Tesamorelin (Egrifta): evidence, side effects, dosing

Q: What is tesamorelin and what does it do?

Tesamorelin is a lab-made version of growth hormone releasing hormone, the brain signal that tells the pituitary to release growth hormone. It raises the body's own growth hormone and IGF-1 (a growth factor that growth hormone raises), and in trials it reduced deep abdominal (visceral) fat without changing fat under the skin. FDA approved it in 2010 for one use: reducing excess abdominal fat in adults with HIV and lipodystrophy, an abnormal shift of body fat linked to HIV and its treatment. It is sold as Egrifta WR and Egrifta SV, and the label states it is not indicated for weight loss.

Q: Is tesamorelin legal and FDA approved?

Yes. Tesamorelin has been FDA approved since 2010, first as Egrifta and now as Egrifta WR and Egrifta SV, for reducing excess abdominal fat in adults with HIV lipodystrophy. It is prescription only. Because Egrifta became a biologic in 2020 and FDA states that biologics are not eligible for the 503A or 503B compounding exemptions, compounded tesamorelin has no lawful basis. A clinician may prescribe Egrifta WR off-label, but use for fat loss in people without HIV has little trial support.

Q: What is the tesamorelin dosage on the FDA label?

It depends on the formulation, and the labels state the formulations are not substitutable. Egrifta WR: 1.28 mg injected under the skin of the abdomen once daily. Egrifta SV: 1.4 mg once daily. The original Egrifta used in the phase 3 trials: 2 mg once daily. Treatment continues for as long as it is prescribed, because visceral fat returned after stopping in trials. There is no labeled dose for anyone without HIV lipodystrophy, and compounded tesamorelin has no FDA labeled dose.

Q: Does tesamorelin work for belly fat?

In HIV lipodystrophy, yes, modestly. In 806 patients, 2 mg daily for 26 weeks reduced visceral fat by 15.4% relative to placebo (about 24 cm2 on CT), lowered triglycerides, and improved how patients rated their belly, without changing subcutaneous fat or weight much. The fat came back after stopping. Outside HIV, one 12 month trial in 60 adults with abdominal obesity and reduced growth hormone secretion found visceral fat fell about 35 cm2 relative to placebo. It has not been tested as a general weight loss drug, and the label says it is not one.

Q: How long does tesamorelin take to work?

The approval trials measured results at 26 weeks, when visceral fat was 15.4% lower than on placebo, and the reduction held at 52 weeks in people who kept taking it. People switched to placebo regained visceral fat. The label advises weighing whether to continue in anyone whose visceral fat has not fallen. Trial results were measured by CT scans, which is why before and after photos are not a substitute for trial data.

Q: Does tesamorelin help build muscle?

It is not approved or tested for muscle growth. In a secondary analysis of the HIV trials, people whose visceral fat fell on tesamorelin (193, compared with 148 on placebo) had small gains in trunk muscle area, about 0.6 to 1.1 cm2 of lean area per muscle group on CT, and higher muscle density, a sign of less fat inside the muscle. A 2026 meta-analysis of five HIV trials found about 1.4 kg more lean body mass than placebo. No trial has tested it in healthy people or athletes, and it is prohibited in sport.

Q: Is tesamorelin safe?

It has been through FDA review for its approved use, and the label lists real risks. It raises IGF-1, a growth factor, so it is contraindicated with active cancer and IGF-1 should be monitored. It can impair glucose tolerance: by week 26, 5% of treated patients versus 1% on placebo reached an HbA1c of 6.5% or higher. It can also cause fluid retention, joint pain, carpal tunnel symptoms, hypersensitivity reactions, and injection site reactions (25% versus 14% on placebo). Long-term cardiovascular safety has not been established. Compounded or research-labeled tesamorelin is not a lawful product and has not been tested the same way.

Q: Can women take tesamorelin?

For the approved use, yes: the label covers adults with HIV and lipodystrophy, although about 85% of participants in the two phase 3 trials were men. It is contraindicated in pregnancy, because visceral fat normally rises in pregnancy and rat studies showed harm to offspring, and the label says to stop it if pregnancy occurs. The label also advises against breastfeeding while taking it. Use for fat loss in women without HIV is off-label.

Q: Is there a tesamorelin pill?

No. Every FDA approved tesamorelin product (Egrifta, Egrifta SV, and Egrifta WR) is a powder made into an injection given under the skin, and the trials behind the approval used daily injections. No oral, sublingual, or nasal tesamorelin has been approved or tested in a published trial, so products sold in those forms are unapproved and unstudied.

Q: Does tesamorelin help fatty liver?

In people with HIV, a 12 month NIH funded randomized trial of 61 patients found tesamorelin 2 mg daily reduced liver fat by an absolute 4.1 percentage points, a 37% relative reduction, and 35% of treated patients cleared steatosis versus 4% on placebo. Glucose did not worsen. It has not been tested for fatty liver in people without HIV and is not approved for that use.

Summary

Tesamorelin is a stabilized growth hormone releasing hormone analog, a lab-made version of the brain signal that tells the pituitary to release growth hormone, approved by FDA in 2010 as Egrifta for reducing excess abdominal fat in adults with HIV who have lipodystrophy (an abnormal shift of body fat linked to HIV and its treatment); the current formulations are Egrifta WR and Egrifta SV. In pooled phase 3 trials of 806 patients, 2 mg daily for 26 weeks reduced visceral adipose tissue (deep belly fat around the organs) by 15.4% relative to placebo and lowered triglycerides (blood fats) without meaningful changes in glucose, and a later 61 patient randomized trial in HIV associated fatty liver cut liver fat by 37% relative to baseline. Outside HIV, one 60 person trial in abdominal obesity with reduced growth hormone secretion found a similar visceral fat drop, but use for fat loss or anti-aging in people without HIV is off-label (outside the approved use), and tesamorelin is prohibited in sport under WADA section S2.

What is Tesamorelin?

Tesamorelin is a synthetic 44 amino acid analog of human growth hormone releasing hormone with an N-terminal trans-3-hexenoic acid modification that resists enzymatic degradation. It is also known as Egrifta, Egrifta SV, Egrifta WR, TH9507, Tesamorelin acetate, GHRH(1-44) analog.

How does it work?

Tesamorelin binds pituitary GHRH receptors and stimulates pulsatile release of endogenous growth hormone, which raises IGF-1. Growth hormone increases lipolysis, particularly of visceral fat, and the physiological feedback loops remain intact, which is why tesamorelin causes less glucose disturbance than direct growth hormone injection. The hexenoyl modification protects the peptide from dipeptidyl peptidase cleavage, extending its action compared with native GHRH or sermorelin.

Key facts
Cluster	Metabolic and growth hormone axis
Routes	Subcutaneous injection into the abdomen once daily (Egrifta WR, Egrifta SV); No oral, sublingual, or nasal form is FDA approved or tested in a published trial
Conditions studied	Growth hormone deficiency and GH secretagogue use; Fatty liver disease (MASLD and MASH); Fat loss and body composition; HIV associated lipodystrophy
Record	v4, draft, verified Sep 23, 2026

What does the evidence say about Tesamorelin?

Human RCT evidenceGrade assigned per the methodology.

Two multicenter, double-blind, placebo-controlled phase 3 trials with 806 HIV patients on antiretroviral therapy with excess abdominal fat (pooled analysis, Falutz 2010): at 26 weeks visceral adipose tissue fell 24 cm2 versus a 2 cm2 rise on placebo (treatment effect minus 15.4%), triglycerides fell 37 mg/dL versus a 6 mg/dL rise, IGF-1 rose 108 ng/mL, and glucose parameters did not differ meaningfully; visceral fat returned toward baseline after discontinuation. A 12 month NIH funded randomized trial in 61 people with HIV and nonalcoholic fatty liver disease (Stanley 2019) found an absolute reduction in hepatic fat fraction of 4.1 percentage points (37% relative reduction) and resolution of steatosis in 35% versus 4% on placebo, with more injection site complaints but no glucose difference. Outside HIV, a 12 month randomized trial in 60 abdominally obese adults with reduced GH secretion (Makimura 2012) found a visceral fat treatment effect of minus 35 cm2 with lower triglycerides and C-reactive protein and no change in glucose. A 2026 meta-analysis of five randomized trials in HIV found lower visceral, trunk, and liver fat and about 1.4 kg more lean body mass than placebo, with no significant change in subcutaneous fat or BMI.

Indexed studies by evidence grade
Evidence type	Indexed studies	Participants (human)
Human randomized trials	6	1268
Human observational studies	0	n/a
Animal studies	0	n/a
All indexed studies	6	1,268

Human evidence

Falutz 2010: pooled analysis of two phase 3 trials, 806 patients randomized 2:1 to tesamorelin 2 mg or placebo subcutaneously daily; VAT change minus 24 versus plus 2 cm2 at 26 weeks (p < 0.001), no change in abdominal subcutaneous fat, triglycerides minus 37 versus plus 6 mg/dL, improved patient rated belly appearance; in patients continued to 52 weeks VAT reduction was maintained at minus 17.5%, and those switched to placebo regained visceral fat. Stanley 2019: 61 patients with HIV and hepatic fat fraction of 5% or more randomized to tesamorelin 2 mg or placebo daily for 12 months; hepatic fat fraction fell by an absolute 4.1% (95% CI minus 7.6 to minus 0.7) and 35% versus 4% reached a hepatic fat fraction below 5%; fasting glucose and HbA1c did not differ. Stanley 2012: reductions in visceral fat with tesamorelin were associated with improved triglycerides and adiponectin. Makimura 2012: 60 abdominally obese adults without HIV and with reduced GH secretion randomized to tesamorelin 2 mg or placebo daily for 12 months; visceral fat minus 16 versus plus 19 cm2 (treatment effect minus 35 cm2), triglycerides and C-reactive protein improved, carotid intima media thickness fell, and fasting glucose, 2 hour glucose, and HbA1c did not change. Adrian 2019: secondary CT analysis of the phase 3 trials (193 tesamorelin responders, 148 placebo) found small increases in trunk muscle density and lean muscle area (about 0.6 to 1.1 cm2 per muscle group) at 26 weeks. Badran 2026: meta-analysis of five RCTs in HIV, lean body mass plus 1.42 kg and hepatic fat minus 4.28 percentage points versus placebo.

Animal evidence

Preclinical studies in rodents and dogs characterized tesamorelin's GHRH receptor agonism, growth hormone release, and pharmacokinetics; carcinogenicity studies in rodents informed labeling. Animal data are secondary to the human trials for this approved drug.

Key studies

Indexed studies of Tesamorelin
Study	Design and population	Outcome	Grade
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 data2010 PMID 20554713	Pooled analysis of two randomized, double-blind, placebo-controlled phase 3 trials, 26 weeks plus 26 week extensionn = 806 Adults with HIV on antiretroviral therapy with excess abdominal fat	Visceral adipose tissue minus 24 versus plus 2 cm2 (treatment effect minus 15.4%), triglycerides minus 37 versus plus 6 mg/dL, IGF-1 plus 108 ng/mL, no meaningful glucose change; effect maintained at 52 weeks with continued treatment	Evidence: Human RCT evidence
Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial2019 PMID 31611038	Randomized, double-blind, placebo-controlled trial, 12 months plus 6 month open-label phasen = 61 Adults with HIV and hepatic fat fraction of 5% or more	Hepatic fat fraction absolute change minus 4.1% (37% relative reduction); 35% versus 4% achieved hepatic fat below 5%; no difference in glucose or HbA1c	Evidence: Human RCT evidence
Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin2012 PMID 22495074	Secondary analysis of the phase 3 trialsHIV patients with excess abdominal fat treated with tesamorelin	Visceral fat reduction with tesamorelin was associated with improved triglycerides and adiponectin	Evidence: Human RCT evidence
Metabolic effects of a growth hormone-releasing factor in obese subjects with reduced growth hormone secretion: a randomized controlled trial2012 PMID 23015655	Randomized, double-blind, placebo-controlled trial, 12 monthsn = 60 Abdominally obese adults without HIV with reduced growth hormone secretion	Visceral fat treatment effect minus 35 cm2; triglycerides, C-reactive protein, and carotid intima media thickness improved; no change in glucose or HbA1c	Evidence: Human RCT evidence
The growth hormone releasing hormone analogue, tesamorelin, decreases muscle fat and increases muscle area in adults with HIV2019 PMID 31237318	Secondary exploratory CT analysis of two randomized phase 3 trials, 26 weeksn = 341 Adults with HIV and abdominal obesity (tesamorelin visceral fat responders and placebo)	Greater increases in trunk muscle density and lean muscle area (about 0.6 to 1.1 cm2 per muscle group) than placebo	Evidence: Human RCT evidence
Body composition, hepatic fat, metabolic, and safety outcomes of tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: a meta-analysis of randomized controlled trials2026 PMID 41545261	Meta-analysis of five randomized controlled trialsAdults with HIV associated lipodystrophy	Visceral fat minus 27.7 cm2, hepatic fat minus 4.28 percentage points, lean body mass plus 1.42 kg versus placebo; no significant change in subcutaneous fat or BMI	Evidence: Human RCT evidence

Conditions studied

Conditions with evidence for Tesamorelin
Condition	Grade	Note
Growth hormone deficiency and GH secretagogue use	Evidence: Human RCT evidence	FDA approved as Egrifta; 15 to 18% reduction in visceral fat over 26 weeks in HIV lipodystrophy trials.
Fatty liver disease (MASLD and MASH)	Evidence: Human RCT evidence	In 61 adults with HIV and fatty liver, liver fat fell by a relative 37% versus placebo and 35% versus 4% reached normal liver fat; not approved for fatty liver.
Fat loss and body composition	Evidence: Human RCT evidence	Visceral fat fell about 15% versus placebo over 26 weeks in adults with HIV associated abdominal fat excess, the only population it is approved for.
HIV associated lipodystrophy	Evidence: Human RCT evidence	Pooled phase 3 data (n = 806): visceral fat minus 15.4% versus placebo and triglycerides down 37 mg/dL, with no meaningful glucose change; effect maintained at 52 weeks only with continued treatment.

Is Tesamorelin legal in the United States?

FDA approvedWADA prohibited

FDA and compounding status

FDA approved as Egrifta (tesamorelin for injection) on November 10, 2010, for reduction of excess abdominal fat in HIV infected adults with lipodystrophy; Egrifta SV, a 2 mg vial formulation, was approved in 2019, and Egrifta WR, an 11.6 mg vial formulation, in March 2025. Tesamorelin is a 44 amino acid protein, and on March 23, 2020 FDA deemed the Egrifta application (022505) to be a biologics license. FDA states that biological products are not eligible for the 503A or 503B compounding exemptions, so compounded tesamorelin sold by telehealth and anti-aging clinics has no lawful basis, and Egrifta WR by prescription is the only lawful product. A clinician may prescribe Egrifta WR off-label, but use for fat loss in people without HIV has only limited trial support.

WADA status

WADA prohibited. Athletes subject to anti-doping testing should treat this as prohibited at all times unless the current prohibited list says otherwise.

Regulatory timeline

Sep 21, 2026WADA
WADA publishes the 2027 Prohibited List
WADA published the 2027 Prohibited List on September 21, 2026, and it takes effect January 1, 2027. The S2 peptide hormone and growth factor classes are unchanged. BPC-157 is still named under S0, and MOTS-c is still named under S4.4 as an activator of AMP-activated protein kinase. WADA added a note that many peptides without approval for human use fall under S0 or another section, and that a peptide not named on the list may still be prohibited. GLP-1 receptor agonists such as semaglutide and tirzepatide are still not on the list.
Source: WADA 2027 Prohibited List
Jan 1, 2026WADA
WADA 2026 Prohibited List takes effect
The 2026 WADA Prohibited List took effect on January 1, 2026 and continues to prohibit the S2 peptide hormone and growth factor classes (GHRH analogs, growth hormone secretagogues, GH fragments, IGF-1 and analogs, MGF, thymosin beta-4 and derivatives, hCG and GnRH-class releasing factors in males), myostatin inhibitors, insulin and the AMPK activator MOTS-c under S4, desmopressin under S5, and BPC-157 under S0. GLP-1 receptor agonists such as semaglutide and tirzepatide are not on the list.
Source: WADA Prohibited List
Jan 1, 2025WADA
WADA 2025 Prohibited List keeps peptide hormones and growth factors banned at all times
The 2025 WADA Prohibited List took effect on January 1, 2025. Section S2 (peptide hormones, growth factors, related substances and mimetics) covers GHRH analogs such as CJC-1295, sermorelin, and tesamorelin, growth hormone secretagogues such as ipamorelin, GHRP-2, GHRP-6, hexarelin, and ibutamoren (MK-677), growth hormone fragments such as AOD-9604, growth factors including IGF-1 and its analogs, MGF, and thymosin beta-4 (TB-500), and chorionic gonadotropin and releasing factors such as gonadorelin and kisspeptin (prohibited in males). Myostatin inhibitors such as ACE-031 fall under S4, insulin under S4 metabolic modulators, desmopressin under S5, and BPC-157 remains an S0 non-approved substance.
Source: WADA Prohibited List
Mar 23, 2020FDA
Egrifta (tesamorelin) is deemed a biologics license
Under the biologics transition provision of the Biologics Price Competition and Innovation Act, FDA deemed the Egrifta application (022505) to be a biologics license on March 23, 2020. FDA states that biological products are not eligible for the 503A or 503B compounding exemptions, so tesamorelin cannot be lawfully compounded; the approved product remains available by prescription.
Regulatory: FDA approvedSource: FDA: List of approved NDAs for biological products that were deemed to be BLAs on March 23, 2020 (includes tesamorelin, Egrifta and Egrifta SV, application 022505)
Nov 10, 2010FDA
FDA approves Egrifta (tesamorelin) for HIV-associated lipodystrophy
FDA approved tesamorelin injection (Egrifta), a growth hormone-releasing hormone analog, to reduce excess abdominal fat in HIV-infected adults with lipodystrophy.
Regulatory: FDA approvedSource: Drugs@FDA: Egrifta (tesamorelin) NDA 022505

Full tracker for Tesamorelin or the category-wide tracker.

Tesamorelin dose on the FDA label

Doses below are quoted from the FDA label for its approved uses, plus the doses used in the pivotal trials where noted. The prescriber sets the dose; PeptideAgent does not recommend doses or protocols.

FDA label dosing (tesamorelin is FDA approved, so these are labeled doses in mg for the approved use). Egrifta WR (11.6 mg vial, label revised March 2025): 1.28 mg injected subcutaneously into the abdomen once daily. Egrifta SV (2 mg vial): 1.4 mg subcutaneously into the abdomen once daily. Original Egrifta (1 mg vials, approved 2010): 2 mg subcutaneously once daily, the dose used in the phase 3 trials and the 12 month fatty liver trial. The formulations differ in strength and preparation and the labels state they are not substitutable, so the dose depends on which product is prescribed. The label bases efficacy on 26 weeks of treatment and advises weighing whether to continue in people whose visceral fat has not fallen; in trials, visceral fat returned after stopping. There is no labeled dose for people without HIV lipodystrophy, and compounded tesamorelin has no FDA labeled dose.

Routes reported

Routes of administration reported for Tesamorelin
#	Route
1	Subcutaneous injection into the abdomen once daily (Egrifta WR, Egrifta SV)
2	No oral, sublingual, or nasal form is FDA approved or tested in a published trial

Tesamorelin side effects

Side effects

Side effects reported for Tesamorelin
#	Reported side effect
1	Arthralgia (about 13%)
2	Injection site reactions (redness, itching, pain, irritation, bruising) in 25% versus 14% on placebo over 26 weeks
3	Peripheral edema, myalgia, pain in extremities
4	Paresthesia and hypoesthesia
5	Nausea, vomiting, rash
6	Glucose intolerance: HbA1c reached 6.5% or higher in 5% versus 1% on placebo by week 26 (label advises checking glucose before and during treatment)
7	Increased IGF-1 (label recommends monitoring; consider stopping if persistently elevated)
8	Hypersensitivity reactions including rash, urticaria, and rare anaphylaxis
9	Fluid retention (edema, carpal tunnel syndrome) typical of growth hormone axis stimulation

Interactions

Interactions reported for Tesamorelin
#	Interaction
1	Glucocorticoids and other drugs metabolized by CYP450: growth hormone may alter cytochrome P450 activity; monitor drugs with narrow therapeutic windows
2	Cortisone acetate and prednisone: growth hormone can inhibit 11 beta hydroxysteroid dehydrogenase type 1, potentially requiring glucocorticoid dose adjustment
3	Insulin and antidiabetic drugs: tesamorelin can raise glucose; monitor and adjust

Contraindications

Contraindications for Tesamorelin
#	Contraindication
1	Disruption of the hypothalamic pituitary axis from hypophysectomy, hypopituitarism, pituitary tumor or surgery, head irradiation, or head trauma
2	Active malignancy (newly diagnosed or recurrent)
3	Pregnancy (visceral fat increases normally in pregnancy and the drug may harm the fetus)
4	Known hypersensitivity to tesamorelin or any ingredient in the product
5	Athletes subject to WADA testing (prohibited at all times under S2)

How do people access Tesamorelin legally?

Typical cost: Egrifta WR has no published list price; a retail cash listing put one 28 day kit at about 10,709 USD, and a manufacturer co-pay program helps eligible commercially insured patients with the approved HIV indication. Compounded tesamorelin has no lawful price, because tesamorelin is a biologic and biologics cannot be compounded. Prices checked 2026-09-22.

Verified access options

Step 1
Prescription from an HIV specialist filled at a specialty pharmacy as Egrifta WR for the approved indication.
Step 2
Off-label prescription of Egrifta WR by a licensed clinician, usually paid in cash because coverage follows the HIV indication. Compounded tesamorelin is not a lawful option, because biologics cannot be compounded under 503A.
Step 3
Not available for athletic or cosmetic use through any lawful channel consistent with sport rules.

Access paths are verified against public regulatory records and prescriber licensing. We never list unlicensed vendors.

Compare Tesamorelin

What's actually offered, and what that means for you

Compounded tesamorelin is widely offered by clinics and telehealth prescribers. Tesamorelin is FDA approved, but FDA deemed its application (022505) a biologics license in March 2020, and biologics cannot be compounded under 503A or 503B. Compounded versions have no lawful basis. [5] [8] [13]

Enforcement is uneven. FDA mostly acts through warning letters to compounders and online sellers and import alerts that let it detain shipments, rather than stopping every pharmacy. State pharmacy boards oversee pharmacies day to day, and their rules differ. [5] [14] [15] [16]

What changes for you

No FDA review of the product: FDA does not check a compounded drug's safety, effectiveness, or quality before it is sold. [5]
Identity, purity, sterility, and dose accuracy can vary from batch to batch. [5]
Insurance rarely covers it, so you usually pay cash.
For tested athletes, tesamorelin is prohibited at all times on the WADA list, whatever the source. [6]

What to check

No check makes a compounded version lawful. To be sure you get the approved product, check for:

The approved product by name (Egrifta WR) on the pharmacy label, dispensed against your prescription. [8]
The word "compounded" on the label or in the offer, which means it is not the approved product. [5] [13]
A real evaluation by a licensed prescriber, not just an online form.

The approved option is Egrifta WR, by prescription. See Egrifta WR cost by channel.

Blends that contain Tesamorelin

Tesamorelin is sold in a premixed blend under the name below. No blend has been tested as a combination, and a mix is only as lawful as its least lawful ingredient.

Tesamorelin and ipamorelin: with Ipamorelin. No lawful path.

All peptide blends

Frequently asked questions

What is tesamorelin and what does it do?

Tesamorelin is a lab-made version of growth hormone releasing hormone, the brain signal that tells the pituitary to release growth hormone. It raises the body's own growth hormone and IGF-1 (a growth factor that growth hormone raises), and in trials it reduced deep abdominal (visceral) fat without changing fat under the skin. FDA approved it in 2010 for one use: reducing excess abdominal fat in adults with HIV and lipodystrophy, an abnormal shift of body fat linked to HIV and its treatment. It is sold as Egrifta WR and Egrifta SV, and the label states it is not indicated for weight loss. [1] [8]

Is tesamorelin legal and FDA approved?

Yes. Tesamorelin has been FDA approved since 2010, first as Egrifta and now as Egrifta WR and Egrifta SV, for reducing excess abdominal fat in adults with HIV lipodystrophy. It is prescription only. Because Egrifta became a biologic in 2020 and FDA states that biologics are not eligible for the 503A or 503B compounding exemptions, compounded tesamorelin has no lawful basis. A clinician may prescribe Egrifta WR off-label, but use for fat loss in people without HIV has little trial support. [4] [5] [8] [13]

What is the tesamorelin dosage on the FDA label?

It depends on the formulation, and the labels state the formulations are not substitutable. Egrifta WR: 1.28 mg injected under the skin of the abdomen once daily. Egrifta SV: 1.4 mg once daily. The original Egrifta used in the phase 3 trials: 2 mg once daily. Treatment continues for as long as it is prescribed, because visceral fat returned after stopping in trials. There is no labeled dose for anyone without HIV lipodystrophy, and compounded tesamorelin has no FDA labeled dose. [1] [8] [9]

Does tesamorelin work for belly fat?

In HIV lipodystrophy, yes, modestly. In 806 patients, 2 mg daily for 26 weeks reduced visceral fat by 15.4% relative to placebo (about 24 cm2 on CT), lowered triglycerides, and improved how patients rated their belly, without changing subcutaneous fat or weight much. The fat came back after stopping. Outside HIV, one 12 month trial in 60 adults with abdominal obesity and reduced growth hormone secretion found visceral fat fell about 35 cm2 relative to placebo. It has not been tested as a general weight loss drug, and the label says it is not one. [1] [8] [10]

How long does tesamorelin take to work?

The approval trials measured results at 26 weeks, when visceral fat was 15.4% lower than on placebo, and the reduction held at 52 weeks in people who kept taking it. People switched to placebo regained visceral fat. The label advises weighing whether to continue in anyone whose visceral fat has not fallen. Trial results were measured by CT scans, which is why before and after photos are not a substitute for trial data. [1] [8]

Does tesamorelin help build muscle?

It is not approved or tested for muscle growth. In a secondary analysis of the HIV trials, people whose visceral fat fell on tesamorelin (193, compared with 148 on placebo) had small gains in trunk muscle area, about 0.6 to 1.1 cm2 of lean area per muscle group on CT, and higher muscle density, a sign of less fat inside the muscle. A 2026 meta-analysis of five HIV trials found about 1.4 kg more lean body mass than placebo. No trial has tested it in healthy people or athletes, and it is prohibited in sport. [6] [11] [12]

Is tesamorelin safe?

It has been through FDA review for its approved use, and the label lists real risks. It raises IGF-1, a growth factor, so it is contraindicated with active cancer and IGF-1 should be monitored. It can impair glucose tolerance: by week 26, 5% of treated patients versus 1% on placebo reached an HbA1c of 6.5% or higher. It can also cause fluid retention, joint pain, carpal tunnel symptoms, hypersensitivity reactions, and injection site reactions (25% versus 14% on placebo). Long-term cardiovascular safety has not been established. Compounded or research-labeled tesamorelin is not a lawful product and has not been tested the same way. [1] [5] [8]

Can women take tesamorelin?

For the approved use, yes: the label covers adults with HIV and lipodystrophy, although about 85% of participants in the two phase 3 trials were men. It is contraindicated in pregnancy, because visceral fat normally rises in pregnancy and rat studies showed harm to offspring, and the label says to stop it if pregnancy occurs. The label also advises against breastfeeding while taking it. Use for fat loss in women without HIV is off-label. [8]

Is there a tesamorelin pill?

No. Every FDA approved tesamorelin product (Egrifta, Egrifta SV, and Egrifta WR) is a powder made into an injection given under the skin, and the trials behind the approval used daily injections. No oral, sublingual, or nasal tesamorelin has been approved or tested in a published trial, so products sold in those forms are unapproved and unstudied. [1] [8] [9]

Does tesamorelin help fatty liver?

In people with HIV, a 12 month NIH funded randomized trial of 61 patients found tesamorelin 2 mg daily reduced liver fat by an absolute 4.1 percentage points, a 37% relative reduction, and 35% of treated patients cleared steatosis versus 4% on placebo. Glucose did not worsen. It has not been tested for fatty liver in people without HIV and is not approved for that use. [2]

What are the side effects of tesamorelin?

Joint pain (about 13%), injection site redness, itching, and bruising (25% versus 14% on placebo), swelling of the hands and feet, muscle aches, tingling, and nausea are the common ones. Because it raises growth hormone and IGF-1 it can impair glucose tolerance, so the label advises checking blood sugar before and during treatment and monitoring IGF-1. It is contraindicated with active cancer, pituitary disease, and pregnancy. [1] [4] [8]

How much does tesamorelin cost?

Egrifta WR, which replaced Egrifta SV, has no published list price; a retail cash listing put one 28 day kit at about 10,709 USD, and a manufacturer co-pay program helps eligible commercially insured patients with the HIV indication. Compounded tesamorelin has no lawful price, because tesamorelin is a biologic and biologics cannot be compounded. Prices checked 2026-09-22. [4] [7] [8] [13]

Is tesamorelin banned by WADA?

Yes. The WADA Prohibited List names tesamorelin explicitly in section S2 among growth hormone releasing hormone analogues, prohibited at all times in and out of competition. An athlete with HIV lipodystrophy would need a therapeutic use exemption. [6]

Tesamorelin vs sermorelin: what is the difference?

Both are GHRH analogs, but tesamorelin is the full 44 amino acid sequence with a stabilizing modification and has large randomized trials plus a current FDA approval. Sermorelin is the 29 amino acid fragment, was approved as Geref for children with growth hormone deficiency, and was discontinued in 2008; its adult data are small and old. Tesamorelin is the better evidenced and much more expensive option; both are prohibited by WADA. [1] [6]

Decisions about starting, stopping, or combining any treatment belong with a licensed clinician who knows your history.

From the blog

Tesamorelin vs HGH: how they differ and which is approved
Tesamorelin (Egrifta) signals the pituitary to release growth hormone and is approved for HIV-associated belly fat; HGH (somatropin) is the hormone itself, approved for other conditions.
Does tesamorelin build muscle? What the trials show
Tesamorelin raised lean body mass about 1.2 kg in HIV trials and slightly increased trunk muscle area, but no trial tested strength or muscle growth, and it is prohibited in sport.
Tesamorelin before and after: what the trials measured
Tesamorelin results from the 26 and 52 week trials: about 15 to 18% less visceral fat, little change in weight, and fat that came back after stopping. Why photos are not trial data.
Tesamorelin prescription: who qualifies and how to get one
How to get tesamorelin legally: who qualifies for Egrifta WR on label, how off-label prescribing works, why compounded tesamorelin is not lawful, what a visit should check, and cost.
Tesamorelin vs sermorelin vs ipamorelin: evidence and legality
Tesamorelin, sermorelin, and ipamorelin compared in one table: mechanism, FDA approval, compounding status, human evidence, and WADA status, with links to each pairwise comparison.
How to get peptides prescribed legally in 2026
Which peptides a licensed prescriber can lawfully write for today, which are waiting on an FDA rule, how telehealth rules work, and the red flags that mean a product is not a prescription at all.

Sources

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APA style: PeptideAgent. (2026, September 23). Tesamorelin: evidence, legality, and access. https://peptideagent.ai/peptides/tesamorelin
HTML link: <a href="https://peptideagent.ai/peptides/tesamorelin">Tesamorelin: evidence, legality, and access</a>, PeptideAgent, updated September 23, 2026.

Tesamorelin (Egrifta)

At a glance