Yes. As of September 2026, tesamorelin is FDA-approved as Egrifta in the United States. The approval, first granted on 10 November 2010 under BLA 022505, covers one use: reducing excess abdominal fat in HIV-infected patients with lipodystrophy. It is dispensed on prescription through specialty pharmacies, and the later Egrifta SV and Egrifta WR formulations sit under the same application. Research-grade tesamorelin is not the approved product, and WADA prohibits tesamorelin at all times.
The table below shows tesamorelin's position on the five registers that decide whether a compound is approved, compoundable or prohibited in sport, and each row carries the as-of date its Peptigrity source gives.
Register | Tesamorelin's position | As of (Peptigrity source) |
|---|---|---|
FDA approval | Approved. Egrifta, 10 November 2010, BLA 022505, for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. The Egrifta SV reformulation was approved in 2019, and Egrifta WR is also on the current US label. Available by prescription through specialty pharmacies. | August 2026 — tesamorelin compound page (label as of August 2026) and the regulatory snapshot (as of August 2026) |
FDA Category 2 bulk list | Not listed. Tesamorelin is on neither of FDA's bulk-substances tables: not the 14-substance active Category 2 list and not the 17-substance "nominated but withdrawn" table. It reaches 503A compounding through the component-of-an-approved-drug prong. | FDA page current 22 April 2026 — ipamorelin vs sermorelin vs tesamorelin |
PCAC review | No review on record. Peptigrity's sources contain no Pharmacy Compounding Advisory Committee review of tesamorelin, and it was not among the seven substances the committee reviewed on 23–24 July 2026. | Through the 23–24 July 2026 meeting — FDA regulation timeline (as of August 2026) |
WADA | Prohibited at all times under section S2.2.4 (GHRH analogues), classified as non-specified. | WADA 2026 Prohibited List — drug-testing guide and the three-way comparison |
Other jurisdictions | US approval only on record. Peptigrity's regulatory snapshot records a US approval and no other; tesamorelin's status in other countries is not assessed on Peptigrity. | Snapshot as of August 2026 |
Do you need a prescription for tesamorelin?
Yes. The approved product, Egrifta, is available by prescription through specialty pharmacies. A compounded tesamorelin preparation also runs through a prescription, because the compounding route permits a licensed pharmacist to prepare the substance for a named patient who holds one. Research-grade tesamorelin sold by third-party laboratories is neither of those things: it is not the FDA-approved prescription product and does not carry pharmacy-grade quality controls.
This page states what published documents say. It is legal information, not legal advice; it does not address any individual's position, and anything touching your own circumstances belongs with a qualified professional.
Can a pharmacy compound tesamorelin?
Yes, through one statutory prong. Under 21 U.S.C. § 353a(b)(1)(A), a bulk substance used in 503A compounding must comply with a USP or NF monograph, be a component of an FDA-approved drug, or appear on FDA's 503A bulks list, which holds six substances and none of them is a peptide. Tesamorelin qualifies as a component of an approved drug, and with no ambiguity, because the drug it is a component of is currently marketed under BLA 022505.
Qualifying under a prong is narrower than it sounds. Nothing in Peptigrity's record says FDA has evaluated compounded tesamorelin favourably; it says the statutory prong is satisfied and the substance has not been flagged. Those are different claims, and vendors tend to collapse them. FDA's own language sets the ceiling for every compounded product: "Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed." The mechanics are set out in compounding pharmacy versus research peptide.
Where does research-grade tesamorelin fit?
Outside the approval. The FDA approval applies to the prescription Egrifta product, not to research-grade tesamorelin sold by third-party laboratories, which is a separate supply chain with its own quality risks: wider purity variance, occasional under-filled vials and inconsistent endotoxin control.
A research-use label does not change the regulatory position in FDA's view. The agency "has warned companies that have illegally sold unapproved drugs... falsely labeled 'for research purposes' or 'not for human consumption.' These products have been sold directly to consumers for human use." The enforcement in Peptigrity's record runs against sellers, and this page does not address the position of any purchaser. The wider market is described on the grey market overview.
What does the FDA approval cover, and what does it not?
One indication in one population. Egrifta is approved for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, and the label states that tesamorelin "is not indicated for weight loss management as it has a weight neutral effect." An approval is for a population and a purpose, not for a molecule, so use outside that indication is not what FDA assessed.
The approval also changes nothing in sport. WADA's 2026 list names tesamorelin explicitly at S2.2.4 as a GHRH analogue, prohibited at all times. The mechanism that can permit a prohibited substance for an athlete is a therapeutic use exemption granted by an anti-doping organisation, which is a separate process from holding a prescription. Legal to prescribe is not legal to compete on. Tesamorelin sits in the growth hormone category, and its dated regulatory context is in the FDA regulation timeline for 2025–2026.
What does Peptigrity's lab record show for tesamorelin?
As of 21 September 2026, Peptigrity holds 543 independent lab tests of tesamorelin, averaging 99.42% HPLC purity (the average covers the 515 tests that report a purity figure), from 24 laboratories. Every result is listed on the tesamorelin lab tests page, with the compound record on the tesamorelin compound page, per-milligram prices on the tesamorelin price comparison and volume arithmetic in the tesamorelin calculator.
Read those figures for what they are. A purity percentage measures what is in a vial; it says nothing about legal status, and it cannot turn research-grade material into Egrifta. The certificates are ones shops chose to publish, a selection bias Peptigrity states openly.
Frequently Asked Questions
Is tesamorelin legal in the United States?
Tesamorelin is an FDA-approved prescription medicine, sold as Egrifta, and it can also be compounded for a named patient under the component-of-an-approved-drug prong. Research-grade tesamorelin is not the approved product. This page states what published documents say and does not address any individual's legal position.
What is tesamorelin FDA approved for?
The reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. That is the whole indication. The label states it is not indicated for weight loss management, because it has a weight neutral effect.
Do you need a prescription for tesamorelin?
Yes. Egrifta is available by prescription through specialty pharmacies, and a compounded preparation is made for a named patient with a prescription. Research-grade tesamorelin is not the FDA-approved prescription product.
Is tesamorelin on FDA's Category 2 list?
No. It is on neither the 14-substance active Category 2 list nor the 17-substance "nominated but withdrawn" table, on FDA's page current 22 April 2026. That is an absence, not an endorsement: the statutory prong is satisfied, and FDA has not flagged the substance.
Can a pharmacy compound tesamorelin?
Yes, for a named patient with a prescription, because tesamorelin is a component of a currently marketed FDA-approved drug. Compounded drugs are not FDA-approved, so FDA does not verify their safety, effectiveness or quality before they are marketed.
Is tesamorelin banned by WADA?
Yes. WADA's 2026 Prohibited List names tesamorelin at section S2.2.4 as a GHRH analogue, prohibited at all times and classified as non-specified. An FDA approval does not change that; only a therapeutic use exemption from an anti-doping organisation can.
Sources
External documents cited on Peptigrity's own pages for the statements above.
EGRIFTA SV (tesamorelin) — US Prescribing Information (DailyMed)
FDA — Certain bulk drug substances for use in compounding that may present significant safety risks (page current 22 April 2026)
WADA — Prohibited List (2026)
This article is for educational and informational purposes only and does not constitute medical advice. Peptides discussed may be investigational compounds not approved by the FDA (or equivalent regulators in your jurisdiction) for human use. Always consult a qualified healthcare provider before using any peptide or research compound. Peptigrity is an independent review platform and does not sell, endorse, or recommend specific products or vendors.
Tesamorelin's status row, lab record and listings live on the tesamorelin compound page. How its position compares with other compounds, axis by axis and country by country, is in are peptides legal? Regulatory status by country.