Tesamorelin: FDA-Approved GHRH Analog for Visceral Fat - Dosage, Results, vs Sermorelin

Key takeaways

• Tesamorelin is a stabilized synthetic copy of the full 44-amino-acid growth hormone-releasing hormone. It is the only GHRH analog with a current FDA approval (Egrifta, Egrifta SV and, since 2025, Egrifta WR) and the only wellness peptide with large placebo-controlled trials behind its main claim.
• In adults with HIV and treatment-related belly fat, 2 mg a day for 26 weeks cut visceral fat by about 15% while subcutaneous fat and body weight did not change. Liver fat fell too. The label says it is weight neutral and not for weight loss.
• Outside HIV the evidence is thin: one 12-month trial in 60 abdominally obese adults with low growth hormone output, and one 20-week cognition trial in older adults. Nobody has tested it for ordinary belly fat in a large trial.
• The trials used 2 mg daily of the original formulation; the current labels give 1.4 mg daily for Egrifta SV and 1.28 mg daily for Egrifta WR. IGF-1 and glucose must be monitored: 47% of trial patients had IGF-1 more than two standard deviations above normal at 26 weeks, and new diabetes was more common than on placebo. The fat returns when you stop.
• Legally it is an approved drug that a clinician may prescribe off-label, but only as the brand. FDA regulates tesamorelin as a biological product, which no pharmacy may compound, so the cheaper 'compounded tesamorelin' some clinics sell is not a lawful product. The brand costs about $2,400 to $2,800 a month, and insurance generally covers only the HIV indication.

Tesamorelin at a glance

Also called

Egrifta, Egrifta SV, Egrifta WR, TH9507, tesamorelin acetate, GHRH(1-44) analog

Class

Growth hormone-releasing hormone (GHRH) analog; a growth hormone secretagogue

Route

Subcutaneous injection into the abdomen, once daily

FDA status

FDA-approved (Egrifta, 2010; Egrifta SV; Egrifta WR, 2025) for the reduction of excess abdominal fat in adults with HIV and lipodystrophy, and regulated as a biological product (BLA 022505) since March 23, 2020. Any other use is off-label, and tesamorelin cannot be lawfully compounded.

FDA Category 2 (compounding restricted)

No

Available by prescription (US)

Yes, as brand Egrifta only (Egrifta WR, or Egrifta SV where still supplied), on prescription. Not compoundable: tesamorelin is a biological product, and biological products are not eligible for compounding under sections 503A or 503B

Best-studied use

Visceral fat reduction in HIV-associated lipodystrophy (the approved indication); liver fat in HIV-associated NAFLD; one 12-month trial in abdominally obese adults without HIV

Typical monthly cost (telehealth, 2026)

Brand Egrifta about $2,400 to $2,800 a month at specialty pharmacies; insurance generally covers it only for the HIV indication

What tesamorelin is and how it works

Growth hormone-releasing hormone (GHRH) is a 44-amino-acid peptide made in the hypothalamus. Tesamorelin is that full sequence with a six-carbon hexenoyl chain attached to the first amino acid, a modification that makes it last longer in the body than natural GHRH, which is cleared within minutes (Egrifta WR label 2025). It binds the GHRH receptor on the pituitary with about the same potency as the natural hormone and triggers pulses of growth hormone (GH), which in turn raise insulin-like growth factor 1 (IGF-1). GH is lipolytic, and visceral fat, the fat packed around the organs inside the abdomen, is the depot most sensitive to it.

Two things follow from that mechanism and both show up in the trials. First, tesamorelin works through your own pituitary, so the feedback loops that normally cap GH output stay in place; it cannot push a healthy adult into acromegaly-range GH the way injected growth hormone can, but it also needs a working pituitary, which is why a disrupted hypothalamic-pituitary axis is a contraindication. Second, because the effect is on fat distribution rather than appetite or energy balance, it moves fat out of the visceral compartment without moving the number on the scale.

It is the same class as sermorelin, the 29-amino-acid GHRH fragment that most telehealth clinics prescribe. The difference is not mechanism but evidence and potency: tesamorelin has the approval, the 800-patient trials and the measured visceral-fat effect; sermorelin has small 1990s hormone studies and a lower price.

Tesamorelin was approved by FDA in November 2010 as Egrifta, for the reduction of excess abdominal fat in adults with HIV and lipodystrophy, the fat-redistribution syndrome associated with older antiretroviral regimens (Traynor 2010). A 2 mg-per-vial version (Egrifta SV) followed, and in March 2025 FDA approved Egrifta WR, a more concentrated formulation that is reconstituted once a week and injected at 1.28 mg a day, a dose shown to give the same drug exposure as the original 2 mg (Egrifta WR label 2025). The indication has never been widened. Because tesamorelin is longer than 40 amino acids, FDA has regulated it as a biological product since March 23, 2020, a detail that decides whether it can be compounded (it cannot; see the legal section below).

What the evidence actually shows

Tesamorelin claims, graded by the evidence behind them

Claim	Grade	What the evidence shows	Sources
Reduces visceral fat in HIV-associated lipodystrophy	A	Two phase 3 trials, 806 patients, 2 mg daily for 26 weeks: visceral fat fell about 15% against a slight rise on placebo (-27 and -21 cm2 per CT slice in the label), with no loss of subcutaneous fat. Patients who continued to 52 weeks kept the reduction (-17.5%). A 2026 meta-analysis of five randomized trials put the effect at -27.7 cm2.	Falutz 2007; Falutz 2010 JCEM; Badran 2026
Reduces liver fat in people with HIV	B	In 50 patients, 6 months of 2 mg daily cut liver fat by a net 2.9 percentage points alongside visceral fat. In 61 patients with HIV and fatty liver disease, 12 months reduced the hepatic fat fraction by 37% relative to baseline, and 35% versus 4% reached under 5% liver fat. Both trials were small and neither proved a benefit on liver histology.	Stanley 2014; Stanley 2019
Reduces visceral fat in people without HIV	B	One trial. Sixty abdominally obese adults with reduced GH secretion took 2 mg daily or placebo for 12 months: visceral fat -16 versus +19 cm2 (treatment effect -35 cm2), with lower triglycerides and C-reactive protein and a small improvement in carotid wall thickness, no change in subcutaneous fat or glucose. That is the entire controlled evidence base in non-HIV abdominal obesity.	Makimura 2012
Causes weight loss	D	No. Body weight changed by under 1 kg in both phase 3 trials, and the label states tesamorelin is not indicated for weight loss and has a weight-neutral effect. Trunk fat fell by about 1 kg and lean mass rose by about 1.2 to 1.4 kg; the scale does not move.	Egrifta WR label 2025; Badran 2026
Improves triglycerides and cholesterol	A	Triglycerides fell about 37 to 50 mg/dL versus placebo and the total-to-HDL cholesterol ratio improved in the phase 3 trials. The lipid and glucose benefits tracked with how much visceral fat was lost: responders (8% or more reduction) improved, non-responders did not.	Falutz 2007; Falutz 2010 JCEM; Stanley 2012
Builds muscle	B	Lean body mass rose about 1.2 to 1.3 kg versus placebo over 26 weeks. A secondary analysis of responders found small increases in trunk muscle area and density on CT. No trial has measured strength or physical function; one is now recruiting.	Egrifta WR label 2025; Adrian 2019; Badran 2026
Improves cognition in older adults	B	152 adults aged 55 to 87, 66 with mild cognitive impairment, took tesamorelin 1 mg nightly or placebo for 20 weeks: a favorable effect on a cognitive composite, driven by executive function, with IGF-1 up 117% and body fat down 7.4%. A single trial, never replicated; a 2025 open-label trial in 73 people with HIV found no clear cognitive benefit at 6 months.	Baker 2012; Ellis 2025
Does not worsen blood sugar	B	Mixed. Fasting glucose rose about 7 mg/dL at 2 weeks in one trial but not at 6 months, and 12 weeks of 1 or 2 mg did not change insulin response or HbA1c in 53 people with type 2 diabetes. But across the phase 3 program 5% of tesamorelin patients versus 1% on placebo developed an HbA1c of 6.5% or higher, a hazard ratio of 3.3.	Stanley 2014; Clemmons 2017; Egrifta WR label 2025
Visceral fat returns when treatment stops	A	Yes. Patients re-randomized from tesamorelin to placebo after 26 weeks rapidly lost the visceral-fat reduction, while those who continued kept it. Tesamorelin is a maintenance drug, not a course.	Falutz 2010 JAIDS; Falutz 2010 JCEM
Anti-aging or a safer alternative to HGH for healthy adults	D	No trial in healthy adults has measured aging, strength, recovery or function. The two trials in people without HIV measured fat, lipids and cognition in selected populations, and the label warns that the long-term cardiovascular safety and the effects of prolonged IGF-1 elevation are unknown.	Makimura 2012; Baker 2012; Egrifta WR label 2025

Three things to take from the table.

The visceral-fat effect is real and specific. In the pooled phase 3 analysis of 806 patients, visceral adipose tissue fell by 24 cm2 on tesamorelin and rose by 2 cm2 on placebo, while subcutaneous fat was unchanged in both groups (Falutz 2010 JCEM). That selectivity is unusual, and it is why the drug does not change weight.

The population matters. Almost everything we know comes from adults with HIV, 84% to 86% of them men, with a fat-redistribution syndrome that is partly a drug effect. The one trial in people without HIV, 60 adults selected for abdominal obesity plus a blunted growth hormone response, found a visceral-fat effect of similar size, in a single-center study with 30 people per arm (Makimura 2012).

Responders and non-responders. Roughly 30% of trial patients did not achieve an 8% reduction in visceral fat, and those people got none of the lipid or glucose benefits (Stanley 2012). The label tells prescribers to reconsider continuing in anyone whose visceral fat has not fallen, which is only possible if someone measures it.

What you are promised versus what is documented

Clinic pages for tesamorelin promise a flatter stomach, lower visceral fat, better sleep, more lean muscle, improved cholesterol, sharper cognition, "HGH benefits without HGH" and healthy aging. Sorted by the evidence:

• Documented in humans: a 15% to 18% reduction in visceral fat in HIV-associated lipodystrophy; lower triglycerides; about 1 kg more lean mass; a modest reduction in liver fat in HIV; higher IGF-1.
• Plausible, one trial each: visceral-fat reduction in abdominally obese adults without HIV; a cognitive signal in older adults at 1 mg a night.
• Not supported: weight loss (the label says weight neutral), loss of subcutaneous fat, muscle strength, sleep, recovery, testosterone, longevity, or any outcome in healthy young adults.

For someone without HIV, the honest summary is that tesamorelin probably reduces visceral fat, on the strength of one trial, requires indefinite use, and has never been compared with the cheaper things that also reduce visceral fat, including GLP-1 therapy.

Tesamorelin vs sermorelin, CJC-1295/ipamorelin and GLP-1 drugs

For a person whose problem is abdominal obesity, the ranking by evidence is GLP-1 therapy first, by a wide margin; tesamorelin as a specialist tool when visceral fat is the specific target and weight is not; sermorelin as the cheaper, weaker GH nudge; and the CJC-1295/ipamorelin stack last, with the weakest data and no legal supply. The sermorelin profile, the CJC-1295/ipamorelin profile and our best peptides for weight loss ranking cover each in detail.

Dosage: what the label and the trials used

Unlike sermorelin, where clinics prescribe a fraction of the studied dose, clinics usually prescribe tesamorelin in the range the trials used. The gap is elsewhere: the trials dosed every day for 6 to 12 months and measured visceral fat by CT; most telehealth programs dose 5 nights a week and measure nothing but the waist.

Reconstitution example

Egrifta WR is reconstituted with 1.3 mL of the supplied bacteriostatic water, giving roughly 8 mg/mL, so the 1.28 mg dose is 0.16 mL, which reads as 16 units on a U-100 insulin syringe (Egrifta WR label 2025). Egrifta SV, where still supplied, is a single-dose vial with its own diluent and volume, so follow the instructions for the product you are dispensed. You can check the arithmetic with the reconstitution calculator, but trust the label over the calculator if they disagree; our bacteriostatic water guide shows why the Egrifta WR label and simple division give different volumes. Technique is covered in how to reconstitute peptides and how to inject peptides; the label specifies the abdomen, rotating sites and avoiding the navel, scars and bruises.

Monitoring the label requires

• IGF-1. Tesamorelin stimulates GH production and increases serum IGF-1, a growth factor; the label says to monitor IGF-1 during therapy and consider stopping if it stays persistently elevated (above 3 standard deviation scores), particularly when the fat response is weak. In the trials 47% of patients had an IGF-1 more than 2 standard deviations above normal at 26 weeks and 36% were above 3 (Egrifta WR label 2025).
• Glucose. Evaluate glucose status before starting and periodically after; people with diabetes need retinopathy checks because IGF-1 can worsen it.
• The fat itself. Waist circumference at minimum; CT or DEXA if the prescriber is serious. The label says to reconsider treatment in patients whose visceral fat has not fallen.

Side effects and who should not use it

The safety database is 740 adults with HIV treated in clinical trials, 543 of them in the 26-week placebo-controlled phases. The most common reactions, versus placebo (Egrifta WR label 2025):

Hypersensitivity reactions (itching, redness, flushing, hives, rash) occurred in 4% of treated patients. In the NEJM trial, adverse-event rates did not differ overall, but more patients on tesamorelin withdrew because of one (Falutz 2007). The 2026 meta-analysis found the same pattern: more arthralgia, myalgia, paresthesia and injection-site erythema, no serious signal, no effect on CD4 counts (Badran 2026).

Fluid retention (edema, joint pain, carpal tunnel) comes from the GH surge and usually resolves with time or on stopping. Glucose intolerance and new diabetes are the metabolic cost: 5% versus 1% reached an HbA1c of 6.5% or higher over 26 weeks. IGF-1 elevation is the long-term unknown; the label says plainly that the effects of prolonged IGF-1 elevation are not known, and that long-term cardiovascular safety has not been established. Growth signaling is why cancer is a contraindication: GH and IGF-1 are growth factors, and the label requires any prior malignancy to be inactive and fully treated, with discontinuation at any sign of recurrence.

Do not use tesamorelin if you have:

• a disrupted hypothalamic-pituitary axis (hypophysectomy, hypopituitarism, pituitary tumor or surgery, head irradiation, head trauma): it cannot work and is contraindicated;
• an active malignancy, or a cancer history that has not been assessed by the prescriber;
• a known hypersensitivity to tesamorelin or its excipients;
• a pregnancy, or plans for one: visceral fat is supposed to rise in pregnancy, and tesamorelin acetate caused hydrocephaly in rat offspring at two to four times the clinical exposure (Egrifta WR label 2025).

Use it only with specialist oversight in diabetes or prediabetes, diabetic retinopathy, and acute critical illness (the label notes increased mortality with GH-axis drugs in critically ill patients). Two interactions matter: GH can change the clearance of drugs metabolized by cytochrome P450 enzymes (corticosteroids, sex steroids, anticonvulsants, cyclosporine), and people on glucocorticoid replacement may need higher doses because GH blocks the conversion of cortisone to cortisol.

Tesamorelin is a prohibited substance in sport under WADA's category for peptide hormones and growth factors; tested athletes should treat it as banned.

Legal status in the United States

Tesamorelin's legal status turns on one fact that most clinic pages leave out: FDA regulates it as a biological product, not as an ordinary peptide drug.

• It is an FDA-approved drug. Egrifta was approved in 2010 and Egrifta WR in 2025; the indication is reduction of excess abdominal fat in adults with HIV and lipodystrophy (Traynor 2010). Insurance generally covers it only for that diagnosis.
• It is a biological product. Since 2020 federal law has defined a protein as a chain of more than 40 amino acids (Federal Register 2020). Tesamorelin has 44, so on March 23, 2020 its new drug application was deemed a biologics license, and the current DailyMed labels for Egrifta WR and Egrifta SV list application BLA022505 (Egrifta WR label 2025) (Egrifta SV label 2026).
• Off-label prescribing is legal and is the prescriber's decision. A clinician may prescribe an approved drug for a use outside its label; what they may not do is promise results the label does not support. Off-label use still means the brand, and because insurance generally pays only for the labeled HIV indication, off-label patients usually pay cash.
• No pharmacy may compound it. Being the active ingredient of an approved drug would normally let a state-licensed 503A pharmacy compound a substance. Biological products are the exception: FDA's position since March 23, 2020 is that biological products subject to licensure under section 351 of the Public Health Service Act, including those with deemed biologics licenses, are not eligible for the compounding exemptions in sections 503A and 503B of the FD&C Act (FDA notice to compounders 2020). That shuts out 503B outsourcing facilities as well as 503A pharmacies, and it is the same rule that keeps somatropin, mecasermin and hCG out of compounding. Tesamorelin has never been placed in Category 2 (FDA categories 2026), but that does not make it compoundable. See the peptide legal tracker for the full list and the 2026 changes.
• 'Compounded tesamorelin' is not a lawful product. Some clinics and telehealth companies sell tesamorelin they describe as compounded, at a fraction of the brand price. Whatever the seller says, it is not made under a compounding exemption FDA recognizes, and no regulator reviews its potency, purity or sterility. FDA's warning-letter database, searched on October 10, 2026, held no letter to a pharmacy or clinic over tesamorelin; that is an absence of enforcement, not a permission.
• Research vials are a different product. FDA's warning letters of August 24, 2026 (posted September 1) to five online peptide vendors listed tesamorelin among the unapproved new drugs they sold with research-use labels and human dosing instructions, and rejected the label as a defense (ArentFox Schiff 2026). The approval covers Egrifta, not a vial with the same name from a website.

Cost and how to get it prescribed

As of October 2026, brand Egrifta runs about $2,400 to $2,800 a month at specialty pharmacies, and insurance generally covers it only with an HIV lipodystrophy diagnosis and prior authorization. That is the only lawful price. Tesamorelin sold by clinics as 'compounded', at a fraction of that, is not made under a compounding exemption FDA recognizes, and no 503B outsourcing facility may make it either. Baseline labs add $100 to $400. The peptide therapy cost guide has the sources and dates for each figure.

A legitimate prescription path looks like this:

1. A clinician licensed in your state takes a history that specifically covers cancer, pituitary disease, diabetes and pregnancy, because those are the contraindications.
2. Baseline labs: IGF-1, fasting glucose or HbA1c, a lipid panel. A waist measurement at minimum; imaging if visceral fat is the stated target.
3. A pharmacy that dispenses brand Egrifta, usually a specialty pharmacy, with the manufacturer's labeled kit. A program that ships tesamorelin from a compounding pharmacy is offering a product no pharmacy may lawfully compound.
4. Follow-up with repeat IGF-1 and glucose at about 3 months, and a decision rule: if the waist or the scan has not moved, stop.

Before paying, ask what this drug is expected to do that losing weight would not. For most people with abdominal obesity, the answer favors GLP-1 therapy, which removes visceral and subcutaneous fat, lowers weight, and has far larger trials. Tesamorelin earns its price in a narrower group: a visceral-fat problem out of proportion to weight, documented low GH output, and a clinician willing to measure the result.

Tesamorelin for women and older adults

The phase 3 program was 84% to 86% male, so the visceral-fat data in women come from about 120 participants. There is no tesamorelin trial in perimenopause or menopause, where visceral fat rises for hormonal reasons tesamorelin does not address; menopausal hormone therapy has better evidence for that problem. Pregnancy is a contraindication, and the drug should not be used while trying to conceive or breastfeeding.

In older adults the one dedicated trial (mean age 68) used 1 mg nightly, half the 2 mg trial dose, and reported mild adverse events in 68% of treated participants versus 36% on placebo, with a rise in fasting insulin in those with mild cognitive impairment (Baker 2012). Age-related declines in GH are normal, and no trial has shown that reversing them with tesamorelin changes how anyone ages. See best peptides for women and best peptides for longevity.

Bottom line

Tesamorelin is what a peptide with real evidence looks like: an approved drug, 806 patients in placebo-controlled trials, a measured 15% reduction in visceral fat, a labeled dose, labeled side effects and a list of contraindications. The limits are just as clear. The evidence is almost entirely in HIV-associated lipodystrophy; it does not reduce weight; it raises IGF-1 and the risk of diabetes; the fat comes back when you stop; and the brand costs more than most people will pay for a cosmetic and metabolic effect of this size.

A reasonable use is an adult with documented visceral adiposity and a prescriber who measures IGF-1, glucose and the fat itself, and who stops if nothing changes. An unreasonable use is "HGH without the HGH" bought by the vial, a cheaper "compounded" tesamorelin that no pharmacy may lawfully make, or a tesamorelin plus CJC-1295/ipamorelin "stack" that no licensed pharmacy can legally fill.

Frequently asked questions

+−What does taking tesamorelin do?

Tesamorelin makes the pituitary release more of your own growth hormone, which raises IGF-1 and increases the breakdown of fat, especially the visceral fat packed around the abdominal organs. In the approved population, adults with HIV and treatment-related belly fat, 2 mg a day for 26 weeks cut visceral fat by about 15% and lowered triglycerides, while subcutaneous fat and body weight barely changed. It is a fat-redistribution drug, not a weight-loss drug.

+−Will tesamorelin get rid of belly fat?

It reduces visceral belly fat in the people it has been tested on: about 15% to 18% over 6 to 12 months in HIV-associated lipodystrophy, and a treatment effect of about 35 square centimeters on a CT slice in one 12-month trial of 60 abdominally obese adults without HIV. It does not remove the subcutaneous fat you can pinch, it does not lower weight, and the visceral fat came back quickly in patients who stopped. About 30% of patients in the trials did not respond at all.

+−Is tesamorelin similar to Ozempic?

No. Ozempic (semaglutide) is a GLP-1 receptor agonist that lowers appetite and produces large reductions in total body weight; tesamorelin raises growth hormone and shifts fat out of the visceral compartment without changing weight. For a person with ordinary abdominal obesity, GLP-1 therapy has far more evidence and far larger effects. Tesamorelin is the more specific tool for a visceral-fat problem in someone who is not overweight overall, and the evidence outside HIV is one trial.

+−Who should not take tesamorelin?

The label lists four contraindications: a disrupted hypothalamic-pituitary axis (after pituitary surgery, hypopituitarism, pituitary tumor, head irradiation or head trauma), an active cancer, known hypersensitivity to tesamorelin, and pregnancy. People with diabetes or prediabetes need glucose monitoring, people with a history of treated cancer need a careful risk discussion, and anyone with diabetic retinopathy needs eye follow-up because IGF-1 can worsen it. It should also not be used during critical illness.

+−Tesamorelin vs sermorelin: which is better?

They act on the same GHRH receptor, but tesamorelin is a stabilized version of the full 44-amino-acid hormone with an FDA approval, large placebo-controlled trials and a documented 15% visceral-fat reduction, while sermorelin is the 29-amino-acid fragment with a withdrawn pediatric approval, small 1990s trials and no visceral-fat data. Tesamorelin also costs far more, because the only legal version is the brand. If the goal is measured visceral fat, tesamorelin has the evidence; if the goal is a modest, cheaper nudge to growth hormone output, sermorelin is what most clinics prescribe.

+−Can I use CJC-1295/ipamorelin and tesamorelin together?

There is no trial of the combination, and in the United States there is no legal way to fill it: FDA placed CJC-1295 and ipamorelin in Category 2 in 2023 and its advisory committee voted against both in late 2024, so no licensed pharmacy may compound them. Stacking two GHRH analogs also makes little pharmacological sense, since both act on the same receptor and the pituitary response has a ceiling. A clinician who offers this stack is sourcing at least part of it from research vendors.

+−Does tesamorelin increase testosterone?

No. Tesamorelin acts on the growth hormone axis, not the gonadal axis, and the trials did not report changes in testosterone. Men on testosterone therapy were included in the HIV trials and the drug worked the same way. If low testosterone is the problem, tesamorelin is the wrong tool.

+−What happens when you stop tesamorelin?

The visceral fat returns. In the 12-month phase 3 study, patients who were switched from tesamorelin to placebo after 26 weeks rapidly lost the reduction they had gained, while those who continued kept it. Tesamorelin is a maintenance treatment, and its label tells prescribers to reconsider continuing in anyone whose visceral fat has not fallen.

+−Is tesamorelin a peptide, and is it legal?

Chemically it is a chain of 44 amino acids, but anything longer than 40 amino acids counts as a protein under FDA's definition, so since March 23, 2020 tesamorelin has been regulated as a biological product. It is legal as an FDA-approved prescription drug, Egrifta, for HIV-associated abdominal fat, and a clinician may prescribe the brand off-label. It cannot be legally compounded: biological products are not eligible for the compounding exemptions in sections 503A and 503B, so 'compounded tesamorelin' is not made under any exemption FDA recognizes, whatever the seller says. Vials sold as research chemicals are unapproved drugs; FDA named tesamorelin in its August 24, 2026 warning letters to five online vendors.

Sources

1. StudyFalutz J et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med 2007;357:2359-70. (2007)
2. StudyFalutz J et al. Effects 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 data. J Clin Endocrinol Metab 2010;95:4291-304. (Falutz 2010 JCEM) (2010)
3. StudyFalutz J et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr 2010;53:311-22. (Falutz 2010 JAIDS) (2010)
4. StudyStanley TL et al. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin. Clin Infect Dis 2012;54:1642-51. (2012)
5. StudyStanley TL et al. Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial. JAMA 2014;312:380-9. (2014)
6. StudyStanley TL et al. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. Lancet HIV 2019;6:e821-e830. (2019)
7. StudyMakimura H et al. Metabolic effects of a growth hormone-releasing factor in obese subjects with reduced growth hormone secretion: a randomized controlled trial. J Clin Endocrinol Metab 2012;97:4769-79. (2012)
8. StudyBaker LD et al. Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial. Arch Neurol 2012;69:1420-9. (2012)
9. StudyClemmons DR, Miller S, Mamputu JC. Safety and metabolic effects of tesamorelin, a growth hormone-releasing factor analogue, in patients with type 2 diabetes: a randomized, placebo-controlled trial. PLoS One 2017;12:e0179538. (2017)
10. StudyAdrian S et al. The growth hormone releasing hormone analogue, tesamorelin, decreases muscle fat and increases muscle area in adults with HIV. J Frailty Aging 2019;8:154-9. (2019)
11. StudyEllis RJ et al. Effects of tesamorelin on neurocognitive impairment in persons with HIV and abdominal obesity. J Infect Dis 2025;231:1230-8. (2025)
12. ReviewBadran AS et al. Body composition, hepatic fat, metabolic, and safety outcomes of tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: a meta-analysis of randomized controlled trials. Obes Res Clin Pract 2026;20:2-12. (2026)
13. NewsTraynor K. FDA approves tesamorelin for HIV-related lipodystrophy. Am J Health Syst Pharm 2010;67:2082. (2010)
14. LabelTheratechnologies. EGRIFTA WR (tesamorelin) for injection, 11.6 mg per vial: full prescribing information, revised March 2025; DailyMed SPL published August 3, 2026, application BLA022505. (Egrifta WR label 2025) (2025)
15. LabelTheratechnologies. EGRIFTA SV (tesamorelin) for injection, 2 mg per vial: prescribing information; DailyMed SPL published July 31, 2026, application BLA022505. (Egrifta SV label 2026) (2026)
16. RegulatoryFederal Register. Definition of the term 'biological product': final rule defining a protein as any alpha amino acid polymer with a specific, defined sequence greater than 40 amino acids in size. 85 FR 10057, February 21, 2020. (Federal Register 2020) (2020)
17. RegulatoryFDA. Notice to compounders: changes that affect compounding as of March 23, 2020 (biological products subject to licensure under section 351 of the PHS Act, including those with deemed biologics license applications, are not eligible for the exemptions in sections 503A and 503B). Content current as of March 5, 2020. (FDA notice to compounders 2020) (2020)
18. NewsArentFox Schiff. RUO-ined: five peptide vendors learn that research use only is not a legal strategy (FDA warning letters of August 24, 2026). September 18, 2026. (2026)
19. RegulatoryFDA. Bulk drug substances nominated for use in compounding under section 503A: Category 1, 2 and 3 lists and updates (updated May 14, 2026). (2026)