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    Tesofensine (500mcg)

    Oral or SubcutaneousOnce daily500mcg

    Reviewed by the AllPeptides.eu Editorial Team·Last reviewed: 2026-06-16

    🇺🇸 Phase II
    🇪🇺 Phase II

    Educational information. Not medical advice, and no efficacy claim is implied. Regulatory approval is not a use recommendation by AllPeptides.eu.

    Research-only — no FDA/EMA approval
    Educational information. Not medical advice or a recommendation for use.

    ⚠️ For informational/educational purposes only. Not medical advice. We do not sell any products. Self-treatment carries serious risks — consult a healthcare professional. Disclaimer

    Free Access

    How It Works

    Tesofensine inhibits the reuptake of serotonin, norepinephrine, and dopamine in the brain, reducing appetite and possibly increasing basal metabolism. In Phase IIb clinical trials, patients with obesity lost 6–13% of their body weight over 24 weeks.

    Quick Start

    • Form: 500 mcg capsule or lyophilized vial.
    • Typical dose: 250–500 mcg daily.
    • Administration: Oral or subcutaneous (investigational).
    • Storage: Room temperature (capsule) or 2–8 °C (vial).
    Detailed Protocol Data

    Typical Dosing (500 mcg capsule/vial)

    Educational only

    Route: Oral or Subcutaneous | Frequency: Once daily

    WeekDoseUnits (per injection)
    Weeks 1–2
    250 mcg
    Half capsule or appropriate units
    Weeks 3+
    500 mcg
    1 capsule / full dose

    Once daily, preferably in the morning. The 500 mcg dose corresponds to the Phase IIb study.

    Related compounds

    Reconstitution Steps

    1. If using lyophilized form, reconstitute according to manufacturer's instructions.
    2. Capsules: no reconstitution needed.

    Protocol Overview

    • Goal: Weight loss through appetite reduction and increased energy expenditure.
    • Mechanism: Triple reuptake inhibition (5-HT, NE, DA).
    • Schedule: Daily, continuous use.

    Dosing Protocol

    • Initiation: 250 mcg daily × 2 weeks.
    • Maintenance: 500 mcg daily.
    • Duration: 12–24 weeks (based on Phase IIb studies).
    • Break between cycles: Gradual reduction before discontinuation. Monitor weight after stopping.

    Washout & Cycle Restart

    When can I restart?

    Gradual reduction before discontinuation. Monitor weight after stopping.

    Minimum wait period: 4 weeks

    Storage Instructions

    • Capsules: Room temperature, away from moisture.
    • Vial: 2–8 °C after reconstitution.

    Important Notes

    • NOT approved — Phase IIb completed, Phase III ongoing.
    • Differs from GLP-1 agonists — central action on neurotransmitters.
    • May increase heart rate and blood pressure.
    • Contraindicated in patients with uncontrolled hypertension.
    • Interactions with MAOIs and antidepressants.
    Clinical Analysis & Safety

    Potential Benefits & Side Effects

    Potential Benefits:

    • Significant weight loss (6–13% in Phase IIb).
    • Appetite reduction.
    • Possible increase in metabolism.
    • Mood improvement (dopaminergic action).

    Potential Side Effects:

    • Increased heart rate.
    • Dry mouth.
    • Insomnia.
    • Constipation.
    • Nausea.

    ⚠️ Serious Warnings & Long-Term Risks

    The following warnings are based on published literature, FDA labels, and post-marketing surveillance. They do not constitute medical advice. Consult a healthcare professional.

    ❤️ Cardiovascular
    🔴 High Risk

    Increased heart rate & blood pressure

    Tesofensine (triple reuptake inhibitor — 5-HT/NA/DA) caused dose-dependent increase in heart rate (+7-8 bpm) and blood pressure. Contraindicated in uncontrolled hypertension.

    📄 TIPO-1 & TIPO-2 Phase 2 Trials — Lancet 2008
    🧠 Neurological
    🔴 High Risk

    Psychiatric adverse events

    As a monoamine reuptake inhibitor, may cause insomnia, anxiety, mood changes. Contraindicated in patients with psychiatric history or on MAOIs.

    📄 Phase 2 Safety Data — Obesity Reviews 2010

    References

    1. Tesofensine Phase IIb: Weight Loss in Obese Patients (TIPO-1) — The Lancet (2008) — Tesofensine Phase IIb: weight loss in obese patients (TIPO-1)
      View Source
    2. Int J Obes — Tesofensine mechanism and metabolism
      View Source
    3. Obesity Reviews — Review of tesofensine as an anti-obesity agent
      View Source

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    Research Sources & Verified Data
    …
    Clinical Trials
    …
    PubMed Studies
    Research-only
    FDA Status
    0
    Regulatory Approvals
    Verified across ClinicalTrials.gov, PubMed & FDA

    External Sources & Regulatory Status

    Regulatory Approvals

    🇺🇸
    FDA
    Phase II

    Obesity

    🇪🇺
    EMA
    Phase II

    Obesity

    Phase II clinical trials

    No official regulatory source available yet — research peptide.

    Educational information. Not medical advice, and no efficacy claim is implied. Regulatory approval is not a use recommendation by AllPeptides.eu.

    Summary:
    0 Approvals
    0 PubMed
    0 Clinical Studies

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