Tesamorelin (Egrifta): what it is approved for and what the evidence shows
Tesamorelin is a growth hormone-releasing hormone analog. The FDA approved it, under the brand name Egrifta, for one job: reducing excess belly fat in adults with HIV who have lipodystrophy. Everything outside that use is off-label. This page covers the approved use, the trial numbers, the side effects, and exactly where tesamorelin stands with pharmacies.
Information current as of November 10, 2026. Educational only. Confirm everything here with your own clinician before starting, stopping or changing any medication.
At a glance
What it is
A 44 amino acid synthetic version of the hormone that tells the pituitary to release growth hormone (GH). It does not contain GH itself.
Approved for
Reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. The label says it is not for weight loss.
How it is given
A daily injection under the skin, as set out in the FDA label. Your physician reviews the product-specific directions.
What it changes
In trials, visceral (deep belly) fat fell and IGF-1, a growth hormone marker, rose. Weight on the scale did not change.
Main cautions
Joint pain, swelling, higher blood sugar, and a warning about tumors because GH is a growth factor. Not for active cancer or pregnancy.
Pharmacy status
Dispensed by a pharmacy as the FDA-approved product. It is a biologic, so the compounding route is closed by FDA rules.
Uses
What tesamorelin is used for
The approved use is narrow. Egrifta is indicated to reduce excess abdominal fat in HIV-infected adults with lipodystrophy. Lipodystrophy here means a pattern of fat redistribution that can follow years of HIV treatment, with deep fat building up around the organs in the belly. This visceral fat is linked to heart and metabolic risk, and it is hard to shift with diet and exercise.
The label spells out limits. Long-term cardiovascular safety has not been established. It is not indicated for weight loss, because its effect on weight is neutral. There are no data showing it improves adherence to HIV medicines. The label also tells prescribers to weigh whether to continue in patients who have not had a drop in visceral fat.
Off-label use
Some clinics offer tesamorelin to people who do not have HIV, for body composition or for general growth hormone support. The FDA has not approved that, and the pivotal trials did not study it. Anything said about results in that group goes beyond the evidence. Dr. Miranda says so plainly at the visit.
If you are not living with HIV, a better starting point is usually the foundation: sleep, strength training, protein, and a look at testosterone, thyroid and blood sugar. For weight, see our pages on semaglutide and tirzepatide.
How it works
How tesamorelin works and how it is given
Your pituitary gland releases growth hormone in pulses. Tesamorelin mimics the signal that tells it to do that, so your own GH rises, followed by IGF-1, the liver hormone GH drives. That is different from taking GH itself. The body’s feedback system stays in the loop, which is part of why it is attractive, though the label warns about the same growth-factor concerns that apply to any drug that raises GH.
It is given as a daily subcutaneous injection, and the product comes as a kit. Egrifta has two marketed formulations, and the directions differ between them. Your physician and pharmacist walk through the one you receive. This page does not give amounts or schedules, because those come from the label and your own prescription.
Tesamorelin is a biologic product under current FDA rules. That matters for where it can come from, and it is covered under regulatory status below.
Evidence
What the trials showed
The approval rests on two multicenter, randomized, placebo-controlled trials in HIV-infected adults with excess abdominal fat. Patients were randomized 2 to 1 to tesamorelin or placebo for 26 weeks, then followed through an extension. People with diabetes, a history of cancer or pituitary disease were excluded.
Visceral fat, trial 1
Per the FDA label, visceral fat fell by 27 cm squared on tesamorelin and rose by 4 on placebo. The treatment difference was 31 cm squared, or 20 percent.
Visceral fat, trial 2
In the second trial, the drop was 21 cm squared versus no change. The treatment difference was 21 cm squared, or 12 percent.
Pooled analysis
A 2026 meta-analysis of 5 randomized trials found less visceral fat and trunk fat, less liver fat, and more lean mass. It found no change in subcutaneous fat or BMI.
A separate 404-patient trial with a 12-month safety extension reported the same direction of effect. Patients also rated their own belly appearance as less distressing. In 61 people with HIV and fatty liver, a smaller randomized trial found drops in visceral and liver fat in the subgroup on integrase inhibitor regimens, with no worsening of blood sugar control.
What is missing matters too. The trials enrolled people with HIV. Long-term cardiovascular outcomes were not measured. There are no trials that show tesamorelin helps people without HIV, and results vary from person to person.
Safety
Side effects and warnings
The label lists these as the most common reactions: joint pain, redness and itching at the injection site, pain in an arm or leg, swelling of the hands or feet, and muscle pain. Injection site reactions occurred in about 17 percent of tesamorelin patients and 6 percent of placebo patients.
Blood sugar
Tesamorelin can cause glucose intolerance. In the trials, 5 percent of patients on tesamorelin reached a hemoglobin A1c of 6.5 percent or higher by week 26, compared with 1 percent on placebo. The label says to check glucose before starting and to monitor during treatment.
Tumors, fluid and allergy
Because tesamorelin raises GH, a growth factor, the label contraindicates it in anyone with active cancer. Any past cancer should be inactive with treatment complete. Fluid retention can cause swelling, joint pain and carpal tunnel symptoms. Hypersensitivity reactions have occurred. The label also advises considering stopping in people who are critically ill, because of reports of higher mortality in that setting.
Do not use if
- You have active cancer
- You have a pituitary problem, a pituitary tumor or surgery, head radiation or serious head injury
- You are pregnant, because the label says it offers no benefit and could cause fetal harm
- You have had an allergic reaction to tesamorelin
Regulatory status
Where tesamorelin stands with pharmacies
Tesamorelin is FDA-approved as Egrifta, under application BLA022505. It was originally approved as a drug. On March 23, 2020, the FDA transitioned certain protein products, including tesamorelin, to biologics, and its compounding guidance states that biological products are not eligible for the 503A and 503B compounding exemptions.
That is the FDA’s statement, and this page repeats it so you know what you are getting. Compounded tesamorelin is not FDA-approved, and the FDA has not evaluated it for safety, effectiveness or quality. The route Summit uses for tesamorelin is the approved product, written as a prescription and filled by a pharmacy.
Summit’s role
What Summit does with tesamorelin
Dr. Miranda prescribes tesamorelin after a physician evaluation. The prescription is for the FDA-approved product and is filled by a pharmacy. Your evaluation covers your history, blood sugar, cancer history, medications and whether tesamorelin fits at all. Summit does not dispense or sell it, and it keeps no stock in the office.
Nothing on this page promises a prescription. If tesamorelin does not fit your history, labs and goals, you will hear why. See pricing for what the program includes, including labs.
Common questions
Questions people ask
Is tesamorelin a steroid or growth hormone?
No. It is a releasing hormone. It signals your pituitary to make more of its own growth hormone. It is not testosterone, an anabolic steroid, or GH itself.
Is tesamorelin good for weight loss?
No. The label says it is not indicated for weight loss, because its effect on body weight is neutral. In trials it reduced visceral fat, not scale weight.
Can I take it without HIV?
It is not approved for that, and the pivotal trials did not include those patients. Any use outside HIV lipodystrophy is off-label, and results in that group are not established.
Why not a compounded version?
The FDA treats tesamorelin as a biologic and says biologics are not eligible for the compounding exemptions. Compounded products are also not evaluated by the FDA for safety, effectiveness or quality.
Does it need lab monitoring?
Yes. The label calls for checking glucose before and during treatment, and IGF-1 is commonly followed as a marker of GH effect. Your physician sets the schedule.
Sources
Where this comes from
All retrieved November 10, 2026.
- EGRIFTA WR (tesamorelin) for injection prescribing information. DailyMed. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75
- FDA. Notice to Compounders: Changes that affect compounding as of March 23, 2020. https://www.fda.gov/drugs/human-drug-compounding/notice-compounders-changes-affect-compounding-march-23-2020
- Falutz J et al. Effects of tesamorelin in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr 2010. https://pubmed.ncbi.nlm.nih.gov/20101189/
- Meta-analysis of randomized trials of tesamorelin in HIV-associated lipodystrophy. Obes Res Clin Pract 2026. https://pubmed.ncbi.nlm.nih.gov/41545261/
- Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors. AIDS 2024. https://pubmed.ncbi.nlm.nih.gov/38905488/
Confirm with your provider. This page is general education, not medical advice, and it does not diagnose or treat anything. Every medication carries risks and is not right for everyone. Medication is prescribed only after a physician evaluation determines it is appropriate for you. Individual results vary and no outcome is guaranteed. Information current as of November 10, 2026.
Next step
Start with a physician evaluation
Dr. Miranda reviews your history, blood sugar and medications before any treatment decision.