Tesamorelin

• Published findings, not claims for this RUO material: a pooled analysis of two Phase 3 studies in 806 antiretroviral-treated adults with HIV and excess abdominal fat reported a week-26 visceral-adipose-tissue treatment effect of -15.4% versus placebo
• A 12-month extension found an approximately 18% reduction among participants continuing treatment, while earlier improvements were rapidly lost after switching to placebo
• The FDA indication is limited to reducing excess abdominal fat in adults with HIV and lipodystrophy; the label describes the product as weight-neutral and not indicated for weight-loss management
• In a separate 12-month randomized study of 61 people with HIV and NAFLD, the estimated relative liver-fat reduction was 37%, but the authors called for further study and this is not an approved indication
• Exploratory cognition and muscle-composition analyses do not establish approved benefits.

CAS

218949-48-5

Formula

C₂₂₁H₃₆₆N₇₂O₆₇S

Molecular weight

5,135.9 Da

Appearance

White lyophilized powder

Purity

≥ 99.0% · target, verify batch COA

Storage

Follow the released-lot COA and supplier instructions. Unless batch documentation specifies otherwise, keep sealed lyophilized RUO tesamorelin desiccated, protected from light, and at or below -20°C; avoid repeated freeze-thaw cycles after reconstitution and establish solution stability in the receiving laboratory's validated protocol. The FDA-labelled EGRIFTA SV and WR products are distinct sterile formulations with product-specific room-temperature handling; those conditions must not be transferred to bulk RUO material.

MOQ

On request

Lead time

10–18 days

Tesamorelin is a 44-residue synthetic analog of human growth hormone-releasing hormone (GHRH 1-44) in which the N-terminal Tyr1 is acylated with trans-3-hexenoic acid. PubChem records the free peptide as CID 16137828, CAS 218949-48-5, formula C₂₂₁H₃₆₆N₇₂O₆₇S, and molecular weight 5,135.9 Da. FDA-approved EGRIFTA SV and EGRIFTA WR contain tesamorelin as an acetate salt and are indicated specifically to reduce excess abdominal fat in adults with HIV and lipodystrophy. Their labels state that they are not indicated for weight-loss management, that long-term cardiovascular safety has not been established, and that SV and WR are not substitutable. LyoPep's catalog material is a bulk Research Use Only reference and is not the approved finished drug.

• Evidence is strongest for the FDA-approved finished-product indication: reduction of excess abdominal fat in adults with HIV and lipodystrophy
• Other published research includes visceral- and liver-fat imaging in people with HIV, a 12-month randomized NAFLD study in people with HIV, biomarker analyses, exploratory muscle-composition analyses, and a 20-week cognition study in 152 older adults with or without mild cognitive impairment
• These research contexts differ in population, formulation, regimen, and outcome, and none expands the FDA indication
• Tesamorelin is not labelled for general weight loss, anti-aging, bodybuilding, or routine treatment of NAFLD or cognitive impairment.

Tesamorelin binds and stimulates pituitary growth hormone-releasing factor receptors, promoting synthesis and pulsatile release of endogenous growth hormone (GH). GH acts through multiple tissues, with some effects mediated by insulin-like growth factor 1 (IGF-1), and can influence lipolysis and visceral adipose tissue. The N-terminal trans-3-hexenoyl group increases resistance to enzymatic degradation relative to unmodified GHRH. A short plasma half-life is compatible with a transient receptor stimulus but does not by itself establish efficacy, dose, frequency, or safety for an RUO lot.

• FDA-labelled contraindications include disruption of the hypothalamic-pituitary axis, active malignancy, hypersensitivity to tesamorelin or excipients, and pregnancy
• Warnings address neoplasms, elevated IGF-1, fluid retention, glucose intolerance or diabetes, hypersensitivity, injection-site reactions, and increased mortality with pharmacologic GH exposure in acute critical illness
• In combined 26-week studies, injection-site reactions occurred in 17% versus 6% with placebo, arthralgia in 13% versus 11%, pain in extremity in 6% versus 5%, myalgia in 6% versus 2%, and peripheral edema in 6% versus 2%
• The label reports a hazard ratio of 3.3 (95% CI 1.4-9.6) for HbA1c reaching at least 6.5% and documents frequent IGF-1 elevations
• Long-term cardiovascular safety has not been established
• These prescription-label findings do not qualify a bulk RUO lot for human use.

Interactions reported in the literature

• The FDA label states that GH may alter clearance of compounds metabolized by CYP450 enzymes and identifies glucocorticoid replacement therapy as a specific consideration; it also reports dedicated studies with simvastatin and ritonavir
• These label observations concern the approved prescription products and require qualified clinical oversight
• No authoritative evidence identified for this review establishes the safety or effectiveness of combining tesamorelin with ipamorelin, CJC-1295, sermorelin, exogenous GH, octreotide, or other research peptides
• This catalog does not recommend combinations or provide medication-management advice.

Tesamorelin2 mg · WHJLP-TSM2-260401-A

Tesamorelin5 mg · WHJLP-TSM5-260401-A

Tesamorelin10 mg · WHJLP-TSM10-260401-A

Tesamorelin20 mg · WHJLP-TSM20-260331-E

Representative records, refreshed periodically

Published COAs show representative factory batches and may not be the latest available. For a current quote or shipment, our sales team can confirm the applicable lot and provide its COA.

Independent testing, arranged on request

Third-party reports are not routinely published. If independent verification is required, we can agree the laboratory, method, acceptance criteria and remedy before testing. If the agreed specification is not met, an appropriate resolution—including a refund where applicable—can be discussed under the agreed terms. Unless otherwise agreed in writing, the buyer pays the cost of this optional testing.

Help reviewing your COA

Need help reading a factory COA or third-party report? Our sales team can clarify test items, specifications and how the results relate to the lot under discussion.

Ask for the current packet, not a generic certificate

• Require a released-lot COA specifying free peptide versus acetate salt, acetate or other counterion content, exact N-terminal trans-3-hexenoyl modification, full 44-residue sequence, theoretical and measured intact mass, identity method, chromatographic purity and impurity profile, water content, residual solvents, and net peptide assay
• For cell or animal research, define endotoxin and bioburden acceptance criteria in the receiving laboratory's protocol
• Analytical purity alone does not establish correct acylation, salt stoichiometry, sterility, clinical grade, or equivalence to EGRIFTA SV/WR.

Follow the released-lot COA and supplier instructions. Unless batch documentation specifies otherwise, keep sealed lyophilized RUO tesamorelin desiccated, protected from light, and at or below -20°C; avoid repeated freeze-thaw cycles after reconstitution and establish solution stability in the receiving laboratory's validated protocol. The FDA-labelled EGRIFTA SV and WR products are distinct sterile formulations with product-specific room-temperature handling; those conditions must not be transferred to bulk RUO material.

State destination, season, acceptable transit exposure and whether your protocol requires insulated or cold-chain service. Additional temperature-control cost is quoted explicitly.

• 1) FDA and DailyMed. EGRIFTA WR prescribing information, revised March 2025, set ID 839334d3-8c1d-4c26-9036-2ab524a6ea75; NDA 022505/S-020. 2) FDA and DailyMed. EGRIFTA SV prescribing information, revised March 2024, set ID 3d783378-b02d-4f19-99dd-0fc91a042224. 3) PubChem. Tesamorelin, CID 16137828; CAS 218949-48-5; formula C₂₂₁H₃₆₆N₇₂O₆₇S. 4) Falutz J, et al. Effects of tesamorelin in HIV-infected patients with excess abdominal fat: pooled analysis of two Phase 3 trials. J Clin Endocrinol Metab. 2010. PMID 20554713. 5) Falutz J, et al. Long-term safety and effects of tesamorelin in HIV patients with abdominal fat accumulation. AIDS. 2008. PMID 18690162; doi:10.1097/QAD.0b013e32830a5058. 6) Stanley TL, et al. Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients. JAMA. 2014. PMID 25038357. 7) Stanley TL, et al. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV. Lancet HIV. 2019. PMID 31611038; PMCID PMC6981288; doi:10.1016/S2352-3018(19)30338-8. 8) Baker LD, et al. Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults. Arch Neurol. 2012. PMID 22869065.

1. 01

   Metabolic effects of a growth hormone-releasing factor in patients with HIV

   New England Journal of Medicine · 2007 · peer-reviewed original research (pivotal Phase 3 randomized controlled trial)

   Open source
2. 02

   Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension

   Journal of Acquired Immune Deficiency Syndromes (JAIDS) · 2010 · peer-reviewed original research (Phase 3 RCT with 12-month safety extension)

   Open source
3. 03

   Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial

   JAMA · 2014 · peer-reviewed original research (randomized, double-blind, placebo-controlled trial)

   Open source
4. 04

   Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial

   The Lancet HIV · 2019 · peer-reviewed original research (randomized, double-blind, multicenter trial)

   Open source
5. 05

   Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial

   Archives of Neurology (now JAMA Neurology) · 2012 · peer-reviewed original research (randomized, double-blind, placebo-controlled trial)

   Open source
6. 06

   Body composition, hepatic fat, metabolic, and safety outcomes of Tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: a meta-analysis of randomized controlled trials

   Obesity Research & Clinical Practice · 2026 · systematic review and meta-analysis of randomized controlled trials

   Open source
7. 07

   Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data

   The Journal of Clinical Endocrinology & Metabolism · 2010 · peer-reviewed original research (pooled analysis of two Phase 3 RCTs)

   Open source
8. 08

   Full Prescribing Information — EGRIFTA WR (tesamorelin for injection), for subcutaneous use

   FDA.gov (accessdata.fda.gov, NDA 022505) · 2025 · regulatory document (FDA-approved prescribing information/label)

   Open source