FDA-Approved Growth Hormone Secretagogue Peptides for Adults
Yes, there is one FDA-approved GHS peptide: teduglutide (a GLP-2 analogue) is approved for adults with short bowel syndrome and chronic intestinal failure, though it functions primarily to enhance intestinal absorption rather than stimulate growth hormone for growth purposes. 1
Direct Answer to Your Question
For adult growth hormone deficiency specifically, there are no FDA-approved GHS peptides. The FDA has only approved recombinant human growth hormone (somatropin) products like Humatrope for replacement therapy in adults with confirmed GH deficiency. 2
FDA-Approved GHS Peptide (Non-GH Deficiency Indication)
- Teduglutide is the only FDA-approved GLP-2 analogue GHS peptide, indicated for short bowel syndrome in adults to reduce parenteral nutrition/fluid requirements 1
- This medication works by increasing intestinal wet weight absorption, not by treating growth hormone deficiency 1
- The European Society for Clinical Nutrition and Metabolism recommends teduglutide as first-choice growth factor treatment for carefully selected short bowel syndrome patients 1
What About Other GHS Peptides?
Growth hormone secretagogue peptides like GHRP-2 (pralmorelin), GHRP-6, and hexarelin have been studied extensively but lack FDA approval for adult GH deficiency treatment. 3, 4
- GHRP-2 (pralmorelin) is approved only for diagnostic testing of GH deficiency in some countries, not for treatment 5
- These synthetic peptides stimulate GH release via specific receptors distinct from GHRH, but clinical development for therapeutic use has not progressed to FDA approval 3, 4
- Research from the 1990s-2000s showed these compounds could increase IGF-I levels in various populations, but long-term safety and efficacy data remain insufficient 6, 3, 7
Standard of Care for Adult GH Deficiency
The FDA-approved treatment for adult growth hormone deficiency is recombinant human somatropin (direct GH replacement), not GHS peptides. 2
- Humatrope dosing for adults starts at low doses and is individualized based on IGF-I levels and clinical response 2
- Adults previously treated for childhood GH deficiency must be re-evaluated after epiphyseal closure before continuing therapy 2
Critical Distinction: Growth Hormone vs. Growth Hormone Secretagogue
- Somatropin (Humatrope, Genotropin, etc.) = actual recombinant human growth hormone, FDA-approved for adult GH deficiency 2
- GHS peptides = compounds that stimulate endogenous GH release, not FDA-approved for adult GH deficiency treatment 3, 4, 7
Why GHS Peptides Haven't Achieved FDA Approval
- Despite promising early research showing GHS peptides could increase GH and IGF-I levels, definitive long-term efficacy and safety studies were never completed 7
- The availability of effective recombinant GH products likely reduced commercial incentive to develop GHS peptides as therapeutic alternatives 7
- Concerns about non-selective effects (particularly with ghrelin analogues) and potential unforeseen side effects remain unresolved 7