What Is Tesamorelin? GHRH, EGRIFTA & Clinical Evidence

Identity

Tesamorelin is a synthetic analogue of human growth hormone-releasing factor. Literature and FDA labeling also call it a GHRF or GHRH analogue. That is an identity definition, not a use permission.^1,4

This page answers “what is it.” It is not a treatment guide, it does not summarize doses, and it does not turn an approved product into Peptra’s research vial. The broader map is in the tesamorelin research hub.

The 44-amino-acid GRF backbone

Current labeling describes tesamorelin as a synthetically produced human GRF analogue comprising the 44-amino-acid sequence of human GRF. That length distinguishes it from shorter GRF fragments, including 29-residue analogues that appear in other secretagogue literature.¹

Peptra’s research listing records that same 44-residue backbone, amidated at the C-terminus. That documents how the peptide is named in a laboratory material. It does not, by itself, document the salt, the excipients, or the manufacturing context of a licensed drug product. research-material product page

The hexenoyl modification

In addition to the 44-amino-acid sequence, FDA describes a hexenoyl moiety: a C6 chain with a double bond at position 3, attached to the tyrosine at the N-terminal part of the molecule. That modification is part of how tesamorelin is identified against unmodified GHRH.^1,4

Peptra documentation describes a trans-3-hexenoyl group on tyrosine. That is consistent with the analogue identity FDA describes. Backbone consistency is not pharmaceutical equivalence.

A GHRH analogue

GHRH, also called GHRF or GRF, is a hypothalamic peptide that acts on pituitary somatotrophs to stimulate synthesis and pulsatile release of growth hormone. Tesamorelin is described as an analogue that binds that receptor.¹

The GHRH–GH–IGF-1 axis is covered on the mechanism page. The distinction needed here is simpler: being a GHRH analogue explains why visceral fat was studied in a specific endocrine setting. It does not explain a general weight-loss, bodybuilding, or “anti-aging” use. Tesamorelin: GHRH, growth hormone & IGF-1

FDA approval history

Tesamorelin is the active ingredient in licensed U.S. EGRIFTA products. Original U.S. tesamorelin approval was 10 November 2010. The FDA product record places EGRIFTA WR as a later presentation, licensed on 25 March 2025.^3,1

That history is regulatory. It describes products, supplements, and labeling. It does not describe Peptra’s research vial, and it is not read here as an approval badge for laboratory material.

The EGRIFTA indication

Current EGRIFTA WR labeling indicates the product for reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. That is the indication. It is not general obesity and it is not weight-loss management.^1,2

The same labeling adds limitations: long-term cardiovascular safety has not been established, and EGRIFTA is not indicated for weight-loss management. The trials that support approval measured visceral adipose tissue in people with HIV, not a scale-weight program in the general population.^1,5,6

What approval applies to

FDA approval applies to licensed drug products, their formulation, their manufacturing controls, and the use the label describes. It does not automatically extend to another material that contains or is labeled as the same peptide.

The approved drug is prepared as tesamorelin acetate. Peptra’s public documentation names Tesamorelin without establishing that salt, without listing the licensed product’s excipients, and without an equivalence study. This page therefore does not say that Peptra’s vial is EGRIFTA.¹

The research-material distinction

Peptra offers tesamorelin as research-use-only material, currently documented as a 10 mg vial, with a lot certificate of analysis. A COA reports purity and mass identification. It does not establish approval, indication, equivalence, or clinical effectiveness. tesamorelin COA archive

Peptra’s catalog also does not sell a 20 mg variant. An orphan PDF does not create a product or an HTML lot record. This page does not use that file as the identity sheet of a commercial size.

Current evidence map

• Two pivotal Phase 3 trials in people with HIV and abdominal fat accumulation: 412 and 404 participants, with visceral adipose tissue as the primary endpoint.^5,6
• A pooled analysis of those two programs. It is not a third independent trial.⁷
• Later liver-fat trials in people with HIV. Clinical research, not an approved liver indication.^8,9
• FDA labeling and WADA 2026 status, covered on the regulatory page.^1,10

Next reading: the visceral-fat clinical trials, why visceral fat is not weight loss, and EGRIFTA, FDA & WADA.