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.

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.

What is the difference between tesamorelin and sermorelin?

Both are GHRH analogs. Sermorelin is the 29-residue fragment; tesamorelin's PubChem record lists 44 residues, the first 29 identical to sermorelin's. Tesamorelin holds a current approval; sermorelin's Geref is discontinued.

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. This is not an approved use.

Tesamorelin (Egrifta): Trials, Side Effects, FDA Status

Q: What are the side effects of tesamorelin?

Across randomized trials, arthralgia, myalgia, paresthesia and injection-site reactions such as erythema were reported. 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.

Tesamorelin

A synthetic GHRH analog and the only growth-hormone-axis peptide on this site with a current FDA approval: reducing excess abdominal fat in people with HIV-associated lipodystrophy.

Also called TH9507 · Egrifta

Best evidence: 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.

FDA-approved — Egrifta (2010)

**Identifiers** retrieved from PubChem.
PubChem CID	16137828 “Tesamorelin”
Formula	C221H366N72O67S
Molecular weight	5,136 g/mol
CAS (as listed)	218949-48-5, 804475-66-9
FDA UNII	MQG94M5EEO
InChIKey	QBEPNUQJQWDYKU-BMGKTWPMSA-N
Length	44 residues
Route in trials	Daily subcutaneous injection
Originator	Theratechnologies
Mechanism	GHRH (growth-hormone-releasing factor) analog

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 hormone66PubMedTesamorelin: a review of its use in the management of HIV-associated lipodystrophy. Dhillon S Drugs. 2011.. PubChem's record gives a 44-residue sequence, shown in Figure 1, whose first 29 residues match sermorelin's77PubChemPubChem compound record: Tesamorelin. C221H366N72O67S · MW 5136 g/mol.,88PubChemPubChem compound record: Sermorelin. C149H246N44O42S · MW 3357.9 g/mol.; the label classes it as a growth-hormone-releasing factor analog1. 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 data2.

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 discontinued3.

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 months99PubMedEffect 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.. 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 count5.

What adverse events were reported in trials?

The meta-analysis listed arthralgia, myalgia, paresthesia and injection-site reactions such as erythema5. A 2011 review reported serious treatment-emergent adverse events in under 4% of patients over 26 weeks6. 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 months9, and glycemic measures did not differ at 12 months in the liver trial4.

Is Tesamorelin FDA-approved?

**Table 1. Regulatory status of Tesamorelin in the United States** — from Drugs@FDA (openFDA) and FDA’s bulk-substance compounding categories, as fetched.
Record	Status	Source
EGRIFTA BLA022505 · THERATECHNOLOGIES	FDA-approved original approval 2010-11-10 POWDER SUBCUTANEOUS	10

Egrifta was first approved in November 20101010FDADrugs@FDA: EGRIFTA (BLA022505). THERATECHNOLOGIES; original approval 2010-11-10; Prescription.. 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 loss1.

What is still unknown?

Liver histology. The NAFLD trial authors called for studies of long-term effects on liver histology4.
Uses outside HIV. Registry studies test other populations1111TrialClinicalTrials.gov registry search: tesamorelin. 24 registered studies at fetch.; none is an approved use.

What effects has Tesamorelin shown, by body system?

Each row is graded separately using the Residue evidence scale: a compound can carry an A for one use and a D for another.

**Table 2.** Research-observed effects of Tesamorelin by body system, with the strongest evidence available for each.
System	What was observed	Grade
Visceral fat (HIV lipodystrophy)	Approved use1; −15.4% treatment effect at 26 weeks in pooled phase 3 data2.	A
Liver fat	Absolute hepatic-fat reduction of 4.1% versus placebo over 12 months in people with HIV and NAFLD4.	B
Lipids	Triglycerides fell by a treatment effect of 12.3% at 26 weeks2.	B
Lean body mass	+1.42 kg across five RCTs5.	B
Glucose	Fasting glucose rose transiently at 2 weeks, with no significant difference at 6 months9.	B
Musculoskeletal (adverse)	Arthralgia, myalgia and paresthesia reported across RCTs5.	B

How much research is there on Tesamorelin?

Figure 2. PubMed records per publication year matching (tesamorelin[tiab] OR TH9507[tiab]) — 105 in total; peak 15 in 2026. The 2026 bar is year-to-date (hatched). Volume of literature is not evidence of efficacy. Run this query on PubMed.

Registered studies of Tesamorelin by phase and status
Phase	Studies	Breakdown
Phase 1	2	2 completed, 0 active or recruiting, 0 stopped, 0 other
Phase 2	10	5 completed, 3 active or recruiting, 2 stopped, 0 other
Phase 3	2	2 completed, 0 active or recruiting, 0 stopped, 0 other
Phase 4	2	0 completed, 0 active or recruiting, 2 stopped, 0 other
Not applicable	5	4 completed, 0 active or recruiting, 1 stopped, 0 other
Observational	3	1 completed, 0 active or recruiting, 2 stopped, 0 other

Figure 3. 24 studies on ClinicalTrials.gov match the registry search tesamorelin. Multi-phase studies are counted at their highest phase. Open the full trial feed

Tesamorelin

What is Tesamorelin?

Key findings

What is Tesamorelin, chemically?