Tesamorelin (Egrifta)
Tesamorelin acetate (trans-3-hexenoic acid-GHRH(1-44)-NH2; TH9507)
An FDA-approved synthetic GHRH analog with N-terminal lipid modification, indicated for reduction of excess visceral abdominal fat in HIV-infected adults with lipodystrophy. Marketed as Egrifta/Egrifta SV/Egrifta WR by Theratechnologies.
Last updated: 2026-03-12
Safety Summary
Overall well-tolerated at approved dose (2 mg SC daily). Most adverse events are Grade 1-2 and consistent with effects of increased GH levels (fluid retention, joint pain). Immunogenicity: anti-tesamorelin IgG antibodies developed in ~49-50% of treated patients in pooled Phase 3 data; antibody titers decline over time and no neutralizing effect on efficacy or clear clinical adverse consequences demonstrated (up to 52 weeks). Glucose monitoring required (GH/IGF-1 axis stimulation can worsen glycemic control); blood glucose and HbA1c should be monitored especially in patients with or at risk for diabetes. No evidence of tachyphylaxis through 52 weeks of continuous treatment. VAT reaccumulates upon discontinuation. No classical dependence or withdrawal syndrome. Long-term cancer risk is theoretical (IGF-1 elevation is mitogenic); FDA mandated long-term post-marketing observational study to monitor cancer incidence. EMA flagged insufficient long-term safety data when MAA was withdrawn.
Known Side Effects
Common (-¥5%)
Common (-¥5%)
Common (-¥5%)
Common (-¥5%)
Common (-¥5%)
Uncommon (<5%, -¥1%)
Uncommon (<5%, -¥1%)
Uncommon
Uncommon (monitored)
Uncommon to rare
Who Should NOT Use This
Tesamorelin raises IGF-1 which is a growth factor and could potentially stimulate tumor growth.
Risk of allergic reaction including anaphylaxis.
Drug's mechanism relies on functional pituitary; requires intact somatotroph function.
No established benefit in pregnant women; potential for fetal harm.
GH axis stimulation can worsen glycemic control. Diabetes was exclusion criterion in many trials.
GH/IGF-1 changes may alter cortisol metabolism.
No dedicated studies; caution advised.
Talk to Your Doctor
Before considering Tesamorelin (Egrifta), discuss it with your healthcare provider. Ask about potential interactions with your current medications, whether it is appropriate for your health conditions, and what monitoring may be needed.
Sources: [1-6]
Evidence Assessment
FDA-approved drug (Egrifta, NDA 022505, approved Nov 2010; Egrifta WR supplemental approval March 2025) for reduction of excess visceral abdominal fat in HIV-infected adults with lipodystrophy. Supported by two pooled Phase 3 RCTs (N=806, LIPO-010 and CTR-1011) with robust efficacy data and 52-week safety extensions, plus multiple Phase 2 RCTs for hepatic fat/NAFLD. Active clinical development pipeline.
1Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in HIV-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension dataNCT00435136 / NCT00608023PMID 20554713
Falutz J, Allas S, Blot K, et al. - J Clin Endocrinol Metab (2010) - Pooled Phase 3 RCTs - 806
VAT change at 26 weeks: tesamorelin -15.2% vs placebo +5.0% (P<0.001). No significant change in subcutaneous fat. Also significantly reduced triglycerides and increased IGF-1. Maintained through 52-week extension.
Limitations: HIV-specific population; may not generalize to non-HIV individuals. 52-week max follow-up. Industry-sponsored. VAT reverses on discontinuation. Long-term CV outcomes not assessed.
2Effect of Tesamorelin on Visceral Fat and Liver Fat in HIV-Infected Patients With Abdominal Fat Accumulation: A Randomized Clinical TrialPMID 24915220
Stanley TL, Falutz J, Marsolais C, et al. - JAMA (2014) - Phase 2 RCT - 54
Hepatic fat fraction: absolute reduction -4.1% (95% CI -7.6 to -0.7; P=0.018); relative ~37% reduction. 35% achieved HFF <5% vs 4% placebo (P=0.0069).
Limitations: Small sample (n=54); single center; HIV population. Generalizability to non-HIV NAFLD unknown.
3Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trialNCT02196831PMID 31452484
Grinspoon SK, Stanley TL, Telo GH, et al. - Lancet HIV (2019) - Phase 2 RCT (multicenter) - 61
Confirmed hepatic fat reduction consistent with JAMA 2014 study. Proportion achieving HFF <5% significantly higher with tesamorelin. Did not assess long-term histological outcomes.
Limitations: Small sample; HIV population; 12-month treatment period.
4A phase 2 randomized trial of tesamorelin for cognition in aging HIV-infected personsNCT02572323PMID 39813152
Ellis RJ, Letendre SL, Fields JA, et al. - AIDS (2025) - Phase 2 RCT (neurocognitive endpoints) - 64
Tesamorelin for 6 months did NOT result in statistically significant improvement in composite neurocognitive performance vs placebo, despite reducing VAT and increasing IGF-1. NEGATIVE RESULT.
Limitations: Relatively short duration for cognitive endpoints. Specific to older HIV-positive individuals with mild cognitive impairment.
5Population pharmacokinetic analysis of tesamorelin in HIV-infected patients and healthy subjectsPMID 25358450
Population PK study authors - Clin Pharmacol Drug Dev (2014) - Population PK analysis
Vd ~200 L; clearance ~1060 L/h; terminal t½ ~26-40 min SC. Low absolute bioavailability (<4%).
Limitations: PK modeling study; not an efficacy trial.
6Body composition, hepatic fat, metabolic, and safety outcomes of Tesamorelin: A meta-analysis of randomized controlled trialsPMID 41545261
Meta-analysis authors - PubMed (2025) - Meta-analysis of RCTs
Confirmed reduction in liver fat with no signal of liver enzyme deterioration. Consistent body composition improvements (including modest lean mass increase ~1.4 kg) across pooled data.
Limitations: Meta-analysis; dependent on included trial quality.