Yes. Tesamorelin is FDA-approved, but only as the brand Egrifta and only for one condition [1]. That makes it unusual among the growth-hormone peptides sold online, most of which were never approved at all. The catch is that approval of the brand says nothing good about the "compounded tesamorelin" many clinics advertise. For the full background on the molecule, see the tesamorelin guide.
Yes, tesamorelin is approved, but only as Egrifta
FDA approved Egrifta (tesamorelin) for Theratechnologies on November 10, 2010, as a new molecular entity under application 022505 [1]. The September 2026 Purple Book lists two prescription versions: Egrifta SV, a 2 mg vial, and Egrifta WR, an 11.6 mg vial approved in March 2025 [7].
Both carry the same single indication. Neither label covers anti-aging, muscle gain, general fat loss or sleep. Any of those uses would be off-label, which means a prescriber is using the drug outside what FDA reviewed.
The approval rests on trials in people with HIV. In the first phase 3 trial, 412 adults with HIV and abdominal fat buildup took tesamorelin or placebo for 26 weeks; deep belly fat fell 15.2% on the drug and rose 5.0% on placebo [9]. Theratechnologies sponsored that trial. Whether the drug does anything useful for people without HIV is a separate question, covered in does tesamorelin work.
The label covers belly fat in HIV lipodystrophy, and nothing else
The Egrifta SV label states the indication in one sentence, then lists three limits. They matter, because the limits are where most online marketing goes wrong.
EGRIFTA SV is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Limitations of Use: Long-term cardiovascular safety of EGRIFTA SV has not been established. [...] EGRIFTA SV is not indicated for weight loss management as it has a weight neutral effect. There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA SV.[2]
The Egrifta WR label repeats the same indication and the same limits word for word, with the WR name [3]. It adds one line you should know if you are switching: "EGRIFTA WR and EGRIFTA SV are not substitutable." The two have different recommended dosages, so a prescriber sets which one you use.
Only two of the versions you'll see are approved
Search results mix the brand, a discontinued vial and products with no approval at all. This table sorts them by what FDA's records say.
| Version | FDA-approved? | Who makes it | Route under FDA rules | What it means for you |
|---|---|---|---|---|
| Egrifta SV (2 mg vial) | Yes, for one use | Theratechnologies | Prescription brand, licensed as a biologic | A formulation with its own prescribing instructions |
| Egrifta WR (11.6 mg vial) | Yes, since March 2025 | Theratechnologies | Prescription brand, licensed as a biologic | Different dosing from SV; the label says the two are not substitutable |
| Original Egrifta (1 mg vial) | Approved in 2010 | Theratechnologies | Listed as discontinued in FDA's Purple Book | Ask the dispensing pharmacy about current availability |
| "Compounded tesamorelin" | No | A compounding pharmacy or clinic | No 503A or 503B exemption since March 23, 2020 | Not made under FDA's compounding rules |
| "Research use only" vials | No | Chemical suppliers | Not an FDA-approved human product | A research-use label does not authorize human administration |
Sources: Drugs@FDA application 022505; FDA Purple Book data, September 2026; FDA notice to compounders, March 2020.
Since March 2020, tesamorelin has been regulated as a biologic
A federal law, the Biologics Price Competition and Innovation Act, required FDA to move certain protein drugs approved as ordinary drugs onto biologics licenses. That switch happened on March 23, 2020, and Egrifta was on FDA's list of products that moved [4]. Drugs@FDA now labels the file plainly: "This Former NDA Was Deemed To Be a BLA on March 23, 2020" [1].
The switch changed what pharmacies may do. FDA's notice to compounders, issued ahead of the transition, put it this way [5]:
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 make drugs FDA hasn't approved product by product. A biologic falls outside both. The same notice describes narrow conditions for mixing, diluting or repackaging a licensed biologic, which is handling the finished brand, not making a copy from raw powder.
"Compounded tesamorelin" has no exemption under the compounding rules
Because tesamorelin is a biologic, a pharmacy cannot use the 503A or 503B exemptions to make it. A product sold as "compounded tesamorelin" is therefore not made under FDA's compounding rules, and its quality and safety cannot be inferred from Egrifta's approval. The approved product is Egrifta.
That is different from other peptides on this site. Sermorelin, for example, was once approved and then withdrawn, and its compounding status follows a separate set of FDA lists; see is sermorelin FDA-approved. If you are weighing the two, tesamorelin vs sermorelin lays out the differences side by side.
Each change to the approval has a dated FDA record
| Date | What happened | Source |
|---|---|---|
| November 10, 2010 | FDA approves Egrifta (tesamorelin) for Theratechnologies as a new molecular entity | Drugs@FDA, application 022505 |
| March 23, 2020 | Egrifta's approval is deemed a biologics license | FDA's deemed-BLA list |
| March 23, 2020 | Transitioned biologics lose the 503A and 503B compounding exemptions | FDA notice to compounders |
| January 23, 2024 | FDA sends an action letter on the Egrifta WR application; the company answers in November 2024 | Egrifta WR approval letter |
| February 27, 2024 | FDA approves a labeling supplement; the current Egrifta SV label is dated February 2024 | Drugs@FDA; DailyMed |
| March 25, 2025 | FDA approves Egrifta WR: a new formulation, a multiple-dose vial and a new manufacturing site | Egrifta WR approval letter |
Dates are the dates printed on each FDA document.
The January 2024 letter is the event some news headlines call a rejection. FDA's own record shows the company answered it and the formulation was approved 14 months later [6].
Tesamorelin is a peptide, not a steroid, and not a controlled substance
The label calls Egrifta "a growth hormone-releasing factor (GHRF) analog" [2]. It is a chain of amino acids that prompts the pituitary to release your own growth hormone. Anabolic steroids are a different class of drug.
The current Egrifta SV label lists DEA Schedule: None [2]. It is a prescription drug, not a scheduled one. Sport is a different matter: WADA's Prohibited List names it under S2.2.4, growth hormone releasing factors, as one of the "analogues (e.g. CJC-1293, CJC-1295, sermorelin and tesamorelin)" of GHRH [8].
Any use outside HIV lipodystrophy is off-label
Use outside HIV-associated lipodystrophy is off-label. The label also says Egrifta is not indicated for weight-loss management, because it has a weight-neutral effect [2]. That matters when a clinic pitches it as a fat-loss or anti-aging shot.
Off-label does not change what the product is. A prescription for the brand is still the approved drug; a vial labeled "tesamorelin" cannot be assumed to be the approved brand without confirming its identity and source. The risks the label lists, from blood sugar to fluid retention, are set out in is tesamorelin safe.
What to ask a prescriber before you start
The answers to these questions tell you which row of the status table you are in.
- Is this Egrifta SV, Egrifta WR or something else? Ask for the brand name in writing.
- Which pharmacy dispenses it? A brand biologic comes from a pharmacy that dispenses the manufacturer's product.
- Why this drug for me? If you do not have HIV-associated lipodystrophy, ask what evidence supports the off-label use.
- Which labs will you run? The label says to evaluate glucose before and during treatment and to monitor IGF-1 levels.
- Do I have anything that rules it out? The label lists active cancer, a disrupted pituitary axis, hypersensitivity and pregnancy.
These are the same pharmacy and status questions behind every provider check on this site. How we check providers explains what each one looks for.