Investigational monoamine reuptake inhibition; evidence-quality caveat applies.
What does it do?
A small-molecule triple monoamine-reuptake inhibitor studied for obesity; it is not a peptide or FDA-approved weight medicine.
Approved & studied uses
Evidence limits
View research →Research-market product identity, purity and formulation cannot be established from a publication.12
2 distinct primary sources or abstracts checked. Evidence may concern a parent compound, individual blend ingredient, animal, or cell model; it does not necessarily establish a benefit for this exact product.
Evidence definitions →Key safety information
All risks →Heart-rate and tolerability signals
The paper reported increased heart rate and dry mouth, GI symptoms and insomnia; its expression of concern also limits confidence in safety estimates.12
Not FDA approved; the key early efficacy paper has an expression of concern.
Molecular information
Amino-acid sequence
Not applicable: this compound is not a single peptide.
Formula, sequence notation & identity
Monoamine reuptake inhibitor
Salt, hydration, glycosylation and blend composition may change the supplied material; no unsupported formula or mass is assigned.
How long does it stay in the body?
This value is reported by a secondary reference. The stated attribution has not been independently verified as a route- and formulation-matched human PK measurement.
Illustrative scenario using an unverified reference estimate.
Five half-lives in this estimated model. This is not a prediction of when effects stop.
Evidence and model details
Population: Not established by the reference estimate
Source’s stated attribution: Phase 2/3 Clinical Trials
Source’s reported peak time: 8 hrs. This has not been independently confirmed and is not used in the elimination curve.
100 × 2−time / half-life. Time zero is a reference level, not the moment of administration. Absorption, repeated dosing, metabolites and clinical effects are not modeled. Five half-lives leaves 3.125%, not zero. This curve cannot determine a dosing interval.
What to expect
Study outcomes
Major evidence-quality caveat
The Lancet issued an expression of concern about the widely cited 2008 trial. Its headline weight-loss estimates should not be presented as uncontested evidence.12
Reported timelines
Reference & communitySource expectations
Appetite 1–2 weeks; weight change 2–4 weeks through 3–6 months. Persistence for weeks is plausible, not proof of stable effects.9
These are reported timelines, not a prediction of your response.
Community poll 10 topics · Pep-Pedia snapshot
Voluntary, unverified reports. These percentages do not measure effectiveness or safety.
Duration of use
Number of responses to this question: not disclosed.
Age range
Number of responses to this question: not disclosed.
Gender
Number of responses to this question: not disclosed.
Primary goal
The source hides 1 additional categories. Their labels and percentages are unavailable.
Number of responses to this question: not disclosed.
Experience
Number of responses to this question: not disclosed.
Effectiveness
The source hides 2 additional categories. Their labels and percentages are unavailable.
Number of responses to this question: not disclosed.
Side effects
The source hides 2 additional categories. Their labels and percentages are unavailable.
Number of responses to this question: not disclosed.
Dosage frequency
Number of responses to this question: not disclosed.
Would recommend
Number of responses to this question: not disclosed.
How discovered
The source hides 1 additional categories. Their labels and percentages are unavailable.
Number of responses to this question: not disclosed.
Source & limitations
The source displays “273 responses” for this profile. This is not a confirmed participant count or a denominator for individual questions.
- Voluntary self-reports from Pep-Pedia visitors; identity, treatment, outcomes and timing are unverified. These data are not efficacy or safety estimates.
- The source displays a profile-wide response label, not a confirmed unique participant count. It stays unchanged across questions. Question-specific denominators and absolute option counts are not exposed.
- Only the top five categories are displayed for some questions. Extra categories are retained as an undisplayed-category count; their labels and percentages are unavailable.
- Displayed percentages are rounded. They may not total 100%, especially where categories are hidden.
- This is a dated snapshot, not a live survey or current recommendation.
Doses & schedules
Compare purpose, amount, route, frequency, and duration.
Source corrections
Reference contraindication labels describe precautions for an investigational compound, not a U.S. prescribing label.
Scroll to compare all columns →
| Route | Dose | Frequency | Goal / evidence | Duration | References |
|---|---|---|---|---|---|
| Oral | 0.25 mg | Once daily | TIPO-1 phase II studyHuman study | 24 weeks | 1 |
Population 203 adults with obesity Context The publication has an expression of concern; protocol description is not a recommendation. Source dose wording 0.25, 0.5 or 1.0 mg | |||||
| Oral | 0.5 mg | Once daily | TIPO-1 phase II studyHuman study | 24 weeks | 1 |
Population 203 adults with obesity Context The publication has an expression of concern; protocol description is not a recommendation. Source dose wording 0.25, 0.5 or 1.0 mg | |||||
| Oral | 1 mg | Once daily | TIPO-1 phase II studyHuman study | 24 weeks | 1 |
Population 203 adults with obesity Context The publication has an expression of concern; protocol description is not a recommendation. Source dose wording 0.25, 0.5 or 1.0 mg | |||||
| Oral | 0.5 mg | Once daily in the morning | Standard Weight LossReference report | 12-24 weeks typical in clinical trials | 9 |
Population Population not independently verified; see the reference and linked research. Context Reported in Pep-Pedia’s educational protocol table. Study attribution and applicability to this exact product are not independently established. Reference contraindication labels describe precautions for an investigational compound, not a U.S. prescribing label. Source tabs Oral | |||||
| Oral | 0.25 mgStarting dose | Once daily in the morning | Conservative/Starting DoseReference report | 12-24 weeks typical in clinical trials | 9 |
Population Population not independently verified; see the reference and linked research. Context Reported in Pep-Pedia’s educational protocol table. Study attribution and applicability to this exact product are not independently established. Reference contraindication labels describe precautions for an investigational compound, not a U.S. prescribing label. Source tabs Oral | |||||
| Oral | 1.0 mg | Once daily (higher side effect rate) | Maximum Studied DoseReference report | 12-24 weeks typical in clinical trials | 9 |
Population Population not independently verified; see the reference and linked research. Context Reported in Pep-Pedia’s educational protocol table. Study attribution and applicability to this exact product are not independently established. Reference contraindication labels describe precautions for an investigational compound, not a U.S. prescribing label. Source tabs Oral | |||||
No protocols match these filters.
Study and label doses retain their study context. Reference reports are unvalidated practices, not personal treatment instructions. Ranges remain ranges; escalation stages are labeled.
Reported use periods and breaks. These do not establish a safe cycle or prove that breaks prevent tolerance.
Oral
- Use period
- 12-24 weeks typical in clinical trials
- Break
- Unknown - long half-life means effects persist weeks after stopping
Reported timing
Morning dosing recommended due to stimulant-like effects
Side effects & safety
Heart-rate and tolerability signals
The paper reported increased heart rate and dry mouth, GI symptoms and insomnia; its expression of concern also limits confidence in safety estimates.
12Common
Dry mouth, insomnia, pulse and BP increases.
Serious
Serotonergic, seizure and cardiovascular risks; long persistence can prolong adverse effects.
Stop symptoms
Chest pain/dyspnea, palpitations, sustained BP rise, severe insomnia/headache, dehydration, agitation/fever/rigidity or suicidal mood changes.
Not a complete safety screen. Discuss health decisions with a qualified clinician.
Combinations & interactions
9 entriesCheck cautions and reported pairings. A compatibility claim does not establish that a combination is safe.
SSRIs
Avoidance reportedSerotonergic overlap.9
Reference report · Pep-Pedia label: Avoid CombinationSNRIs
Avoidance reportedSerotonin/noradrenaline overlap.9
Reference report · Pep-Pedia label: Avoid CombinationMAOIs
Avoidance reportedPotential hypertensive/serotonergic crisis.9
Reference report · Evidence context: ContraindicatedStimulants
Avoidance reportedCardiovascular stress.9
Reference report · Pep-Pedia label: Avoid CombinationBupropion
Avoidance reportedSeizure/BP concerns.9
Reference report · Pep-Pedia label: Avoid CombinationCaffeine
Caution reportedStimulation/BP concerns.9
Reference report · Pep-Pedia label: Use CautionSemaglutide / tirzepatide
Unverified pairingUntested pairing.9
Reference report · Evidence context: Insufficient dataBeta-blockers
Unverified pairingStudied pairing, not DIY protection.9
Reference report · Evidence context: Potentially beneficialOther medicines and research compounds
Not establishedNo clinical interaction study for the exact proposed combination was verified; absence of evidence does not establish compatibility.3
Research contextNo matching interactions. Try another name or filter.
Reconstitution
No universal bacteriostatic-water volume or validated preparation method is established for this entry.3
Reference preparation details
Reported handling information, not a validated formulation or instruction to prepare an injectable product.
Oral
The source describes capsules or measured oral material rather than vial reconstitution.
- Form
- Source describes a prepared product
- Reported parameters
- Storage follows the oral product instructions.
Appearance & documentation
Appearance and a purity certificate cannot establish sterility, identity, or suitability for injection.
Available forms
No verified packaging examples included.
Packaging examples, not a market survey. Approved and research products are not interchangeable.
Storage after mixing
Reconstituted research vials
The available sources describe prepared products or do not establish a reconstitution method.9
Storage depends on the formulation, diluent, container, and handling. Follow the specific product label or pharmacist’s instructions.
Research findings
Human trialsSource context
Reference contraindication labels describe precautions for an investigational compound, not a U.S. prescribing label.
Compound identity & other names
An oral drug investigated for obesity. The widely cited 2008 weight-loss trial has a published expression of concern, which materially limits confidence in that result.
Not FDA approved; the key early efficacy paper has an expression of concern.
How it may work
Raises dopamine, noradrenaline and serotonin signaling, influencing appetite and energy regulation.9
Major evidence-quality caveat
The Lancet issued an expression of concern about the widely cited 2008 trial. Its headline weight-loss estimates should not be presented as uncontested evidence.
12Research areas and evidence gaps
Obesity drug research. Investigational monoamine reuptake inhibition; evidence-quality caveat applies.12
- Research-market product identity, purity and formulation cannot be established from a publication.
Community reports Unvalidated
Weight discussions as described by Pep-Pedia.3
No representative survey, independently verified products, or controlled outcomes.
Search coverage and review status
The targeted check identified relevant additional literature or current regulatory information; checked findings are separated from retained bibliography-only references.
- Checked
- 2026-10-12
- Search
- tesofensine 2025 2026 trial site:pubmed.ncbi.nlm.nih.gov
- Catalog
- Pep-Pedia ↗ · 5 listed references retained
- Targeted search, not an exhaustive systematic review.
- Bibliography-only entries are retained for traceability and are not treated as verified findings.
AI-prepared summaries. Independent medical editorial review is pending.
References
Original sources and review status. Open a reference to read its summary.
1TIPO-1 Phase IIB Trial (2008)Expression of concern published in 2013Abstract checked
2008 24-week trial reported weight loss but carries a 2013 Lancet expression of concern; treat efficacy estimates cautiously.
The Lancet issued an expression of concern about the widely cited 2008 trial. Its headline weight-loss estimates should not be presented as uncontested evidence.
Pep-Pedia bibliography · Checked 2026-10-12
2Expression of concern: tesofensine bodyweight-loss trialPrimary source checked
Lancet published an expression of concern concerning the 2008 trial; this is distinct from a retraction.
The Lancet issued an expression of concern about the widely cited 2008 trial. Its headline weight-loss estimates should not be presented as uncontested evidence.
Additional research · Checked 2026-10-12
3Pep-Pedia: Tesofensine — community referenceCommunity source checked
Accessed October 12, 2026. Secondary descriptions and bibliography; community schedules are unvalidated reports, not recommendations.
4TIPO-4 Extension Trial (48 weeks)Pep-Pedia report · Primary source not checked
Pep-Pedia reports: An open-label extension reported maintenance of about 13–14 kg weight loss; continuing participants can differ from the original trial population.
Reported population / model
140 participants
Reported study details
0.5-1.0mg daily · 48 weeks · 13-14kg total weight loss
Pep-Pedia supplies no original study link for this card. Study identity, design, doses and result remain unverified.
Read the Pep-Pedia report ↗Pep-Pedia reference card; original summary of its reported findings · Checked 2026-10-12
5Viking Phase 3 Trial (2018)Pep-Pedia report · Primary source not checked
Pep-Pedia reports: The source reports successful weight and metabolic endpoints in a 372-participant registration study; detailed estimates are not supplied.
Reported population / model
372 participants
Reported study details
0.25-0.5mg daily · 24 weeks · Significant weight loss
Reported by Pep-Pedia; the linked publication, design, doses and result have not been independently verified here.
Read the Pep-Pedia report ↗Pep-Pedia reference card; original summary of its reported findings · Checked 2026-10-12
6GABAergic Hypothalamic Mechanism Study (2024)Pep-Pedia report · Primary source not checked
Pep-Pedia reports: Animal work implicated hypothalamic GABA neurons in appetite effects; a 5-HTP interaction does not establish a safe human combination.
Reported population / model
Animal model
Reported study details
Various doses · Acute/chronic · Neuronal activity
Reported by Pep-Pedia; the linked publication, design, doses and result have not been independently verified here.
Read the Pep-Pedia report ↗Pep-Pedia reference card; original summary of its reported findings · Checked 2026-10-12
7Appetite Suppression Mechanism StudyPep-Pedia report · Primary source not checked
Pep-Pedia reports: Rat appetite suppression was linked to indirect alpha-1 and D1 signaling during two weeks of exposure.
Reported population / model
Rat model
Reported study details
2mg/kg · 14 days · Alpha-1 and D1 receptor pathways
Reported by Pep-Pedia; the linked publication, design, doses and result have not been independently verified here.
Read the Pep-Pedia report ↗Pep-Pedia reference card; original summary of its reported findings · Checked 2026-10-12
8Pep-Pedia: Tesofensine — reported pharmacokineticsReference estimate; not independently verified human PKCommunity source checked
Lists a half-life of 9.2 days and a peak time of 8 hrs. Stated attribution: Phase 2/3 Clinical Trials. This value is reported by a secondary reference. The stated attribution has not been independently verified as a route- and formulation-matched human PK measurement. Five half-lives is not complete clearance, and the source’s “cleared” value is not used as a measured endpoint.
Secondary reference page checked; the underlying quantitative claim is not independently confirmed. · Checked 2026-10-12
9Pep-Pedia: Tesofensine — route-specific referenceReference page checked; underlying claims require separate verification.Community source checked
Source page checked across available routes. Protocols, cycles, storage, mechanisms and pairing claims are secondary reports; checking the page does not independently validate those claims. Original concise summaries are used here.
Content coverage audit · Checked 2026-10-12