Tesamorelin: EGRIFTA, FDA & WADA Status

FDA approval

Tesamorelin is the active ingredient in licensed U.S. EGRIFTA products. Original U.S. tesamorelin approval was 10 November 2010, under application BLA 022505.^3,1,4

That date approves specific drug products. It does not approve “all tesamorelin.” It does not approve a laboratory material sold under the same peptide name.

Approved indication

Current EGRIFTA WR labeling indicates the product for reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. That is the exact scope.^1,2

The trials that support that indication measured visceral adipose tissue in that population, not a general-obesity program. The trials page summarizes the 412 and 404 participants.^6,7 Visceral-fat clinical trials

EGRIFTA SV

EGRIFTA SV is one of the current licensed tesamorelin presentations. EGRIFTA WR labeling refers readers to the EGRIFTA SV prescribing information for that formulation and makes clear that the two are not read as the same sheet.¹

This page does not reproduce EGRIFTA SV’s labeled preparation. The regulatory fact is enough: it is a distinct licensed product with its own formulation context.

EGRIFTA WR

EGRIFTA WR is the presentation licensed on 25 March 2025. The March 2025 labeling is the primary source used here for the current indication, limitations, molecular identity, and the relationship to EGRIFTA SV.^3,1

The approved drug is prepared as tesamorelin acetate. Labeling describes the 44-amino-acid human GRF sequence and the N-terminal hexenoyl modification. That description belongs to the licensed product.^1,5

Formulations are not automatically substitutable

Current labeling states that EGRIFTA WR and EGRIFTA SV are not substitutable. The same active ingredient does not make two formulations interchangeable when labeled preparation, labeled strength, excipients, or approved-product storage instructions differ.^1,2

If two licensed products from the same application are not substitutable with each other, a research material that shares only the peptide name does not inherit that interchangeability. This page does not provide practical preparation instructions for either product.

Peptra research material

Peptra sells a research-use-only material labeled Tesamorelin. Public documentation does not establish acetate, does not list EGRIFTA excipients, and does not present a pharmaceutical-equivalence study. The current catalog documents a 10 mg vial, not a 20 mg product. research-material product page

A certificate of analysis describes a lot. It does not establish EGRIFTA equivalence, FDA approval, or clinical effectiveness. tesamorelin COA archive

Important FDA label limitations

• EGRIFTA is not indicated for weight-loss management.¹
• Long-term cardiovascular safety has not been established.¹
• Labeling does not claim that the product improves compliance with antiretroviral therapy.¹

Labeling also groups precaution categories for the approved product: neoplasm risk, elevated IGF-1, fluid retention, glucose intolerance or diabetes, hypersensitivity reactions, injection-site reactions, and increased mortality in acute critical illness. They are named here as label categories, not as a treatment guide and not as an instruction list.¹

For the “tesamorelin = weight loss” confusion, read visceral fat versus body weight.

WADA 2026

The WADA 2026 Prohibited List has been in force since 1 January 2026. Tesamorelin is named explicitly under class S2.2.4: growth hormone releasing factors / GHRH analogues.^8,9

That classification is an anti-doping status as of the review date. It is not a medical decision and it is not an FDA approval or withdrawal. This page does not discuss detection windows, washout times, clearance, or ways to evade testing.

United States versus Mexico

• EGRIFTA approval is U.S. regulatory information.
• This page does not invent a COFEPRIS status.
• WADA publishes an international anti-doping standard, not a Mexican marketing authorization.
• Peptra places its material as laboratory research use, not as a medicine.

Identity and the evidence map are in What Is Tesamorelin? and in the tesamorelin hub.

This page does not reproduce doses, reconstitution, or storage for the approved product. Labeling contains those instructions for the licensed medicine. The purpose of this text is to place the approval, the indication, the formulation distinction, and the anti-doping status — not to guide a use.

A 2026 warning-letter context around research-peptide sellers is also not turned into an article here. It is only an internal reminder: published tesamorelin evidence can be discussed; the Peptra listing must not imply that the research material is the approved drug.