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Sermorelin

GHRH analog (first 29 amino acids of human GHRH). Stimulates endogenous growth hormone release. Approved for pediatric GH deficiency, widely used off-label in adults.

Educational only — not medical advice. SmartPeptide does not prescribe, diagnose, or treat. Always consult a licensed healthcare provider before using any peptide, supplement, medication, or protocol.

What the research shows

Pediatric GH deficiency: FDA approved (now discontinued for marketing in the US but evidence stands). Stimulates GH/IGF-1 release in healthy adults short-term.

What's still experimental

Adult anti-aging use, body recomposition, and long-term safety. Most clinic-marketed indications are NOT FDA-approved.

Anecdotal / community reports

Anti-aging and 'optimization' claims overwhelmingly come from anecdote + marketing. Rigorous adult RCTs for these endpoints are missing.

Anecdotal reports are NOT scientific evidence. They reflect personal experience and may not generalize.

FDA approval status

Source: openFDA + DailyMed (NIH/NLM)
No FDA-approved drug label exists for “Sermorelin”. This peptide is not currently approved by the FDA as a finished pharmaceutical product. Any commercial product claiming FDA approval should be treated with suspicion.

Doses studied in research

Source: Published clinical trial

What published trials tested or FDA-approved labels specify. Reporting research facts — not a SmartPeptide recommendation.

Phase 2 trialWalker 1995 — pediatric GHD trial (historical)
Indication studied: Pediatric growth hormone deficiency (historical FDA approval, marketing discontinued)
Citation: Walker R, 1995
Typical
300µg
daily at bedtime · subcutaneous

Pediatric trial dose — adult anti-aging use is NOT FDA-approved and lacks rigorous RCT support

Open calculator

Notes from the source: Adult/anti-aging dosing widely discussed in clinic protocols is NOT supported by published adult RCT data. Original pediatric formulation was discontinued from US marketing.

Important framing: The numbers above are what published trials tested or what FDA-approved labels specify. They are NOT a SmartPeptide recommendation for you. Trial doses come paired with screening, monitoring, and clinician oversight. Always consult a licensed clinician before any peptide use.

FDA enforcement & recalls

Live · openFDA Drug Enforcement API
Total actions
92
recalls + withdrawals
Ongoing
13
not yet completed
Class I (serious)
2
health hazard / death risk
  • Class IIOngoing· Voluntary: Firm initiated
    FDA record

    Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

    Reason: Lack of Assurance of Sterility

    Jul 30, 2025·GenoGenix LLC
  • Class IICompleted· Voluntary: Firm initiated
    FDA record

    Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

    Reason: Lack of Assurance of Sterility

    Aug 26, 2022·Carolina Infusion
  • Class IICompleted· Voluntary: Firm initiated
    FDA record

    Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0059-00

    Reason: Lack of assurance of sterility.

    May 9, 2022·Olympia Compounding Pharmacy dba Olympia Pharmacy
  • Class IITerminated· Voluntary: Firm initiated
    FDA record

    Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

    Reason: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

    Apr 5, 2022·North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
  • Class IITerminated· Voluntary: Firm initiated
    FDA record

    Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

    Reason: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

    Apr 5, 2022·North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Showing 8 of 92 total enforcement actions. See full FDA history →
FDA classifications: Class I = reasonable probability of serious adverse health consequences or death. Class II = temporary or medically reversible adverse consequences. Class III = unlikely to cause adverse health consequences.

Mechanism & targets

ChEMBL · UniProt · Open Targets

Molecule (ChEMBL)

View on ChEMBL
Known mechanisms of action
  • CHEMBL2032
    agonistGrowth hormone-releasing hormone receptor agonist

Protein targets (UniProt)

  • Somatoliberin
    P01286gene: GHRHHomo sapiens· 108 aaReviewed

    GRF is released by the hypothalamus and acts on the adenohypophyse to stimulate the secretion of growth hormone

  • Growth hormone-releasing hormone receptor
    Q02643gene: GHRHRHomo sapiens· 423 aaReviewed

    Receptor for GRF, coupled to G proteins which activate adenylyl cyclase. Stimulates somatotroph cell growth, growth hormone gene transcription and growth hormone secretion

Live research

PubMed · ClinicalTrials.gov · Europe PMC · OpenAlex
PubMed papers
330
total
Human studies
206
MeSH: humans
Clinical trials
29
published
Active trials
3
42 total registered

Recent PubMed studies

Search "sermorelin" on PubMed

Europe PMC — 478 additional records

Includes EU/UK studies and PubMed Central full-text articles. Often surfaces research weeks before PubMed indexes it.

Research volume (OpenAlex topic graph)

Total works
149
all years
Last 5 years
77
recent activity
Open access
122
freely readable
OA share
82%
of all works

Human clinical evidence

Semantic Scholar · AI TLDRs · influence-ranked
Semantic Scholar API is currently rate-limited.

Human-study summaries for “sermorelin” are available on Semantic Scholar but the shared free-tier API quota is exhausted right now. Try refreshing in a few minutes, or check the PubMed and Europe PMC panels above for the same literature.

Research funding & verification

NIH RePORTER · CrossRef DOI registry

NIH-funded research

U.S. National Institutes of Health
Funded projects
4
all years
Top award sum
$648K
aggregate USD
Years covered
3
research span
Largest active / recent grants

Publication landscape

CrossRef · DOI registry
Indexed works (CrossRef)
15
all DOIs registered
Retracted papers
0
no retractions on record

Preprints — cutting edge

bioRxiv · medRxiv · via Europe PMC

Preprints have NOT been peer-reviewed. They are early research shared by authors before formal validation. Treat findings as preliminary.

Showing 3 of 3 preprints indexed by Europe PMC.

Known risks

Hyperglycemia, fluid retention, hypothyroidism risk, possible carpal tunnel symptoms. Long-term cancer risk theoretical but understudied.

Reported side effects

Injection-site reactions, headache, flushing, transient sleepiness, dizziness.

FDA adverse event reports (FAERS)

Updated quarterly by FDA
Reports filed
58
FAERS, all years
Serious reports
35
60% of reports
Top reporting countries
  • US34

Most-reported reactions

  • Pruritus
    6
  • Nausea
    5
  • Hypersensitivity
    4
  • Malaise
    4
  • Rash
    4
  • Anaphylactic Reaction
    3
  • Burning Sensation
    3
  • Erythema
    3
  • Hyperhidrosis
    3
  • Infection
    3

Counts from FDA Adverse Event Reporting System (FAERS). Voluntary reports — they show what was reported, not whether the drug caused the event. Many reports lack confirmation. FAERS docs

What requires medical supervision

If used, should be under clinician care with monitoring of IGF-1, glucose, and thyroid.

Questions for your clinician

  • What's the evidence base for my specific goal?
  • What labs do we track and at what intervals?
  • Why sermorelin vs CJC-1295 vs ipamorelin?

Editorially curated references

Discussions about Sermorelin

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