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Approved medicine · randomized human evidenceFDA-approved for a specific HIV-associated indication

Tesamorelin

Growth-hormone-releasing-factor analogue

FDA-approved growth-hormone-releasing-factor analogue used to reduce excess abdominal fat in adults with HIV-associated lipodystrophy.

EGRIFTA SV single-dose vialEGRIFTA WR multidose vialGrowth HormoneWeight & Metabolism

Reference dose

1–2 mg daily

Source-specific educational reference, not an individualized recommendation.

Reference schedule

Daily · 12–16 weeks

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Profiles include evidence, formats, units, source-specific reference amounts and, where relevant, device details. If any of those terms are unfamiliar, do not guess your way through them. Start with a Personalised Guide and we will put the foundations in the right order for you.

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At a glance

Drug class

GHRF analogue

Stimulates endogenous growth-hormone secretion.

Approved use

HIV lipodystrophy

Reduction of excess abdominal fat in affected adults.

Current U.S. products

SV + WR

Different formulations, mixing instructions and daily doses.

Not approved for

General weight loss

The prescribing information explicitly limits the indication.

What it is

Tesamorelin is a synthetic analogue of human growth-hormone-releasing factor. It acts at the pituitary to increase endogenous growth-hormone secretion rather than supplying growth hormone directly.

In the United States it is marketed as EGRIFTA products for a specific HIV-associated lipodystrophy indication.

Research focus

HIV-associated lipodystrophyVisceral adipose tissueGrowth hormone / IGF-1Body composition

How it works

Tesamorelin is a synthetic growth-hormone-releasing-factor analogue that stimulates endogenous pulsatile growth-hormone secretion and increases IGF-1, producing measurable effects on visceral adipose tissue in the approved HIV-associated population.

Important context

Tesamorelin is an approved prescription medicine, but its approval is narrow: reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. The label specifically states that it is not indicated for general weight-loss management.

What it is studied for

The approved research programme focused on reducing excess visceral abdominal fat in adults with HIV-associated lipodystrophy.

Body-composition studies have examined visceral fat, waist measures, lean mass and liver fat rather than treating scale weight as the only endpoint.

Endocrine monitoring is important because the mechanism increases GH and IGF-1 signalling rather than acting as a direct fat-loss agent.

More contextWhy the current formulation mattersSee the deeper context, evidence details and practical distinctions behind this profile.

There are currently two U.S. EGRIFTA formulations with different vial strengths, reconstitution instructions and recommended daily doses. EGRIFTA SV and EGRIFTA WR are not substitutable.

Older clinical trials commonly used 2 mg daily formulations. Current prescribing information should therefore take priority over copying historical milligram doses into a modern dosing chart.

  • EGRIFTA SV uses a 2 mg single-dose vial and has a labelled recommended dose of 1.4 mg once daily.
  • EGRIFTA WR uses an 11.6 mg multidose vial and has a labelled recommended dose of 1.28 mg once daily.
  • Randomized HIV-lipodystrophy studies showed reductions in visceral adipose tissue, while the effect diminished after treatment discontinuation.
  • The labels state that long-term cardiovascular safety has not been established and that tesamorelin is not indicated for weight-loss management.

Why people are interested

What makes Tesamorelin worth researching.

Human randomized trials

Visceral-fat reduction

Randomized trials in adults with HIV-associated abdominal fat accumulation showed meaningful reductions in visceral adipose tissue compared with placebo.

Established human pharmacology

Growth hormone / IGF-1 axis

Tesamorelin stimulates endogenous growth-hormone secretion and increases IGF-1, which is central to both its mechanism and several important safety-monitoring considerations.

Human randomized trial

Liver-fat research

A smaller randomized study reported reductions in liver fat alongside visceral-fat reduction in people with HIV and abdominal fat accumulation.

Human extension data

Effect is treatment-dependent

Trial data showed that visceral-fat improvements were lost relatively quickly in participants switched from tesamorelin to placebo.

Evidence

Where the evidence is strongest, and what kind of evidence it is.

Human · randomized · placebo controlled

Pivotal HIV-lipodystrophy evidence

Phase 3 programmes established reduction of visceral adipose tissue in adults with HIV-associated abdominal fat accumulation and supported the approved indication.

FDA-approved prescribing information

Current formulation labels

EGRIFTA SV and EGRIFTA WR are both prescription tesamorelin products, but their vial strength, reconstitution and labelled daily dose differ and they are not substitutable.

Not an approved indication

General obesity

The current labels explicitly state that tesamorelin is not indicated for weight-loss management.

Important uncertainty

Long-term risk

The label states that long-term cardiovascular safety has not been established and requires attention to IGF-1, glucose and malignancy-related precautions.

Human research

A randomized placebo-controlled study in 404 adults with HIV-associated abdominal fat accumulation reported a roughly 10.9% reduction in visceral adipose tissue at six months with the then-studied 2 mg daily formulation versus minimal change with placebo.

Extension data showed further visceral-fat reduction in participants continuing treatment and loss of much of the benefit after switching from tesamorelin to placebo.

A separate randomized study in 50 antiretroviral-treated adults with HIV and abdominal fat accumulation found reductions in visceral adipose tissue and modest reductions in liver fat over six months.

More recent systematic reviews and meta-analyses continue to support visceral-fat reduction in the approved population, while emphasizing ongoing questions about long-term safety and durability.

Preclinical research

Preclinical endocrine work supports GHRF receptor activity and the downstream GH/IGF-1 mechanism, but current clinical use is supported primarily by controlled human trials and approved labeling.

Reference dosing

Reference amount, schedule and conversion.

A reference amount is only useful when you know the formulation, concentration and delivery device it belongs to. Do not transfer a vial amount into a pen, a pen click count into another pen, or a syringe-unit number into a different concentration.

01

Identify the format

Vial, reusable cartridge pen, prefilled multi-dose pen or single-dose autoinjector.

02

Confirm concentration

Know the total peptide amount and liquid volume or the manufacturer/vendor concentration.

03

Understand the units

Keep mg/mcg, mL and syringe units or device clicks separate.

04

Then use the reference

Only convert a known reference amount with the calculator that matches the actual device.

Source-specific reference

1–2 mg daily

Daily · 12–16 weeks

The 1–2 mg daily range is the Pep Report research reference. Current EGRIFTA products have formulation-specific labelled doses and are not interchangeable.

Calculator connection

This profile does not currently use a vial or pen calculator. Follow the formulation-specific information shown for the product or reference you are using.

For an approved EGRIFTA product, use its exact prescribing information and supplied mixing instructions. The generic vial calculator is intentionally disabled because the product-specific reconstitution and dose should not be replaced by informal concentration arithmetic.

Storage

Start with the format. Then verify the exact product.

Learn the storage framework

Rule of thumb, not a product instruction

Rule of thumb only: tesamorelin is a strong example of why storage belongs to the exact formulation. Two approved tesamorelin products have materially different reconstitution and storage instructions.

Vial rule of thumb

For tesamorelin vials, do not assume 'reconstituted peptide = refrigerate'. The approved WR and SV formulations prove that the correct post-mixing condition can differ even when the active peptide is the same.

Known data

For tesamorelin, the strongest storage data comes from the approved EGRIFTA WR and EGRIFTA SV formulations. EGRIFTA WR 11.6 mg vials are stored at 20–25°C (68–77°F), protected from light; after reconstitution with the supplied bacteriostatic water, the vial remains at 20–25°C and unused solution is discarded 7 days after mixing. It should not be frozen.

For tesamorelin, EGRIFTA SV uses a different system. The 2 mg vial is stored at 20–25°C and protected from light, but after reconstitution with the supplied sterile water it is used immediately; unused solution is discarded, and the reconstituted product should not be refrigerated or frozen.

Formulation context

For tesamorelin, formulation context matters because EGRIFTA WR and EGRIFTA SV contain the same active peptide but use different excipients, diluents, concentrations and product designs. FDA labeling explicitly states that the formulations have different storage requirements and are not substitutable.

For tesamorelin, those differences are a practical demonstration that the molecule name alone cannot determine storage.

What is not established

For tesamorelin, what remains unestablished is whether an unrelated third-party research vial shares either approved product's post-reconstitution stability. The seven-day WR window cannot simply be copied onto every tesamorelin vial.

For tesamorelin, a different research formulation may require a different diluent, temperature or beyond-use period and therefore needs its own validated instructions.

Practical reference

Formats

EGRIFTA SV single-dose vial

EGRIFTA WR multidose vial

Reconstitution & units

EGRIFTA SV and EGRIFTA WR use different vial presentations and mixing instructions. Follow the product-specific Instructions for Use rather than a generic research-vial recipe.

The generic vial calculator is disabled on this profile because the approved product label already specifies how the formulation is prepared and administered.

The current labelled daily dose is 1.4 mg for EGRIFTA SV and 1.28 mg for EGRIFTA WR.

Do not convert between products by assuming equal vial strength, volume or concentration.

Safety, status & open questionsOpen the practical cautionsTesamorelin is FDA approved as EGRIFTA products for reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. That approval should not be generalized to routine obesity treatment, bodybuilding or other off-label wellness uses.

Open questions

The approved evidence does not establish tesamorelin as a general obesity or cosmetic weight-loss treatment.

Long-term cardiovascular safety has not been established in the approved labeling.

Historical trial doses should not be confused with current EGRIFTA SV and EGRIFTA WR product-specific dosing.

The clinical significance and long-term consequences of changes in liver fat and other secondary metabolic measures continue to be studied.

Regulatory notes

Tesamorelin is FDA approved as EGRIFTA products for reduction of excess abdominal fat in adults with HIV-associated lipodystrophy.

EGRIFTA SV and EGRIFTA WR are not substitutable and use different recommended daily doses.

The current labels state that tesamorelin is not indicated for weight-loss management.

Practical notes

Tesamorelin is contraindicated in people with disruption of the hypothalamic-pituitary axis, active malignancy, known hypersensitivity to tesamorelin or product excipients, and pregnancy.

The labels warn about elevated IGF-1 and recommend monitoring because the effects of prolonged IGF-1 elevation are not fully established.

Fluid retention can occur and may present as edema, arthralgia or carpal-tunnel-type symptoms.

Glucose intolerance or diabetes may develop or worsen, so glucose status is an important clinical consideration.

Injection-site reactions and hypersensitivity reactions are also described in the prescribing information.

Common mistakes

Calling tesamorelin a generally approved weight-loss peptide.

Using the older 2 mg clinical-trial dose as if it were the current dose for every EGRIFTA formulation.

Treating EGRIFTA SV and EGRIFTA WR as interchangeable because they contain the same active ingredient.

Using generic vial-calculator arithmetic instead of the product-specific reconstitution and dosing instructions.

Common questions

Is tesamorelin FDA approved?

Yes, but for a specific indication: reduction of excess abdominal fat in adults with HIV-associated lipodystrophy.

Is tesamorelin approved for general weight loss?

No. The current EGRIFTA prescribing information explicitly states that it is not indicated for weight-loss management.

Why do I see 2 mg, 1.4 mg and 1.28 mg in tesamorelin references?

Older trials commonly studied 2 mg daily. Current EGRIFTA SV and EGRIFTA WR formulations have different labelled daily doses and are not substitutable.

Why is the generic vial calculator disabled?

Because approved EGRIFTA products have exact formulation-specific mixing and dosing instructions. Generic arithmetic should not replace those instructions.

Related peptides & blends

References