Tesamorelin
Tesamorelin is an FDA-approved active (Egrifta). Prescription-only, physician-reviewed.
- Routesubcutaneous injection
- Baseline labsTypically required
- EvidenceFDA-approved active
- AvailabilityAvailable with Rx
How it works
Tesamorelin is a stabilized GHRH analog and an FDA-approved active (marketed as Egrifta). Like other GHRH analogs it acts on the growth-hormone-releasing hormone pathway, prompting the pituitary to release growth hormone — but unlike compounded GHRH peptides, the molecule itself has been through FDA review for a specific use.
It is FDA-approved to reduce excess visceral (deep abdominal) fat in people with HIV-associated lipodystrophy, and that indication was established in randomized clinical trials. Its mechanism is the same family as sermorelin, but its evidence base and regulatory status are notably stronger and more specific.
What it's been studied for
- Excess visceral (deep abdominal) fat in its FDA-approved indication
- Effects on the GHRH pathway and IGF-1 in randomized trials
“Studied for” describes what research has examined — not a promise of any outcome for you.
What the evidence says
Tesamorelin is an FDA-approved active studied in randomized clinical trials. Source: Falutz et al., NEJM 2007.
What to expect at Clyne
As an FDA-approved active, tesamorelin is prescribed under standard prescription rules after a provider reviews your intake. A provider typically reviews baseline labs — IGF-1 and glucose among them — and may order follow-up labs to guide care.
Your provider directs the specifics and explains what to monitor. Because it affects the GH axis and blood sugar, that monitoring is a real part of the therapy.
Safety & considerations
Your provider screens for conditions and medications — including any history of cancer or active malignancy — that affect whether GHRH-axis therapy is appropriate, since stimulating the GH/IGF-1 axis is a relevant consideration there. It can also affect glucose tolerance, so blood-sugar monitoring may be part of the plan.
Even though tesamorelin is FDA-approved, that approval is for a specific population and use. Whether it makes sense for you is a clinical decision, and a provider may conclude it doesn't.
Regulatory status
This is an FDA-approved active medication, prescribed under standard prescription rules. A regulatory category that permits compounding is not the same as FDA approval.
Common questions
Is tesamorelin FDA-approved?
Yes — tesamorelin (Egrifta) is an FDA-approved active studied in randomized clinical trials, approved to reduce excess visceral fat in HIV-associated lipodystrophy. Whether it's right for you is a decision for your provider.
How is it different from sermorelin?
Both are GHRH analogs acting on the same pathway. Tesamorelin is an FDA-approved drug with a specific approved use and trial evidence; the sermorelin offered here is a compounded preparation that is not FDA-approved.
