Tesofensine (NS2330) is an oral triple monoamine reuptake inhibitor that was first tested in Alzheimer's and Parkinson's disease and then developed for obesity.
Human trialsNon-peptide compound reference
Also known as: NS-2330, NS2330, Tesofensina, UNII BLH9UKX9V1, DrugBank DB06156, CHEMBL3989690, Tesomet (fixed combination with metoprolol)
Amounts reported for Tesofensine are listed under Reported protocols, each with its source and study kind. No amount ladder is inferred from them. This is educational source context, not a protocol or recommendation.
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Clinical context
Human study rows are described per source under Reported protocols; they belong to their trial populations and are not a general amount.
Storage, handling and interpretation
Product identity
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Prepared solutions
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Reported protocols for Tesofensine
What published studies and recent community write-ups report about amounts, timing and course length. 3 clinical and 2 community-reported rows, each linked to its source. These are descriptions of what others report, not instructions, and nothing here is medical advice.
Context
Dose
Frequency
Route
Course
Source
Clinical3 rows
TIPO-1 phase 2 dose-ranging trial in obesity203 obese adults (BMI 30-40) at five Danish obesity centres, on an energy-restricted diet
Weight fell by 4.5%, 9.2% and 10.6% on the three doses against 2.0% on diet and placebo, with dry mouth, nausea, constipation, hard stools, diarrhoea and insomnia the most common adverse events; heart rate rose 7.4 beats a minute at 0.5 mg while blood pressure was unchanged at the two lower doses. The authors suggested 0.5 mg could roughly double the weight loss of drugs then approved, and the PubMed record carries a 2013 expression of concern from the journal.
Phase 3 registration trial in Mexico (Viking)372 Mexican adults with obesity randomised 1:1:1 at two centres, 288 (77.4%) completing
0.25 mg or 0.50 mg, against placebo
Once daily
Oral tablets
24 weeks, with all arms on the same reduced-calorie diet and exercise programmeNone described
Absolute weight loss at 24 weeks was 1.9 kg on placebo, 5.3 kg on 0.25 mg and 8.6 kg on 0.50 mg; 12 of the 84 who discontinued did so because of an adverse event. Saniona's December 2018 release on the same study reported about 10% average weight loss with more than half of patients losing over 10%, a small but significant rise in heart rate and no significant blood pressure effect, and a safety database of roughly 1,600 patients across the programme.
Tesomet phase 2 trial in hypothalamic obesity21 adults with hypothalamic obesity after pituitary or hypothalamic injury, 16 of them women, at a Copenhagen referral centre
0.5 mg tesofensine with 50 mg metoprolol
Once daily
Oral
24 weeks, with diet and lifestyle counselling in both armsNone described
Weight fell 6.3% more than on placebo (95% CI 1.3-11.3), 8 of 13 on Tesomet lost at least 5% against 1 of 8 on placebo, and heart rate and blood pressure did not differ between groups, which was the point of adding the beta-blocker. Sleep disturbance (50%), dry mouth (43%) and headache (36%) were the common drug-related effects and one patient stopped because of worsened pre-existing anxiety. Saniona staff are co-authors.
Community-reported2 rows
Vendor capsule listing
500 mcg per capsule
Not stated
Oral capsule
Not stated
Community resource2026
This is a vendor claim: the vendor sells tesofensine as 500 mcg GMP capsules for monoamine transporter research and states no dosing. The capsule strength equals the 0.5 mg daily dose used in the phase 2 and phase 3 trials, but the vendor product is not the pharmaceutical tablet tested in those trials.
Consumer-health evidence summary
0.5 mg once daily is the trial dose the guide summarises; it gives no dose of its own
Not stated
Not stated
Not stated
Community resource2026
A September 2026 guide records that tesofensine is not FDA-approved and not approved in Mexico, that COFEPRIS issued only a non-binding favourable technical opinion in February 2023, and that Medix continues to pursue approval. It summarises the Tesomet trial's cardiovascular findings as the strongest human support for pairing tesofensine with a beta-blocker.
How a course is commonly described
1
Weeks 1-2Clinical
The trials began with a two-week run-in on diet alone before randomisation, then started tesofensine at the full once-daily dose (0.25, 0.5 or 1.0 mg) with no titration. Dry mouth, nausea, constipation and insomnia were the early complaints.
2
Weeks 2-12Clinical
In the Tesomet trial weight loss was steepest during the first 12 weeks and then continued more slowly. Heart rate rose by about 7 beats a minute at 0.5 mg when tesofensine was given alone, and did not rise when 50 mg of metoprolol was co-formulated.
3
Week 24Clinical
Every controlled trial ended its primary measurement at 24 weeks: 9.2% weight loss at 0.5 mg in TIPO-1, 8.6 kg at 0.5 mg in the Mexican phase 3, and 6.3% beyond placebo with Tesomet. No published tesofensine trial defines a stopping point, a taper or an off period.
The human dose range is narrow and well documented: 0.25-1.0 mg once daily, with 0.5 mg the dose carried into phase 3 and into Tesomet. Those figures belong to adults with obesity in supervised trials with diet and exercise.
Tesofensine is not approved anywhere as of October 2026. Saniona announced on 6 and 12 November 2024 that COFEPRIS had not granted approval, and on 20 February 2025 that Medix had resubmitted a roughly 20,000-page dossier; no decision has been published since. Claims that it was approved in Mexico in 2024 are not supported by the company's own releases.
It is an oral small molecule, so no vial, reconstitution or syringe maths is involved. The rows above record what sources report, not endorsements of use.
Plus 2 community resources (dosing guides, forum threads and vendor write-ups), reported above but not linked.
Overview
Tesofensine (NS2330) is an oral triple monoamine reuptake inhibitor that was first tested in Alzheimer's and Parkinson's disease and then developed for obesity, where it reduces appetite and food craving. In a Danish phase 2 trial 0.5 mg a day produced about 9% weight loss over 24 weeks, and a 372-patient phase 3 trial run by Medix in Mexico reported about 10%, but as of October 2026 it is not approved anywhere: Mexico's regulator withheld approval in November 2024 and Medix resubmitted a revised dossier in February 2025. Saniona also tests it combined with metoprolol, as Tesomet, for hypothalamic obesity.
What researchers are exploring
These themes describe recurring questions in published research. They are not claims of effectiveness or recommendations for use.
1
Metabolic research
Energy balance, body composition and incretin signaling.
2
TIPO-1 phase 2 dose-ranging trial in obesity
Weight fell by 4.5%, 9.2% and 10.6% on the three doses against 2.0% on diet and placebo, with dry mouth, nausea, constipation, hard stools, diarrhoea and insomnia the most common adverse events; heart rate rose 7.4.
3
Phase 3 registration trial in Mexico (Viking)
Absolute weight loss at 24 weeks was 1.9 kg on placebo, 5.3 kg on 0.25 mg and 8.6 kg on 0.50 mg; 12 of the 84 who discontinued did so because of an adverse event. Saniona's December 2018 release on the same study.
4
Tesomet phase 2 trial in hypothalamic obesity
Weight fell 6.3% more than on placebo (95% CI 1.3-11.3), 8 of 13 on Tesomet lost at least 5% against 1 of 8 on placebo, and heart rate and blood pressure did not differ between groups, which was the point of adding the.
5
Vendor capsule listing
This is a vendor claim: the vendor sells tesofensine as 500 mcg GMP capsules for monoamine transporter research and states no dosing. The capsule strength equals the 0.5 mg daily dose used in the phase 2 and phase 3.
6
Consumer-health evidence summary
A September 2026 guide records that tesofensine is not FDA-approved and not approved in Mexico, that COFEPRIS issued only a non-binding favourable technical opinion in February 2023, and that Medix continues to pursue.
What the current evidence can support
Study models remain visible so laboratory and animal findings are not mistaken for established human outcomes.
Human
Human studies and registrations
3 protocol rows on this page come from human trials, trial registrations, regulator labels or reviews of human data. Approval status and populations are stated per row.
Not graded
Community-reported use
2 rows record what blogs, vendor write-ups or forums describe for Tesofensine. None has been verified against primary literature.
Chemistry identifiers
Sequence, synonyms and registry identifiers as recorded in PubChem, the National Library of Medicine's open chemistry database. Formula, mass and CAS number are summarized at the top of the page.
Also listed as
NS-2330, NS2330, Tesofensina, UNII BLH9UKX9V1, DrugBank DB06156, CHEMBL3989690, Tesomet (fixed combination with metoprolol)