Peptide dossier, updated Nov 1, 2026

Tesamorelin

Tesamorelin acetate, a modified form of growth hormone-releasing hormone (GHRH). Brand name Egrifta. An FDA-approved prescription injection for reducing excess abdominal fat in HIV-infected adults with lipodystrophy. It is a lab-made analogue of the brain hormone that prompts growth hormone release. Other uses are not approved. In August 2026 FDA sent warning letters to two companies selling tesamorelin products as unapproved new drugs. This page lays out what each source actually says.

See all 14 verified records for Tesamorelin on the Records page

In plain terms

Approved for: Reduction of excess abdominal fat in HIV-infected adults with lipodystrophy (Egrifta SV and Egrifta WR labels). Not for weight loss, and not approved for other uses.

What it is: A lab-made version of GHRH, the brain hormone that prompts the pituitary gland to release growth hormone, given as a daily injection.

What it is said to do, and by whom:

FDA, through the labels: approved for the use above, with warnings on neoplasms, raised IGF-1, fluid retention, glucose intolerance, hypersensitivity, injection site reactions and mortality in acute critical illness. Long-term cardiovascular safety is not established.
Trial investigators, 2007: in 412 patients with HIV and abdominal fat, 26 weeks of tesamorelin cut visceral fat 15.2% versus a 5.0% rise on placebo.
Sellers of “research” tesamorelin: FDA’s August 2026 letters say products sold this way are unapproved new drugs.

How strong the evidence is: Strong for the approved use: randomized phase 3 data in HIV-associated abdominal fat. Weak or absent for other uses promoted online. The label says it is not for weight loss.

FDA approval

Approved

Egrifta, BLA 022505, original Nov 10, 2010 (Drugs@FDA through openFDA). Current labels on DailyMed: Egrifta SV (revised 03/2024) and Egrifta WR (revised 03/2025).

Label use

HIV lipodystrophy

Reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. The label says it is not indicated for weight loss and that long-term cardiovascular safety has not been established.

Label contraindications

Four listed

Disruption of the hypothalamic-pituitary axis, active malignancy, known hypersensitivity, and pregnancy.

FDA warning letters, Aug 2026

Two letters name it

FDA told two companies that tesamorelin products they sold as “research peptides” are unapproved new drugs.

HHS enforcement, Oct 30

Not covered

The draft policy’s covered list names six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. Tesamorelin is not one of them. Draft policy. Not binding.

FDA advisory panel, July

Not reviewed

FDA’s Federal Register notice for the July 23–24 meeting lists seven peptides. Tesamorelin is not among them.

WADA prohibited list

Named

The 2026 list names tesamorelin in section S2.2.4, GHRH analogues. We read WADA’s own file through a text extraction and cross-checked a copy hosted by an athletics federation.

FDA approval and labels

The original approval date is from Drugs@FDA through the openFDA API. Label content is paraphrased from the DailyMed labels we read; the labels govern.

Brand	Application	Original approval	Label, as we read it
Egrifta	Drugs@FDA BLA022505	Nov 10, 2010	Reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.
Egrifta SV	Same application, per DailyMed	See the application	Same indication. Revised 03/2024. DailyMed label
Egrifta WR	Same application, per DailyMed	See the application	Same indication. Revised 03/2025. DailyMed label

What the label says

We read the Egrifta SV label on DailyMed (revised 03/2024) and the indication of the Egrifta WR label.

Warnings and precautions, in the label’s own headings

Increased risk of neoplasms: any preexisting malignancy should be inactive and treatment complete before starting.
Elevated IGF-1: monitor levels; consider stopping with persistent elevation. The effects of prolonged elevation are unknown.
Fluid retention, which can include edema, joint pain and carpal tunnel syndrome.
Glucose intolerance or diabetes mellitus: evaluate glucose before and during therapy.
Hypersensitivity reactions, in 4% of patients in clinical trials; injection site reactions.
Increased mortality in patients with acute critical illness.

What we did not do

We did not read the adverse reaction tables or the Egrifta WR warnings in full.
We did not tie the SV and WR formulations to specific supplement dates; openFDA lists labeling and manufacturing supplements in Feb 2024 and Mar 2025.

Key trial papers

PubMed returns 95 results for tesamorelin in the title or abstract as of Nov 1, 2026, and ClinicalTrials.gov returns 24 studies (a broad GHRH search; several are not tesamorelin). We read the abstract of the pivotal paper.

Papers

Pivotal phase 3, 2007. 412 patients with HIV and abdominal fat, 2 mg daily or placebo for 26 weeks. Visceral fat fell 15.2% on tesamorelin and rose 5.0% on placebo. Triglycerides fell 50 mg/dL versus a 9 mg/dL rise. IGF-1 rose 81.0% versus a 5.0% fall. Adverse events did not differ significantly, but more tesamorelin patients withdrew because of an adverse event. N Engl J Med PubMed
Pooled analysis, 2010. Pools the two phase 3 studies: 806 patients with HIV and excess abdominal fat randomized 2:1 to tesamorelin 2 mg or placebo for 26 weeks, then a 26-week safety extension. The 2007 paper above is one of the two studies. J Clin Endocrinol Metab PubMed
Extension phase, 2008. The 26-week extension of the first phase 3 study: 410 patients were randomized at the start, and patients were re-randomized or switched at week 26. The abstract says tesamorelin was generally well tolerated. AIDS PubMed
Fatty liver in HIV, 2019. A randomised, double-blind trial in the USA of tesamorelin 2 mg or placebo for 12 months in people with HIV and liver fat of 5% or more, then 6 months open-label. Off-label for this use. Lancet HIV PubMed
Integrase inhibitors, 2024. A secondary analysis of a 61-person randomized trial, asking whether tesamorelin works in people on integrase inhibitor regimens, which did not exist when the phase 3 trials ran. AIDS PubMed
Drug review, 2011. Review of its use in HIV-associated lipodystrophy. Drugs PubMed

Read with care

The pivotal trial was in people with HIV and abdominal fat. It does not speak to use in people without HIV.
The 2007 abstract does not say who funded the trial; we did not read full text.
One recruiting record, NCT07481734 from Hudson Biotech, has “(Mock Study)” in its title. We cannot tell whether it is a real trial and did not rely on it.

FDA warning letters

We found three FDA warning letters that mention tesamorelin. This rests on web searches, not a full pull of FDA’s database.

Recipient	Date	Letter	What it says
NuScience Peptides LLC	Aug 24, 2026	Warning letter 733652	FDA says products including “Tesamorelin Research Peptide” and a tesamorelin-ipamorelin blend, among others, are unapproved new drugs under section 505(a) of the FD&C Act. We read the letter text.
Royal Peptides LLC	Aug 24, 2026	Warning letter 734884	FDA says products including “Tesamorelin”, among others, are unapproved new drugs under section 505(a), and are drugs because of the intended use the website describes. We read the letter text.
Tailor Made Compounding LLC, a compounding pharmacy	Apr 1, 2020	Warning letter 594743	FDA acknowledges the firm’s voluntary recall of its tesamorelin products made between July 6 and Sep 11, 2018, due to an incorrect beyond-use date on the vial labels. We read the letter text.

A warning letter is FDA’s statement about one firm’s conduct on one date. It is not a finding about the substance. FDA’s list of letters cannot be searched by peptide, so other letters could exist that we did not find. The 2026 letters concern companies selling products as “research” peptides, not Theratechnologies’s approved Egrifta.

Timeline

Newest first. Every entry links to the document it comes from.

Government or registry record
Journal

Oct 30, 2026Regulatory
HHS publishes draft policy pausing enforcement on six peptides; Tesamorelin is not one of them
The draft policy’s appendix names six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. The policy is a draft and not FDA approval. We read the appendix through a text extraction.
Federal Register Docket HHS policy appendix BakerHostetler summary
Aug 24, 2026Enforcement
FDA sends warning letters to two companies selling tesamorelin products as unapproved new drugs
The letters are to NuScience Peptides LLC and Royal Peptides LLC.
NuScience Royal Peptides
Aug 3, 2026Label
Egrifta WR label posted on DailyMed
DailyMed publication date; the label text says revised 03/2025.
DailyMed
July 23–24, 2026Regulatory
FDA advisory committee meets on seven peptides; Tesamorelin is not among them
The committee recommended six of the seven, all nonbinding. FDA’s notice of the meeting does not list Tesamorelin.
Federal Register notice Holland & Knight summary
Jan 1, 2026Anti-doping
WADA’s 2026 Prohibited List names tesamorelin in S2.2.4
The list names it among GHRH analogues. We read WADA’s own file through a text extraction.
WADA 2026 list (PDF)
Apr 1, 2020Enforcement
FDA warning letter to a compounding pharmacy names tesamorelin among its compounded substances
The letter says drugs the firm compounded from these bulk substances were not eligible for the 503A exemptions.
Warning letter 594743
Nov 10, 2010Approval
FDA approves Egrifta (BLA 022505)
Original approval date per Drugs@FDA through openFDA.
Drugs@FDA BLA022505
2007Literature
Pivotal trial: visceral fat down 15.2% versus up 5.0% on placebo
412 patients with HIV. Published in N Engl J Med.
PubMed

Still not covered

Left off rather than guessed:

HHS policy: we read the draft policy appendix through a text extraction, not as the original PDF layout. It names six covered peptides and not tesamorelin.
FDA review: we found no FDA briefing document or advisory committee evaluation for tesamorelin. FDA’s notice for the July meeting does not name it.
SV and WR approval dates: openFDA lists a labeling supplement on Feb 27, 2024 and a manufacturing supplement on Mar 25, 2025 for BLA 022505. We did not tie these to the SV and WR formulations.
Full label and clinical review: we read the indication, contraindications and warnings headings, not the full clinical studies section or any FDA review document.
Trials beyond the approved use: we did not review the nerve injury, cognition, COPD or exercise studies listed on the registry.
Patents and SEC filings: not researched for this dossier.
Seller claims and independent lab reports: how gray-market product is marketed versus what testing finds. We have not collected testing data.
Unread items: full text of most papers; EU and other non-US regulators and registries; WADA lists for years other than 2026; FDA warning letters beyond those listed, which rest on web searches.