Tesamorelin
Also sold as: Tesamorelin acetate, TH9507, EGRIFTA, EGRIFTA SV, EGRIFTA WR, trans-3-hexenoyl-GHRH(1-44) amide
Tesamorelin is an FDA-approved prescription drug — EGRIFTA, application 022505, approved 2010-11-10 — but its approval covers exactly one use: the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. The EGRIFTA SV label's own Limitations of Use state that it 'is not indicated for weight loss management as it has a weight neutral effect', so 'tesamorelin is FDA-approved' is true of the drug and says nothing about the fat-loss and body-recomposition uses it is sold for.
Which molecule this is. A synthetic analog of human growth hormone-releasing factor, GHRH(1-44), stabilised by a trans-3-hexenoyl group on the N-terminus. The label's own term is 'growth hormone-releasing factor (GHRF) analog'. It is a secretagogue: it does not supply growth hormone, it induces release of endogenous GH. That mechanism is why the label's malignancy contraindication and IGF-1 monitoring requirement exist, and it is the same mechanism sold casually as 'GH support'.
FDA status
FDA has approved this as a drug. Approval is always for a specific indication and a specific population — check which one, because it is frequently not the use it is marketed for.
FDA-approved. Approval is always for a specific indication and population — see the approval record below, because it is routinely not the use this is marketed for.
Evidence
Efficacy established by adequate, well-controlled trials in humans.
Administration confirmed, not inferred. The pivotal trial was opened and read: the drug was administered subcutaneously to randomised human subjects against placebo. This is the opposite of the MOTS-c and TB-500 pattern, where every apparent 'human trial' measures the endogenous peptide as a biomarker and none administers anything. The quote above is truncated: the source sentence specifies a complete regimen, and this site publishes no dosing. The truncation removes amount, frequency and duration and keeps the randomisation fact the tier rests on. THE TIER IS SCOPED TO THE APPROVED INDICATION AND NOTHING ELSE. What is proven, per the attached source: in a 2007 multicentre double-blind placebo-controlled phase 3 trial of 412 HIV-infected adults with excess abdominal fat, researchers reported visceral adipose tissue decreased 15.2% versus a 5.0% increase on placebo, and IGF-I rose 81.0% versus a 5.0% decrease on placebo. Limitations. The investigators of the second phase 3 trial (Falutz et al., J Acquir Immune Defic Syndr 2010;53(3):311-22, PMID 20101189, n=404) rerandomised patients from tesamorelin to placebo and reported, in their words, that 'the initial improvements over 6 months in VAT were rapidly lost in those switching from tesamorelin to placebo' — so any benefit those trials measured was contingent on continued use. The label separately states long-term cardiovascular safety has not been established. The studied population is HIV-infected adults on antiretroviral therapy, not healthy adults. In HIV-negative people the evidence is real but far thinner and does NOT reach this tier: a 2012 randomised, double-blind, placebo-controlled trial of 60 abdominally obese adults with reduced GH secretion (Makimura et al., J Clin Endocrinol Metab 2012;97(12):4769-79, PMID 23015655) reported a visceral fat treatment effect over 12 months with no significant effect on subcutaneous adipose tissue. One 60-subject trial in a GH-deficient-selected population is not an approval-grade evidence base for the general body-composition market, and its own finding — visceral fat moved, subcutaneous fat did not — is a poor match for what buyers are told to expect. The two studies named in this note are cited inline with journal, volume, pages and PMID because the schema attaches exactly one source per field and that slot holds the pivotal trial. Each was opened and verified individually on 2026-07-16; neither claim rides on the attached NEJM source. The pooled phase 3 analysis an earlier draft cited (n=806, JCEM 2010) has been dropped rather than left uncited — it was corroborative, not load-bearing.
“We randomly assigned 412 patients with HIV (86% of whom were men) who had an accumulation of abdominal fat to receive … tesamorelin or placebo …”Checked against the source on .
What FDA actually approved
- Application
- BLA022505 — EGRIFTA SV
- Approved indication
- Reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.
The label does not merely fail to support the body-recomposition pitch — it affirmatively contradicts it. Limitations of Use, verbatim: 'EGRIFTA SV is not indicated for weight loss management as it has a weight neutral effect.' The sponsor's own approved labelling says the drug is weight neutral.
“EGRIFTA SV is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.”Checked against the source on .
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
FDA-approved indication, verbatim: 'EGRIFTA SV is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.'
Recorded verbatim because the gap between this sentence and the sales pitch IS the story. The indication is bounded four ways at once — a specific compartment (excess abdominal fat), a specific population (HIV-infected), a specific age group (adult), and a specific condition (lipodystrophy). Every one of those bounds is dropped when the molecule is sold for body recomposition. 'FDA-approved' is true of the drug and says nothing about that use.
EGRIFTA SV (tesamorelin for injection) — Highlights of Prescribing Information — DailyMed (FDA Structured Product Labeling), 23 December 2025“EGRIFTA SV is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.”
Checked against the source on .The label's own Limitations of Use state that EGRIFTA SV is not indicated for weight loss management as it has a weight neutral effect, and that long-term cardiovascular safety has not been established.
This is the most load-bearing sentence on the page and it is printed in section 1 of the sponsor's own label. The fat-loss market's central claim about tesamorelin is contradicted by the labeling of the product that makes the claim possible. 'Weight neutral' is not editorial hedging — it is the approved finding. The trials reported a reduction in visceral adipose tissue in a diseased population; the label states the drug is not indicated for weight loss management, and the sponsor is not permitted to say otherwise.
EGRIFTA SV (tesamorelin for injection) — Highlights of Prescribing Information — DailyMed (FDA Structured Product Labeling), 23 December 2025“EGRIFTA SV is not indicated for weight loss management as it has a weight neutral effect.”
Checked against the source on .EGRIFTA SV is contraindicated in patients with active malignancy, in patients with disruption of the hypothalamic-pituitary axis, in known hypersensitivity to tesamorelin or excipients, and in pregnancy.
Four absolute contraindications on an approved product. The malignancy contraindication is mechanistic, not incidental: the label's stated reason is that the drug induces release of endogenous GH, a known growth factor. Section 5.1 additionally directs prescribers to weigh the increased background risk of malignancies in HIV-positive patients before starting. None of this survives a purchase that involves no prescriber and no screening.
EGRIFTA SV (tesamorelin for injection) — Highlights of Prescribing Information — DailyMed (FDA Structured Product Labeling), 23 December 2025“EGRIFTA SV induces the release of endogenous growth hormone (GH), a known growth factor. Do not treat patients with active malignancy with EGRIFTA SV”
Checked against the source on .Life-time carcinogenicity studies in rodents have not been conducted with tesamorelin acetate, per section 13.1 of the EGRIFTA SV label.
Read this next to the malignancy contraindication above, because the two are the same fact seen from both ends. FDA contraindicates the drug in active malignancy on the stated mechanistic ground that it induces release of endogenous GH, a known growth factor — and the standard nonclinical study that would characterise lifetime tumour risk was never run. The label does report that a battery of mutagenicity tests, including the Ames test, revealed no potential mutagenicity; mutagenicity and carcinogenicity are not the same endpoint and the label does not offer the former as an answer to the latter. This is an approved drug — the most-studied molecule in this library — and its lifetime cancer risk is an open question on its own label. Nothing about an unapproved vial of the same molecule closes that question; it only removes the prescriber who would weigh it.
EGRIFTA SV (tesamorelin for injection) — Highlights of Prescribing Information — DailyMed (FDA Structured Product Labeling), 23 December 2025“Life-time carcinogenicity studies in rodents have not been conducted with tesamorelin acetate.”
Checked against the source on .EGRIFTA SV is not indicated for use in pediatric patients with open or closed epiphyses, and the label states that in pediatric patients with open epiphyses treatment may result in linear growth acceleration and excessive growth.
Recorded because the approved indication is bounded to ADULTS and this is the label saying why, rather than us inferring it. Section 8.4 also states plainly that safety and effectiveness in pediatric patients have not been established. Note the exclusion covers closed epiphyses too — it is not merely a growth-plate caveat that expires at skeletal maturity. The under-25 market for GH secretagogues is real, and this is the sponsor's own approved labelling refusing that population in both directions.
EGRIFTA SV (tesamorelin for injection) — Highlights of Prescribing Information — DailyMed (FDA Structured Product Labeling), 23 December 2025“In pediatric patients with open epiphyses, treatment with EGRIFTA SV may result in linear growth acceleration and excessive growth. EGRIFTA SV is not indicated for use in pediatric patients with open or closed epiphyses.”
Checked against the source on .The label's Limitations of Use state there are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA SV.
A small sentence that does disproportionate work, and the reason it is here is scope. This is FDA declining to let the sponsor claim a downstream benefit even INSIDE the approved population, for the approved use, on the approved label. The approval buys the sponsor one claim — visceral fat reduction in HIV-infected adults with lipodystrophy — and an explicit 'no data' on the adjacent claim a reasonable person would assume followed from it. Measure the distance between that and what is claimed for an unapproved vial.
EGRIFTA SV (tesamorelin for injection) — Highlights of Prescribing Information — DailyMed (FDA Structured Product Labeling), 23 December 2025“There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA SV.”
Checked against the source on .
Documented safety signals
Elevated IGF-1: the label requires monitoring IGF-1 during therapy and states that the effects of prolonged elevations in IGF-1 levels are unknown.
Elevated IGF-1 is the intended pharmacology — a GHRH analog works by inducing endogenous GH release, and IGF-1 rises downstream. The pivotal trial's own IGF-I figures are recorded under evidence above, where the trial is the attached source; they are not repeated here, because this label does not state them. It is also the reason for a labeled monitoring requirement with a discontinuation trigger. A monitoring requirement is a safety control that only exists inside a prescribing relationship; it does not travel with the molecule.
EGRIFTA SV (tesamorelin for injection) — Highlights of Prescribing Information — DailyMed (FDA Structured Product Labeling), 23 December 2025“The effects of prolonged elevations in IGF-1 levels are unknown. Monitor IGF-1 levels during EGRIFTA SV therapy. Consider discontinuing in patients with persistent elevations.”
Checked against the source on .Glucose intolerance or diabetes mellitus may develop with use; the label directs evaluating glucose prior to and during therapy.
Worth stating precisely in both directions, because the trials cut against the intuition here. The 2012 HIV-negative trial cited under evidence above (Makimura et al., J Clin Endocrinol Metab 2012;97(12):4769-79, PMID 23015655) reported 'no changes in fasting, 2-h glucose, or glycated hemoglobin' — that finding is the trial's, not this label's. FDA nonetheless carries this as a labeled warning with a monitoring instruction. Trial-level reassurance over 26 to 52 weeks in selected populations is not the same as an absence of risk, which is precisely why the warning survived approval.
EGRIFTA SV (tesamorelin for injection) — Highlights of Prescribing Information — DailyMed (FDA Structured Product Labeling), 23 December 2025Checked against the source on .Increased risk of neoplasms; fluid retention including edema, arthralgia and carpal tunnel syndrome; hypersensitivity reactions; injection site reactions; and increased mortality in patients with acute critical illness.
The label's Warnings and Precautions in full. Most commonly reported adverse reactions (>5%): arthralgia, injection site erythema, injection site pruritus, pain in extremity, peripheral edema, and myalgia. Safety was characterised in 740 HIV-infected patients with lipodystrophy, 543 of whom received drug during the 26-week placebo-controlled phase. Note the scope: this safety database is HIV-infected adults with lipodystrophy under trial monitoring. It is the best-characterised safety profile of any compound in this library and it still does not describe healthy adults using the drug for body composition, because nobody has studied that.
EGRIFTA SV (tesamorelin for injection) — Highlights of Prescribing Information — DailyMed (FDA Structured Product Labeling), 23 December 2025Checked against the source on .The 2 mg/vial EGRIFTA SV formulation was not itself tested for safety; its safety is bridged from clinical trials conducted with the original 1 mg/vial EGRIFTA formulation.
A precision point that cuts against over-reading the approval, and it comes from the label rather than from us. The currently marketed product's safety is inferred from the original formulation via bridging, not established de novo. If the marketed product's own safety is a bridge from a different formulation of the same approved drug, the inferential distance from that trial evidence to an unapproved research-chemical vial of 'tesamorelin' is not a bridge at all.
EGRIFTA SV (tesamorelin for injection) — Highlights of Prescribing Information — DailyMed (FDA Structured Product Labeling), 23 December 2025“The safety of EGRIFTA SV (2 mg/vial formulation) has been established based on clinical trials conducted with EGRIFTA (1 mg/vial formulation).”
Checked against the source on .The 11.6 mg/vial EGRIFTA WR formulation was likewise not itself tested for safety; its safety is bridged from clinical trials conducted with the original 1 mg/vial EGRIFTA formulation.
Recorded as a separate entry with its own source because this sentence lives in the EGRIFTA WR label, not the SV one — the SV SPL contains no occurrence of 'EGRIFTA WR' or '11.6 mg'. Both SPLs carry id extension 'BLA022505', so all three formulations do sit under the same application; that is the claim the two labels jointly support. Every currently marketed strength of this drug therefore rests on trials of a formulation none of them is.
EGRIFTA WR (tesamorelin for injection) — Highlights of Prescribing Information — DailyMed (FDA Structured Product Labeling), 31 March 2025“The safety of EGRIFTA WR (11.6 mg/vial formulation) has been established based on clinical trials conducted with EGRIFTA (1 mg/vial formulation).”
Checked against the source on .Anti-tesamorelin IgG antibodies were detected in 50% of patients who received EGRIFTA for 26 weeks and 47% at 52 weeks; cross-reactivity to endogenous growth hormone-releasing hormone was observed in approximately 60% of patients who developed those antibodies.
The most under-reported fact about this molecule, and it is on the label. Roughly half of treated patients raised antibodies to the drug, and in about 60% of those the antibodies also recognised the patient's OWN GHRH. Section 12.6 further reports that neutralizing antibodies to tesamorelin and to human GHRH were detected in vitro at Week 52 in 10% and 5% of EGRIFTA-treated patients respectively, and that among a group antibody-positive at 26 weeks who were reassessed six months after stopping, 18% remained antibody positive. State the limits honestly in both directions, because the label does: patients with and without antibodies had similar mean reductions in visceral adipose tissue and similar IGF-1 response, so no loss of the measured effect was demonstrated, and the label's own preamble warns that anti-drug antibody incidence is assay-dependent and not comparable across studies. What is recorded here is exposure, not proven harm. It is recorded because an immune response against an endogenous hypothalamic hormone is the kind of thing a buyer of a 'GH support' vial has never been told is on the table.
EGRIFTA SV (tesamorelin for injection) — Highlights of Prescribing Information — DailyMed (FDA Structured Product Labeling), 23 December 2025“Cross-reactivity to endogenous growth hormone-releasing hormone (GHRH) was observed in approximately 60% of patients who developed anti-tesamorelin antibodies.”
Checked against the source on .Tesamorelin appears in none of the three 503A categories in the FDA bulks list updated 2026-05-14.
Verified by fetching and text-extracting the document directly: zero hits. Recorded here as an anti-signal, because for this compound absence from the list means the reverse of what it means for BPC-157 or TB-500. Those are absent because their nominations were withdrawn and they remain non-compoundable. Tesamorelin is absent because an approved drug's component never enters that pathway. Do not read either absence as legality, and do not read this one as evidence that FDA reviewed and cleared tesamorelin for compounding — FDA never took up that question, because 503A never posed it.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .
Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Is tesamorelin FDA-approved?
Yes, but for one indication only. FDA approved tesamorelin on 2010-11-10 under application 022505 (sponsor Theratechnologies, brand name EGRIFTA), and the approved indication is the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. That is the whole of the approval: it does not cover weight loss, body composition, anti-aging, athletic performance, or use in people without HIV-associated lipodystrophy, and it does not cover pediatric patients.
EGRIFTA SV (tesamorelin for injection) — Highlights of Prescribing Information — DailyMed (FDA Structured Product Labeling), 23 December 2025“EGRIFTA SV is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.”
Checked against the source on .- Does tesamorelin cause weight loss?
No — the FDA-approved labeling for tesamorelin says the opposite. The EGRIFTA SV label's Limitations of Use state verbatim: 'EGRIFTA SV is not indicated for weight loss management as it has a weight neutral effect.' What the pivotal trials measured was a reduction in visceral adipose tissue in HIV-infected adults with lipodystrophy, which is not the same endpoint as body weight; the label states the drug is weight neutral. The sponsor is not permitted to market tesamorelin for weight loss, and the reason is printed in section 1 of its own label.
EGRIFTA SV (tesamorelin for injection) — Highlights of Prescribing Information — DailyMed (FDA Structured Product Labeling), 23 December 2025“EGRIFTA SV is not indicated for weight loss management as it has a weight neutral effect.”
Checked against the source on .- Is there any human evidence that tesamorelin works?
Yes — tesamorelin has more human evidence behind it than any other compound in this library, and that evidence is scoped to HIV-associated lipodystrophy. In a 2007 multicentre double-blind placebo-controlled phase 3 trial of 412 HIV-infected adults with excess abdominal fat (Falutz et al., N Engl J Med 2007;357:2359-2370), researchers reported visceral adipose tissue decreased 15.2% on tesamorelin versus a 5.0% increase on placebo. Two limits matter. The investigators of the second phase 3 trial (J Acquir Immune Defic Syndr 2010;53(3):311-22, n=404) rerandomised patients from tesamorelin to placebo and reported the initial improvements in visceral fat were rapidly lost, so the benefit was contingent on continued use. And in HIV-negative people the evidence is far thinner: the largest such trial (Makimura et al., J Clin Endocrinol Metab 2012;97(12):4769-79) randomised 60 abdominally obese adults with reduced growth hormone secretion and reported a visceral fat effect with no significant effect on subcutaneous fat.
Metabolic effects of a growth hormone-releasing factor in patients with HIV — PubMed (N Engl J Med 2007;357:2359-2370), 6 December 2007“We randomly assigned 412 patients with HIV (86% of whom were men) who had an accumulation of abdominal fat to receive … tesamorelin or placebo …”
Checked against the source on .- Can I get tesamorelin from a compounding pharmacy?
Tesamorelin is not blocked by FDA's 503A bulks list — but that is not the permission it is often taken for, and a different provision of the same statute is the one that bites. Under 21 U.S.C. 353a(b)(1)(A)(i), the bulks list is only reached for a substance that has no USP/NF monograph AND is not a component of an FDA-approved drug; tesamorelin is a component of an approved drug (EGRIFTA), so it never enters that pathway and its absence from the list reflects nothing FDA decided about it. Separately, 353a(b)(1)(D) bars compounding, regularly or in inordinate amounts, any drug product that is essentially a copy of a commercially available drug product — and both EGRIFTA products are listed in Drugs@FDA with marketing status 'Prescription' as of 2026-07-16. That bar has a statutory exception, and any honest answer has to state it: 353a(b)(2) provides that 'essentially a copy of a commercially available drug product' does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner. That is the provision compounded versions of approved drugs run through, and whether any given preparation qualifies is a determination for the prescriber, not something this page can answer. What does not turn on it: section 353a(a) conditions the entire exemption on a drug compounded for an identified individual patient based on a valid prescription order, so nothing in 503A reaches a vial bought online without one.
21 U.S.C. 353a — Pharmacy compounding (FD&C Act section 503A) — Office of the Law Revision Counsel, U.S. House of Representatives, 6 January 2025“does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product. … For purposes of paragraph (1)(D), the term "essentially a copy of a commercially available drug product" does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product.”
Checked against the source on .- Is tesamorelin safe?
Tesamorelin has the best-characterised safety profile of any compound in this library, and that profile is not a clean bill of health. Its FDA-approved labeling carries four absolute contraindications — active malignancy, disruption of the hypothalamic-pituitary axis, known hypersensitivity, and pregnancy — with the malignancy contraindication resting on the label's stated ground that the drug induces release of endogenous growth hormone, a known growth factor. The label additionally states that life-time carcinogenicity studies in rodents have not been conducted with tesamorelin acetate, that the effects of prolonged elevations in IGF-1 are unknown and IGF-1 must be monitored during therapy, and that long-term cardiovascular safety has not been established. Every one of those is a control that exists inside a prescribing relationship; none of them travels with the molecule. The safety database is also scoped to 740 HIV-infected adults with lipodystrophy under trial monitoring — nobody has studied healthy adults using tesamorelin for body composition.
EGRIFTA SV (tesamorelin for injection) — Highlights of Prescribing Information — DailyMed (FDA Structured Product Labeling), 23 December 2025“Life-time carcinogenicity studies in rodents have not been conducted with tesamorelin acetate.”
Checked against the source on .