Tesamorelin vs sermorelin: what’s approved and what isn’t

Tesamorelin and sermorelin both tell the pituitary gland to release more of the body’s own growth hormone, which is why they are often compared. Their legal standing is very different. Tesamorelin is an FDA-approved brand-name drug, Egrifta, with one approved use: reducing excess belly fat in adults with HIV who have lipodystrophy. Sermorelin was approved decades ago as Geref, left the market in 2008, and is now sold only as a compounded drug that isn’t FDA-approved. This guide sets out what each one is, what the FDA has and hasn’t reviewed, and what the tesamorelin label says about safety.

Tesamorelin vs sermorelin at a glance

How each one works

Growth hormone-releasing hormone (GHRH) is made in the brain and tells the pituitary gland to release growth hormone in pulses. Growth hormone then raises IGF-1, a growth factor made mostly in the liver. Both drugs copy GHRH. Neither is growth hormone itself.

Tesamorelin is the full 44-amino-acid sequence of human growth hormone-releasing factor with a hexenoyl group attached at one end, according to its label. The label describes growth hormone as “both anabolic and lipolytic,” meaning it builds tissue and breaks down fat.

Sermorelin is a shorter, lab-made copy: the first 29 amino acids of GHRH, which researchers call “GHRH 1-29.”

Tesamorelin: what the FDA approved

Two brand-name versions

The FDA first approved tesamorelin as Egrifta on Nov 10, 2010 (Drugs@FDA). Two versions are on DailyMed today:

• Egrifta SV: a 2 mg vial mixed for each dose, with a label dose of 1.4 mg injected under the skin once a day (label).
• Egrifta WR: approved on Mar 25, 2025 as a new formulation (FDA letter). One 11.6 mg vial is mixed once a week and gives seven daily doses of 1.28 mg. The label says Egrifta WR and Egrifta SV “are not substitutable.”

The approved use

Both labels give the same indication: “the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.” They also set limits. Tesamorelin “is not indicated for weight loss management as it has a weight neutral effect,” and the SV label adds that its long-term cardiovascular safety has not been established. Any other use is off-label.

What the trials found

The approval rests on two 26-week trials of adults with HIV lipodystrophy and excess belly fat: 412 people in Study 1 and 404 in Study 2, using the 2 mg dose of the original Egrifta. Visceral fat, the fat around the organs, was measured by CT scan.

The effect lasted only while people kept taking it. In the 26-week extension phases, people switched from tesamorelin to placebo saw belly fat rise again by 22% and 16%, while those who stayed on it had changes of 0% and down 5%.

Why it can’t be compounded

Egrifta’s application was deemed a biologics license on Mar 23, 2020. In its guidance on biological products, the FDA says sections 503A and 503B, the compounding exemptions, do not apply to biological products licensed under the Public Health Service Act (FDA). So only brand-name Egrifta can be prescribed, and an offer of compounded tesamorelin is not lawful. Vials labeled for research are unregulated and unsafe for the same reason: no licensed pharmacy stands behind them.

Tesamorelin safety: what the label says

The label lists four groups who should not use it: people with a disrupted hypothalamic-pituitary axis (for example after pituitary surgery, head radiation or head trauma), people with active cancer, people allergic to tesamorelin, and anyone who is pregnant. Its warnings:

• Cancer. Any past cancer should be inactive and its treatment complete before starting, and the drug should be stopped if cancer comes back.
• Raised IGF-1. After 26 weeks, 47% of patients had IGF-1 levels more than 2 standard deviation scores above normal. The label says the effects of long-term high IGF-1 are unknown and calls for monitoring.
• Blood sugar. 5% of patients reached an HbA1c of 6.5% or higher, against 1% on placebo.
• Fluid retention, which can show up as swelling, joint pain or carpal tunnel syndrome.
• Allergic reactions in 4% of patients, including itching, flushing, hives and rash.
• Injection-site reactions in 25% of patients on tesamorelin and 14% on placebo over the first 26 weeks.

These are the side effects reported more often than on placebo during the first 26 weeks of the trials (543 people on tesamorelin, 263 on placebo):

Sermorelin: approved once, compounded now

The FDA approved sermorelin acetate twice as Geref, made by EMD Serono: on Dec 28, 1990 as a test of how well the pituitary releases growth hormone, and on Sep 26, 1997 for idiopathic growth hormone deficiency in children with growth failure (Federal Register). EMD Serono discontinued both in 2008, and their approvals were withdrawn effective June 18, 2009. On Mar 4, 2013, the FDA determined that Geref was “not withdrawn from sale for reasons of safety or effectiveness.”

That finding is why sermorelin can still be compounded. Under section 503A, a pharmacy may compound from a bulk ingredient that is a component of an FDA-approved drug (FDA interim policy), and sermorelin qualifies. It does not make compounded sermorelin FDA-approved. No approved sermorelin is on the market, the FDA doesn’t review compounded drugs for safety, effectiveness or quality before they’re sold, and prescribing it to adults for energy, sleep, recovery or body composition is off-label. Our guide on whether sermorelin is legal covers how it’s prescribed online.

What the small trials measured

Trials of sermorelin in adults are small and short, and none tested aging outcomes:

• In 11 healthy men aged 64 to 76, nightly sermorelin injections for 6 weeks raised night-time growth hormone release. IGF-1 did not change. Two of six strength measures improved, and weight, muscle and fat measured by body scan did not change. No significant adverse effects were reported (Vittone 1997).
• In 19 adults aged 55 to 71, 16 weeks of nightly injections of a close analog of sermorelin raised growth hormone and IGF-1, with IGF-1 drifting back toward baseline by week 16. Lean mass rose in the men but not the women. The only side effect reported was a temporary rise in blood fats (Khorram 1997).

There is no current FDA label for sermorelin, so there is no FDA-reviewed list of warnings or side effects for adults. Geref’s labeling covered children. Because sermorelin raises growth hormone, tell the prescriber about any history of cancer, diabetes or pituitary problems, and every medicine you take.

Can you get either one online?

Tesamorelin is prescribed as brand-name Egrifta SV or Egrifta WR for the approved use. None of the online providers we track prescribes it, so we have no price to compare. See the tesamorelin medication page for the label details in one place.

Sermorelin is prescribed online as a compounded drug after a clinician review. As of October 2026, prices start at $99 a month at PepScribe, with medication, care, syringes and shipping included. Our sermorelin cost guide compares each provider’s price and membership, and the ranked list of sermorelin providers scores them.

Neither drug is on the DEA’s list of controlled substances (DEA). Both are banned for athletes at all times: WADA’s 2026 list names “sermorelin and tesamorelin” as growth hormone releasing factors in class S2 (WADA).

Which one fits which situation

• You have HIV and excess belly fat from lipodystrophy. Tesamorelin is the FDA-approved option. Ask your HIV clinician whether it suits you, and expect blood sugar and IGF-1 checks.
• You want help with aging, energy or sleep. Neither drug is approved for that. Sermorelin is prescribed off-label for these goals, and its trials are small and short. Weigh that with a licensed clinician.
• You want to lose weight. Neither is a weight-loss drug, and tesamorelin’s label says so directly. The peptides FDA-approved for weight loss are the GLP-1 medications; see peptides for weight loss.
• You compete in tested sport. Both are prohibited.

The bottom line

Tesamorelin is an approved, brand-only biologic with a narrow label: belly fat in adults with HIV lipodystrophy, backed by two 26-week trials, with label warnings about blood sugar, IGF-1, fluid retention and cancer. Sermorelin is a compounded, off-label treatment whose approved form left the market in 2008, with only small, short trials in adults. No trial has compared them, and neither is approved for aging or weight loss. For where every other peptide stands, see are peptides legal in 2026 or the peptides hub.