Tesamorelin: Safety Profile & Research Summary
24 PubMed CitationsExpert ReviewedGMP CertifiedLast Reviewed: April 2026
Clinical Trials
✅ Tesamorelin is one of very few GHRH analogs with formal FDA approval. The pivotal program included 816 study subjects in Phase 3 trials, with expanding research into NAFLD, cognitive function, and nerve regeneration.
| Trial | Phase | n= | Indication | Key Result | Outcome |
|---|---|---|---|---|---|
| Pivotal (Study 1+2) | Phase 3 | 816 | HIV Lipodystrophy | -18%/-14% VAT (P<0.001) | ✅ FDA-registered |
| Dose-Ranging | Phase 2 | 61 | HIV Lipodystrophy | -15.7% VAT (2mg group) | ✅ Positive |
| NAFLD | RCT | 61 | HIV + NAFLD | -37% hepatic fat; fibrosis prevented | ✅ Positive |
| MCI/Aging | RCT | 152 | Cognitive Function | Exec function P=0.005; IGF-1 +117% | ✅ Positive |
| HIV Neuro | Phase 2 | 73 | HIV Neurocognitive | Trend only (P=0.060) | ❌ Negative |
| Obesity/GH-Low | RCT | 60 | Obesity | -18% VAT (P<0.001) | ✅ Positive |
| T2D Tolerability Assessment | RCT | 53 | Type 2 Diabetes | Neutral glucose — tolerability demonstrated | ✅ Well-tolerated |
| Healthy Men | PK | 13 | Physiology | +GH pulsatility, no insulin change | ✅ Positive |
Reported Tolerability Profile
Established through 800+ study subjects in Phase 3 trials. [4]
- Common (>5%): Arthralgia, injection site erythema/pruritus, pain in extremity, peripheral edema, myalgia
- Hypersensitivity: 3.6–4% (pruritus, erythema, flushing, urticaria)
- Glucose: Increased risk of HbA1c ≥6.5% (HR 3.3 vs placebo); monitor glucose
- Reproductive: Pregnancy Category X — hydrocephaly in rat offspring at 2–4x human dose; delayed skull ossification at lower doses
- Contraindications: Active malignancy, hypophysectomy/pituitary tumor, pregnancy, hypersensitivity
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References
- Falutz J, Allas S, Kotler D, et al. A placebo-controlled, dose-ranging study of a growth hormone releasing factor in HIV-infected study subjects with abdominal fat accumulation. AIDS, 19(12), 1279-87, 2005.
- Ferdinandi ES, Brazeau P, High K, et al. Non-clinical pharmacology and tolerability evaluation of TH9507, a human growth hormone-releasing factor analogue. Basic Clin Pharmacol Toxicol, 100(1), 49-58, 2007.
- Falutz J, Allas S, Blot K, et al. Metabolic effects of a growth hormone-releasing factor in study subjects with HIV. N Engl J Med, 357(23), 2359-70, 2007.
- Falutz J, Mamputu JC, Potvin D, et al. Effects of tesamorelin (TH9507) in HIV-infected study subjects with excess abdominal fat: pooled analysis of two Phase 3 trials. J Clin Endocrinol Metab, 95(9), 4291-304, 2010.
- Wang Y, Tomlinson B. Tesamorelin, a human growth hormone releasing factor analogue. Expert Opin Investig Drugs, 18(3), 303-10, 2009.
- Grunfeld C, Dritselis A, Kirkpatrick P. Tesamorelin. Nat Rev compound Discov, 10(2), 95-6, 2011.
- Stanley TL, Chen CY, Branch KL, Makimura H, Grinspoon SK. Effects of a growth hormone-releasing hormone analog on endogenous GH pulsatility and insulin sensitivity in healthy men. J Clin Endocrinol Metab, 96(1), 150-8, 2011.
- Dhillon S. Tesamorelin: a review of its use in the management of HIV-associated lipodystrophy. Drugs, 71(8), 1071-91, 2011.
- Spooner LM, Olin JL. Tesamorelin: a growth hormone-releasing factor analogue for HIV-associated lipodystrophy. Ann Pharmacother, 46(2), 240-7, 2012.
- Stanley TL, Falutz J, Marsolais C, et al. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected study subjects receiving tesamorelin. Clin Infect Dis, 54(11), 1642-51, 2012.
- Stanley TL, Fourman LT, Feldpausch MN, et al. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. Lancet HIV, 6(12), e821-e830, 2019.
- Adrian S, Scherzinger A, Sanyal A, et al. The Growth Hormone Releasing Hormone Analogue, Tesamorelin, Decreases Muscle Fat and Increases Muscle Area in Adults with HIV. J Frailty Aging, 8(3), 154-159, 2019.
- Baker LD, Barsness SM, Borson S, et al. Effects of Growth Hormone-Releasing Hormone on Cognitive Function in Adults With Mild Cognitive Impairment and Healthy Older Adults. Arch Neurol, 69(11), 1420-9, 2012.
- Lopez J, Quan A, Budihardjo J, et al. Growth Hormone Improves Nerve Regeneration, Muscle Re-innervation, and Functional Outcomes After Chronic Denervation Injury. Sci Rep, 9(1), 3117, 2019.
- Grinspoon SK, Fourman L, Stanley T, et al. Impact of Tesamorelin on Cardiovascular Disease Risk Prediction Scores: Subanalysis. Open Forum Infect Dis, 12(Suppl 1), 2025.
- Clemmons DR, Miller S, Mamputu JC. tolerability and metabolic effects of tesamorelin in study subjects with type 2 diabetes: A randomized, placebo-controlled trial. PLoS One, 12(6), e0179538, 2017.
- Makimura H, Feldpausch MN, Rope AM, et al. Metabolic effects of a growth hormone-releasing factor in obese subjects with reduced growth hormone secretion. J Clin Endocrinol Metab, 97(12), 4769-79, 2012.
- Fourman LT, Czerwonka N, Feldpausch MN, et al. Visceral fat reduction with tesamorelin is associated with improved liver enzymes in HIV. AIDS, 31(16), 2253-9, 2017.
- Mangili A, Falutz J, Mamputu JC, et al. Predictors of research application response to tesamorelin in HIV-infected study subjects with excess abdominal fat. PLoS One, 10(10), e0140358, 2015.
- Lake JE, La K, Erlandson KM, et al. Tesamorelin Improves Fat Quality Independent of Changes in Fat Quantity. AIDS, 35(9), 1395-1402, 2021.
- Makimura H, Murphy CA, Feldpausch MN, Grinspoon SK. The Effects of Tesamorelin on Phosphocreatine Recovery in Obese Subjects With Reduced GH. J Clin Endocrinol Metab, 99(1), 338-343, 2014.
- Stanley TL, Feldpausch MN, Oh J, et al. Effect of tesamorelin on visceral fat and liver fat in HIV-infected study subjects: a randomized clinical trial. JAMA, 312(4), 380-9, 2014.
- Ellis RJ, Vaida F, Hu K, et al. Effects of Tesamorelin on Neurocognitive Impairment in Persons With HIV and Abdominal Obesity. J Infect Dis, 231(5), 1230-1238, 2025.
- Falutz J, Potvin D, Mamputu JC, et al. Effects of tesamorelin in HIV-infected study subjects with abdominal fat accumulation: a randomized placebo-controlled trial with safety extension. J Acquir Immune Defic Syndr, 53(3), 311-22, 2010.
Related Research Questions
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