AI illustration · not actual product photoDetails from the source.
This catalogue entry records Sermorelin, 5 mg × 10 vials (SKU SMO5), using the supplied source listing. The cited dossier describes: Human research chiefly examined pituitary growth-hormone stimulation testing and growth-hormone release in children with growth disorders. Historical Geref formulations had distinct FDA-labeled uses for evaluating pituitary secretion and treating idiopathic growth hormone deficiency in children with growth failure. It also distinguishes available human evidence, limitations, safety concerns, and regulatory context. It does not verify this supplier-specific item’s identity, formulation, lot quality, or approval. This is not medical advice, a treatment recommendation, or authorization for human use.
- Catalogue code
- SMO5
- Source specification
- 5mg*10vials
- Source document
- PriceList(1).pdf, page 2
- Photograph
- AI-generated illustration only — not an actual product photo or verified molecular depiction; owner-approved product photo still pending.
Product information is presented from supplied source materials. Inclusion on this website does not state that a product is an approved medicine or authorize human use. This is educational content, not medical advice.
Compound-level research and safety context.
Evidence below concerns the research family associated with this listing. For blends, findings about individual components do not establish evidence for the combination. This does not verify the supplier-specific vial or lot. Reviewed 2026-10-30.
What it is
Sermorelin is a synthetic 29-amino-acid peptide. This compound-level identity does not verify the contents or status of the supplier-specific SMO5 or SMO10 vials.
Biological mechanism
Sermorelin is an active fragment analogue of human growth hormone-releasing hormone (GHRH). It stimulates GHRH receptors on anterior-pituitary somatotroph cells, prompting release of endogenous growth hormone; growth hormone can then increase insulin-like growth factor 1 (IGF-1). A pituitary response is required. [3]
Research focus
Human research chiefly examined pituitary growth-hormone stimulation testing and growth-hormone release in children with growth disorders. Historical Geref formulations had distinct FDA-labeled uses for evaluating pituitary secretion and treating idiopathic growth hormone deficiency in children with growth failure. [1] [3]
Potential applications in the evidence
Evidence supports describing historical investigation—not a claim for these catalogue vials—in pituitary growth-hormone stimulation testing and pediatric growth-hormone deficiency. A small clinical study also examined growth in children with idiopathic short stature, a different population from diagnosed growth hormone deficiency. These studies do not establish broader adult wellness, athletic-performance, anti-aging, or other unstudied applications. [1] [3] [4]
Human evidence
A one-year multicenter, open-label study treated 110 prepubertal children with growth hormone deficiency; 86 were included in the efficacy analysis. Mean height velocity increased during the study. Without a concurrent control group, with limited duration and no adult-height endpoint, it cannot establish long-term outcomes or effectiveness of the catalogue vial. [4] A review describes the overall treatment evidence as limited and notes final adult height had not been established. A small study in children without growth hormone deficiency observed increased growth velocity during treatment and a return toward pretreatment velocity after treatment stopped; this does not establish a general use. [3]
Known and potential effects
Historical clinical reports most commonly described transient facial flushing and injection-site pain. One small study also reported increases in fasting glucose and insulin during treatment. A one-year clinical trial in children with growth hormone deficiency reported overall tolerability, but its size and duration cannot rule out uncommon or long-term harms. These reports concern studied sermorelin/Geref contexts and do not estimate risks for SMO5 or SMO10. [3] [4]
Safety and contraindications
Sermorelin can stimulate the growth-hormone/IGF-1 axis, and the cited evidence does not establish long-term safety across populations. The catalogue provides no approved labeling, contraindications, interactions, patient information, or product-specific safety data for SMO5 or SMO10; contraindications for these exact vials therefore cannot be verified. This information is educational and does not assess whether an individual should use a product.
U.S. FDA / regulatory status
FDA records show historical approval for specific branded Geref sermorelin acetate formulations: a diagnostic formulation was approved in 1990 and therapeutic injection vials in 1997 for a pediatric labeled indication. FDA later recorded those Geref products as discontinued and withdrew their NDAs effective June 18, 2009. In 2013 FDA determined Geref was not withdrawn for safety or effectiveness; that determination concerned the discontinued branded products and did not approve other sermorelin vials. [1] FDA's orphan-drug database also records Geref marketing approval in 1997. [2] FDA's May 2026 503A compounding nomination document does not list sermorelin among the displayed categories; that does not establish whether either catalogue vial is compounded or eligible for a compounding pathway. [5] The exact SMO5 and SMO10 vial manufacturer, formulation source, lot, jurisdiction, approval status, and classification are not provided and cannot be verified. Do not imply the historical Geref approval transfers to these SKUs.
Evidence limitations
The available clinical evidence is old and mainly concerns children. It includes diagnostic work, small or open-label studies, and limited follow-up. Findings about identified historical Geref formulations cannot verify equivalence, composition, quality, safety, or effectiveness of vials identified only as SMO5 and SMO10, and do not support extrapolation to unstudied uses.
Supporting sources
- Determination That GEREF (Sermorelin Acetate) Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness U.S. Food and Drug Administration / Federal Register · Regulatory notice. Supports: Historical Geref NDA approvals and indications, discontinuation and NDA withdrawal, and FDA's conclusion that withdrawal was not for safety or effectiveness.
- Search Orphan Drug Designations and Approvals: Sermorelin acetate U.S. Food and Drug Administration · Regulatory database. Supports: Geref orphan designation and 1997 marketing approval date.
- Sermorelin: A Review of Its Use in the Diagnosis and Treatment of Children with Idiopathic Growth Hormone Deficiency BioDrugs / Springer Nature · Peer-reviewed review. Supports: Peptide identity, GHRH mechanism, historical diagnostic and pediatric research, limitations including final adult-height uncertainty, and commonly reported adverse events.
- Once Daily Subcutaneous Growth Hormone-Releasing Hormone Therapy Accelerates Growth in Growth Hormone-Deficient Children During the First Year of Therapy Journal of Clinical Endocrinology & Metabolism / PubMed, National Library of Medicine · Human clinical trial. Supports: Design, population, one-year growth findings, analysis population, and short-term tolerability in a multicenter open-label pediatric clinical trial.
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A, updated May 14, 2026 U.S. Food and Drug Administration · Regulatory compounding list. Supports: The listed 503A nomination categories and their displayed contents; sermorelin is not listed among the displayed categories, which alone does not determine status of the exact vial.