Tesamorelin Peptide Dosage: Complete Guide to TH9507 Protocols

Tesamorelin is approved by the FDA for use at a dose of 2 mg subcutaneously, once daily for the original formulation or 1.4 mg subcutaneously once a day for the SV formulation. A newer one, Egrifta WR (approved March 2025), is 1.28 mg subcutaneously daily. All three have been approved to treat excess abdominal fat in HIV infected adults with HIV-associated lipodystrophy. Rotate site and inject in the abdomen. Tesamorelin is not approved for weight loss or anti-aging.

What Is Tesamorelin (TH9507)?

Tesamorelin, under the development code TH9507, is a synthetic analog of growth hormone-releasing hormone (GHRH). It acts by stimulating the pituitary to produce more of its own natural growth hormone which in turn increases the amount of insulin-like growth factor 1 (IGF-1) in the body. It is marketed in Canada as Egrifta, Egrifta SV and Egrifta WR.

The following is a summary of information on the dosing of tesamorelin. The FDA-approved dose of tesamorelin peptide is either 2 mg daily (Egrifta), 1.4 mg daily (Egrifta SV) or 1.28 mg daily (Egrifta WR). Each is given as one shot under the skin into the abdomen. It is only approved for use in adults for HIV-related lipodystrophy and not for weight loss. Side effects are typical at the site of the injection, joint pain and increased blood sugar. Cardiovascular safety is not known, according to the FDA prescribing information.

Tesamorelin was first approved by the FDA in 2010 for use in adults with HIV who have excess abdominal fat (lipodystrophy). It is still the only FDA approved drug for this condition. Tesamorelin is available in some clinics under the designation of an off-label use, which are not approved and do not have any long-term data. August AI is the ideal solution for wellness tracking tools.

The FDA-Approved Tesamorelin Peptide Dosage

The dose of the standard formulation of tesamorelin varies according to the particular formulation prescribed by a doctor. The original Egrifta comes in the form of a powder to be mixed before use which is 1 mg per vial. The dose is 2 mg/day which translates to a 2 mg solution (mix 2 1 mg vials together). This is then injected once a day.

The newer Egrifta SV is a 2 mg per vial. The dosage of egrifta for SV is 1.4 mg/day (0.35 mL from two vials of the mixed solution). Egrifta SV does not require water for mixing, it requires only one vial per dose, thus it is easier to prepare.

The multi-dose vial of Egrifta WR contains 11.6 mg and is approved by the FDA in March 2025 and lasts approximately a week when mixed. The dosage of the Egrifta WR solution is 1.28 mg per day or 0.16 mL of the mixed solution. This is a formulation where bacteriostatic water used instead of sterile water, enabling multi-day storage.

Per DailyMed labelling, all three formulations provide once-daily administration of tesamorelin by sub-cutaneous injection into the abdomen.

Tesamorelin Dose by Formulation: Egrifta, Egrifta SV, and Egrifta WR

Each tesamorelin formulation has its own mixing, dose, and storage rules. Here is how they compare.

Egrifta (original, 1 mg/vial). The dose is 2 mg daily. Reconstitute the first 1 mg vial with 2.2 mL of sterile water for injection. Mix by rolling gently for 30 seconds. Do not shake. The injection volume is 2 mL. Two vials are needed for each dose.

Egrifta SV (2 mg/vial). The dose is 1.4 mg daily. Reconstitute one 2 mg vial with 0.5 mL of sterile water for injection. Mix by rolling gently for 30 seconds. Do not shake. The injection volume is 0.35 mL. Only one vial is needed per dose.

Egrifta WR (11.6 mg/vial, multi-dose). The dose is 1.28 mg daily. Reconstitute one vial with 1.3 mL of bacteriostatic water. Swirl in a circle to mix. The injection volume is 0.16 mL. One vial lasts about a week with proper storage.

The three formulations are not interchangeable. Patients should not switch between them without provider guidance. The Egrifta WR prescribing information emphasizes this point directly.

This tesamorelin protocol structure was developed through Phase 3 clinical trials that showed clinically meaningful reductions in visceral adipose tissue over 26 to 52 weeks.

How to Inject Tesamorelin Properly

A critical aspect of treatment is how to properly self-inject tesamorelin. Subcutaneous injection is the injection right under the skin into the layer of fat over the muscle.

Only inject into abdomen. Move around to a new location daily. Do not use the scar tissue, bruises, stretch marks or the navel area. Clear visual guides for safe injection sites are provided in the FDA Egrifta SV label.

Follow the instructions for use with kit diluents and syringes provided. Mixing directions differ from formulation to formulation and are found in the instructions on the package; please read the directions closely. Mix and check the solution. It must be clear, free of particles.

Always use a new sterile needle and syringe for each injection. Needles used should be disposed of in a sharps disposal container.

Store unopened vials in the refrigerator. Egrifta WR vials, once mixed, can be kept at room temperature for the labeled time. Always follow the storage instructions on your package.

Keep a tesamorelin schedule by taking the dose at the same time each day. Many patients inject at bedtime to align with the body's natural growth hormone release.

Tesamorelin for Adults: Who Qualifies and Who Doesn't

The FDA approves tesamorelin for adults living with HIV who have excess abdominal fat from lipodystrophy. This is the only FDA-approved indication. The drug is not approved for:

• General weight loss or obesity

• Anti-aging or longevity

• Bodybuilding or athletic performance

• Children under 18

Tesamorelin should not be used by people with active cancer, pituitary gland problems, a history of head radiation, or hypersensitivity to tesamorelin or mannitol. It is also not safe during pregnancy. According to the Mayo Clinic and RxList drug profile, tesamorelin therapy may cause glucose intolerance and increase the risk of type 2 diabetes. People with existing diabetes need careful monitoring.

Your provider should check IGF-1 levels and blood glucose before starting and during treatment.

Tesamorelin Side Effects and Warnings

The most common side effects from FDA clinical trials include:

• Injection site reactions (redness, pain, itching, bruising)

• Peripheral edema (swelling of legs or arms)

• Joint pain (arthralgia)

• Muscle pain (myalgia)

• Tingling or numbness (paresthesia)

• Hyperglycemia (high blood sugar)

• Headache and fatigue

About 49.5% of patients develop antibodies to tesamorelin after 26 weeks of treatment, according to the FDA prescribing information. These antibodies do not appear to reduce the drug's effectiveness, but some can cause hypersensitivity reactions.

Tesamorelin raises IGF-1 levels, which may have unknown long-term effects. The FDA label notes that long-term cardiovascular safety has not been established. A 2017 PLOS One study by Clemmons and colleagues found that tesamorelin did not worsen blood sugar control in patients with type 2 diabetes over 12 weeks, but longer studies are needed.

Stop the drug and call your doctor for severe injection site reactions, signs of high blood sugar, fluid retention, or symptoms suggesting cancer.

Off-Label Tesamorelin Use: What You Should Know

Some clinics offer tesamorelin for body composition, anti-aging, or as part of growth hormone optimization in adults without HIV. These uses are off-label and not FDA-approved.

The main concerns with off-label use include lack of long-term safety data in healthy adults, possible cardiovascular risk from raised IGF-1 levels, glucose intolerance and diabetes risk, and high monthly cost (often over $3,000 without insurance coverage).

Tesamorelin injection through compounded versions or research peptide vendors carries added risks. These products are not FDA-approved for purity, potency, or safety. Buying tesamorelin online without a prescription is illegal in most U.S. states and may expose patients to contaminated or counterfeit products.

If you are considering off-label tesamorelin, work only with a licensed medical provider who can monitor your blood work, IGF-1 levels, and glucose tolerance. See August AI for tools that can help track injection routines under medical supervision.