What Is Tesamorelin? Egrifta, FDA Approval and Research Vials (2026)

Tesamorelin is a synthetic analog of growth hormone-releasing hormone (GHRH) and the active ingredient of Egrifta, an FDA-approved prescription drug for reducing excess abdominal fat in adults with HIV and lipodystrophy. FDA first approved it in 2010, and a newer formulation, EGRIFTA WR, was approved in March 2025. Tesamorelin sold online as a "research peptide" is a different matter: it isn't Egrifta, and FDA named research-labeled tesamorelin in two warning letters in August 2026.

Notice: Research peptides are sold for in-vitro laboratory research only. Research-labeled tesamorelin vials are not the approved drug (Egrifta), not for human or animal consumption, and this page is not medical advice. It contains no dosing or use guidance.

What tesamorelin is

Growth hormone-releasing hormone (also called growth hormone-releasing factor, GRF) is the hypothalamic peptide that signals the pituitary to release growth hormone. Tesamorelin is a modified copy of it.

According to the EGRIFTA WR prescribing information (revised March 2025):

• Sequence: the full 44-amino-acid human GRF sequence.
• Modification: a hexenoyl group, a six-carbon chain with one double bond, attached to the N-terminal tyrosine.
• Salt and size: supplied as an acetate salt, with a free-base molecular weight of 5,135.9 Da.

That makes it larger than the other GHRH analogs sold as research peptides. Sermorelin and CJC-1295 are built on only the first 29 amino acids. We compare them in tesamorelin vs sermorelin and tesamorelin vs ipamorelin, which covers a ghrelin-receptor peptide rather than a GHRH analog.

Egrifta: the approved drug

Theratechnologies developed tesamorelin and holds the US approval.

Theratechnologies says the WR formulation is bioequivalent to the original Egrifta and needs less than half the administration volume of EGRIFTA SV.

The approval comes with clear limits. Theratechnologies' release lists three:

• "Long-term cardiovascular safety of EGRIFTA WR™ has not been established."
• It "is not indicated for weight loss management as it has a weight-neutral effect."
• There are no data showing improved adherence to antiretroviral therapy.

What the approval trials showed

The label summarizes two multicenter, randomized, double-blind, placebo-controlled trials in about 816 HIV-infected adults with excess abdominal fat. Each had a 26-week main phase and a 26-week extension. The primary endpoint was percent change in visceral adipose tissue (VAT), measured by CT scan, at week 26 (label).

These results apply to the approved product in that population. They don't transfer to anything else.

Label warnings and contraindications

The label lists warnings for increased risk of neoplasms, elevated IGF-1 levels, fluid retention, glucose intolerance or diabetes, hypersensitivity reactions, injection site reactions, and increased mortality in patients with acute critical illness. It's contraindicated in pregnancy, active malignancy, disruption of the hypothalamic-pituitary axis and known hypersensitivity.

Why a research-labeled vial isn't Egrifta

FDA's approval covers Egrifta as made, tested and labeled under Theratechnologies' application. A vial sold online as "tesamorelin, for research use only" has no connection to that application:

• No regulator checks it. Identity, purity and fill depend on the seller and whatever lab it uses.
• FDA has named it directly. The August 24, 2026 Royal Peptides letter lists tesamorelin and a tesamorelin-ipamorelin blend among unapproved new drugs. The same-day Peptide Partners letter lists "Tesa Peptide (Tesamorelin)," citing the seller's description of liver research in people with HIV.
• The trial data doesn't transfer. The VAT results above describe Egrifta in a defined patient group, not a gray-market vial.

Regulatory status (October 2026)

• FDA: approved as Egrifta (now EGRIFTA WR) for one indication. Research-labeled tesamorelin isn't an approved drug, and FDA treated it as an unapproved new drug in the 2026 letters above. More in FDA peptide regulation in 2026.
• Compounding lists: tesamorelin doesn't appear on FDA's Category 2 compounding page (content current as of April 22, 2026), and it wasn't on the July 2026 Pharmacy Compounding Advisory Committee agenda.
• WADA: the 2026 Prohibited List names tesamorelin under S2.2.4, "growth hormone-releasing hormone (GHRH) and its analogues," prohibited at all times (WADA; 2026 list text).
• DEA: not on DEA's controlled substances list dated August 27, 2026.

See also are peptides legal?

Research-grade vials: what the market looks like

As of October 21, 2026, 74 vendors in our tesamorelin price index had it in stock, at a median of $7.50 per mg. The cheapest in-stock listings per mg:

Prices are as listed on vendors' sites on October 21, 2026 and change often. We compare documentation, not just price, in best tesamorelin vendors.

How to check a tesamorelin COA

1. Identity by mass spectrometry. Tesamorelin's free-base mass is about 5,136 Da. A result near sermorelin's or CJC-1295's mass means a different molecule.
2. The compound named as tesamorelin, not a code like "Tesa" alone.
3. Measured net content vs the label, not just HPLC purity. See peptide purity vs net content.
4. A lot number matching the vial and a recent test date.
5. A named lab you can verify. Use our COA guide and COA checklist.

Bottom line

Tesamorelin is one of the few peptides sold in research vials that's also a real, FDA-approved drug, which makes the distinction easy to blur. The approval covers Egrifta for one indication in adults with HIV. Research-labeled tesamorelin isn't covered by it, and FDA has said so in writing.

Sources are linked inline and were checked October 21, 2026.