Tesofensine

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)

(how we review)

Dosing & scaling, explained

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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No independently verified schedule

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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Storage & handling

Follow the product label, certificate and validated laboratory SOP; no universal storage assumption is applied here.

Prepared solutions

Label concentration and preparation date, use sterile technique where applicable, and follow a validated stability protocol.

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.

ContextDoseFrequencyRouteCourseSource
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 diet0.25, 0.5 or 1.0 mg, against placeboOnce dailyOral24 weeks after a 2-week run-inNone describedThe Lancet (PubMed)2008
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%) completing0.25 mg or 0.50 mg, against placeboOnce dailyOral tablets24 weeks, with all arms on the same reduced-calorie diet and exercise programmeNone describedUMIN Clinical Trials Registry2024
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 centre0.5 mg tesofensine with 50 mg metoprololOnce dailyOral24 weeks, with diet and lifestyle counselling in both armsNone describedEuropean Journal of Endocrinology (PubMed)2022
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 listing500 mcg per capsuleNot statedOral capsuleNot statedCommunity 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 summary0.5 mg once daily is the trial dose the guide summarises; it gives no dose of its ownNot statedNot statedNot statedCommunity 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.
Sources for this section (8)
  1. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trialThe Lancet (PubMed)2008Clinical
  2. Efficacy and safety of tesofensine for the treatment of obesity in adults: a phase 3 randomized controlled study (UMIN000054277)UMIN Clinical Trials Registry2024Clinical
  3. Saniona's tesofensine meets primary and secondary endpoints in Phase 3 obesity registration trialSaniona AB via GlobeNewswire2018Clinical
  4. Randomized controlled trial of Tesomet for weight loss in hypothalamic obesityEuropean Journal of Endocrinology (PubMed)2022Clinical
  5. Update on Tesofensine Application (Saniona regulatory release, 12 November 2024)Saniona AB via Inderes2024Clinical
  6. Medix has resubmitted tesofensine application to COFEPRIS (Saniona regulatory release, 20 February 2025)Saniona AB via Inderes2025Clinical

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)

InChIKey

VCVWXKKWDOJNIT-ZOMKSWQUSA-N

IUPAC name

(1R,2R,3S,5S)-3-(3,4-dichlorophenyl)-2-(ethoxymethyl)-8-methyl-8-azabicyclo[3.2.1]octane

Limitations and unknowns

Important limitations

  • Every amount on this page is a report of what a source describes, not a protocol to follow.
  • Preclinical and community rows do not establish a human amount, schedule or route.
  • Formulation, purity and presentation vary by supplier and are not covered by the dossier.

Sources

7 curated references, each with its journal, year and study model, plus 2 community resources reported but not linked.

  1. Tesofensine (PubChem CID 11370864)PubChem, National Library of Medicine2026Not graded
  2. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trialThe Lancet (PubMed)2008Human
  3. Efficacy and safety of tesofensine for the treatment of obesity in adults: a phase 3 randomized controlled study (UMIN000054277)UMIN Clinical Trials Registry2024Human
  4. Saniona's tesofensine meets primary and secondary endpoints in Phase 3 obesity registration trialSaniona AB via GlobeNewswire2018Human
  5. Randomized controlled trial of Tesomet for weight loss in hypothalamic obesityEuropean Journal of Endocrinology (PubMed)2022Human
  6. Update on Tesofensine Application (Saniona regulatory release, 12 November 2024)Saniona AB via Inderes2024Human
  7. Medix has resubmitted tesofensine application to COFEPRIS (Saniona regulatory release, 20 February 2025)Saniona AB via Inderes2025Human