Tesamorelin: research

A peptide approved for deep abdominal fat in adults with HIV lipodystrophy.

Also called: TH9507, TH-9507, Egrifta, Egrifta SV, Egrifta WR.

GHRH analogues · Growth hormone-releasing hormone receptor agonist · Evidence: Approved drug.

63 human research records include reused data, reviews and ongoing or stopped trials. Some share participants; two large HIV trials give the strongest evidence.

Studies

First human dose study. crossover-rct, n=6, Healthy adults. FDA review documents this human study; detailed clinical results are limited. (source)
Early seven-day doses. rct, n=39, Healthy adults. FDA review documents this human study; detailed clinical results are limited. (source)
Once versus twice daily. crossover-rct, n=24, Healthy adults. FDA review documents this human study; detailed clinical results are limited. (source)
SC versus IV exposure. pk-study, n=44, Healthy adults. FDA review documents this human study; detailed clinical results are limited. (source)
Original formulation comparison. pk-study, n=88, Healthy adults. FDA review documents this human study; detailed clinical results are limited. (source)
Two drug lots. pk-study, n=12, Healthy adults. FDA review documents this human study; detailed clinical results are limited. (source)
Two-week HIV exposure. pk-study, n=18, Adults with HIV. FDA review documents this human study; detailed clinical results are limited. (source)
Two-week healthy exposure. pk-study, n=24, Healthy adults. FDA review documents this human study; detailed clinical results are limited. (source)
Seven-day sleep study. rct, n=12, Healthy men without HIV. FDA review documents this human study; detailed clinical results are limited. (source)
Fourteen-day sleep study. rct, n=82, Healthy adults without HIV. FDA review documents this human study; detailed clinical results are limited. (source)
Older-adult vaccine response. rct, n=87, Older adults undergoing immunization, without HIV. FDA review documents this human study; detailed clinical results are limited. (source)
Original COPD study. rct, n=109, Adults with chronic obstructive pulmonary disease, without HIV. FDA review documents this human study; detailed clinical results are limited. (source)
Recovery after hip fracture. rct, n=127, Older adults recovering from hip-fracture surgery, without HIV. FDA review documents this human study; detailed clinical results are limited. (source)
HIV dose finding. rct, n=61, Adults with HIV and excess abdominal fat. The 2 mg dose reduced trunk fat; this small trial did not establish a significant visceral-fat difference. (source)
First pivotal HIV trial. rct, n=412, Adults with HIV-associated abdominal fat accumulation; 86% men. Daily original-formulation tesamorelin reduced deep abdominal fat in adults with HIV. (source)
First trial: continue or stop. rct, n=315, Completers of the first pivotal HIV trial. Fat reduction persisted while dosing continued and faded after stopping. (source)
Second pivotal HIV trial. rct, n=404, Adults with HIV-associated abdominal fat accumulation. The second large trial replicated visceral-fat reduction and loss of benefit after withdrawal. (source)
Second trial: posted extension results. rct, n=263, Second pivotal HIV trial extension participants. Posted extension results show maintenance with continued dosing. (source)
Pooled pivotal trials. meta-analysis, n=806, Treated participants in the two pivotal HIV trials. The main effect was on deep abdominal fat; skin-level belly fat changed little. (source)
Healthy men: GH pulses. single-arm, n=13, Healthy men; mean age 45 years and BMI 27.3. Two weeks increased GH pulses and IGF-1; it did not test long-term recomp. (source)
Tesamorelin versus injected GH. open-label, n=25, Adults with HIV. A very small registry trial compared endogenous GH secretion after tesamorelin or injected GH. (source)
Obesity with low GH output. rct, n=60, Adults without HIV who had abdominal obesity and reduced GH secretion. A selected obesity group lost visceral fat; this was not a general weight-loss trial. (source)
SMART: cognition in older adults. rct, n=152, Adults aged 55–87; 66 with mild cognitive impairment. One older trial found cognitive benefits, which later small trials have not clearly replicated. (source)
Twelve-week diabetes safety. rct, n=53, Adults at least 50 years old with stable type 2 diabetes. Short-term average glucose control did not worsen; the small study cannot rule out individual diabetes risk. (source)
HIV: visceral and liver fat. rct, n=50, Adults with HIV and excess abdominal fat. Tesamorelin reduced both visceral fat and liver fat in a small HIV trial. (source)
HIV and fatty liver. rct, n=61, Adults with HIV and liver fat fraction at least 5%. Liver fat fell and fewer paired-biopsy participants had worsening scarring. (source)
Fatty liver without HIV: posted results. rct, n=51, Adults without HIV with fatty liver disease. Registry results suggest lower liver fat; biopsy scarring did not show a clear median improvement. (source)
HIV cognition trial. open-label, n=73, Virally suppressed adults with HIV, abdominal obesity and cognitive impairment. Waist size fell, but cognition did not differ significantly from standard care. (source)
Ten-week cognition pilot. rct, n=22, Older adults; 17 cognitively normal and 5 with mild cognitive impairment among completers. This small 2026 paper did not show a clear clinical cognitive benefit. (source)
Later COPD trial stopped early. rct, n=3, Adults with COPD and muscle wasting. A 3 mg daily human arm existed, but one exposed participant cannot establish efficacy or safety. (source)
Body-composition study stopped. single-arm, n=6, Adults with HIV and central adiposity. Drug unavailability prevented a usable longitudinal study. (source)
Long-term safety registry. cohort, n=391, Adults with HIV exposed to Egrifta. The long-term observational program was terminated without posted results. (source)
Diabetic eye-safety study. rct, n=129, Adults with HIV at risk of diabetic retinopathy. The dedicated eye-safety study ended without posted results. (source)
Peripheral nerve injury: ongoing. rct, n=36, Adults after peripheral nerve injury. A nerve-recovery trial is registered; no results were posted. (source)
TRIUMPH: exercise plus tesamorelin. rct, n=100, Sedentary adults aged 50–80 with HIV, frailty risk and excess abdominal fat. A published protocol tests physical function; it has no outcome results yet. (source)
Phase 3: inflammation. cohort, n=410, Two pivotal trial groups. A small marker change does not show fewer clots or heart attacks. (source)
Healthy men: adiponectin. cohort, n=13, Healthy-men pulsatility study. Raising GH for two weeks did not change adiponectin. (source)
Who loses visceral fat?. cohort, n=402, Pivotal trial tesamorelin participants. Post hoc responders had better metabolic changes than nonresponders. (source)
SMART: brain chemicals. cohort, n=30, SMART cognition substudy. A brain-chemistry substudy does not prove a clinical benefit. (source)
Obesity: muscle energy. cohort, n=39, Obesity and reduced GH trial substudy. Muscle-energy recovery correlated with hormone change; clinical performance was not established. (source)
Phase 3: response predictors. cohort, n=806, Pooled pivotal HIV trial participants. An exploratory prediction analysis reused the pivotal participants. (source)
Phase 3: liver enzymes. cohort, n=516, 516 of 806 parent-trial participants had baseline ALT or AST >30 U/L; week-26 tesamorelin comparison: 177 responders and 80 nonresponders. Responders had better liver-enzyme changes; this was not a separate liver-disease trial. (source)
HIV liver fat: FGF21. cohort, n=50, Six-month HIV liver-fat trial. Liver-fat reduction was not explained by increased FGF21. (source)
Phase 3: muscle fat. cohort, n=341, 193 tesamorelin responders and 148 placebo participants. Selected responders gained muscle area; strength and physical function were not measured. (source)
Phase 3: fat density. cohort, n=341, 193 tesamorelin responders and 148 placebo participants. Fat density changed in selected responders; its clinical meaning is uncertain. (source)
HIV fatty liver: gene activity. cohort, Paired biopsies from the 61-person HIV fatty-liver trial. Gene-expression changes offer possible mechanisms, not evidence of cancer prevention. (source)
HIV fatty liver: IGF proteins. cohort, n=61, HIV fatty-liver trial participants; 39 liver RNA samples. A secondary hormone analysis cannot establish a new dosing protocol. (source)
HIV fatty liver: scarring predictors. cohort, n=61, HIV fatty-liver trial participants. Baseline visceral fat helped identify scarring risk in this small cohort. (source)
HIV fatty liver: immune markers. cohort, n=61, HIV fatty-liver trial participants. Immune-marker changes are exploratory and reuse the liver-fat cohort. (source)
HIV fatty liver: response pathways. cohort, HIV fatty-liver trial stored samples. Exploratory protein changes do not mean tesamorelin prevents cancer. (source)
HIV fatty liver: fibrosis proteins. cohort, Stored samples from the HIV fatty-liver trial. This biomarker analysis is not an additional tesamorelin efficacy trial. (source)
Does a neck fat pad change response?. cohort, Post hoc pivotal HIV trial participants. This did not test removal of the neck fat pad itself. (source)
HIV on integrase inhibitors. cohort, n=38, HIV fatty-liver trial participants on integrase inhibitors. A small subgroup supports visceral-fat effects with modern HIV medicines. (source)
Measuring visceral fat. cohort, n=457, 313 adults with HIV and 144 without HIV across five studies. DXA and CT estimates of deep abdominal fat are not interchangeable. (source)
Canadian clinical evidence review. systematic-review, Three placebo-controlled HIV trials reviewed for Canadian reimbursement. Independent review found limited evidence for patient-important long-term benefits. (source)
Population drug-exposure model. pk-study, n=38, Healthy adults and adults with HIV from earlier phase 1 studies. A model described earlier exposure data; it did not establish a new regimen. (source)
Population GH and IGF-1 model. pk-study, n=41, Healthy adults and adults with HIV from earlier phase 1 studies. Hormone modeling cannot validate cycling or bodybuilding stacks. (source)
Simvastatin and ritonavir interaction trials. crossover-rct, Healthy adults in two separate crossover studies. These two studies found no need to change simvastatin or ritonavir doses. (source)
Carpal tunnel safety signal. cohort, Spontaneous FDA adverse-event reports, 2003–September 2024. Carpal tunnel appeared disproportionately in reports; the analysis cannot estimate its incidence. (source)
Two HIV clinical cases. case-series, n=2, Two adults with HIV and different patterns of abdominal fat. Two cases illustrate prescribing choices; they do not prove combination benefit. (source)
2026 body-composition meta-analysis. meta-analysis, Five randomized trials in adults with HIV. Trials support changes in fat distribution; pooled effects do not prove long-term health benefits. (source)
2026 HIV systematic review. meta-analysis, n=909, Four RCTs as counted by the review authors. A second review found visceral-fat reduction, with substantial variation between studies. (source)
Earlier GH-axis systematic review. systematic-review, n=1511, Ten trials of several GH-axis drugs in HIV lipodystrophy. This older review pooled several different drugs; its effect is not tesamorelin-specific. (source)

Tesamorelin dosage

Typical reported dose: 1.28 mg once a day (Egrifta WR)

Egrifta WR: 1.28 mg: 1.28 mg subcutaneously once daily once daily, under the skin. Drug label. Studied in: Adults with HIV-associated lipodystrophy and excess abdominal fat. (source)
Egrifta SV: 1.4 mg: 1.4 mg, 0.35 mL of the reconstituted solution, injected subcutaneously once daily once daily, under the skin. Drug label. Studied in: Adults with HIV-associated lipodystrophy and excess abdominal fat. (source)
Original Egrifta: historical 2 mg: 2 mg injected subcutaneously once daily once daily, under the skin. Drug label. Studied in: Adults with HIV-associated lipodystrophy and excess abdominal fat. (source)
Pivotal HIV regimen: Original tesamorelin 2 mg SC daily once daily, under the skin. Studied in a trial. Studied in: Adults with HIV-associated lipodystrophy and excess abdominal fat. (source)
1 mg dose-finding arm: 1 mg SC once daily once daily, under the skin. Studied in a trial. Studied in: Adults with HIV-associated lipodystrophy and excess abdominal fat. (source)
2 mg dose-finding arm: 2 mg SC once daily once daily, under the skin. Studied in a trial. Studied in: Adults with HIV-associated lipodystrophy and excess abdominal fat. (source)

Highest studied: A 3 mg SC daily arm exposed only one COPD participant; the main efficacy trials used 2 mg daily.; Early FDA-reviewed study used 2 mg SC twice daily for 14 days..

These are doses reported in labels, trials or user reports, not a personal plan. Check the source behind each one.

Work out syringe units with the dosing calculator

Tesamorelin side effects and risks

Reported side effects

Injection-site redness, itching or pain: All injection site reactions: 25% versus 14% placebo over 26 weeks., mild. Rotate abdominal sites; seek care for spreading redness, warmth, pus or fever. (source)
Joint pain: 13% versus 11% placebo in the pooled 26 week adverse reaction table., moderate. Discuss persistent symptoms and reassess the dose or need for treatment. (source)
Muscle pain: 6% versus 2% placebo., moderate. Discuss persistent symptoms and reassess the dose or need for treatment. (source)
Swollen ankles or other fluid retention: 6% versus 2% placebo., moderate. Discuss persistent symptoms and reassess the dose or need for treatment. (source)
Arm or leg pain: 6% versus 5% placebo., moderate. Discuss persistent symptoms and reassess the dose or need for treatment. (source)
Tingling: 5% versus 2% placebo., moderate. Discuss persistent symptoms and reassess the dose or need for treatment. (source)
Reduced skin sensation: 4% versus 2% placebo., moderate. Discuss persistent symptoms and reassess the dose or need for treatment. (source)
Rash: 4% versus 2% placebo., mild. A rash with breathing trouble, facial swelling or faintness needs emergency care. (source)
High blood sugar or new diabetes: HbA1c ≥6.5% developed in 5% versus 1% placebo by week 26., serious. Check glucose; the label advises reassessing treatment if glucose worsens without clear benefit. (source)
Allergic reaction: 4% of tesamorelin trial participants; the warning gives no placebo rate., serious. Stop and seek prompt medical attention; use emergency care for breathing or circulation symptoms. (source)
Carpal tunnel syndrome: 1% versus 0% placebo in the pooled adverse reaction table., moderate. Discuss persistent symptoms and reassess the dose or need for treatment. (source)
Vomiting: 3% versus 0% placebo., moderate. Persistent vomiting needs review and assessment of hydration. (source)
Stomach discomfort: Indigestion: 2% versus 1% placebo., mild. Discuss persistent symptoms and reassess the dose or need for treatment. (source)
High IGF-1: IGF 1 >3 standard deviations above the age average: 36% at 26 weeks; 23% at 52 weeks among continuing patients., moderate. Monitor IGF-1; the label advises considering stopping if levels stay this high. (source)

Stop and get help if

Trouble breathing, swelling of the face or tongue, widespread hives or faintness: Stop dosing and get emergency care now.
New severe breathlessness, chest pain, fainting or rapidly worsening swelling: Get urgent medical care now; severe symptoms need emergency services.
Marked thirst or frequent urination with vomiting, confusion or deep breathing: Check glucose if available and get urgent care for possible severe high blood sugar.
New blurred vision, sudden vision loss or a curtain over vision: Get same-day eye assessment; sudden vision loss is an emergency.
Spreading injection-site redness, heat, pus or fever: Stop using that vial and get prompt care for possible infection.

Who should avoid it

pregnant: Contraindicated by the label. Changing pregnancy-related visceral fat has no known benefit and may harm the fetus.
tryingToConceive: Listed as a reason to avoid it.
breastfeeding: No human milk or infant-safety data. The product label says mothers receiving tesamorelin should not breastfeed.
under18: Safety and effectiveness are not established; the label does not indicate pediatric use.
activeCancer: Contraindicated because tesamorelin raises GH and IGF-1. Stop if a prior cancer recurs.
cancerHistory: Past cancer must be inactive with treatment complete; review the possible risk of recurrence before starting.
other: Contraindicated with pituitary-axis disruption, including pituitary tumor or surgery, head irradiation, hypopituitarism or relevant head trauma.
other: Contraindicated after a known allergy to tesamorelin or an ingredient in the specific product.
diabetes: New diabetes can develop. Existing diabetes needs glucose follow-up and retinal monitoring.
diabeticRetinopathy: Raised IGF-1 may worsen retinal disease; the label calls for regular monitoring in people with diabetes.
kidneyDisease: Drug levels and needed dose changes with kidney impairment are unknown.
liverDisease: Drug levels and needed dose changes with liver impairment are unknown, including in advanced liver failure.
heartCondition: Fluid retention may worsen swelling or heart-failure symptoms; long-term cardiovascular safety is unknown.
surgeryPlanned: Critical illness after major surgery or trauma warrants reassessment; the label advises considering discontinuation in critically ill patients.
other: Consider stopping during sudden breathing failure or severe critical illness. The warning comes from growth hormone drug treatment.
testedAthlete: Prohibited at all times under the 2026 WADA List, section S2.2.4.

Interactions

Insulin and sulfonylureas: Tesamorelin may raise blood sugar and change medication needs. Watch for highs or lows after diabetes medicines change.
Glucocorticoid replacement: Growth hormone can reduce cortisone's conversion to cortisol. Clinicians may review routine or stress steroid replacement.
Other growth hormone and IGF-1 drugs: May add to effects on blood sugar, swelling and tissue growth. Combination safety is unknown.
Cyclosporine and some seizure medicines: Growth hormone may change drug breakdown. Clinicians can check drug effects and blood levels.
Sex steroids: The label warns sex hormone breakdown may change. A clinician should review possible interactions.
Simvastatin and ritonavir: Small crossover studies in healthy volunteers found no drug level changes requiring dose adjustment.
Anticoagulants: No direct interaction is established. Injections can bruise; review medicines with a clinician if bleeding risk is high.

Product quality risks

An FDA-approved molecule does not make an online vial an approved product. Identity, amount and injectable quality may differ.
Poor preparation can cause contamination or too much or too little active drug; FDA describes serious injury and death from compounding failures.
No independent tesamorelin retail-sampling study or drug-specific counterfeit-pen series was found. Do not borrow semaglutide contamination rates.
A purity percentage alone does not establish the dose, sterility, endotoxin level or stability after mixing.

How Tesamorelin works

It prompts growth hormone release from the pituitary gland. This raises IGF-1, a growth signal, and helps break down fat. HIV lipodystrophy trials showed less fat deep inside the abdomen.

GHRH receptor on pituitary cells: Stimulates the body’s own growth-hormone pulses.
GH and downstream IGF-1 signaling: Changes fat breakdown and tissue-growth signals.

Half-life: Egrifta WR: mean 11 minutes after one injection under the skin in healthy adults. Original repeated-dose estimates differ.

Gaps: Healthy-user recomp, muscle strength and long-term performance benefits have little direct evidence. No controlled evidence establishes five-on/two-off schedules, long cycling breaks or fasting windows for recomp. No controlled outcome trials establish tesamorelin stacks with ipamorelin, CJC-1295, retatrutide, MOTS-c or IGF-1 LR3. Long-term cardiovascular, cancer and retinal safety remain uncertain; dedicated safety registries ended without posted results. Early FDA-only sleep, immune, COPD and hip-fracture studies lack accessible full per-arm results. The later COPD 3 mg arm had one exposed person; it cannot establish a safe upper clinical dose. The non-HIV fatty-liver registry retains both 2 mg and F4 1.4 mg wording; transition timing is unknown. The HIV cognition paper says 2 mg daily; the updated registry says 1.4 mg. The transition could not be reconstructed. UK product licensing and Australian ARTG authorization were not confirmed. No reliable tesamorelin-specific retail purity survey, poisoning rate or validated community-vial shelf life was found. Community prevalence is qualitative in a convenience sample; no population denominator or reliable independent-user count was available. The schema supports one handling label. Community 10 mg plus 1–2 mL reports are kept in community records, not mixed into label handling.

Related to Tesamorelin

CJC-1295 without DAC: A peptide intended to trigger growth hormone release, with no human dosing study found.
Sermorelin: An experimental short-acting peptide that triggers growth hormone release, with limited evidence of adult benefits.
CJC-1295 with DAC: An experimental long-acting peptide that triggers growth hormone release, with no proven muscle or recovery benefit.
Tirzepatide: A weekly GIP/GLP-1 injection with strong diabetes and weight-loss evidence and common stomach side effects.
Retatrutide: An experimental weekly injection with phase 3 weight-loss results.
Ipamorelin: An experimental peptide that triggers growth hormone release.

Tesamorelin: the short version

Sources

Compounding and the FDA: Questions and Answers, FDA · FDA · 2026
Purple Book Search, FDA · 2026
Search results summary, Health Canada · 2026
The 2026 Prohibited List, World Anti-Doping Agency · WADA · 2026
Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, Australian Government · Australian Government · 2026
EGRIFTA WR (tesamorelin) for injection, for subcutaneous use, U.S. Food and Drug Administration · FDA · 2025
Supply unlicensed medicinal products (specials), MHRA · 2025
EGRIFTA SV (tesamorelin) for injection, for subcutaneous use, 2024
Egrifta, 2012
EGRIFTA (tesamorelin for injection) for Subcutaneous Use, 2010
EGRIFTA: Chemistry Review, NDA 22-505, 2010
EGRIFTA: Clinical Pharmacology and Biopharmaceutics Review, NDA 22-505, 2010
EGRIFTA: Clinical Review, NDA 22-505, 2010
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. · Obesity research & clinical practice · 2026
Differing Presentations of Excess Visceral Abdominal Fat in People Living With HIV: Two Clinical Cases Highlighting Distinct Therapeutic Pathways With Tesamorelin and Glucagon-Like Peptide-1 Receptor Agonists., Beach R et al. · Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026

Sources checked: 2026-10-18.

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