Compound monograph
Tesamorelin
Also known as: Egrifta, Egrifta SV, Egrifta WR, TH9507
§1 Definition
Tesamorelin is a synthetic growth-hormone-releasing hormone (GHRH) analog, FDA-approved as Egrifta for the reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. Administered as a once-daily subcutaneous injection of reconstituted lyophilized powder, it stimulates the pituitary gland to release the patient's own growth hormone rather than supplying growth hormone directly.
Educational purposes only, not medical advice. Dosing figures below are documented ranges from cited literature, not a recommendation for any individual. Consult a qualified provider before administering anything.
§2 Evidence tier and regulatory status
Evidence tier
1 — FDA-approved
Approved by the FDA for at least one indication, backed by multiple randomized controlled trials.
FDA-approved. Originally approved as Egrifta on November 10, 2010, for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Reformulated as Egrifta SV in 2019, then as Egrifta WR (tesamorelin F8) on March 25, 2025 — a lower-volume formulation reconstituted weekly rather than daily. The formulations are not substitutable with each other.
§3 Documented dosing
| Context | Range | Frequency | Source |
|---|---|---|---|
| HIV-associated lipodystrophy, excess abdominal fat (Egrifta SV) | 1.4–1.4 mg | once daily, subcutaneous (0.35 mL of the reconstituted solution) | [2] |
| HIV-associated lipodystrophy, excess abdominal fat (Egrifta WR) | 1.28–1.28 mg | once daily, subcutaneous (0.16 mL of the reconstituted solution) | [1] |
§4 Reconstitution math
Unlike the GLP-1 monographs on this site, FDA-approved tesamorelin genuinely is supplied as a lyophilized powder requiring reconstitution. Egrifta SV (2mg/vial) is reconstituted with 0.5mL of Sterile Water for Injection. Egrifta WR (11.6mg/vial) is reconstituted with 1.3mL of Bacteriostatic Water for Injection and is mixed weekly rather than daily. The two formulations use different diluents and are not interchangeable.
| Vial | Water | Concentration | Draw volume | Units (U-100) |
|---|---|---|---|---|
| 2 mg | 2.0 mL | 1000 mcg/mL | 1.4 mL | 140.0 |
| 11.6 mg | 2.0 mL | 5800 mcg/mL | 0.241 mL | 24.1 |
This input can't be calculated:
- Draw volume exceeds the barrel capacity of the selected syringe.
§5 What the research shows
| Trial | Phase | n | Duration | Endpoint | Result | Source |
|---|---|---|---|---|---|---|
| Study 1 (NCT00123253) | Phase 3 | 412 | 26-week main phase plus a 26-week extension | Percent change in visceral adipose tissue (VAT) measured by CT scan | 18% VAT reduction with tesamorelin vs a 2% increase with placebo. | [1] |
| Study 2 (NCT00435136) | Phase 3 | 404 | 26-week main phase plus a 26-week extension | Percent change in visceral adipose tissue (VAT) | 14% VAT reduction with tesamorelin vs a 2% decrease with placebo. | [1] |
§6 Safety and reported adverse effects
| Effect | Incidence | Source |
|---|---|---|
| Injection site erythema | 17% | [1] |
| Arthralgia (joint pain) | 13% | [1] |
| Pain in extremity | 6% | [1] |
| Peripheral edema | 6% | [1] |
| Myalgia | 6% | [1] |
| New-onset diabetes / hyperglycemia | hazard ratio approximately 3.3x vs placebo | [1] |
Rates above are the label's most commonly reported (≥5%) adverse reactions from the pivotal trials; this is not an exhaustive list of every reported event.
Contraindications
- Disruption of the hypothalamic-pituitary axis (e.g. from hypophysectomy, hypopituitarism, a pituitary tumor or pituitary surgery, or head irradiation)
- Active malignancy, or a history of malignancy without adequate treatment or surveillance
- Known hypersensitivity to tesamorelin or any excipient
- Pregnancy
Known interactions
- No specific drug-drug interaction data was located in this research pass beyond the contraindications listed above.
§7 Storage and handling
- Lyophilized
- Unreconstituted vials are stored per the product's refrigeration requirements before first use.
- Reconstituted
- Egrifta WR: store the reconstituted solution at room temperature, 20-25°C (68-77°F), and discard 7 days after mixing. Egrifta SV's specific in-use storage duration was not independently confirmed in this research pass.
§8 Sourcing considerations
- Confirm the product is an FDA-approved formulation (Egrifta SV or Egrifta WR) obtained through a legitimate pharmacy, not an unregulated compounded or research-chemical version.
- If handling a compounded version, verify the diluent and reconstituted concentration match the specific formulation being used — Egrifta SV and Egrifta WR are not interchangeable and use different diluents and volumes.
- For any non-FDA-regulated tesamorelin, request a Certificate of Analysis from an independent, named third-party lab.
§9 FAQ
What is tesamorelin used for?
It is FDA-approved (as Egrifta) to reduce excess abdominal fat in HIV-infected adults with lipodystrophy.
Is Egrifta the same as human growth hormone?
No. Tesamorelin is a GHRH analog — it stimulates the pituitary gland to release the patient's own growth hormone, rather than supplying growth hormone directly.
What is the difference between Egrifta SV and Egrifta WR?
Egrifta WR (approved 2025) is a newer, lower-volume formulation reconstituted weekly for daily injections, using a different diluent and vial size than Egrifta SV. The two are not substitutable.
How is Egrifta reconstituted and dosed?
Egrifta SV (2mg vial) is reconstituted with 0.5mL of Sterile Water for Injection, dosed at 1.4mg (0.35mL) once daily. Egrifta WR (11.6mg vial) is reconstituted with 1.3mL of Bacteriostatic Water for Injection, dosed at 1.28mg (0.16mL) once daily.
What are the most common tesamorelin side effects?
Injection site erythema, joint pain (arthralgia), pain in the extremities, peripheral edema, and muscle pain (myalgia) were each reported in 6% or more of trial participants.
Can tesamorelin cause diabetes?
Trial data showed an increased risk of new-onset diabetes and hyperglycemia, with a hazard ratio of approximately 3.3x versus placebo.
Who shouldn't take tesamorelin?
It is contraindicated in people with disruption of the hypothalamic-pituitary axis, active malignancy or inadequately treated/monitored prior malignancy, known hypersensitivity to tesamorelin, or pregnancy.
§10 Sources
- [1] EGRIFTA WR (tesamorelin) for injection — full prescribing information. DailyMed, National Library of Medicine (NIH), 2025. FDA. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75
- [2] EGRIFTA SV (tesamorelin for injection) — Highlights of Prescribing Information. U.S. Food and Drug Administration, 2019. FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf
- [3] FDA Approves F8 Formulation of Theratechnologies' Tesamorelin (Egrifta WR) for HIV-Associated Lipodystrophy. Contagion Live, 2025. Other. https://www.contagionlive.com/view/fda-approves-f8-formulation-of-theratechnologies-tesamorelin-for-hiv-associated-lipodystrophy