Library / Peptides / Hormone Optimization / Tesamorelin
Strong evidence · Grade A

Tesamorelin

Tesamorelin (Egrifta)
Score
84 / 100
Half-life
~30 min
Brand
Egrifta
FDA
2010
TL;DR
01
A synthetic growth hormone-releasing hormone (GHRH) analog, FDA-approved as Egrifta (2010) for one specific use: reducing excess abdominal fat in people with HIV-associated lipodystrophy.
02
In pooled phase 3 trials (n=806), daily tesamorelin cut visceral fat by about 15% versus placebo over 26 weeks, and the effect held through 52 weeks of continued use.
03
A later randomized trial also showed reductions in liver fat — relevant to fatty liver disease — though fasting glucose ticked up transiently early on.
04
It works by stimulating the body's own pulsatile growth-hormone release, so IGF-1 rises; benefit depends on continued dosing and reverses when stopped.
05
It is approved and studied only for HIV lipodystrophy — there is no trial evidence for general anti-aging, bodybuilding, or weight-loss use.
Visceral fat (phase 3)
−15.4%
treatment effect · JCEM 2010 · 26 wk
IGF-1 rise
+108 ng/mL
vs −7 placebo · phase 3
Liver fat (RCT)
−2.9%
net lipid/water · JAMA 2014
Durability
Reverses off-drug
benefit requires continued use
Approved use
HIV lipodystrophy
only indication
Part 01 · How it works

Mechanism.

Tesamorelin is a stabilized copy of GHRH, the hypothalamic hormone that tells the pituitary to release growth hormone. Rather than injecting growth hormone directly, it prompts the body to make its own in the normal pulsing rhythm — which raises IGF-1 and, in HIV-associated lipodystrophy, preferentially shrinks deep abdominal (visceral) fat. Because it amplifies a natural signal, it also raises the metabolic considerations that come with more growth hormone: IGF-1 elevation and mild glucose effects.

Instead of pouring in growth hormone from outside, tesamorelin leans on the body's own thermostat — nudging the pituitary to release more GH on its natural schedule.

GHRH-receptor agonism
Agonist at the pituitary GHRH receptor, stimulating endogenous, pulsatile GH secretion (GHRH(1-44) analog).
Visceral-fat selectivity
Preferentially reduces visceral adipose tissue with little change in subcutaneous fat in HIV lipodystrophy.
IGF-1 axis
Raises IGF-1 substantially; the driver of both benefit and the glucose/mitogenic cautions.
Short half-life
~26–38 min, cleared quickly — dosed once daily by subcutaneous injection.
Part 02 · Dosing & administration

How it's taken.

Clinical · trial-validated

Values below describe how Tesamorelin has been administered in human clinical trials and/or approved labeling. Provided for educational purposes only — this is not medical advice and not instructions for self-administration. Consult your healthcare provider before making any health decision.

Standard
2 mg
Once-daily subcutaneous injection (approved Egrifta regimen for HIV lipodystrophy).
·
Doses below are values from labeling and trials, not instructions.
·
Approved only for HIV-associated lipodystrophy; use outside that indication is unstudied.
·
IGF-1 and glucose are monitored during treatment.
Need help with reconstitution?

Use the free peptide calculator for dilution, unit conversion, and injection volume.

Open calculator
Part 03 · Safety

Side effects, rare serious events, who shouldn't.

Common
Injection-site reactions
Erythema, pruritus, pain at the site.
Common
Arthralgia / myalgia
Joint and muscle aches, a classic GH-axis effect.
Common
Peripheral edema
Fluid retention from increased GH signaling.
Common
Paresthesia
Tingling; part of the GH-excess symptom cluster.
Common
Serious · rare
Glucose intolerance / new diabetes
GH raises insulin resistance; fasting glucose can rise, usually transiently.
Monitored
IGF-1 elevation / mitogenic concern
IGF-1 is mitogenic; contraindicated in active malignancy. Monitor IGF-1.
Expected
Hypersensitivity
Discontinue if serious allergic reaction occurs.
Rare
Absolute · do not use
×
Active malignancy (FDA contraindication — tesamorelin stimulates GH which can promote tumor growth)
×
Disruption of the hypothalamic-pituitary axis from hypophysectomy, hypopituitarism, or pituitary tumor/surgery (FDA contraindication)
×
Pregnancy (FDA contraindication — Category X)
×
Known hypersensitivity to tesamorelin or mannitol (FDA contraindication)
×
Breastfeeding
Relative · discuss first
!
Active malignancy — contraindicated (GH/IGF-1 is mitogenic)
!
Pregnancy — contraindicated
!
Disruption of the hypothalamic-pituitary axis (surgery, radiation, tumor) — contraindicated
!
Diabetes or impaired glucose tolerance — monitor closely
!
Anyone seeking anti-aging or athletic use — no supporting trials
Interactions
Insulin
Per FDA label: tesamorelin may increase insulin resistance; monitor glucose and adjust insulin dose as needed
Major
Oral hypoglycemics
GH elevation may counteract glucose-lowering effects; per FDA label, monitor blood glucose
Moderate
Corticosteroids (prednisone, hydrocortisone)
Per FDA label: glucocorticoids inhibit GH secretion and may reduce tesamorelin efficacy; 11beta-HSD1 activity altered by GH
Moderate
Cortisone acetate and prednisone (specifically)
Per FDA label: tesamorelin may reduce conversion of cortisone to cortisol and prednisone to prednisolone; patients on replacement therapy may need dose adjustment
Moderate
Labs to monitor
IGF-1
Baseline and every 3 months
Monitor growth hormone axis stimulation
Fasting Glucose & Insulin
Baseline and every 3 months
GH can impair insulin sensitivity
HbA1c
Baseline and every 3 months
FDA labeling notes glucose monitoring
CMP (Comprehensive Metabolic Panel)
Baseline and every 3 months
Liver function (studied in MASH/NAFLD)
Lipid Panel
Baseline and every 3 months
Monitor lipid changes
Visceral Fat Assessment (CT or DEXA)
Baseline and every 6 months
Primary efficacy endpoint
Part 04 · Evidence

How strong is the evidence?

84
Grade A
Grade A — within its indication. Two multicenter phase 3 trials and an independent liver-fat RCT support FDA approval for HIV lipodystrophy. The ceiling on the score is scope: benefit is indication-specific, reverses off-drug, and there is no evidence base outside HIV.
Mechanistic plausibility
Amplifies endogenous pulsatile GH via a well-characterized GHRH pathway.
88
Human evidence
Pooled phase 3 (n=806) plus an NIH-funded liver-fat RCT — strong for the approved indication.
88
Safety & tolerability
Generally well tolerated; injection-site reactions, arthralgia, and IGF-1 elevation with transient glucose effects.
80
Durability
Effect maintained while dosing but reverses on discontinuation; long-term (>1 yr) data limited.
74
Independence
Pivotal trials industry-sponsored, but the liver-fat RCT was NIH-funded and independent.
78
Part 05 · Research log

Every study we cite.

We list each study with its methodology, funding source, and our quality grade. Flagged studies aren't dismissed — they're tagged so you can weigh them.

01
2010
J Clin Endocrinol Metab Industry funded
Pooled analysis of two phase 3 tesamorelin trials in HIV lipodystrophy
Visceral fat −15.4% treatment effect at 26 wk (maintained to 52 wk on continued drug); triglycerides and body image improved; IGF-1 rose ~108 ng/mL; glucose parameters not clinically changed.
Two RCTs, 26 wk + 26-wk extension, placebo-controlled · n = 806 · Sponsor-funded pooled analysis; consistent across two trials.
PMID 20554713 ↗
High
02
2014
JAMA Flagged
Tesamorelin effect on visceral and liver fat in HIV — randomized trial
Visceral fat −42 cm² and liver fat reduced (net −2.9% lipid/water) vs placebo; fasting glucose rose transiently at 2 weeks but not significantly at 6 months.
RCT, 6 mo, placebo-controlled · n = 50 · NIH-funded, independent of manufacturer; small preliminary sample.
PMID 25038357 ↗
High
Evidence against

What didn't work, and where the evidence is thin.

Every publication is incentivized to tell you a peptide works. We catalogue the null results, failed trials, and mechanism limits we found in the same literature — so you can weigh them against the upside, with your provider.

01
Benefit is indication-specific and reverses when stopped
Discontinuation effect
JCEM (phase 3) · 2010
Visceral-fat reduction is maintained only while dosing continues; the pivotal data are entirely in HIV-associated lipodystrophy, with no trials supporting general anti-aging, athletic, or non-HIV weight-loss use.
What this means: Tesamorelin is a chronic, indication-specific therapy — not a one-course body-recomposition tool. Off-label use rests on extrapolation, not evidence.
PMID 20554713 ↗
02
Raises IGF-1 and can transiently worsen glucose
Safety signal
JAMA (RCT) · 2014
Fasting glucose rose significantly at 2 weeks before normalizing, and IGF-1 increases substantially — the expected consequence of raising growth-hormone output.
What this means: The GH/IGF-1 axis carries glucose-intolerance and theoretical mitogenic (cancer-promotion) considerations; it is contraindicated in active malignancy and requires IGF-1 and glucose monitoring.
PMID 25038357 ↗
Part 06 · Cost & access

Where it's available, at what price.

United States
FDA-approved
Rx as Egrifta (and Egrifta SV) for HIV-associated lipodystrophy only. Not approved for any other use.
Specialty pricing; typically covered for the approved HIV indication
European Union
Limited / withdrawn
Marketing history varies; not broadly available. Prescription-only where present.
N/A / varies
United Kingdom
Not routinely available
Not a routine NHS product.
N/A
Canada
Approved
Approved as Egrifta for HIV lipodystrophy; prescription-only.
Specialty pricing
The Peptide Column takes no affiliate commission from any source. Tesamorelin is a prescription-only medicine approved specifically for HIV-associated lipodystrophy; we link only to clinician-directed access, never to sellers.
Part 07 · Your appointment

Questions to bring.

01
Do I meet criteria for FDA-approved tesamorelin use (HIV-associated lipodystrophy), or would this be off-label?
02
What are the risks of elevating IGF-1 levels, particularly given any personal or family history of cancer?
03
How does tesamorelin differ from exogenous growth hormone in terms of safety?
04
Should my IGF-1 and glucose levels be monitored during treatment?
References

Every citation, numbered.

Citation list. For our editorial read of each study — including bias flags and quality grades — see the Research log above.

  1. 01.
    Pooled analysis of two phase 3 tesamorelin trials in HIV lipodystrophy · J Clin Endocrinol Metab, 2010 · PMID 20554713 ↗
  2. 02.
    Tesamorelin effect on visceral and liver fat in HIV — randomized trial · JAMA, 2014 · PMID 25038357 ↗
  3. 03.
    FDA prescribing information. Official US label — Egrifta / Egrifta SV · Source ↗
  4. 04.
    ClinicalTrials.gov. Tesamorelin visceral/liver-fat RCT (NCT01263717) · Source ↗