Growth-hormone axis research

Popular product

Tesamorelin

N-terminally acylated GHRH analog · active ingredient in approved HIV-lipodystrophy products

≥ 99.0% · target, verify batch COACAS 218949-48-5RUO
Batch COA
MOQ1 kit (10 vials) per SKU
Supplied form44-residue peptide (GHRH analog, N-terminally acylated with trans-3-hexenoic acid)
Lead time10–18 days
Tesamorelin — White lyophilized powder
Tesamorelin — White lyophilized powder · Representative packaging image · verify the ordered lot
Representative packaging image · verify the ordered lot

Decision summary

Key benefits

  • 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.
Published research context is presented for literature orientation only. It is not a dosing, treatment or human-use instruction.

Qualification data

Specifications to confirm against the released lot

CAS
218949-48-5
Formula
C221H366N72O67S
Molecular weight
5135.9 g/mol
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
1 kit (10 vials) per SKU
Lead time
10–18 days
PubChem CID 16137828

Qualification matrix

Identity, purity and content are separate release questions.

Identity

Confirm the stated molecule and supplied form. Start with the matching batch COA; request sequence-level evidence only when the buyer's written procedure requires it and availability or a separate scope has been agreed.

Purity

Review RP-HPLC method conditions, wavelength, integration and related-peak handling. A percentage without the method is not enough.

Content

Net peptide content is not the same as gross lyophilized powder weight. Ask which assay supports the stated amount and whether water/counter-ion is addressed.

Stability

Follow the storage condition stated on the batch COA or label from receipt onward.

Research context

What researchers study about Tesamorelin

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.

Mechanism context

The question the literature is testing

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.

Evidence map

Research routes and exposure context

Evidence tierApproved finished-product context
Routes reported in sources
Subcutaneous
Dose / exposure contextProtocol-specific; verify the cited primary source
Routes and exposure contexts summarize cited studies or approved finished-product labels. They are not instructions for administering this RUO material; no customer dose is provided.

Evidence boundaries

Compatibility, limitations and decision context

  • 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.
Literature context is not a supplier release result or human-use instruction. Follow your institution's approved laboratory risk assessment.

Batch documentation

Tesamorelin batch COAs

Laboratory: Manufacturer's QC laboratoryTests: HPLC purity · MS identity · endotoxin · fill amount

  • Blurred preview of a Tesamorelin 2 mg batch COA2 mg
  • Blurred preview of a Tesamorelin 5 mg batch COA5 mg
  • Blurred preview of a Tesamorelin 10 mg batch COA10 mg
  • Blurred preview of a Tesamorelin 20 mg batch COA20 mg

Previews are blurred on purpose so the documents cannot be reused; third-party reports show their first page only. Sales sends the clear full version for the product and strength you ask about.

Independent test fails? Full refund.

Representative records, refreshed periodically

Published COAs show recent representative batches and may not be the newest. For a quote or shipment, sales confirms the lot and sends its COA.

Third-party reports, added progressively

Previews of the first page of third-party reports are on our Quality page and on the matching product pages; sales sends the full report on request. You can also send any vial from your order to an independent laboratory of your choice. Unless agreed otherwise in writing, the buyer pays for optional testing.

Help reviewing your COA

Need help reading a batch COA or third-party report? Sales can explain the test items, specifications and how the results relate to the lot under discussion.

On every batch COA: HPLC purity · MS identity · endotoxin · fill amount · Verify LyoPep

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.
Batch COA for the released lotHPLC purity with method contextMS identity resultEndotoxin resultFill amount (measured content per vial)SDS and handling statement

Available fills

Quote the fill and pack configuration you need

Reference SKUFillBase pack
TSM22 mg10 vials
TSM55 mg10 vials
TSM1010 mg10 vials
TSM2020 mg10 vials

Other format

Also available as a nasal spray (US stock)

Black 10 mL nasal spray bottle with a clear cap
10 mL nasal spray bottle

Besides lyophilized vials, Tesamorelin is also supplied as a nasal spray solution, shipped from our US stock.

Strengths
2 mg · 5 mg
Bottle sizes
10 mL or 20 mL
Minimum order
10 bottles per strength and bottle size
Ships from
Our US stock

Handling

Plan storage before the parcel arrives

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 the destination and timing so receipt can be planned, then move the material into its stated storage condition on arrival.

Buyer FAQ

Terms to settle before the purchase order

Can a buyer arrange third-party testing?+

Yes. You can send any vial from your order to an independent laboratory of your choice. If you want the laboratory, specification, sampling, method and acceptance rule agreed with us before testing, sales confirms them in writing. Unless otherwise agreed in writing, the buyer pays the cost of this optional testing.

What if my own lab test shows the product is out of specification?+

Send any vial from your order to an independent laboratory of your choice. If the report shows the product does not meet the specification on its COA — purity below the stated minimum, or an identity that does not match — share the report with our sales team and we refund that product in full.

Does HPLC purity prove peptide content?+

No. Chromatographic purity describes the relative peak profile under a stated method. Identity, water, counter-ion, residual solvents and assay/content may require separate methods.

How should material be stored after delivery?+

Move it into the storage condition stated on the batch COA or label as soon as it arrives, and record the package condition on receipt.

How are payment terms handled?+

Available methods and milestones depend on order value, destination and project type. The pro forma invoice should state currency, bank details, fees, payment milestones and the release condition.

Why must the testing laboratory understand peptide chemistry?+

Free-base and salt forms, hydrophilic and hydrophobic sequences, aggregation and adsorption can change sample preparation and method suitability. Use a laboratory experienced with the molecule class.

These are buyer-qualification references, not claims that this RUO material is regulated, certified or released under those frameworks. Applicability depends on the buyer's workflow and jurisdiction.

Selected sources

Literature behind the research context

  • 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

Product FAQ

Questions buyers ask about Tesamorelin

How is Tesamorelin different from the other GHRH analogues?+

Tesamorelin is a 44-residue human GHRH(1-44) analog with an N-terminal trans-3-hexenoyl group. Sermorelin is a shorter GHRH(1-29) analog, while CJC-1295 variants contain different substitutions and, in some forms, a drug-affinity-complex moiety. These molecules are not interchangeable reference standards. Match the exact sequence, terminal modification, salt form, and cited study material to the batch COA.

What's the recommended analytical packet for first-time Tesamorelin qualification?+

For first-time qualification, request the released-lot HPLC chromatogram and impurity profile, intact-mass result against the theoretical mass of the stated form, LC-MS/MS coverage of the N-terminus to confirm the trans-3-hexenoyl modification, full-sequence confirmation, acetate or other counterion content, water, residual solvents, and net peptide assay. For cell or animal research, define endotoxin and microbial limits in the receiving laboratory's protocol. A ≥99.0% area result alone does not prove correct acylation, content, sterility, or equivalence to EGRIFTA.

Evidence before order

Buyer intelligence