Yes. Tesamorelin is the active ingredient of Egrifta, which FDA approved on November 10, 2010 to reduce excess abdominal fat in HIV-infected patients with lipodystrophy[1]. That remains its only approved use[2].
What FDA approval does not cover is just as important for a buyer. It does not cover weight loss, and it does not cover a compounded version. This site lists no compounded seller or price for tesamorelin for that reason, and the brand has no published list price. What the brand costs, and who pays, is in the tesamorelin cost guide.
Egrifta, Egrifta SV and Egrifta WR
Nov 2010
Egrifta approved
NDA 022505, a 1 mg vial, for excess abdominal fat in HIV-infected patients with lipodystrophy.
Mar 2020
Deemed a biologics license
The approval transitioned from a drug application to a biologics license under the Public Health Service Act.
Mar 2025
Egrifta WR approved
A new 11.6 mg multiple-dose formulation, approved as a supplement to the same license.
The 2025 supplement approved a new formulation, a new multiple-dose presentation and a new manufacturing site[3]. The WR label notes a second formulation, Egrifta SV, a 2 mg vial[2].
The two differ in dose, vials per dose, mixing and storage, and the label says they are not substitutable[2]. A prescription names one or the other. The WR label’s dose is 1.28 mg injected under the skin once daily[2].
Who the label covers
Egrifta WR is indicated for the reduction of excess abdominal fat in HIV-infected adults with lipodystrophy[2]. The label adds three limits: long-term cardiovascular safety is not established, it is not indicated for weight loss management, and there are no data that it improves adherence to antiretroviral therapy[2].
The label calls tesamorelin a growth hormone-releasing factor analog. Unlike sermorelin, it has no compounded price on this site's boards. The label warns that it raises IGF-1 and says to monitor IGF-1 during therapy[2]. What that blood test costs, and who pays for it, is in the IGF-1 blood test guide.
Why it is not a compounding candidate
On March 23, 2020, approved applications for biological products were deemed to be biologics licenses[4]. FDA’s transition list names tesamorelin acetate, Egrifta and Egrifta SV, under NDA 022505[4]. The 2025 approval letter accordingly refers to it as BLA 022505[3].
FDA told compounders that, from that date, transitioning biological products are not eligible for the compounding exemptions in sections 503A and 503B[5]. FDA’s guidance on biologics states that the FD&C Act provides no legal pathway for marketing a biological product prepared outside an approved license[6].
How the two compounding tiers work for drugs that do qualify is in 503A vs 503B. Products sold as “research use only” are a different category again, covered in what RUO peptides are.
How to get the approved product
The maker’s THERA patient support program checks insurance, finds a specialty pharmacy in your network, and trains patients to prepare and inject the drug[7]. It offers co-pay assistance to eligible commercially insured patients[7].
It also offers qualifying patients the medication at no cost[7]. The program’s own page describes the drug for one group only: adults with HIV and lipodystrophy[7].
The broader legal picture for peptides is in are peptides legal, and the compounding rules for eligible ones are in the guide to compounded peptides.