Tesamorelin (Egrifta): FDA Approval, Side Effects and Cost

Legal status of Tesamorelin

FDA-approved drug

Tesamorelin is FDA-approved as Egrifta, only to reduce excess belly fat in adults with HIV and lipodystrophy ^[1]. FDA treats it as a biologic that cannot be compounded, so compounded versions sold online have no clear legal basis ^[2].

FDA status

FDA first approved tesamorelin in 2010 ^[1]. It is approved to reduce excess abdominal fat in adults with HIV who have lipodystrophy, and it is not for weight loss ^[1]. On March 23, 2020, Egrifta's drug application was deemed a biologics license ^[3]. FDA says these transitioned biologics are not eligible for the 503A or 503B compounding exemptions ^[2]. So compounded tesamorelin offered online has no clear legal basis. FDA has also sent warning letters to sellers of "research use only" tesamorelin ^{[11] [12]}.

Advisory committee

Not applicable. Tesamorelin is an FDA-approved drug, not a bulk substance under review ^[1].

FDA-approved products

Egrifta WR, approved March 2025, injected daily with weekly mixing ^[4]. Egrifta SV, a single-vial version, was approved in 2018 ^[5]. FDA labels say the two are not substitutable ^[1].

Sports (WADA)

Prohibited under class S2 as a growth hormone releasing hormone analog. Tesamorelin is named ^[10].

What happens next

Nothing. A doctor can prescribe Egrifta now for its approved use ^[1].

Checked against FDA sources on Oct 19, 2026. We update this box when FDA acts. Report a change: [email protected].

What tesamorelin is approved for

Egrifta WR is "indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy" ^[1]. That is its only approved use. The label adds three limits: long-term heart safety has not been established, it "is not indicated for weight loss management as it has a weight neutral effect," and there are no data that it helps people stay on HIV medicines ^[1].

FDA first approved tesamorelin in 2010 ^[1]. The maker announced a single-vial version, later sold as Egrifta SV, in 2018 ^[5], and Egrifta WR, which is mixed once a week and injected daily, in March 2025 ^[4]. The label says Egrifta WR and Egrifta SV "are not substitutable" ^[1]. On March 23, 2020, Egrifta's drug application was moved to a biologics license ^[3].

Use for general fat loss or bodybuilding

People search for tesamorelin for fat loss and bodybuilding. That is not its approved use, and the label's trials do not support it as a weight-loss drug: body weight barely changed in either trial ^[1]. It is also banned in sports. The 2026 WADA list names tesamorelin as a growth hormone releasing hormone analog under class S2 ^[10].

Tesamorelin side effects

The most common side effects reported in more than 5% of people in the label's 26-week trials were:

Most common side effects in the Egrifta label's 26-week trials

Side effect	Egrifta	Placebo
Injection site reaction	17%	6%
Joint pain (arthralgia)	13%	11%
Pain in arms or legs	6%	5%
Muscle pain (myalgia)	6%	2%
Swelling of the legs or feet (peripheral edema)	6%	2%

The label also reports injection site reactions in 25% of people on Egrifta vs 14% on placebo over the first 26 weeks, a separate count in the label's warnings section, and allergic (hypersensitivity) reactions in 4% of trial patients ^[1]. Side effects in men and women are not reported separately in the label sections we read.

Warnings on the label

• Cancer risk: the label warns of an increased risk of neoplasms. Prescribers should weigh the higher background cancer risk in people with HIV, should not use it in active cancer, and should stop it if a cancer comes back ^[1].
• Higher IGF-1: tesamorelin raises IGF-1, a growth hormone marker. At week 26, 36% of patients had IGF-1 levels more than 3 standard deviations above normal. The label says to monitor IGF-1 and consider stopping if levels stay high ^[1].
• Fluid retention: swelling, joint discomfort and carpal tunnel symptoms, usually temporary or resolving after stopping ^[1].
• Blood sugar: it can cause glucose intolerance or diabetes, so glucose should be checked before and during treatment ^[1].
• Allergic reactions and injection site reactions; rotate injection sites ^[1].
• Critical illness: growth hormone has been linked to higher death rates in acutely critically ill patients, so stopping should be considered in that setting ^[1].

Who should not use it

The label says not to use Egrifta WR in people with a disrupted hypothalamic-pituitary axis (for example after pituitary surgery or with a pituitary tumor), with active cancer, with known allergy to tesamorelin or its ingredients, or during pregnancy ^[1].

Egrifta dose on the label

"The recommended dosage of EGRIFTA WR is 1.28 mg subcutaneously once daily," injected into the abdomen with rotating sites ^[1]. It comes as a vial holding 11.6 mg of powder that is mixed once a week ^{[1] [4]}. Follow your prescriber's instructions and the pharmacy label, and ask your pharmacist about mixing and injecting. We do not give mixing instructions.

There is no FDA-approved tesamorelin tablet or oral form. The label's only dosage form is powder in a vial for injection under the skin ^[1]. Vial sizes such as "10 mg" sold online do not match the approved Egrifta WR vial, and those products have not been reviewed by FDA.

Tesamorelin results: what the trials showed

The label reports two trials in adults with HIV and lipodystrophy, measured at 26 weeks. Belly fat measured by scan fell, while body weight did not meaningfully change ^[1]:

Egrifta trial results at 26 weeks, from the label

Measure	Study 1: Egrifta	Study 1: placebo	Study 2: Egrifta	Study 2: placebo
Belly (visceral) fat	-18% (-27 cm²)	+2% (+4 cm²)	-14% (-21 cm²)	-2% (about 0 cm²)
Trunk fat	-1.0 kg	+0.4 kg	-0.8 kg	+0.2 kg
Waist	-3 cm	-1 cm	-2 cm	-1 cm
Body weight, difference vs placebo	-0.4 kg		+0.2 kg

The effect did not last after stopping. In the extension phase, from week 26 to week 52, people switched to placebo regained belly fat, +25 cm² in Study 1 and +24 cm² in Study 2, while those who kept taking the drug saw +3 cm² and -11 cm² ^[1]. The label measures results at 26 weeks; it does not give a time to first visible change, so "before and after" claims at 1 month are not from the label.

Egrifta cost, insurance and how to get it

Egrifta WR is a prescription drug filled by a pharmacy ^[4]. Without insurance, published cash prices start at $11,029.87 per kit:

Egrifta WR cash prices, checked Oct 19, 2026

Product	Channel	Price as published	What the price covers	Checked	Source
Egrifta WR (FDA-approved)	SingleCare discount price	$11,037.51 per kit; typical out-of-pocket price listed at $18,218.03	Drug only. Days of supply per kit not stated	Oct 19, 2026	[6]
Egrifta WR 11.6 mg kit (FDA-approved)	Drugs.com price guide	From $11,029.87 per kit	Drug only. Days of supply per kit not stated	Oct 19, 2026	[7]

Insurance and savings programs

• Insurance: some plans cover Egrifta with prior authorization for its approved use. Centene's PA Health & Wellness policy, for example, covers Egrifta SV and Egrifta WR for reducing excess abdominal fat in adults with HIV and lipodystrophy, approving 6 months at first and 12 months on renewal ^[8].
• Co-pay help: the maker's THERA Co-Pay Assistance program serves commercially insured patients. Dollar limits are not published ^[9].
• Patient assistance: the maker says its program "offers qualifying patients THERA medications at no cost" ^[9].
• Off-label use: Centene's policy is written for the approved HIV lipodystrophy use only ^[8]. Ask your plan before assuming it will pay for any other use.

Other legal peptide prices are in our legal peptide price tracker.

Compounded tesamorelin

Compounded tesamorelin has no clear legal basis. When Egrifta became a biologic on March 23, 2020 ^[3], FDA said transitioned biologics "will not be eligible for the exemptions for compounded drugs under sections 503A and 503B" ^[2]. We found online claims that tesamorelin is legal to compound under 503A or 503B; FDA's notice says otherwise ^[2]. Compounded drugs are not FDA-approved, and FDA does not review them for safety, effectiveness or quality.

Tesamorelin labeled "research use only" is also not legal for people. FDA warning letters dated Aug 24, 2026 to Royal Peptides LLC and Peptide Partners LLC cited tesamorelin among the unapproved drugs they sold ^{[11] [12]}. See our FDA warning letter list.

Tesamorelin with ipamorelin or CJC-1295

Stacks that pair tesamorelin with ipamorelin or CJC-1295, like blends such as KLOW, add peptides FDA has rejected for compounding. FDA's advisory committee voted 0 to 12, with 1 abstention, against adding ipamorelin to the bulks list on Oct 29, 2024 ^[14], and unanimously against CJC-1295 free base on Dec 4, 2024 ^[15]. FDA says a published study identified serious adverse events, including death, with ipamorelin acetate, and it has identified serious adverse events with CJC-1295, including increased heart rate ^[13]. Both are banned by WADA under class S2 ^[10].

For other growth hormone related options, see sermorelin and, for low testosterone, testosterone replacement therapy. All peptide statuses are on our peptide FDA status tracker; for a peptide that cannot be legally prescribed, compare BPC-157.

What changed for tesamorelin

Newest first.

• Mar 25, 2025: The maker announced FDA approval of Egrifta WR ^[4].
• Mar 23, 2020: Egrifta's application was deemed a biologics license, which ended eligibility for 503A and 503B compounding ^{[3] [2]}.
• Nov 5, 2018: The maker announced FDA approval of the single-vial version later sold as Egrifta SV ^[5].
• 2010: FDA first approved tesamorelin (Egrifta) ^[1].

How we check

Drug facts on this page come from the Egrifta WR label revised March 2025. Legal status comes from FDA's 2020 compounding notice and biologics list. Prices come from public price pages checked Oct 19, 2026, and coverage from a published insurer policy. We do not link to compounders or research peptide sellers. Our method: editorial standards.