GHRP-2 (pralmorelin)

Not FDA-approved FDA risk list (Category 2)

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 42 of 213 publications on PubMed
Registered clinical trials 0 0 active
Adverse event reports 6 4 classified as serious
  • GHRP-2 (pralmorelin) is not an FDA-approved drug: Drugs@FDA has no record of it.
  • FDA lists it in Category 2, bulk substances that may present significant safety risks in compounding (since September 29, 2023).
  • PubMed lists 213 publications mentioning it, including 42 randomized controlled trials and 64 animal-only studies.
  • No study registered on ClinicalTrials.gov tests it as an intervention.
  • FDA's adverse event system (FAERS) holds 6 reports mentioning it; 4 classified as serious. Reports do not prove causation.

Research topics

  • Growth Hormone-Releasing Hormone 84
  • Human Growth Hormone 78
  • Growth Hormone 48
  • Insulin-Like Growth Factor I 41
  • Hormones 36
  • Pituitary Gland 27
  • Estradiol 24
  • Adrenocorticotropic Hormone 22
  • Doping in Sports 20
  • Ghrelin 19

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

FDA risk list (Category 2) Applies to: 503B Added: September 29, 2023
FDA's stated risk · Original FDA text (English) Compounded drugs containing GHRP-2 for injectable and nasal administration may pose risk for immunogenicity due to the potential for aggregation and peptide-related impurities. GHRP-2 also contains an unnatural amino acid, which adds to the complexity of peptide characterization. FDA is aware of reports of serious adverse advents in patients who received GHRP-2, including increased insulin requirement to maintain the blood glucose level, death of critically ill study subjects, infection and pancreatitis, though causality has not been established.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 213
  • Human (MeSH) 137
  • Animal only 64
  • Clinical trials 56
  • Randomized controlled trials 42
  • Systematic reviews & meta-analyses 0
  • Case reports 5
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

No registered study on ClinicalTrials.gov lists this peptide as an intervention.

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
6
Serious
4
With death outcome
0

Most reported reactions

  • Pain 2
  • Urticaria 2
  • Abdominal pain upper 1
  • Alopecia 1
  • Anxiety 1
  • Arthralgia 1
  • Aspartate aminotransferase increased 1
  • Back pain 1
  • Blood albumin increased 1
  • Blood cholesterol increased 1
  • Blood pressure fluctuation 1
  • Blood pressure increased 1

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.