Mechanism Summary

Sermorelin (acetate) is a synthetic 29-amino-acid peptide corresponding to the amino-terminal, biologically active segment of native human growth hormone-releasing hormone (GHRH); it acts as a GHRH-receptor agonist on the anterior pituitary to stimulate endogenous growth hormone secretion.

Pathways

References

• https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams
• https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=sermorelin
• https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
• +8 more

Notes

Expansion-batch evidence packet requires human review before publication. | Remediation pass 2026-08-29: located two sermorelin/GHRH(1-29)-specific controlled human trials (Vittone et al. 1997, PMID 9005976; Vitiello et al. 2006, PMID 16399214) via institutional-repository (Johns Hopkins Pure) and NIH Bookshelf/PMC secondary-review citations, since direct PubMed/PMC full-text access remained blocked by bot-detection (reCAPTCHA) this session as well. Original journal abstracts (Metabolism; Neurobiology of Aging) could not be independently re-confirmed beyond these secondary citations — this residual gap stays review-gated. | ChEMBL identifier not yet resolved (EBI ChEMBL API was rate-limited/unreachable this session); RxNorm identifier resolved this session via NLM RxNav (RxCUI 56188). | Current FDA 503A/503B bulk-substance listing status for sermorelin was re-verified live against the FDA bulk drug substances page and DailyMed on 2026-08-28 per the independent review; still absent from both. Continue to re-verify at each review cycle since these lists are revised periodically. | Verify DailyMed absence-of-listing finding is still current, since compounded or newly approved products could appear between snapshots. | Reviewer's recommended fix for the lean-body-mass marketing claim (that Vittone et al. 1997 showed increased lean mass and decreased visceral fat) was checked against the primary-source citation this session and found to be incorrect — the trial actually found no DEXA body-composition change, only partial strength/muscle-endurance improvement. The packet was corrected to reflect the verified result, not the reviewer's characterization; this discrepancy should be flagged back to the review process. | Compiled draft requires human review before publication.