Source comparison
Sermorelin FDA Approved Status: Diagnostic vs Therapeutic Comparison
Diagnostic GH testing (original indication) FDA-approved under Geref Diagnostic (1997–2008) Single-dose administration in clinical setting 1 mcg/kg IV bolus Established in pediatric and adult endocrinology Historically covered when branded product available Th
This comparison does not assign a generated winner or score.
- Diagnostic GH testing (original indication)
- FDA-approved under Geref Diagnostic (1997–2008)
- Single-dose administration in clinical setting
- 1 mcg/kg IV bolus
- Established in pediatric and adult endocrinology
- Historically covered when branded product available
- Therapeutic GH optimization (current use)
- Off-label; compounded under 503A/503B exception
- Physician prescription through compounding pharmacy
- 200–500 mcg SC daily
- Supported by JCEM studies (1997) and clinical case series
- Typically not covered; $150–$400/month out-of-pocket
- Research applications
- Not regulated as drug product; research-grade peptides used
- Direct purchase by institutions for in vitro or animal studies
- Variable; protocol-dependent
- Extensive preclinical literature on GHRH analogs
- N/A