Here's the short version. There is one legal way to get tesamorelin in the US: a prescription for the brand Egrifta, filled by a pharmacy. Everything else you see offered, from compounded vials to "research" kits, has no lawful route to you [5].
The approved indication and lawful prescribing are different questions. FDA explains that clinicians may prescribe an approved drug off label when they judge it medically appropriate; that does not create a lawful compounded tesamorelin product or establish benefit for the off-label use [2].
Every version of tesamorelin you'll see, and which ones are legal
Two branded products are legal. Two other things you'll run into are not. The table sorts them in one look.
| Version | FDA status | Who makes it | Legal path for you | What it means |
|---|---|---|---|---|
| Egrifta SV (2 mg vial) | FDA-approved; label revised March 2024 [7] | Theratechnologies | Prescription, filled by a pharmacy | The labeled product |
| Egrifta WR (11.6 mg vial) | FDA-approved March 25, 2025 [6] | Theratechnologies | Prescription; not interchangeable with SV | A newer formulation that needs its own prescription |
| Compounded tesamorelin | Not eligible for 503A or 503B compounding since March 23, 2020 [5] | No lawful maker | None | No legal compounded route exists |
| "Research use only" vials | Not a drug for human use | Unnamed research-chemical sellers | None | No quality or safety standard for people |
Egrifta and Egrifta SV appear on FDA's list of products deemed biologics on March 23, 2020; Egrifta WR is a later supplement to the same application.
Egrifta first won approval on November 10, 2010, under application 022505 [3]. The same application now carries both current labels. Your next step if the brand is what you want: ask a prescriber whether you fit its one labeled use. What it costs, and how insurance plays in, is covered in our tesamorelin cost guide.
Compounded tesamorelin lost its legal route in March 2020
When Egrifta moved to the biologics framework on March 23, 2020, it lost the compounding exemptions that let pharmacies make their own versions of drugs. That's the whole reason no pharmacy can legally make it today.
The Biologics Price Competition and Innovation Act of 2009, enacted in 2010, set that date. On it, protein drugs approved the ordinary way were deemed biologic licenses instead. FDA's published list of those products includes tesamorelin acetate, sold as Egrifta and Egrifta SV [4].
Beginning on March 23, these transitioning biological products will not be eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act.[5]
Sections 503A and 503B are the two parts of federal law that let pharmacies and outsourcing facilities compound. Lose both and there's no door left. That's also why tesamorelin isn't on FDA's 503A nominations list at all, in any category, as of its May 2026 update [9].
Egrifta is labeled for one use: belly fat in adults with HIV
The Egrifta labels cover one use: reducing excess abdominal fat in adults with HIV and lipodystrophy. Lipodystrophy is a shift in where the body stores fat, and in people with HIV it can mean deep belly fat building up around the organs.
EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect.[8]
- Heart safety: long-term cardiovascular safety hasn't been established [7].
- Weight loss: not indicated, because the drug is weight neutral.
- HIV treatment: no data show it helps people stay on their antiretroviral medicines.
- Who shouldn't take it: the label rules it out in pregnancy, active cancer, pituitary problems from surgery, radiation or injury, and known allergy to the drug.
Every efficacy number on the label comes from adults with HIV. Separate research included adults without HIV and measured body composition, but it does not establish a general weight-loss indication [1]. That question belongs with your prescriber. The trial timeline, week by week, is in how long tesamorelin takes to work.
Heads up on the two versions. Both labels say Egrifta SV and Egrifta WR have different recommended dosages and aren't substitutable, so a switch means a new prescription [8]. The maker's support program verifies insurance benefits and works with specialty pharmacies in your plan's network [10].
"Research use only" tesamorelin isn't a legal way to get it
A vial labeled research use only is sold outside the drug system. There's no prescriber, no labeled pharmacy and no quality standard for human use. The label on the box is the seller telling you it isn't meant for people.
These sites tend to look alike. Here's how to spot one before you've spent a cent:
- No prescription is asked for, and no clinician ever talks to you.
- It sells by the vial or the kit, with prices per milligram.
- A "not for human consumption" or "for laboratory use" line sits somewhere on the page.
- Payment runs through crypto, gift cards or a payment app instead of a pharmacy.
- No pharmacy name, license or state appears anywhere.
A clinic offering compounded tesamorelin is offering something FDA says can't be compounded
Some telehealth menus still list tesamorelin next to peptides that are legal to compound. A clinic offering compounded tesamorelin is offering a product with no 503A or 503B route. Ask two questions before anything else:
- Which pharmacy fills it, and is it a licensed pharmacy filling a branded Egrifta prescription?
- If it's compounded, under what legal authority, given the March 2020 change?
If the answer is a compounding pharmacy, you have your answer. The same applies to blends. A tesamorelin mix with another peptide has no lawful source either, as our page on tesamorelin with ipamorelin explains.
What to do instead depends on why you wanted tesamorelin
The legal options depend on the goal you had for tesamorelin. Start with the goal, then pick the route.
| If your goal is… | What the evidence says about tesamorelin | Legal options to look at |
|---|---|---|
| Less belly fat | Pivotal visceral-fat trials in adults with HIV; no general weight-loss indication | GLP-1 programs on our metabolic shortlist |
| More muscle or a leaner build | A small trunk-muscle change in HIV trials (see does tesamorelin build muscle) | Our body composition shortlist |
| Growth hormone support | HIV pivotal trials and separate older-adult cognition/body-composition research | Sermorelin, prescribed as a compounded drug (see how to get sermorelin) |
Sermorelin is a different drug in the same family, a growth-hormone-releasing hormone analog. It's prescribed as a compounded drug, and compounded drugs aren't FDA-approved. If you have HIV and the belly-fat problem the label describes, the brand is the route, and your HIV clinician is the person to ask first.