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Tesofensine regulatory status

Current status of Tesofensine in the United States: Unscheduled. In sport: WADA status unclear. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of Tesofensine?

Regulatory: UnscheduledWADA: WADA status unclearVerified: Verified Sep 22, 2026
FDA and compounding
Not FDA approved and not on any FDA compounding list as of the pages current to April 2026. It is a synthetic small molecule with no US marketing authorization and no 503A nomination, so there is no lawful basis for a US compounding pharmacy to dispense it. Some products sold online as tesofensine are unverified imports or research chemicals.
WADA
WADA status unclear
Access path
  1. No lawful United States access path identified on the last verified date outside a registered clinical trial.
  2. Not available as an FDA approved product and not eligible for compounding under section 503A or 503B.
  3. Products labeled research use only are not lawful for human use and are not verified for identity or purity.

Full Tesofensine page: evidence, dosing in the literature, and sources

How has the status of Tesofensine changed over time?

No dated regulatory event has been recorded for Tesofensine. That usually means no FDA, PCAC, Federal Register, or WADA action has named it specifically. Category-wide actions are listed on the tracker hub.

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for Tesofensine and the source of each dated event.

  1. [1]FDA: Bulk drug substances used in compounding under section 503A of the FD&C ActFDA, 2026
  2. [2]FDA: Certain bulk drug substances for use in compounding may present significant safety risks (Category 2 list, content current as of April 22, 2026)FDA, 2026
  3. [3]WADA Prohibited List (sections S0 non-approved substances and S6 stimulants)WADA, 2026