Is tesofensine approved?

No. Tesofensine is investigational and not FDA approved. It is also not yet approved elsewhere — a Mexican application (via partner Medix) received a favorable technical-committee opinion in 2023 but had not been approved as of late 2024, with the company in dialogue with the regulator.

What is the tesofensine trial dose?

In trials it is an oral tablet, typically 0.25 mg or 0.5 mg once daily, with no titration required. The 0.5 mg/day dose produced roughly 10% weight loss over 24 weeks in Phase 2. These are trial doses, not an approved label.

Is tesofensine a peptide?

No. Tesofensine is a small-molecule triple monoamine reuptake inhibitor (it blocks reuptake of dopamine, serotonin, and noradrenaline). It is included here because it is frequently grouped with peptides in weight-loss discussion, but it is a different class of drug entirely.

Dosage Guide · Investigational · not a peptide

Tesofensine Dosage: Trial Doses, Investigational Status

Last updated May 19, 2026 · Reviewed by Grey Peptides Editorial Board · ⚠️ Investigational — trial data only

← Tesofensine encyclopedia entry · See also: Semaglutide dosage · Regulatory tracker

⚠️ Investigational — and not a peptide

Tesofensine is an investigational small-molecule (a triple monoamine reuptake inhibitor) — not a peptide, included here because it is grouped with peptides in weight-loss circles. It is not FDA approved, and not approved elsewhere either (a Mexican application was not approved as of late 2024). The doses below are trial doses; this page is educational, not a protocol.

The short version

Tesofensine increases brain levels of dopamine, serotonin, and noradrenaline by blocking their reuptake, which suppresses appetite. It was originally developed for Parkinson's and Alzheimer's disease, where it failed — but trials noticed pronounced weight loss, and it was repurposed for obesity. Unlike the injectable incretins, it is an oral tablet, and unlike them it is still investigational everywhere.

The trial dosing

Parameter	As used in trials
Dose	0.25–0.5 mg/day
Route	Oral (tablet)
Titration	None required
Status	Investigational (not approved)

In the Phase 2 program, the 0.5 mg/day dose produced roughly 10% weight loss over 24 weeks — about double what older approved obesity drugs achieved at the time — and a later Phase 3 program reported comparable efficacy. One practical contrast with GLP-1 drugs: tesofensine is a daily pill that does not require titration. Reported side effects include dry mouth, headache, insomnia, nausea, and constipation, with small increases in blood pressure and heart rate.

Regulatory status (read carefully)

This is where accuracy matters. Tesofensine is not FDA approved. It is also not currently approved in Mexico, despite frequent claims to the contrary: the partner company's application to the Mexican regulator (COFEPRIS) received a favorable technical-committee opinion in 2023, but as of late 2024 it had not been approved, and the company was in dialogue with the agency about the path forward. So the correct status is "investigational, with a pending/unresolved foreign application," not "approved abroad." Any tesofensine sold for self-use is unregulated. See the Regulatory Status Tracker.

Frequently asked questions

Is tesofensine like phentermine?

They share the broad idea of monoamine-driven appetite suppression, but tesofensine acts on three neurotransmitters and has its own trial history; it is not the same drug.

Why is it on a peptide site?

Because it is constantly discussed alongside peptides in weight-loss communities. We include it for completeness while being explicit that it is a small molecule, not a peptide.

Can I buy it legally?

It is not an approved medicine anywhere, so it is not legally available as a prescription weight-loss drug; anything sold is unregulated.

Sources

Astrup A, et al. Tesofensine for obesity (TIPO-1 Phase 2). Lancet. 2008;372:1906–1913.
Saniona / Medix — tesofensine Phase 3 program and COFEPRIS (Mexico) application status (2023 favorable opinion; not approved as of late 2024).

Medical disclaimer: Education only, not medical advice. Tesofensine is investigational and not approved for any use. Trial doses apply only within supervised studies. Consult a licensed clinician.