Tesamorelin: where it stands with the FDA, and what it costs
Sold as an FDA-approved brand (Egrifta) for a narrow use; clinics also prescribe compounded tesamorelin.
Go to clinicLowest per monthTesamorelin injection (15mg)
Balanced Hormone Health · ≈ $123/mo ($230 for 56 days)
Go to clinicLowest at a clinic we link toTesamorelin injection
Live Vital · from $150/mo (supply not stated, counted as 4 weeks: ≈ $161 per 30 days)
Where Tesamorelin stands today
Tesamorelin is FDA-approved as EGRIFTA (Theratechnologies; EGRIFTA SV and EGRIFTA WR), for reducing excess abdominal fat in HIV-infected adults with lipodystrophy. The product was deemed a biologics license (BLA) on March 23, 2020. FDA states that biological products subject to a BLA are not eligible for the 503A or 503B compounding exemptions. Tesamorelin is in no 503A or 503B category.
FDA-approved products
EGRIFTA (tesamorelin) for injection (current presentations EGRIFTA SV 2 mg/vial and EGRIFTA WR 11.6 mg/vial), Theratechnologies, approved 2010-11-10 (originally NDA 022505). Prescription (marketed). Deemed a biologics license application (BLA 022505) on March 23, 2020.
“This Former NDA Was Deemed To Be a BLA on March 23, 2020. ... EGRIFTA TESAMORELIN ACETATE EQ 2MG BASE/VIAL POWDER;SUBCUTANEOUS Prescription”
EGRIFTA WR label (March 2025), Theratechnologies, approved 2025-03-25 (supplement 20). Prescription.
“It is comprised of the 44 amino acid sequence of human GRF and a hexenoyl moiety”
For pharmacies compounding one patient's prescription (section 503A)
Not eligible for 503A compounding: tesamorelin (44 amino acids, a 'protein' under FDA's rule) is a licensed biological product, and FDA says biological products subject to a BLA are not eligible for the 503A exemptions. Not in any 503A category.
“Biological products subject to approval in a biologics license application (BLA) under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262) are not eligible for the exemptions in section 503A of the FD&C Act (21 U.S.C. 353a).”
21 CFR 600.3(h)(6)
“A protein is any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size.”
For outsourcing facilities (section 503B)
Not eligible for 503B compounding (biological product); not on the 503B bulks list or in any 503B category.
“Accordingly, such biological products are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act.”
FDA warnings, recalls and letters
21 October 2025: Recall of compounded tesamorelin injection. Class II; recall initiated 2025-07-30, classified 2025-10-21, distributed nationwide. (GenoGenix LLC, Boca Raton, FL (registered 503B outsourcing facility)).
“Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial ... Lack of Assurance of Sterility”
24 August 2026: Five warning letters dated 24 Aug 2026 to research-peptide sellers; each names PT-141 (bremelanotide) and tesamorelin as unapproved new drugs (the sellers' products have no approved application); NuScience also sold a tesamorelin/ipamorelin blend. (NuScience Peptides LLC (online 'research peptide' seller); same-day letters to Royal Peptides, Peak Performance Peptides, Peptide Partners and TXP Innovations dba Tex Peptides name PT-141 and tesamorelin too).
“Based on our review, “GLP-2 Tirz Peptide,” “GLP-1 Sema Research Peptide,” “GLP-3 RT (Retatrutide) Research Peptide,” “Survodutide,” “Mazdutide,” “PT-141 Peptide (Bremelanotide),” “Tesamorelin Research Peptide,” “Tesamorelin Ipamorelin Blend,” and “Bacteriostatic water for Peptides (BAC Water)” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).”
For athletes who are tested
Prohibited at all times (in and out of competition) (World Anti-Doping Agency, 2026 Prohibited List (in force 1 Jan 2026; WADA approved a 2027 list in Sept 2026, effective 1 Jan 2027, not read here)).
“growth hormone-releasing hormone (GHRH) and its analogues (e.g. CJC-1293, CJC-1295, sermorelin and tesamorelin)”
Our reading
On FDA's stated reading, compounding tesamorelin from bulk is outside both 503A and 503B, so the lawful way to get it is the approved, brand EGRIFTA product prescribed by a clinician (off-label use is a prescriber decision). A clinic selling 'compounded tesamorelin' is relying on something FDA's guidance does not recognise.
Every source above was checked again on 14 November 2026.
What 42 clinics charge
- Balanced Hormone HealthTesamorelin injection (15mg)≈ $123/mo$230 for 56 days
- Try NovaTesamorelin injection (3mg/ml)$133/mo
- Live VitalTesamorelin injectionfrom $150/mosupply not stated, counted as 4 weeks: ≈ $161 per 30 days
- Try NovaTesamorelin injection$164/mo
- NuBloomTesamorelin injection (3mg)≈ $169/mo$472.99 for 84 days
What Tesamorelin is
- What it is
- Growth hormone-releasing hormone (GHRH) analog
- How it works
- A stabilized analog of growth hormone-releasing hormone that prompts the pituitary to release growth hormone.
- How it is given
- Subcutaneous injection
- Also called
- tesamorelin acetate, Egrifta
Tesamorelin side by side
About Tesamorelin
Is Tesamorelin FDA-approved?
Only as Egrifta, for excess abdominal fat in adults with HIV-associated lipodystrophy. What online clinics usually sell is compounded Tesamorelin, which the FDA has not approved.
Is Tesamorelin legal in the US?
Whether a pharmacy may compound it for your prescription is what decides it. Tesamorelin is FDA-approved as EGRIFTA (Theratechnologies; EGRIFTA SV and EGRIFTA WR), for reducing excess abdominal fat in HIV-infected adults with lipodystrophy. The product was deemed a biologics license (BLA) on March 23, 2020. FDA states that biological products subject to a BLA are not eligible for the 503A or 503B compounding exemptions. Tesamorelin is in no 503A or 503B category.
How much does Tesamorelin cost?
42 clinics publish a price. The lowest that compares per month is about $123 a month ($230 for 56 days) at Balanced Hormone Health, and the middle of 29 clinics' lowest monthly prices is about $229. What a month buys differs by clinic, so each price lists what it includes. every Tesamorelin price
What forms does Tesamorelin come in?
Clinics sell it as injection (49 prices), other (3 prices).