# Tesamorelin

- Canonical: https://residue.info/c/tesamorelin/
- Also called: TH9507, Egrifta
- Evidence grade: A (Approved / regulatory-grade). FDA-approved (Egrifta) for excess abdominal fat in HIV-associated lipodystrophy, based on two phase 3 trials. Other uses are graded separately.
- Status: FDA-approved — Egrifta (2010)
- PubChem CID: 16137828
- Updated: 2026-10-19 · Reviewed by: Residue Editorial Team

Tesamorelin is a synthetic GHRH analog given by daily injection. It is FDA-approved as Egrifta for excess abdominal fat in adults with HIV lipodystrophy, and its label states it is not indicated for weight loss [1]. In pooled phase 3 trials, visceral fat fell by a treatment effect of 15.4% at 26 weeks, then reaccumulated after stopping [2][3].

## Key findings
- Pooled phase 3 trials: visceral adipose tissue fell 24 cm² versus a 2 cm² rise on placebo at 26 weeks (treatment effect −15.4%), without significant change in subcutaneous fat [2]. (anchor: https://residue.info/c/tesamorelin/#kf-pmid-20554713)
- The reduction was sustained at about −18% over 52 weeks, but visceral fat reaccumulated after discontinuation [3]. (anchor: https://residue.info/c/tesamorelin/#kf-pmid-18690162)
- In a randomized trial of 61 people with HIV and fatty liver disease, hepatic fat fraction fell by an absolute 4.1% versus placebo; 35% versus 4% reached under 5% [4]. (anchor: https://residue.info/c/tesamorelin/#kf-pmid-31611038)
- A 2026 meta-analysis of five RCTs found visceral fat −27.7 cm² and lean mass +1.42 kg, with arthralgia, myalgia, paresthesia and injection-site reactions as adverse events [5]. (anchor: https://residue.info/c/tesamorelin/#kf-pmid-41545261)
- The Egrifta SV label says long-term cardiovascular safety has not been established [1]. (anchor: https://residue.info/c/tesamorelin/#kf-label-bla022505)

## Effects by system
- Visceral fat (HIV lipodystrophy) (grade A): Approved use [1]; −15.4% treatment effect at 26 weeks in pooled phase 3 data [2]. (anchor: https://residue.info/c/tesamorelin/#effect-visceral-fat-hiv-lipodystrophy)
- Liver fat (grade B): Absolute hepatic-fat reduction of 4.1% versus placebo over 12 months in people with HIV and NAFLD [4]. (anchor: https://residue.info/c/tesamorelin/#effect-liver-fat)
- Lipids (grade B): Triglycerides fell by a treatment effect of 12.3% at 26 weeks [2]. (anchor: https://residue.info/c/tesamorelin/#effect-lipids)
- Lean body mass (grade B): +1.42 kg across five RCTs [5]. (anchor: https://residue.info/c/tesamorelin/#effect-lean-body-mass)
- Glucose (grade B): Fasting glucose rose transiently at 2 weeks, with no significant difference at 6 months [6]. (anchor: https://residue.info/c/tesamorelin/#effect-glucose)
- Musculoskeletal (adverse) (grade B): Arthralgia, myalgia and paresthesia reported across RCTs [5]. (anchor: https://residue.info/c/tesamorelin/#effect-musculoskeletal-adverse)

## How does Tesamorelin work?

Tesamorelin is a synthetic analog of human growth-hormone-releasing hormone (also called growth-hormone-releasing factor) that stimulates the synthesis and release of endogenous growth hormone [7]. PubChem's record gives a 44-residue sequence, shown in Figure 1, whose first 29 residues match sermorelin's [8][9]; the label classes it as a growth-hormone-releasing factor analog [1]. Because it works through the pituitary, it raises IGF-1: mean IGF-1 rose by 108 ng/mL versus a fall of 7 ng/mL on placebo in the pooled phase 3 data [2].

## What did the clinical trials find?

**Visceral fat in HIV lipodystrophy.** Two multicenter, double-blind, placebo-controlled phase 3 trials were pooled for analysis. At 26 weeks, visceral adipose tissue (VAT) fell by 24 cm² with tesamorelin and rose 2 cm² with placebo, a treatment effect of −15.4%. Abdominal subcutaneous fat did not change significantly, triglycerides fell (treatment effect −12.3%) and body-image measures improved. At 52 weeks, those who stayed on tesamorelin maintained a VAT reduction of about 17.5% [2].

**What happens after stopping.** The 52-week extension reported a sustained −18% VAT change and −51 mg/dL in triglycerides with continued treatment, and found that VAT reaccumulated when tesamorelin was discontinued [3].

**Liver fat.** A 2014 JAMA randomized trial in 48 treated patients found VAT −34 cm² versus +8 cm² and a modest reduction in liver fat over six months [6]. A larger Lancet HIV trial in 61 people with HIV and non-alcoholic fatty liver disease found an absolute hepatic-fat-fraction reduction of 4.1% (relative −37%); 35% on tesamorelin and 4% on placebo reached a liver-fat fraction below 5% [4].

**Pooled evidence.** A 2026 meta-analysis of five RCTs in HIV-associated lipodystrophy estimated VAT −27.7 cm², trunk fat −1.18 kg, hepatic fat −4.28% and lean body mass +1.42 kg, with no significant change in subcutaneous fat, BMI or CD4 count [5].

## What adverse events were reported in trials?

The meta-analysis listed arthralgia, myalgia, paresthesia and injection-site reactions such as erythema [5]. A 2011 review reported serious treatment-emergent adverse events in under 4% of patients over 26 weeks [7]. Glucose deserves attention: fasting glucose rose by a treatment effect of 7 mg/dL at two weeks in the JAMA trial, though the difference was not significant at six months [6], and glycemic measures did not differ at 12 months in the liver trial [4].

Egrifta was first approved in November 2010 [10]. The current Egrifta SV label limits the indication to excess abdominal fat in HIV-infected adults with lipodystrophy, states that long-term cardiovascular safety has not been established, and says it is not indicated for weight loss [1].

## What is still unknown?

- **Liver histology.** The NAFLD trial authors called for studies of long-term effects on liver histology [4].
- **Uses outside HIV.** Registry studies test other populations [11]; none is an approved use.

## Frequently asked questions
**What is tesamorelin approved for?**
The reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. The label adds that it is not indicated for weight-loss management because it is weight-neutral, and that long-term cardiovascular safety has not been established [1].

**What are the side effects of tesamorelin?**
Across randomized trials, arthralgia, myalgia, paresthesia and injection-site reactions such as erythema were reported [5]. Serious treatment-emergent adverse events occurred in under 4% over 26 weeks, most being injection-site reactions or events known to be associated with GH [7].

**Does tesamorelin reduce belly fat permanently?**
No. The reduction in visceral fat was maintained while treatment continued to 52 weeks, but visceral fat reaccumulated after stopping [3].

**What is the difference between tesamorelin and sermorelin?**
Both are GHRH analogs. Sermorelin is the 29-residue fragment [12]; tesamorelin's PubChem record lists 44 residues, the first 29 identical to sermorelin's. Tesamorelin holds a current approval [10]; sermorelin's Geref is discontinued [13].

**Does tesamorelin help fatty liver?**
In a 12-month randomized trial in people with HIV and NAFLD, hepatic fat fraction fell by an absolute 4.1% versus placebo [4]. This is not an approved use.


## Sources
[1] EGRIFTA SV prescribing information: Indications and Usage. FDA-approved labeling via openFDA/DailyMed, version effective 2026-07-29. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224
[2] Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. Falutz J et al. J Clin Endocrinol Metab. 2010. https://pubmed.ncbi.nlm.nih.gov/20554713/
[3] Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation. Falutz J et al. AIDS. 2008. https://pubmed.ncbi.nlm.nih.gov/18690162/
[4] Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. Stanley TL et al. Lancet HIV. 2019. https://pubmed.ncbi.nlm.nih.gov/31611038/
[5] Body composition, hepatic fat, metabolic, and safety outcomes of Tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: A meta-analysis of randomized controlled trials. Badran AS et al. Obes Res Clin Pract. 2026. https://pubmed.ncbi.nlm.nih.gov/41545261/
[6] Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial. Stanley TL et al. JAMA. 2014. https://pubmed.ncbi.nlm.nih.gov/25038357/
[7] Tesamorelin: a review of its use in the management of HIV-associated lipodystrophy. Dhillon S Drugs. 2011. https://pubmed.ncbi.nlm.nih.gov/21668043/
[8] PubChem compound record: Tesamorelin. C221H366N72O67S · MW 5136 g/mol. https://pubchem.ncbi.nlm.nih.gov/compound/16137828
[9] PubChem compound record: Sermorelin. C149H246N44O42S · MW 3357.9 g/mol. https://pubchem.ncbi.nlm.nih.gov/compound/16132413
[10] Drugs@FDA: EGRIFTA (BLA022505). THERATECHNOLOGIES; original approval 2010-11-10; Prescription. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505
[11] ClinicalTrials.gov registry search: tesamorelin. 24 registered studies at fetch. https://clinicaltrials.gov/search?intr=tesamorelin
[12] Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. Prakash A & Goa KL BioDrugs. 1999. https://pubmed.ncbi.nlm.nih.gov/18031173/
[13] Drugs@FDA: GEREF (NDA019863). EMD SERONO; original approval 1990-12-28; Discontinued. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019863

---
From Residue. Research and education only; not medical advice. Quote with attribution and a link to the canonical page.