GHRH analogues (growth hormone-releasing hormone analogues)
Tesamorelin (as acetate) 11.6 mg per vial
CAS Number45
Basic Info
| CAS Number | 901758-09-6 |
|---|---|
| Active Ingredient | Tesamorelin, an N-terminal hexenoylated synthetic analogue of human GHRH(1-44), supplied as the acetate salt |
| Dosage Form | Lyophilised powder for injection |
| Specification & Packaging | Strength: 11.6 mg per vial Pack: 1 vial Group: 03 Item No.: 45 |
Storage & Common Excipients
| Storage Conditions | 2–8 °C, protected from light (lyophilised powder). After reconstitution follow the label — it is generally used promptly and not stored |
|---|---|
| Common Excipients | Typical lyophilisate: mannitol (within a stabiliser system that also contains a protease inhibitor such as lysine or arginine), buffer, edetate disodium; reconstituted with sterile water for injection (FDA documentation specifies use within 2 hours of reconstitution). Confirm against COA |
Product Introduction
A synthetic analogue of growth hormone-releasing hormone. The reference product (Egrifta, tesamorelin acetate for injection, lyophilised powder) is indicated for HIV patients on antiretroviral therapy who develop lipodystrophy, to reduce visceral adipose tissue. Longer-acting and higher-concentration presentations are also available
Therapeutic Use
Metabolic fat abnormalities / lipodystrophy in HIV-infected patients receiving antiretroviral therapy (reduction of visceral fat; Egrifta / Egrifta SV / Egrifta WR). Indications follow the locally approved label. **Not for bodybuilding, fat loss or performance enhancement**
Mode of Action
A GHRH analogue that stimulates pituitary GHR receptors **in a pulsatile** manner (unlike inverse-agonist GHRP-class agents), producing physiological pulsatile increases in GH and IGF-1. It lacks the appetite suppression, aldosterone elevation and fluid retention associated with GHRPs, and has no direct androgen-receptor activity
Administration & Monitoring
Subcutaneous injection (usually at bedtime and with rotation of sites); measure visceral adipose tissue (CT or DXA) and waist circumference before treatment; reassess fat mass, bone density (may fall), IGF-1, glucose and lipids at intervals such as 3 and 6 months. Injection-site reactions are the most common adverse events
Important Safety Information
Prescription medicine and a high-value, strongly regulated category (US FDA REMS with dedicated registration). Not for off-label muscle gain or fat loss. May raise blood glucose (monitor in diabetes). Reports of severe pain-like events following inadvertent intrathecal or intraosseous administration mean the product must be injected subcutaneously as specified
Adverse Reactions
Injection-site pain, erythema and bruising (most common); headache; myalgia; reduced bone mineral density; raised blood glucose or new-onset diabetes; fatigue, nausea and diarrhoea; rare reports of severe pain events after intrathecal injection
Important Risks
Hyperglycaemia and new-onset diabetes risk; reduced bone density and long-term fracture risk; compliance risk of off-label use for muscle gain; serious pain events from improper injection technique; REMS-restricted procurement and use
Contraindications
Hypersensitivity; pregnancy (contraindicated — no indication and reproductive-toxicity data); lactation; active malignancy or uncontrolled diabetes (must be controlled first); paediatric use (no indication)
Special Populations
HIV-infected patients are the only approved population and must be receiving antiretroviral therapy; close glucose monitoring in diabetes or glucose intolerance; limited data in renal impairment; no paediatric or adolescent indication; limited geriatric data
Usage Limitations
Prescription medicine under REMS control (trained providers, dedicated registries and follow-up). Strictly prohibited for competitive sport. No off-label aesthetic/muscle-building use. Inject subcutaneously as specified to avoid inadvertent intrathecal or intraosseous administration
Anti-Doping Testing
GHRH- and GHRP-related agents: several are **prohibited** (e.g. GHRP-1, -2, -4, -6, CP 471474, ipamorelin, and most GHRH analogues other than tesamorelin under specified conditions), while **tesamorelin itself is not currently listed as prohibited** on the WADA Prohibited List. Testing targets growth-hormone-releasing agents (GH-dependent markers combined with IGF-1 interpretation). In practice, even though tesamorelin is not directly prohibited, an unexplained abnormal GH/IGF-1 profile leads to an adverse finding, so a TUE should be filed in advance
Product Quality Testing
Identification (peptide mapping/MS), assay (bioactivity and HPLC), purity and aggregation, endotoxin, sterility, lyophilisate appearance and reconstitution time, stability for 2 hours after reconstitution, fill volume. Per FDA release specifications, orthogonal methods include a cell-based bioassay and HPLC content; COA
Inquiry / Request for information
We will respond within 24 hours. Customized synthesis is supported.