# Tesamorelin: FDA Status, Research and Uses

> Tesamorelin (Egrifta SV, Egrifta WR) FDA approval, label dosing and warnings, compounding and WADA status, and the key HIV belly fat and liver trials.

- Canonical URL: https://livingpluspeptides.com/peptides/tesamorelin/
- Last updated: October 25, 2026
- Publisher: Living+

Tesamorelin is a lab-made analog of growth hormone-releasing factor built on 44 amino acids. FDA approved it in 2010, and it is sold as Egrifta SV and Egrifta WR to reduce excess belly fat in adults with HIV and lipodystrophy. It has also been studied for liver fat in people with HIV [1, 3, 7].

## Regulatory status

- FDA approved: Yes: [Egrifta WR (DailyMed label)](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75), [Egrifta SV (DailyMed label)](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224)
- 503A compounding: [Biologic, not eligible for 503A compounding](https://www.fda.gov/drugs/human-drug-compounding/notice-compounders-changes-affect-compounding-march-23-2020). Active ingredient of FDA-approved Egrifta. The application was deemed a BLA on March 23, 2020; FDA says biological products that transitioned that day are not eligible for the 503A compounding exemptions.
- 503B bulks list: [Biologic, not eligible for 503B compounding](https://www.fda.gov/drugs/human-drug-compounding/notice-compounders-changes-affect-compounding-march-23-2020). Deemed a BLA on March 23, 2020; FDA says transitioned biological products are not eligible for the 503B exemptions. Not in any 503B category (list updated March 21, 2025).
- WADA prohibited: [Yes](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf) (S2.2.4 Growth hormone releasing factors (GHRH analog))
- FDA drug shortage: [Not on the shortage list](https://api.fda.gov/drug/shortages.json?search=generic_name:%22tesamorelin%22)
- DEA schedule: [Not scheduled](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)
- Last verified: November 2, 2026

Checked against: [Drugs@FDA: BLA 022505 (Egrifta)](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505), [FDA: Egrifta WR supplement approval letter, March 25, 2025](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022505Orig1s020ltr.pdf), [FDA: Notice to Compounders, changes as of March 23, 2020](https://www.fda.gov/drugs/human-drug-compounding/notice-compounders-changes-affect-compounding-march-23-2020), [FDA: Bulk drug substances nominated for use in compounding under section 503B (updated March 21, 2025)](https://www.fda.gov/media/94164/download), [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf), [openFDA drug shortages query: tesamorelin](https://api.fda.gov/drug/shortages.json?search=generic_name:%22tesamorelin%22), [DEA Diversion: Controlled Substances - Alphabetical Order](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)

## Key facts

- Class: Growth hormone-releasing factor (GHRF) analog [1]
- Amino-acid length: 44 amino acids plus a hexenoyl group at the N-terminal tyrosine [1]
- Half-life: About 8 to 11 minutes after a subcutaneous dose (label, healthy adults) [1, 2]
- Route used in studies: Subcutaneous injection [1]
- First studied: Phase 3 results published in 2007; FDA approval on November 10, 2010 [4, 3]

## How it works

The brain releases a hormone called growth hormone-releasing factor, also known as GHRH. It signals the pituitary gland to make growth hormone. Tesamorelin is a lab-made copy of the full 44 amino acid sequence of human GHRH. It has a small fatty acid group, called a hexenoyl group, added to the first amino acid [1].

Tesamorelin acts on the pituitary and causes it to release the body's own growth hormone. This raises IGF-1, a growth factor. The label says IGF-1 rises during treatment and should be monitored [1]. Because it needs a working pituitary, the label says it must not be used by people whose hypothalamic-pituitary axis has been disrupted, for example by pituitary surgery or head radiation [1].

In people with HIV and extra belly fat, daily tesamorelin lowered fat deep inside the abdomen, called visceral fat, compared with placebo. Fat under the skin of the belly did not change much [5]. Later trials also studied its effect on liver fat [6, 7].

The drug leaves the blood fast. The label lists a mean half-life of 8 minutes for Egrifta SV and 11 minutes for Egrifta WR in healthy adults [2, 1].

## What the research shows

| Study | Year | Participants | Design | Result | Link |
| --- | --- | --- | --- | --- | --- |
| Human trial: Stanley et al., fatty liver in HIV (Lancet HIV) | 2019 | 61 adults with HIV and fatty liver | Randomized, double-blind, placebo-controlled, multicenter, 12 months | Studied for fatty liver: liver fat fraction fell 4.1 points more than placebo. 35% on tesamorelin vs 4% on placebo reached under 5% liver fat [7] | [Source](https://pubmed.ncbi.nlm.nih.gov/31611038/) |
| Human trial: Stanley et al., visceral and liver fat (JAMA) | 2014 | 50 adults with HIV and abdominal fat buildup | Randomized, double-blind, placebo-controlled, 6 months | Visceral fat and liver fat both fell compared with placebo. Net liver fat effect was -2.9% lipid to water [6] | [Source](https://pubmed.ncbi.nlm.nih.gov/25038357/) |
| Human trial: Falutz et al., pooled phase 3 analysis | 2010 | 806 adults with HIV on antiretroviral therapy and excess abdominal fat | Pooled analysis of two double-blind, placebo-controlled trials, 26 weeks plus a 26-week extension | Visceral fat treatment effect was -15.4% at week 26. The drop was maintained to week 52 in people who stayed on drug [5] | [Source](https://pubmed.ncbi.nlm.nih.gov/20554713/) |
| Human trial: Falutz et al., phase 3 (NEJM) | 2007 | 412 adults with HIV and abdominal fat buildup | Randomized, placebo-controlled, 26 weeks | Visceral fat fell 15.2% on tesamorelin 2 mg daily and rose 5.0% on placebo. IGF-1 rose 81% [4] | [Source](https://pubmed.ncbi.nlm.nih.gov/18057338/) |

## Doses used in studies

The FDA label dose for Egrifta SV is 1.4 mg given subcutaneously once daily [2]. The label dose for Egrifta WR is 1.28 mg given subcutaneously once daily. The label says the two products have different doses and are not substitutable [1].

The phase 3 trials and the liver fat trials used 2 mg of tesamorelin once daily [4, 5, 6, 7].

**Dosing is set by a licensed provider.**

## Side effects and safety

The label lists no boxed warning. It is contraindicated in people with a disrupted hypothalamic-pituitary axis, active cancer, known allergy to tesamorelin or its ingredients, and in pregnancy [1].

Warnings include a possible higher risk of new or returning cancers, raised IGF-1, fluid retention (swelling, joint pain, carpal tunnel syndrome), glucose intolerance or diabetes, allergic reactions, injection site reactions, and higher death rates seen with growth hormone in acutely critically ill patients [1].

In trials, allergic reactions occurred in 4% of patients. Injection site reactions occurred in 25% on drug vs 14% on placebo over 26 weeks. Side effects seen in more than 5% of patients were joint pain, injection site redness and itching, pain in the arms or legs, swelling of the legs, and muscle pain [1].

## Legal and regulatory status

- 2026-01-01: The WADA 2026 Prohibited List took effect. It names tesamorelin under S2.2.4 (GHRH and its analogs), banned at all times [8]. [Source](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
- 2025-03-25: FDA approved Egrifta WR, a new formulation and multiple-dose presentation of tesamorelin, under BLA 022505 [10, 3]. [Source](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022505Orig1s020ltr.pdf)
- 2020-03-23: The Egrifta application was deemed to be a biologics license (BLA). FDA says biological products that transitioned on this date are not eligible for the 503A and 503B compounding exemptions [3, 9]. [Source](https://www.fda.gov/drugs/human-drug-compounding/notice-compounders-changes-affect-compounding-march-23-2020)
- 2019-07-05: FDA approved renaming the 2 mg/vial presentation of Egrifta as Egrifta SV [11, 3]. [Source](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022505Orig1s012,%20s013ltr.pdf)
- 2010-11-10: FDA approved Egrifta (tesamorelin) under application 022505 [3]. [Source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505)

See every peptide's status side by side in the [Peptide Status Tracker](https://livingpluspeptides.com/regulation/tracker/#row-tesamorelin).

## Frequently asked questions

### Is tesamorelin FDA approved?

Yes. FDA first approved it in 2010. It is sold as Egrifta SV and Egrifta WR to reduce excess abdominal fat in adults with HIV and lipodystrophy [3, 1, 2].

### Is tesamorelin approved for weight loss?

No. The label says it is not indicated for weight loss management because it has a weight neutral effect [1].

### What is the difference between Egrifta SV and Egrifta WR?

They are two formulations with different label doses: 1.4 mg daily for Egrifta SV and 1.28 mg daily for Egrifta WR. The label says they are not substitutable [2, 1].

### Can tesamorelin be compounded?

Egrifta has been regulated as a biologic since March 23, 2020. FDA says biological products that transitioned on that date are not eligible for the 503A and 503B compounding exemptions [3, 9].

### Does tesamorelin reduce liver fat?

It was studied for this. In a 12-month trial in 61 adults with HIV and fatty liver, liver fat fell more on tesamorelin than on placebo [7]. Fatty liver is not an approved use.

### Does tesamorelin raise blood sugar?

It can. The label warns about glucose intolerance and diabetes and says to check glucose before and during treatment [1].

### Is tesamorelin banned in sports?

Yes. The WADA 2026 Prohibited List names tesamorelin under S2.2.4, banned in and out of competition [8].

### How long does tesamorelin last in the body?

Not long. The label lists a mean half-life of 8 to 11 minutes in healthy adults, depending on the product [2, 1].

## Sources

1. [DailyMed: Egrifta WR (tesamorelin) label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75)
2. [DailyMed: Egrifta SV (tesamorelin) label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224)
3. [Drugs@FDA: BLA 022505 (Egrifta)](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505)
4. [Falutz et al. 2007, N Engl J Med (PubMed)](https://pubmed.ncbi.nlm.nih.gov/18057338/)
5. [Falutz et al. 2010, J Clin Endocrinol Metab (PubMed)](https://pubmed.ncbi.nlm.nih.gov/20554713/)
6. [Stanley et al. 2014, JAMA (PubMed)](https://pubmed.ncbi.nlm.nih.gov/25038357/)
7. [Stanley et al. 2019, Lancet HIV (PubMed)](https://pubmed.ncbi.nlm.nih.gov/31611038/)
8. [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
9. [FDA: Notice to Compounders, changes as of March 23, 2020](https://www.fda.gov/drugs/human-drug-compounding/notice-compounders-changes-affect-compounding-march-23-2020)
10. [FDA: Egrifta WR supplement approval letter, March 25, 2025](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022505Orig1s020ltr.pdf)
11. [FDA: Egrifta and Egrifta SV supplement approval letter (S-012, S-013), July 2019](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022505Orig1s012,%20s013ltr.pdf)

Educational information, not medical advice. This site sells nothing.