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Key Takeaways
- Adipotide (FTPP) is not FDA-approved for any medical indication.
- It is categorized for research purposes only and not on the FDA's approved compounding list.
- Legal use is restricted to research settings, with no prescription or over-the-counter availability.
- Patients should verify clinic legality and be aware of potential legal alternatives.
Current FDA Status
Adipotide (FTPP), a synthetic peptide designed as a targeted proapoptotic compound, is not approved by the FDA for any therapeutic use. It remains classified under research purposes only, meaning it cannot be legally marketed for medical treatment or included in compounded medications. The FDA has not listed Adipotide on its compounding bulk drug substance list, which means it cannot be compounded by 503A or 503B pharmacies (FDA, 2026).
Compounding Status
The FDA's regulations prohibit the compounding of Adipotide (FTPP) due to its classification as a research-only substance. This classification is primarily due to a lack of comprehensive clinical data supporting its safety and efficacy in humans. The FDA's decision aligns with its mandate to ensure that only substances with sufficient evidence of safety and efficacy are compounded (FDA, 2026).
Enforcement Actions
To date, the FDA and the Department of Justice (DOJ) have taken enforcement actions against entities marketing Adipotide for unapproved uses. For example, in 2025, the FDA issued warning letters to several online vendors falsely advertising Adipotide as a weight-loss treatment. These actions emphasize the peptide's restricted status and the legal risks of marketing it for non-research purposes (FDA Warning Letters, 2025).
Prescription vs. Over-the-Counter vs. Research Use
Adipotide is available strictly for research use, which legally restricts its sale and distribution to entities engaged in scientific research. "Research use only" means it cannot be prescribed or sold over the counter for any medical purpose. This designation is intended for laboratory settings where the peptide can be studied under controlled conditions without claims of therapeutic benefit (FDA, 2026).
State-Level Variations
While federal regulations govern the status of Adipotide, some states may have additional restrictions or enforcement practices. It is crucial for researchers and potential users to consult state-specific regulations to ensure compliance with local laws.
What "Off-Label" Actually Means
The term "off-label" applies to drugs approved by the FDA for specific uses but prescribed for non-approved indications. Since Adipotide is not FDA-approved for any use, prescribing it does not constitute off-label use; it is the prescription of an unapproved drug, which is illegal outside of research contexts.
What This Means for Patients
Patients interested in peptide therapies should be cautious of clinics offering Adipotide for therapeutic purposes. Verifying that a clinic operates within legal frameworks is essential. Red flags include claims of guaranteed results, lack of transparency about the peptide's legal status, and absence of licensed healthcare providers overseeing treatment.
Legal Alternatives
For those seeking alternatives to Adipotide, legal peptides such as Semaglutide, which has FDA approval for specific uses, may offer viable options. These alternatives have undergone rigorous testing to ensure safety and efficacy.
FAQ
Is Adipotide (FTPP) FDA-approved?
No, Adipotide is not FDA-approved for any indication. It is available for research purposes only.
Can Adipotide be legally compounded?
No, Adipotide cannot be compounded legally as it is not on the FDA's approved compounding list.
What does "research use only" mean for Adipotide?
"Research use only" indicates that Adipotide can be used in scientific research settings and not for therapeutic purposes in humans.
Are there legal alternatives to Adipotide?
Yes, legal alternatives such as Semaglutide exist and are FDA-approved for specific indications.
How can I verify if a clinic is legally offering peptide therapies?
Ensure the clinic has licensed healthcare providers and does not make unsubstantiated claims about peptide efficacy.
Medical Disclaimer: 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.
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PeptideClinicLocator.com does not provide medical advice. Always consult a qualified healthcare provider before starting any peptide therapy. Regulatory status may change.
