FDA approval discontinued / withdrawn (not for safety)

Sermorelin

GHRH(1-29)-NH₂ (sermorelin acetate) — investigational; not FDA-approved.

Editorial review:

What evidence says

Evidence snapshot

This drawer marks papers. It is not a plan, a dose, or a source. A paper is a bounded report. It is not a protocol. Grades name the object. They are not a safety rating.

Identity lock. Sermorelin is GHRH(1-29)-NH₂ (growth hormone–releasing hormone / factor fragment 1–29 amide) — the bioactive N-terminal portion of endogenous GHRH. Acetate salt notation (sermorelin acetate) is the same peptide object → ONE drawer, not a second identity. PubChem CID 16132413; formula C149H246N44O42S; MW ~3357.9. CAS on PubChem includes 86168-78-7 (and 114466-38-5 on the same record — often acetate-associated); treat dual CAS as a note, not two compounds. Historical branded GHRH(1-29) programs (e.g. Geref-era pediatric work) name this object. It is not CJC-1295 with or without DAC, not Mod GRF 1-29 (tetrasubstituted), and not a GHRP / ghrelin-mimetic. No current approved outpatient “anti-aging” indication in this framing. Off-label does not apply where there is no active label to be off of. Mark GH-axis diagnostic or pediatric growth-velocity papers as what they are.

Bottom line

Real human literature exists for GHRH(1-29)-NH₂: pediatric growth-velocity and GH-deficiency diagnostic/treatment-era trials, plus limited healthy-elderly nightly-injection work. That supports a GHRH-receptor agonist / GH-axis stimulation object — not a bodybuilding, fat-loss, or anti-aging treatment grade. Adult “AO-GHI” commentary is opinion context, not a confirmatory RCT pack. Do not average sermorelin into CJC-1295 or GHRP drawers.

Papers

Pediatric / GHD — GHRH(1-29)

PMID 8772599 — Thorner 1996 (Geref International Study Group)

Tested: multicenter open-label once-daily subcutaneous GHRH(1-29) for up to 1 year in previously untreated prepubertal GH-deficient children; height velocity and bone-age progression.

Does not show: an adult anti-aging indication, or equivalence to CJC-1295 / Mod GRF.

PMID 2140733 — Brain 1990

Tested: continuous subcutaneous GHRH(1-29)-NH₂ for up to 1 year in short, slowly growing children with partial GH insufficiency; growth velocity and 24-h GH profiles.

Does not show: a modern outpatient “wellness” claim, or without-DAC CJC results.

PMID 7955460 — Kirk 1994

Tested: GHRH(1-29)-NH₂ treatment in children with idiopathic short stature; sustained increase in growth velocity reported.

Does not show: adult body-composition efficacy, or a GHRP effect.

PMID 7735368 — Bueno 1994

Tested: priming with GHRH(1-29)-NH₂ as an aid in differential diagnosis between hypothalamic and pituitary GH deficiencies.

Does not show: a chronic adult therapy indication.

PMID 2880720 — Ranke 1986

Tested: GRF(1-29)-NH₂ stimulation testing with somatomedin-C measurements for evaluation of GH deficiency.

Does not show: chronic treatment efficacy or physique outcomes.

Healthy elderly / adult commentary

PMID 9005976 — Vittone 1997

Tested: single nightly injections of GHRH(1-29) in healthy elderly men; endocrine responses (GH-axis oriented).

Does not show: approved anti-aging use, or long-term disease-prevention benefit.

PMID 18046908 — Walker 2006

Tested: short commentary arguing sermorelin as an approach to adult-onset GH insufficiency.

Does not show: a controlled confirmatory adult RCT; opinion/context only.

Related chronic-disease pediatric context (same GHRH 1-29 class — tag carefully)

PMID 9035479 — Pasqualini 1996

Tested: GHRH in children with chronic renal failure and growth impairment.

Does not show: adult anti-aging or recreational GH-axis use.

What is not established

Current approved anti-aging, body-composition, or “recovery” indications. Equivalence of sermorelin to CJC-1295 with DAC, CJC-1295 without DAC / Mod GRF 1-29, or any GHRP. Product identity between historical Geref-class material and unlabeled research vials. Acetate salt does not create a second compound drawer.

Selected sources

8772599 2140733 7955460 7735368 2880720 9005976 18046908 9035479

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