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What Is Tesamorelin?
Tesamorelin is a synthetic analog of human growth hormone-releasing hormone (GHRH), consisting of the 44-amino acid sequence of GHRH with an added trans-3-hexenoic acid modification at the N-terminus. This modification increases stability and potency compared to natural GHRH.
Tesamorelin is notable for being one of the few growth hormone-related peptides with FDA approval, specifically for treating excess abdominal fat in HIV-infected patients with lipodystrophy.
Key Characteristics
- Type: Growth hormone-releasing hormone analog
- Approval: FDA approved (2010)
- Mechanism: Stimulates pituitary GH release
- Specificity: Targets visceral adipose tissue
Mechanism of Action
GHRH Receptor Activation
Tesamorelin works through the natural GH axis:
- Binds to GHRH receptors on pituitary somatotroph cells
- Triggers release of endogenous growth hormone
- GH then stimulates IGF-1 production in the liver
- Maintains physiological pulsatile GH secretion pattern
Why GHRH vs Direct GH?
- Pulsatile Release: More physiological than constant GH injection
- Feedback Intact: Natural negative feedback mechanisms preserved
- Lower Risk: Reduced risk of GH excess side effects
- Targeted Effect: Particularly effective for visceral fat
Clinical Applications
HIV-Associated Lipodystrophy (Approved Indication)
Tesamorelin is FDA-approved specifically for:
- Reduction of excess abdominal fat in HIV patients
- Treatment of lipodystrophy from antiretroviral therapy
- Significant reduction in trunk fat in clinical trials
- Not indicated for weight loss in general population
Research in Other Conditions
Beyond its approved indication, research has explored:
Cognitive Function
- Studies in mild cognitive impairment and early Alzheimer's
- Improved executive function in some trials
- May affect brain amyloid deposition
- Ongoing research at major academic centers
Liver Health
- Research in non-alcoholic fatty liver disease (NAFLD)
- Reduced liver fat content in studies
- Potential application in metabolic syndrome
Body Composition
- Reduction in visceral adipose tissue
- Improvements in lipid profiles
- Some increase in lean body mass
Clinical Trial Results
| Study | Population | Result | Duration |
|---|---|---|---|
| Phase 3 (Approval) | HIV lipodystrophy | ~18% reduction in trunk fat | 26 weeks |
| Extension study | HIV lipodystrophy | Sustained fat reduction | 52 weeks |
| Cognitive trial | MCI/early AD | Improved executive function | 20 weeks |
| NAFLD study | HIV + fatty liver | Reduced hepatic fat | 12 months |
Side Effects and Safety
Based on clinical trials and post-marketing data:
Common Side Effects
- Injection site reactions (most common)
- Joint pain (arthralgia)
- Peripheral edema (swelling)
- Muscle pain (myalgia)
- Numbness/tingling in extremities
Important Warnings
Clinical Considerations
- May increase IGF-1 levels — monitor regularly
- Fluid retention possible, especially initially
- Contraindicated in active malignancy
- May unmask pre-existing glucose intolerance
- Effects reverse upon discontinuation
Comparison with Other GHRH Peptides
| Peptide | Amino Acids | FDA Status | Notes |
|---|---|---|---|
| Tesamorelin | 44 + mod | Approved | Most clinical data |
| Sermorelin | 29 | Previously approved | Shorter, less stable |
| CJC-1295 | 30 | Research only | Extended half-life |
| Modified GRF (1-29) | 29 | Research only | Stabilized sermorelin |
Administration
Prescribed use of Tesamorelin (Egrifta):
- Route: Subcutaneous injection
- Dose: 2mg daily
- Timing: Typically at bedtime to mimic natural GH rhythm
- Duration: Ongoing; effects reverse with discontinuation
Key Published Research
| Year | Focus | Key Finding | Reference |
|---|---|---|---|
| 2010 | Phase 3 trials | Significant trunk fat reduction | Falutz et al., NEJM |
| 2015 | Cognition | Improved executive function | Baker et al., Neurology |
| 2019 | NAFLD | Reduced liver fat | Stanley et al., Lancet HIV |
| 2021 | Brain imaging | Effects on brain amyloid | Mullins et al. |
Prescription Requirement
Tesamorelin (Egrifta) is a prescription medication in the United States, approved only for HIV-associated lipodystrophy. Off-label use requires physician oversight. Research use of tesamorelin follows different regulatory pathways. This information is for educational purposes only.
Summary
Tesamorelin represents an important example of a peptide that has achieved full FDA approval, providing valuable clinical data on both efficacy and safety. Its mechanism of stimulating endogenous GH release through GHRH receptor activation offers a more physiological approach compared to direct GH administration. While approved specifically for HIV-associated lipodystrophy, ongoing research into cognitive benefits and liver health may expand our understanding of GHRH analogs' therapeutic potential.