Tesamorelin

SKU: GHS-TESAMORELIN

Growth Hormone · Fat Loss · Body Composition

Tesamorelin is an FDA-approved growth-hormone-releasing peptide for reducing visceral, deep abdominal fat in adults with HIV-associated lipodystrophy. It's the only compound in this growth-hormone-releasing category with a current, active FDA approval, giving it the most established regulatory track record here. It's delivered as a daily subcutaneous injection directly into the abdomen, the area targeted by its fat-reduction effect.

$100 / 10 mg vial

Dosing

Community reported

Community titration (peptidedosages.com)
Timeframe Dosage Frequency Note
Week 1 1 mg once daily, evening Starting dose1
Weeks 2+ 2 mg once daily, evening Maintenance2
  1. A titrated research-vial schedule, distinct from the fixed-dose FDA-approved product; see Full research for the label dose.
  2. 2 mg/day matches the FDA-approved EGRIFTA SV maintenance dose, but this titration path itself is peptidedosages.com's own community protocol, not FDA prescribing information.

Batches on hand

Availability

10 vials on hand.

DAND-TM10-31072610 vials
Full research

Evidence tier

Approved drug, human RCT evidence

Tesamorelin has a current FDA-approved prescribing label built on randomized controlled trials for a specific indication, plus an independent published meta-analysis of RCT data; this is the only compound in this category with an active, on-market regulatory approval.

Original dosing schedule

The Dosing table above this section now shows a community- or vendor-sourced schedule (peptidedosages.com). The regulatory-label or clinical-trial dosing this entry was originally built on is kept here, unchanged, rather than removed.

Regulatory label

EGRIFTA SV (tesamorelin for injection)
Timeframe Dosage Frequency Note
Ongoing 1.4 mg once daily, evening

Regulatory label

EGRIFTA WR (tesamorelin for injection)
Timeframe Dosage Frequency Note
Ongoing 1.28 mg once daily 1
  1. Reported as 0.16 mL of reconstituted solution in secondary summarization of the WR label; the underlying vial-strength and diluent-volume figures do not arithmetically reconcile in the sources reviewed and should be verified against the primary label before use.

Identity

Full name Tesamorelin (INN), tesamorelin acetate, developmental code TH9507
Class GHRH-receptor agonist, synthetic GHRH(1-44)-NH2 analog
Brand names Egrifta, Egrifta SV, Egrifta WR
Molecular weight 5135.9 g/mol

Mechanism of action

Plain language

This is an engineered version of the brain's own growth-hormone-releasing signal, modified so it survives a bit longer in the blood and specifically reduces the fat that builds up around internal organs.

Technical

GHRH-receptor agonist, same receptor class and mechanism as sermorelin and both CJC-1295 forms, binding GHRHR on anterior pituitary somatotrophs, activating Gs/cAMP signaling, stimulating GH synthesis and pulsatile release. The N-terminal trans-3-hexenoic acid modification is intended to confer resistance to enzymatic degradation, but despite this modification the FDA label reports a measured human half-life of only 8 minutes, materially shorter than the multi-day half-life of CJC-1295 with DAC. This illustrates that DPP-4-type resistance modifications alone do not automatically produce a long half-life; the DAC albumin-conjugation mechanism used in CJC-1295-with-DAC is a categorically different and much more potent half-life-extension strategy. Tesamorelin stimulates GH production and consequently increases serum IGF-1; its approved effect is a selective reduction in visceral adipose tissue.

Sources: FDA-approved prescribing information,

Why: FDA-approved, one use

Tesamorelin is FDA-approved for a single, narrow indication: reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. It is explicitly not indicated for general weight loss, and long-term cardiovascular safety has not been established.

Sources: FDA-approved prescribing information,

Why: Discard after reconstitution

The EGRIFTA SV label requires the reconstituted solution be used immediately, with any unused solution and diluent discarded, because it is reconstituted with plain Sterile Water for Injection, which carries no antimicrobial preservative. This is stricter than the multi-week refrigerated stability commonly claimed by compounding and vendor sources for other peptides in this category, which are typically reconstituted with bacteriostatic water instead.

Sources: FDA-approved prescribing information,

Why: Shortest half-life in class

Despite an N-terminal modification intended to confer resistance to enzymatic degradation, the FDA label reports a measured human half-life of only 8 minutes, materially shorter than CJC-1295 with DAC's multi-day half-life. This shows that DPP-4-type resistance modifications alone do not automatically produce long half-life; albumin conjugation is a categorically more potent extension strategy.

Sources: FDA-approved prescribing information,

What it’s used for

Approved

Human trials, not approved for this use

  • A meta-analysis of five randomized controlled trials in HIV-associated lipodystrophy found a significant reduction in visceral adipose tissue (mean difference -27.71 cm2, 95% CI -38.37 to -17.06, P < 0.001), described as an approximately 18 percent reduction in visceral fat, achieved without significant worsening of pooled glucose or lipid parameters across the trials reviewed. Long-term cardiovascular safety has not been established, and the drug is explicitly not indicated for general weight loss.

    Sources: Body composition, hepatic, FDA-approved prescribing information,

Pharmacokinetics

Bioavailability

Regulatory label

Less than 4 percent after subcutaneous administration

Sources: FDA-approved prescribing information,

Tmax

Regulatory label

0.15 hours (approximately 9 minutes), median

Sources: FDA-approved prescribing information,

Cmax

Regulatory label

2956.1 pg/mL, mean

Sources: FDA-approved prescribing information,

Half-life

Regulatory label

8 minutes

Sources: FDA-approved prescribing information,

Volume of distribution

Regulatory label

4.8 +/- 1.9 L/kg

Sources: FDA-approved prescribing information,

AUC (0 to infinity)

Regulatory label

889.1 pg-h/mL

Sources: FDA-approved prescribing information,

Route

Regulatory label

Subcutaneous, once daily

Sources: FDA-approved prescribing information,

Reconstitution

Vial strength EGRIFTA SV: 2 mg single-dose vial of lyophilized powder
Diluent Sterile Water for Injection, provided in the kit; not bacteriostatic
Diluent volume 0.5 mL
Concentration 4 mg/mL (4000 mcg/mL)

Worked example

2 mg / 0.5 mL = 4 mg/mL = 4000 mcg/mL. The 1.4 mg dose is drawn as 0.35 mL (1.4 mg / 4 mg/mL = 0.35 mL, confirmed). On a U-100 insulin syringe, 0.35 mL corresponds to 35 units (0.35 mL x 100 units/mL); each unit therefore delivers 4000 mcg/mL x 0.01 mL = 40 mcg, and 35 units x 40 mcg/unit = 1400 mcg = 1.4 mg, which checks out arithmetically. Mix by rolling the vial gently for about 30 seconds; do not shake. EGRIFTA WR reconstitution figures are separately flagged as unconfirmed: secondary sources describe an 11.6 mg vial reconstituted with 1.3 mL of Bacteriostatic Water for Injection, but 11.6 mg / 1.3 mL = 8.92 mg/mL, and 0.16 mL at that concentration would deliver approximately 1.43 mg, not the reported 1.28 mg dose. This arithmetic does not reconcile, and the WR vial-strength and diluent-volume figures should be verified against the primary WR label before publication rather than presented with the false precision of a worked example.

Sources: FDA-approved prescribing information,

Dose calculator

Enter a vial strength, diluent volume, and desired dose to see the resulting concentration, dose volume, and units on a standard U-100 insulin syringe. Nothing entered here is saved, stored, or sent anywhere – the calculation runs only in your browser.

Enable JavaScript to use the interactive calculator. The worked example above already shows a complete calculation for this compound.

Storage and post-reconstitution stability

Unopened storage

20-25 degrees C (68-77 degrees F), excursions permitted to 15-30 degrees C; keep in the original carton to protect from light (FDA label, EGRIFTA SV).

Post-reconstitution stability – Regulatory label

Use immediately; discard unused reconstituted solution and diluent. Do not store, refrigerate, or freeze. Reconstituted with plain Sterile Water for Injection, which carries no antimicrobial preservative.

Sources: FDA-approved prescribing information,

Safety

Contraindications

Notable risks

  • Neoplasm risk: monitor for malignancy recurrence and discontinue if evidence emerges.

    Sources: FDA-approved prescribing information,

  • IGF-1 elevation: the label states EGRIFTA SV stimulates GH production and increases serum IGF-1. At 26 weeks, 47 percent of patients had IGF-1 levels more than 2 standard deviation scores above normal, and 36 percent had scores greater than 3; at 52 weeks among patients who continued treatment, 34 percent had scores greater than 2 and 23 percent had scores greater than 3.

    Sources: FDA-approved prescribing information,

  • Fluid retention, which may cause edema, arthralgia, or carpal tunnel syndrome.

    Sources: FDA-approved prescribing information,

  • Glucose intolerance: 5 percent of treated patients developed elevated HbA1c (at or above 6.5 percent) versus 1 percent on placebo, hazard ratio 3.3 (95% CI 1.4-9.6); baseline HbA1c was 5.3 percent in both treatment and placebo groups. By contrast, the independent RCT meta-analysis described the class-level glycemic effect across pooled trials as not significantly worsening glucose or lipid parameters. Both findings are reported here rather than reconciled, since they reflect different endpoints: categorical HbA1c threshold-crossing in the label's pivotal population versus pooled continuous glucose and lipid parameters in the meta-analysis.

    Sources: FDA-approved prescribing information,, Body composition, hepatic

  • Hypersensitivity reactions in 4 percent of patients; injection-site reactions in 25 percent of patients versus 14 percent on placebo during the first 26 weeks; consider discontinuation in acutely critically ill patients. Most common adverse reactions (greater than 5 percent): arthralgia, injection-site erythema, injection-site pruritus, pain in an extremity, peripheral edema, myalgia.

    Sources: FDA-approved prescribing information,

  • Monitoring recommendations: IGF-1 levels during therapy with consideration of discontinuation if persistently elevated; glucose status prior to and periodically during therapy; malignancy screening prior to initiation and ongoing surveillance; monitoring for retinopathy development or worsening in diabetic patients; possible need for glucocorticoid dose adjustment in patients on glucocorticoid replacement.

    Sources: FDA-approved prescribing information,

This is a research and educational reference, not medical advice. Nothing on this site is a recommendation to use any compound.