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Tesamorelin regulatory status

Current status of Tesamorelin in the United States: FDA approved. In sport: WADA prohibited. Details, sources, and the dated timeline follow.

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

What is the current status of Tesamorelin?

Regulatory: FDA approvedWADA: WADA prohibitedVerified: Verified Sep 23, 2026
FDA and compounding
FDA approved as Egrifta (tesamorelin for injection) on November 10, 2010, for reduction of excess abdominal fat in HIV infected adults with lipodystrophy; Egrifta SV, a 2 mg vial formulation, was approved in 2019, and Egrifta WR, an 11.6 mg vial formulation, in March 2025. Tesamorelin is a 44 amino acid protein, and on March 23, 2020 FDA deemed the Egrifta application (022505) to be a biologics license. FDA states that biological products are not eligible for the 503A or 503B compounding exemptions, so compounded tesamorelin sold by telehealth and anti-aging clinics has no lawful basis, and Egrifta WR by prescription is the only lawful product. A clinician may prescribe Egrifta WR off-label, but use for fat loss in people without HIV has only limited trial support.
WADA
WADA prohibited
Access path
  1. Prescription from an HIV specialist filled at a specialty pharmacy as Egrifta WR for the approved indication.
  2. Off-label prescription of Egrifta WR by a licensed clinician, usually paid in cash because coverage follows the HIV indication. Compounded tesamorelin is not a lawful option, because biologics cannot be compounded under 503A.
  3. Not available for athletic or cosmetic use through any lawful channel consistent with sport rules.

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

Is tesamorelin FDA approved?

Yes. Tesamorelin has been FDA approved since November 10, 2010, first as Egrifta, for reducing excess abdominal fat in adults with HIV and lipodystrophy. Egrifta SV (2 mg vial) followed in 2019 and Egrifta WR (11.6 mg vial) in March 2025. It is prescription only. [1] [2] [3]

What is the FDA status of tesamorelin in 2026?

FDA approved, as a biologic. Because tesamorelin is a 44 amino acid protein, FDA deemed the Egrifta application (022505) a biologics license on March 23, 2020. Egrifta WR by prescription is the lawful product, on label for HIV lipodystrophy or off-label when a licensed clinician prescribes it. [1] [2] [4]

Can tesamorelin be compounded?

No. FDA states that biological products are not eligible for the 503A or 503B compounding exemptions, and tesamorelin has been regulated as a biologic since March 23, 2020. Compounded tesamorelin sold by telehealth and anti-aging clinics therefore has no lawful basis; Egrifta WR by prescription is the only lawful source. [4] [5]

Is tesamorelin banned by WADA?

Yes. The WADA Prohibited List names tesamorelin in section S2 among growth hormone releasing hormone analogues, prohibited at all times in and out of competition. An athlete with HIV lipodystrophy would need a therapeutic use exemption. [6]

How has the status of Tesamorelin changed over time?

  1. WADA

    WADA publishes the 2027 Prohibited List

    WADA published the 2027 Prohibited List on September 21, 2026, and it takes effect January 1, 2027. The S2 peptide hormone and growth factor classes are unchanged. BPC-157 is still named under S0, and MOTS-c is still named under S4.4 as an activator of AMP-activated protein kinase. WADA added a note that many peptides without approval for human use fall under S0 or another section, and that a peptide not named on the list may still be prohibited. GLP-1 receptor agonists such as semaglutide and tirzepatide are still not on the list.

    Source: WADA 2027 Prohibited List
  2. WADA

    WADA 2026 Prohibited List takes effect

    The 2026 WADA Prohibited List took effect on January 1, 2026 and continues to prohibit the S2 peptide hormone and growth factor classes (GHRH analogs, growth hormone secretagogues, GH fragments, IGF-1 and analogs, MGF, thymosin beta-4 and derivatives, hCG and GnRH-class releasing factors in males), myostatin inhibitors, insulin and the AMPK activator MOTS-c under S4, desmopressin under S5, and BPC-157 under S0. GLP-1 receptor agonists such as semaglutide and tirzepatide are not on the list.

    Source: WADA Prohibited List
  3. WADA

    WADA 2025 Prohibited List keeps peptide hormones and growth factors banned at all times

    The 2025 WADA Prohibited List took effect on January 1, 2025. Section S2 (peptide hormones, growth factors, related substances and mimetics) covers GHRH analogs such as CJC-1295, sermorelin, and tesamorelin, growth hormone secretagogues such as ipamorelin, GHRP-2, GHRP-6, hexarelin, and ibutamoren (MK-677), growth hormone fragments such as AOD-9604, growth factors including IGF-1 and its analogs, MGF, and thymosin beta-4 (TB-500), and chorionic gonadotropin and releasing factors such as gonadorelin and kisspeptin (prohibited in males). Myostatin inhibitors such as ACE-031 fall under S4, insulin under S4 metabolic modulators, desmopressin under S5, and BPC-157 remains an S0 non-approved substance.

    Source: WADA Prohibited List
  4. FDA

    Egrifta (tesamorelin) is deemed a biologics license

    Under the biologics transition provision of the Biologics Price Competition and Innovation Act, FDA deemed the Egrifta application (022505) to be a biologics license on March 23, 2020. FDA states that biological products are not eligible for the 503A or 503B compounding exemptions, so tesamorelin cannot be lawfully compounded; the approved product remains available by prescription.

    Regulatory: FDA approvedSource: FDA: List of approved NDAs for biological products that were deemed to be BLAs on March 23, 2020 (includes tesamorelin, Egrifta and Egrifta SV, application 022505)
  5. FDA

    FDA approves Egrifta (tesamorelin) for HIV-associated lipodystrophy

    FDA approved tesamorelin injection (Egrifta), a growth hormone-releasing hormone analog, to reduce excess abdominal fat in HIV-infected adults with lipodystrophy.

    Regulatory: FDA approvedSource: Drugs@FDA: Egrifta (tesamorelin) NDA 022505

Sources

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

  1. [1]Drugs@FDA: application 022505, Egrifta (tesamorelin), approval history and labelsFDA
  2. [2]FDA prescribing information for Egrifta WR (tesamorelin) for injection, 11.6 mg vial, via DailyMed (Indications, Dosage and Administration, Warnings and Precautions, Use in Specific Populations, and Clinical Studies sections)FDA, 2025
  3. [3]FDA prescribing information for Egrifta formulations (tesamorelin for injection), via DailyMedFDA, 2025
  4. [4]FDA: List of approved NDAs for biological products that were deemed to be BLAs on March 23, 2020 (includes tesamorelin, Egrifta and Egrifta SV, application 022505)FDA, 2020
  5. [5]FDA: Compounding and the FDA, questions and answers (biological products are not eligible for the 503A or 503B compounding exemptions)FDA, 2026
  6. [6]WADA Prohibited List, section S2 (growth hormone releasing hormone and its analogues, including tesamorelin)WADA, 2026
  7. [7]FDA prescribing information for Egrifta SV (tesamorelin) for injection, 2 mg vial, via DailyMed (Dosage and Administration section)FDA, 2024
  8. [8]WADA 2027 Prohibited ListWADA, 2026

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