U.S. regulatory status
Tesamorelin
Also known as Egrifta, Egrifta SV, Egrifta WR, Tesamorelin acetate
Is Tesamorelin legal right now?
Tesamorelin is a 44-amino-acid growth hormone-releasing factor analog that the FDA approved on November 10, 2010 as Egrifta, to reduce excess abdominal fat in adults with HIV and lipodystrophy.
Theratechnologies markets it as Egrifta SV and Egrifta WR, a newer formulation approved on March 25, 2025. Because it is a protein of more than 40 amino acids, its application was deemed a biologics license on March 23, 2020, and the FDA’s stated position is that biological products subject to licensure are not eligible for the 503A or 503B compounding exemptions.
A pharmacy therefore cannot lawfully compound tesamorelin, even though it is the active ingredient of an approved product, and it appears in none of the FDA’s 503A bulk substance categories. It is lawfully available only as the licensed prescription product.
On August 24, 2026 the FDA sent warning letters to five online “research peptide” sellers, including Royal Peptides and Peptide Partners, naming tesamorelin among unapproved new drugs. No FDA review that would change this is pending; any other tesamorelin product would need its own biologics license.
Restricted: Prescription-only, banned, controlled, or under active FDA enforcement.
Verified Oct 15, 2026 (ET) · status held since Mar 23, 2020
Where it sits in the process
Outside the 503A list process. It is an FDA-approved drug, so the 503A bulks list does not apply to it. The status above says what pharmacies may and may not do.
What changed last
No recorded changes yet - this entry has held one status since it was added.
Status elsewhere
| Jurisdiction | Status | Note |
|---|---|---|
| United States (FDA) | Restricted | Approved Nov 10, 2010 (Egrifta); deemed a biologics license (BLA 022505) on Mar 23, 2020, so outside the 503A/503B compounding exemptions. Aug 24, 2026: FDA warning letters to five online “research peptide” sellers name tesamorelin. |
| Australia (TGA) | Restricted | Not named individually in the Poisons Standard (October 2026), but Appendix D lists growth hormone releasing hormones (GHRHs) as a group among poisons that are illegal to possess without authority. No product on the ARTG. |
| United Kingdom (MHRA) | Restricted | No UK marketing authorisation (no tesamorelin product in the MHRA Products database); supply as a medicine would be unlicensed. |
| European Union (EMA) | Restricted | No EU marketing authorisation: Ferrer Internacional withdrew its application for Egrifta on June 21, 2012, when the CHMP’s provisional opinion was that it could not have been approved. |
| Canada (Health Canada) | Restricted | On the Prescription Drug List since 2014-04-25 (‘Tesamorelin or its salts or derivatives’); both Egrifta DINs are cancelled (2022, 2023), so no product is currently authorized for sale. Named among seized unauthorized peptides (Aug 2025). |
| Sport / anti-doping (WADA) | Restricted | Named in S2.2.4 (GHRH and its analogues) on the 2026 and 2027 Prohibited Lists; prohibited at all times. |
The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it
FDA warning letters
5 FDA warning letters mention tesamorelin, all dated Aug 24, 2026.
- NuScience Peptides LLC
- Peak Performance Peptides
- Peptide Partners LLC
- Royal Peptides LLC
- TXP Innovations LLC dba Tex Peptides
A warning letter is the FDA telling one company it believes the company broke federal law. It does not change the status above. All warning letters, by compound
Sources & transparency
Sources for this entry
- Drugs@FDA - BLA 022505 (Egrifta) FDA · primaryOriginal approval Nov 10, 2010; “This Former NDA Was Deemed To Be a BLA on March 23, 2020.”
- FDA - Egrifta WR supplemental approval letter (BLA 022505/S-020, Mar 25, 2025) FDA · primaryApproves a new formulation and multiple-dose presentation (Egrifta WR) under section 351(a) of the PHS Act.
- FDA guidance - Mixing, diluting, or repackaging biological products outside the scope of an approved BLA (Jan 2018) FDA · primaryBiological products subject to licensure under PHS Act section 351 are not eligible for the 503A and 503B exemptions.
- FDA guidance - Interim policy on compounding using bulk drug substances under section 503A (Jan 2025) FDA · primaryFootnote 20: biological products subject to a BLA are not eligible for the 503A exemptions and will not be considered for the 503A bulks list.
- FDA warning letter - Royal Peptides LLC (Aug 24, 2026) FDA · primaryNames “Tesamorelin” and a tesamorelin/ipamorelin blend among unapproved new drugs sold online.
- EMA - Egrifta: withdrawal of the marketing authorisation application EU · primaryFerrer Internacional withdrew the application on June 21, 2012. Basis for the European Union row.
- Health Canada Prescription Drug List - Human Use Health Canada · primary”Tesamorelin or its salts or derivatives”, 2014-04-25. Basis for the Canada row, with the Drug Product Database (DINs 02438712, 02423677 cancelled).
- TGA - Australian Register of Therapeutic Goods search: tesamorelin TGA · primaryNo matching results. Basis for the Australia row, with the Poisons Standard October 2026 (F2026L01327).
- MHRA Products database - search: tesamorelin UK gov · primaryNo search results. Basis for the United Kingdom row.
- WADA - 2027 Prohibited List (in force Jan 1, 2027) WADA · primaryS2.2.4 names tesamorelin among GHRH analogues; the 2026 List has the same wording.
- Last verified by a human
- Oct 15, 2026 (ET) · how we verify
- Who runs this
- Peptlas Research Team - independent. About us.
- What we sell
- Nothing. No products, no affiliates, no sponsored placements.
This page reports publicly available regulatory status for information only. It is not medical or legal advice and makes no health claim. See our full disclaimer.
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