Growth hormone axis
Tesamorelin
Also known as Egrifta
Synthetic GHRH analog studied for reducing excess abdominal fat in people with HIV-associated lipodystrophy.
Where the evidence comes from
59 verified records from 13 countries. The number of studies or countries is not proof that Tesamorelin works or is safe.
Systematic review / meta-analysis: 2 · Human clinical trial: 25 · Randomized clinical trial: 9 · Narrative review: 16 · Observational human study: 4 · Animal study: 3
What is known
Editorial summary not yet written.
What remains uncertain
Editorial summary not yet written.
Conflicting findings
Editorial summary not yet written.
U.S. regulatory status (FDA)
Compound
Product or formulation
FDA status
FDA-approved branded drug
Approved indication
Metara availability (compounded formulation)
Research material (research use only)
Source
Last verified
Notes
Approval applies only to the exact finished drug, formulation and indication. A shared active ingredient does not make a compounded version, blend or other use FDA-approved. Pharmacy or research-material availability is not FDA approval.
International regulatory status
Kept separate from U.S. status. The regulator's country is not the same as where studies took place.
No sourced international decisions recorded yet.
Continue your research
These are two different pathways, not two ways to get the same thing. Neither changes the FDA status shown above.
Clinical care
Available through Metara Health
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EXPLORE METARA HEALTH →Research materials
Available through BioNex Peptides
Explore research-use materials, lot-specific analytical testing and research documentation.
EXPLORE BIONEX →Limitations
Approved population is narrow (HIV lipodystrophy). Evidence for general body-composition or anti-aging use is limited.
Human clinical evidence (38)
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (TRIUMPH): a clinical trial protocol
Erlandson KM, Gustafson L, Johnson JE, Kulik GL, Khuu V, Chahal N, Walpert AR, Galdamez ME, Zorgno I, Foldyna B, Jarraya M, Reusch JE, Lee H, Grinspoon SK, Jankowski CM, Fourman LT · BMJ open · DOI 10.1136/bmjopen-2026-120740
This protocol describes a registered randomized human trial testing tesamorelin plus exercise versus placebo plus exercise in sedentary older adults living with HIV who have excess abdominal fat and frailty or risk of frailty. The trial will assess physical function, muscle health, quality of life, and exercise adherence. No results are reported.
A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Tesamorelin (GHRH Analog) for Reducing Hepatic Steatosis in Adults With Metabolic Associated Steatotic Liver Disease (MASLD)
Hudson Biotech · ClinicalTrials.gov · NCT07481734
This recruiting, randomized, placebo-controlled human trial is evaluating whether tesamorelin reduces liver fat in adults with metabolic dysfunction-associated fatty liver disease. Researchers will measure liver fat using MRI and monitor blood sugar and IGF-1 for safety. The trial is ongoing, and no results are reported.
Effects of Tesamorelin on Neurocognitive Impairment in Persons With HIV and Abdominal Obesity.
Ellis RJ, Vaida F, Hu K, Dube M, Henry B, Chow F, Heaton RK, Lee D, Sattler F · The Journal of infectious diseases · DOI 10.1093/infdis/jiaf012
This randomized, open-label trial compared tesamorelin with standard care in people with suppressed HIV, abdominal obesity, and cognitive impairment. Tesamorelin reduced waist circumference more than standard care, but cognitive improvement did not differ significantly between groups. Limited statistical power and the absence of a placebo group restricted the conclusions.
Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors
Russo SC, Ockene MW, Arpante AK, Johnson JE, Lee H, Toribio M, Stanley TL, Hadigan CM, Grinspoon SK, Erlandson KM, Fourman LT · AIDS (London, England) · DOI 10.1097/qad.0000000000003965
This analysis of a randomized human trial studied tesamorelin in people with HIV and fatty liver disease who were taking integrase inhibitors. Compared with placebo, tesamorelin significantly reduced fat around internal organs, liver fat, and the ratio of trunk to limb fat. It was well tolerated, with similar adverse-event rates and no worsening of blood sugar control.
Tesamorelin improves fat quality independent of changes in fat quantity.
Lake JE, La K, Erlandson KM, Adrian S, Yenokyan G, Scherzinger A, Dubé MP, Stanley T, Grinspoon S, Falutz J, Mamputu JC, Marsolais C · AIDS (London, England) · DOI 10.1097/QAD.0000000000002897
This analysis used completed human trials to compare tesamorelin responders with placebo recipients among people living with HIV and excess abdominal fat. In responders, fat density on CT scans increased both around internal organs and under the skin, independently of changes in fat quantity. The findings suggest improved fat quality in this selected group.
Growth Hormone Releasing Hormone Reduces Circulating Markers of Immune Activation in Parallel with Effects on Hepatic Immune Pathways in Individuals with HIV-infection and Nonalcoholic Fatty Liver Disease.
Stanley TL, Fourman LT, Wong LP, Sadreyev R, Billingsley JM, Feldpausch MN, Zheng I, Pan CS, Boutin A, Lee H, Corey KE, Torriani M et al. · Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · DOI 10.1093/cid/ciab019
This randomized, placebo-controlled human trial examined tesamorelin in people with HIV and nonalcoholic fatty liver disease. Tesamorelin reduced blood markers related to immune cell activation and reduced activity in immune-related pathways in liver tissue. These findings suggest that increasing growth hormone activity may lessen immune activation in this population.
Effects of tesamorelin on hepatic transcriptomic signatures in HIV-associated NAFLD
Fourman LT, Billingsley JM, Agyapong G, Ho Sui SJ, Feldpausch MN, Purdy J, Zheng I, Pan CS, Corey KE, Torriani M, Kleiner DE, Hadigan CM, Stanley TL, Chung RT, Grinspoon SK · JCI insight · DOI 10.1172/jci.insight.140134
Researchers analyzed liver biopsies from a randomized tesamorelin trial in people with HIV and nonalcoholic fatty liver disease. Tesamorelin increased activity of genes involved in cellular energy production and decreased activity of genes involved in inflammation, tissue repair, and cell division. These changes correlated with an improved gene-based score related to liver scarring.
The Growth Hormone Releasing Hormone Analogue, Tesamorelin, Decreases Muscle Fat and Increases Muscle Area in Adults with HIV
Adrian S, Scherzinger A, Sanyal A, Lake JE, Falutz J, Dubé MP, Stanley T, Grinspoon S, Mamputu JC, Marsolais C, Brown TT, Erlandson KM · The Journal of frailty & aging · DOI 10.14283/jfa.2018.45
This exploratory analysis of human trials examined trunk muscles in adults with HIV and abdominal obesity. Among tesamorelin recipients whose internal abdominal fat decreased meaningfully, tesamorelin was associated with greater increases in muscle density and muscle area than placebo. Long-term effects and the impact on daily life need further study.
Systematic & narrative reviews (18)
Efficacy and Safety of Tesamorelin in People Living With HIV (PLWH) With Lipodystrophy: A Systematic Review and Meta-Analysis
Ditta AM, Naeem RM, Sami MM, Abdul Rafey M, Ali H, Amjad MW, Jahangir F, Rizvi KA, Mohammad F, Abu Dawood H, Suleman M, Saddique MN · Journal of the International Association of Providers of AIDS Care · DOI 10.1177/23259582261475549
This systematic review combined randomized trials of tesamorelin in people with HIV and treatment-associated changes in body fat distribution. Tesamorelin reduced deep abdominal fat, waist size, and trunk fat, increased lean body mass, and modestly improved cholesterol. Growth hormone-related side effects and more treatment discontinuations were observed, while long-term safety and durability of benefits remain uncertain.
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, Helal A, Shata KS, Ayesh H · Obesity research & clinical practice · DOI 10.1016/j.orcp.2026.01.002
This meta-analysis examined randomized trials of tesamorelin in adults with HIV-associated changes in body fat distribution. Tesamorelin was associated with reduced deep abdominal, trunk, limb, and liver fat and increased lean body mass, but no significant reduction in fat under the skin or body mass index. Reported side effects included joint and muscle pain, tingling, and injection-site reactions.
Pharmacologic Treatments for the Preservation of Lean Body Mass During Weight Loss.
Arora G, Conde KR, Desouza CV · Journal of clinical medicine · DOI 10.3390/jcm15020541
This review examined human research on drugs intended to preserve muscle and other lean tissue during weight loss in people with overweight or obesity; animal studies were excluded. Weight loss was accompanied by lean tissue loss across methods, and several drug classes, including tesamorelin, were being explored. Most remained in early development, with some showing promise.
Metabolic dysfunction-associated steatotic liver disease in people with HIV.
Gattu AK, Fourman LT · Current opinion in HIV and AIDS · DOI 10.1097/COH.0000000000000952
This review examined metabolic dysfunction-associated fatty liver disease in people with HIV. It reports a more aggressive disease course than in people without HIV, with HIV-related factors worsening progression. Studies of tesamorelin and GLP-1 receptor agonists have shown promise, but research evaluating therapies specifically in people with HIV remains limited.
CROI 2024: Neuropsychiatric Complications in People With HIV.
Corley MJ, Letendre SL, Nightingale S · Topics in antiviral medicine · PMID 39746672
This review summarized conference findings on brain and mental health complications in people with HIV. Reports included evidence of ongoing HIV genetic activity in brain and spinal fluid cells despite virus-suppressing treatment, alongside links to vascular disease, genetic risk, and aging. Tesamorelin trials were discussed, but the abstract does not state their results.
Non-Alcoholic Steatohepatitis (NASH) - A Review of a Crowded Clinical Landscape, Driven by a Complex Disease.
Fraile JM, Palliyil S, Barelle C, Porter AJ, Kovaleva M · Drug design, development and therapy · DOI 10.2147/DDDT.S315724
This review examined drugs being developed for people with nonalcoholic steatohepatitis, a fatty liver disease involving chronic inflammation. It concluded that the disease's complexity makes a single therapy challenging and that combinations targeting different mechanisms will likely be needed. At publication, tesamorelin was expected to enter late-stage human trials; the abstract gives no tesamorelin results.
Growth hormone deficiency and human immunodeficiency virus.
Rochira V, Guaraldi G · Best practice & research. Clinical endocrinology & metabolism · DOI 10.1016/j.beem.2017.02.006
This review examined growth hormone function in people with HIV, especially those with abnormal body fat distribution. Growth hormone release was reduced, although the underlying causes remain complex and incompletely understood. The review reports that tesamorelin is effective in reducing fat around internal organs in people with HIV-related fat redistribution.
Clinical Review Report: Tesamorelin (Egrifta)
· PMID 30920787
The title identifies a clinical review report on tesamorelin, also called Egrifta, without specifying a patient population. The abstract was not available, so results are not summarized.
Laboratory, animal & other research (3)
Tesamorelin.
Grunfeld C, Dritselis A, Kirkpatrick P · Nature reviews. Drug discovery · DOI 10.1038/nrd3362
This record describes tesamorelin, a growth hormone-releasing factor analogue, in the context of excess abdominal fat in people with HIV and abnormal fat distribution. The abstract does not describe an animal experiment or report study methods or findings.
Non-clinical pharmacology and safety evaluation of TH9507, a human growth hormone-releasing factor analogue
Ferdinandi ES, Brazeau P, High K, Procter B, Fennell S, Dubreuil P · Basic & clinical pharmacology & toxicology · DOI 10.1111/j.1742-7843.2007.00008.x
This animal and laboratory study evaluated TH9507 using pigs, rats, dogs, and animal and human plasma. The modified peptide resisted breakdown and increased growth hormone and IGF-1 in animals. Reversible adverse effects were more evident in dogs and appeared associated with sustained, unusually high growth hormone and IGF-1 levels.
Pulmonary delivery of TH9507, a growth hormone releasing factor analogue, in the dog
Jansen M, Darby I, Abribat T, Dubreuil P, Ferdinandi ES, Hardy JG · International journal of pharmaceutics · DOI 10.1016/j.ijpharm.2004.02.012
This animal study in dogs examined how TH9507, a growth hormone-releasing factor analogue, was absorbed after delivery into the lungs compared with injection. Lung delivery produced absorption into the bloodstream and a longer average time in the body than injection under the skin. The authors concluded that inhalation may provide a suitable alternative to injection under the skin.
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Profile last reviewed September 26, 2026. Educational content only. Not medical advice, a dosing protocol or a treatment recommendation.