What are the guidelines for using Sermorelin (growth hormone-releasing hormone (GHRH) analogue) therapy?

Sermorelin Use in Clinical Practice

Sermorelin is FDA-approved solely for diagnostic testing of growth hormone deficiency in children and for treatment of idiopathic growth hormone deficiency in select pediatric patients, but it is not approved for anti-aging, bodybuilding, or general adult use. 1

Approved Diagnostic Use

For diagnostic testing of growth hormone deficiency:

• Administer sermorelin as a single intravenous dose of 1 mcg/kg body weight 1
• This provides a rapid and relatively specific test for growth hormone deficiency, with fewer false positives compared to other provocative tests 1
• Important caveat: Normal growth hormone responses to sermorelin cannot exclude growth hormone deficiency due to hypothalamic deficits; subnormal responses to other provocative tests are needed to confirm disease in these patients 1

Approved Therapeutic Use in Children

For treatment of prepubertal children with idiopathic growth hormone deficiency:

• Administer sermorelin 30 mcg/kg body weight subcutaneously once daily at bedtime 1
• Alternative regimen: 1-2 mcg/kg administered subcutaneously every 3 hours via pump has shown efficacy 2
• Treatment duration of 12 months produces sustained increases in height velocity, with limited data suggesting effects may be maintained for up to 36 months 1

Patient selection criteria for optimal response:

• Slow-growing children with shorter stature 1
• Delayed bone age and height age 1
• Prepubertal status 1

Expected outcomes:

• Sermorelin induces catch-up growth in the majority of growth hormone-deficient children 1
• However, growth hormone (somatropin) replacement remains superior, producing significantly better height velocity increases than sermorelin at equivalent doses 3
• Growth hormone remains the treatment of choice for growth hormone insufficiency 3

Safety Profile

Common adverse events:

• Transient facial flushing (most common) 1
• Pain at injection site 1
• Overall, sermorelin is well tolerated in both single intravenous doses and repeated subcutaneous administration 1

Critical Limitations and Contraindications

Sermorelin is NOT approved for:

• Adult growth hormone deficiency treatment
• Anti-aging therapy
• Athletic performance enhancement
• Body composition modification in adults

Important clinical pitfall: The effect of long-term sermorelin treatment on final adult height has not been determined 1. When growth hormone deficiency is confirmed, conventional growth hormone replacement therapy produces significantly better outcomes and should be the preferred treatment 3.

Monitoring consideration: Sermorelin may have utility in recurrent glioma patients based on emerging research showing sensitivity in high-grade, IDH-wildtype tumors, though this remains investigational 4.