Is Tesofensine Legal? FDA Status and Regulations Explained (2026)

Key Takeaways

• Tesofensine is not FDA-approved and is designated for research purposes only.
• It is not listed on the FDA's compounding bulk drug substance list, making compounding illegal.
• Tesofensine cannot be prescribed or sold over-the-counter; it is available for research use only.
• Patients should verify clinic legality and watch for red flags indicating illegal operations.

Current FDA Status

Tesofensine is classified as a research-only compound and is not approved by the FDA for any therapeutic use. As of February 2026, it remains unavailable for human consumption outside of research settings. The FDA has not included Tesofensine on its compounding bulk drug substance list, which means it cannot be legally compounded by pharmacies under any category (FDA, 2026).

Compounding Status

The absence of Tesofensine from the FDA's compounding list prohibits both 503A and 503B pharmacies from legally compounding this peptide. The FDA's decision is based on the lack of sufficient safety and efficacy data, as well as the compound's non-approval status. Compounding Tesofensine would contravene FDA regulations, potentially leading to enforcement actions against pharmacies that attempt to do so.

Enforcement Actions

To date, there have been no specific DOJ prosecutions or FDA warning letters directly related to Tesofensine. However, the FDA has issued general warnings against the use of non-approved substances in clinical settings, emphasizing the importance of adhering to regulatory guidelines to ensure patient safety (FDA, 2025).

Prescription vs. Over-the-Counter vs. Research Use

Tesofensine is not available by prescription or over-the-counter. It is strictly for research use, meaning it can only be used in controlled laboratory settings for scientific studies. "Research use only" indicates that the compound is not intended for human or veterinary therapeutic applications, and any sale or use outside of research contexts is illegal.

State-Level Variations

Currently, there are no significant state-level variations in the regulation of Tesofensine. States generally adhere to federal guidelines regarding the use and distribution of non-approved research compounds. However, practitioners should remain vigilant as state regulations can evolve.

What "Off-Label" Actually Means

Off-label prescribing refers to the use of an FDA-approved drug for an unapproved indication. Since Tesofensine is not FDA-approved for any use, prescribing it does not qualify as off-label; it is the use of an unapproved drug. This distinction is crucial for understanding legal prescribing practices.

What This Means for Patients

Patients should ensure that any clinic offering Tesofensine operates within legal boundaries. Verify the clinic's credentials, check for proper licensing, and be cautious of any facility offering Tesofensine for therapeutic purposes. Red flags include lack of transparency, absence of proper documentation, and claims of miraculous benefits.

Legal Alternatives

For those seeking alternatives to Tesofensine for similar research purposes, peptides like semaglutide and liraglutide may offer legal options. These peptides have been studied for metabolic and appetite regulation and are subject to different regulatory statuses.

FAQ

Is Tesofensine a controlled substance?

No, Tesofensine is not classified as a controlled substance, but it is not approved for therapeutic use and is designated for research purposes only.

Can Tesofensine be legally prescribed?

No, Tesofensine cannot be legally prescribed as it is not FDA-approved for any indication.

Are there any legal consequences for using Tesofensine therapeutically?

Yes, using Tesofensine therapeutically outside of a research setting can lead to legal consequences, including potential FDA enforcement actions.

What should I do if a clinic offers Tesofensine for treatment?

Ensure the clinic is operating legally by asking for documentation and verifying their licensing. Be wary of any claims that seem too good to be true.

Can I purchase Tesofensine for personal use?

No, Tesofensine is available for research use only and cannot be legally purchased for personal use.

---

This content is for informational purposes only and does not constitute medical advice. Consult a licensed healthcare provider before starting any treatment. Legal status can change and was last verified February 2026.