C221H366N72O67S · 5136 g/mol · PubChem CID 16137828 ↗
Tesamorelin
also known as Egrifta, TH9507, tesamorelin acetate
Synthetic 44-amino-acid GHRH analogue, FDA-approved (2010) for HIV-associated lipodystrophy. Distinguished from native GHRH by a trans-3-hexenoic-acid modification that extends plasma half-life from ~7 minutes to ~26 minutes. Stimulates pulsatile growth hormone release from the anterior pituitary, elevating IGF-1 and reducing visceral adipose tissue over 26 weeks in the Phase 3 approval trial. [falutz-2007]
- Class
- GHRH Analogue
- Half-life
- ~26 min [fda-egrifta-label-2010]
- Evidence level
- FDA-approved
- Regulatory status
- FDA-approved (US)
At a glance
SQ · Abdomen · Once Daily
Primary target — Hypothalamic GHRH receptors [fda-egrifta-label-2010].
Pathway — GHRH → Pituitary GH release → Liver IGF-1 synthesis [falutz-2007].
Downstream effect — Increased GH pulsatility, elevated IGF-1, lipolysis of visceral adipose tissue [falutz-2010].
Origin — Synthetic 44-AA GHRH analogue with trans-3-hexenoic-acid modification for stability [fda-egrifta-label-2010].
Feedback intact — Yes — physiological pulsatility preserved.
| Parameter | Value |
|---|---|
| Standard dose | 2 mg / day [fda-egrifta-label-2010]FDA-approved protocol. |
| Frequency | Once daily (morning or pre-sleep)Aligns with natural GH pulse. |
| Lower / starter dose | 1 mg / day1 mg still produces significant IGF-1 elevation. |
| Evidence basis | RCT / FDA-approved [falutz-2007][falutz-2010] |
| Duration | 12–52 weeksVAT returns within months of stopping. |
| Reconstitution | Sterile water per labelingPreserved at 2–8 °C after reconstitution. |
| Timing | Empty stomach, pre-sleep preferred |
| Half-life | ~26 min (plasma) [fda-egrifta-label-2010]Modified vs native GHRH (7 min t½). |
Reconstitution
A pure mass-to-volume utility. Enter what you have in the vial; the atlas computes the volume per dose. No prescription information.
816-person double-blind RCT · FDA Phase 3 · 26–52 weeks
| Outcome | Finding |
|---|---|
| Primary fat target | Visceral adipose tissue (VAT) — abdominal |
| Quantified reduction | 15–20% VAT ↓ [falutz-2010]By CT at 26 weeks (Falutz et al., NEJM). |
| IGF-1 impact | +66 ng/mL (2 mg dose) · +81% mean elevation [falutz-2007] |
| Effect on lean mass | Modest lean mass preservation / slight increase |
| Insulin sensitivity | Neutral to slight impairment (monitor HbA1c) [stanley-2014] |
| Triglycerides | Significant TG reduction noted in Phase 3 [falutz-2010] |
| Glucose metabolism | Generally neutral; 4.5% HbA1c elevation risk [stanley-2014][fda-egrifta-label-2010] |
| Effect reversibility | VAT returns within months of stopping |
| Key publication | Falutz et al. NEJM 2007 · Falutz JCEM 2010 · FDA approval 2010 |
- — Active malignancy or history of treated cancer
- — Pregnancy
- — Hypersensitivity to tesamorelin or mannitol
- — Disruption of hypothalamic-pituitary axis (trauma, tumour, radiation)
- — Untreated diabetes (monitor HbA1c)
- — Severe carpal tunnel syndrome
- — Acute critical illness
- 01Reconstitution
Add 2.1 mL sterile water to 2 mg lyophilised vial. Roll gently — do not shake. Solution should be clear.
- 02Injection site
Subcutaneous — abdomen preferred. Rotate sites (avoid same spot within 2 cm). Avoid navel and waistband area.
- 03Timing
Once daily. Preferred: evening, 2–3 hrs post-meal, before sleep — aligns with natural GH secretion pulse.
- 04Storage
Lyophilised: room temp, light-protected. Reconstituted: refrigerate 2–8 °C, use within 21 days.
- 05Needle
27–31G, 4–8 mm insulin syringe. Pinch skin, 45° angle for lean individuals.
Frequently asked
What is the half-life of Tesamorelin?
The reported half-life of Tesamorelin is ~26 min. [fda-egrifta-label-2010]
How does Tesamorelin work?
Tesamorelin acts on Hypothalamic GHRH receptors, signalling via GHRH → Pituitary GH release → Liver IGF-1 synthesis. [fda-egrifta-label-2010][falutz-2007]
Is Tesamorelin FDA-approved?
Yes — Tesamorelin is approved by the US FDA.
Sources
of 68 rendered claims carry a resolvable citation.
- [falutz-2007]Falutz 2007 — Metabolic effects of a growth hormone-releasing factor in patients with HIV
N Engl J Med, 2007
Phase 3 RCT, 412 patients, 26 weeks; basis of FDA tesamorelin approval. - [falutz-2010]Falutz 2010 — 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
J Clin Endocrinol Metab, 2010
Pooled 26-week analysis of FDA pivotal trials. 15-20% VAT reduction figure. - [fda-egrifta-label-2010]EGRIFTA® (tesamorelin for inje 2010 — EGRIFTA® (tesamorelin for injection) prescribing information
fda-label, 2010
FDA-approved label, NDA 022505. Source for approved indication, dose, and contraindications. - [raun-1998]Raun 1998 — Ipamorelin, the first selective growth hormone secretagogue
Eur J Endocrinol, 1998
Original characterisation of ipamorelin's selectivity vs cortisol/prolactin. - [sevigny-2018]Sévigny 2008 — Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation
AIDS, 2008
Authors actually Falutz J et al. ID retained for stable cite-ID; underlying paper is the Falutz 2008 long-term safety extension. - [stanley-2014]Stanley 2014 — Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial
JAMA, 2014
JAMA 2014 randomized clinical trial. Tesamorelin reduced visceral adipose tissue and liver fat; glucose and HbA1c metabolic endpoints reported. Replaces the fabricated clarke-2018 entry (see the corrections log).