GH secretagogues
GHRP-2
Growth hormone releasing peptide-2; pralmorelin
- US status
- No lawful route
- Class
- GH secretagogues
- Approved product
- None
- Route
- None lawful; sold as research-use-only material
Regulatory record
- September 2023
- FDA places growth hormone releasing peptide-2, for injectable and nasal routes of administration, in Category 2 under the section 503B interim policy, with a date added of September 29, 2023. The agency states that compounded drugs containing GHRP-2 may pose a risk for immunogenicity from aggregation and peptide-related impurities, that the substance contains an unnatural amino acid which adds to the complexity of peptide characterization, and that it is aware of reports of serious adverse events in patients who received GHRP-2 — increased insulin requirement, death of critically ill study subjects, infection and pancreatitis — though causality has not been established.
- May 2026
- The section 503A bulks list FDA published May 14, 2026 lists GHRP-2 in Category 3, the file for substances nominated without adequate support to evaluate. It sits in neither of the other two 503A categories, and Category 3 carries no authorization to compound.
- September 2026
- Drugs@FDA holds no approved product with GHRP-2 or pralmorelin as an active ingredient, and the substance was not among the seven peptides the advisory committee reviewed in July 2026. Its position is therefore unchanged by the 2026 meeting.
- FDA final action
- None as of September 2026.
Every entry above is dated; the record is current as of the review date.
Definition
GHRP-2 is a synthetic hexapeptide that stimulates growth hormone release by acting at the ghrelin receptor rather than at the growth hormone-releasing hormone receptor. It was developed as a pituitary provocation agent — a way of asking the pituitary how much growth hormone it is able to release — and most of what has been published about it in people was published for that purpose.
It reaches United States buyers today as research-use-only material, marketed for the effects the provocation studies measured. This index tracks it because its regulatory file is the clearest example of a distinction the marketplace collapses: the size of a compound's literature and the strength of its nomination are different things, and the FDA has filed this one on the second.
Evidence
The literature is neither small nor absent. Across six name variants PubMed returns 260 indexed records, of which 160 carry the Humans subject heading, 59 the clinical-trial publication type, and 43 the randomized-controlled-trial type [1]. Every one of the 59 titles was retrieved and read. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type, the invalid tag returned zero for that control term, and a deliberately invalid record identifier errored at the end of the run [1].
What the 59 records contain is a diagnostic and physiological literature. The dominant design gives GHRP-2 once, or over a few hours, and measures growth hormone, adrenocorticotropic hormone or cortisol release under varying hormonal conditions; a large share come from a single physiology group working on the regulation of growth hormone pulses. A phase 1 study established pharmacokinetics and pharmacodynamics in children [2]; an eight-month study of graded doses in growth-hormone-deficient children is the longest administration record indexed [3]; a study in obese adults measured the effect on food intake [4]; and a study in adults established the compound as a diagnostic test for growth hormone deficiency [5]. One record is a study in pigs [1].
The distance between that record and what the compound is sold for is the finding. A provocation study establishes that a peptide releases growth hormone; it does not establish that releasing growth hormone in a person who is not deficient produces a clinical outcome, and none of the 59 records was designed to answer that question. The eight-month record is a dose-ranging study in deficient children, which is a different population from the one buying the material.
Lawful access
There is no lawful United States supply route. Drugs@FDA holds no approved product with GHRP-2 or pralmorelin as an active ingredient; the same query form in the same session returned one application for bremelanotide and fourteen for liraglutide, and returned nothing for a deliberately invented ingredient name [6].
On the section 503A bulks list FDA published May 14, 2026, GHRP-2 appears in Category 3 — the file for substances nominated without adequate support to evaluate — and in neither of the other two categories [7]. Category 3 is the least understood position on that document. It is not a safety finding, which is Category 2; it is not a permission to compound while review continues, which is Category 1. It records that the nomination submitted for the substance did not contain enough to review, and it confers nothing.
Under the separate section 503B policy governing outsourcing facilities, GHRP-2 for injectable and nasal routes of administration is in Category 2, added September 29, 2023. FDA states there that compounded drugs containing it may pose a risk for immunogenicity from aggregation and peptide-related impurities, that the substance contains an unnatural amino acid which adds to the complexity of peptide characterization, and that the agency is aware of reports of serious adverse events in patients who received GHRP-2 — increased insulin requirement, death of critically ill study subjects, infection and pancreatitis — with causality not established [8]. Neither list gives a pharmacy a route, and the two together are the whole federal position.
The substance was not among the seven peptides the advisory committee reviewed in July 2026, so nothing that happened at that meeting changed its file [7]. What is sold is therefore research-use-only material, and the labeling posture is the subject rather than an aside.
Elsewhere in this index
Filed under
- Research-onlyNo lawful route
- GH secretagogues6 molecules in this class
- The molecule indexEvery molecule, filterable by status and class
Evidence reviews
- Category 3: Nominated, Not ReviewedWhat does Category 3 of the FDA 503A bulks list actually mean?
- What the GHRP Trial Records MeasureDo the trial records for GHRP-2 and GHRP-6 support the uses the compounds are sold for?
Reference tables
- The 2026 recordWhat happened to United States peptide compounding law in 2026, in order?
- The nomination trackerWhat became of each peptide's nomination to the 503A bulks list?
- The human trial recordHow many human clinical trials exist for each peptide in this index?
- The WADA Prohibited ListWhich peptides in this index are prohibited in sport, and under which class?
Same class
- TesamorelinFDA-approved
- SermorelinCompoundable (503A)
- CJC-1295Nomination withdrawn
- IpamorelinNomination withdrawn
- GHRP-6No lawful route
References
- PubMed, National Library of Medicine. Census run 2026-09-01 across six name variants — "GHRP-2" OR "GHRP 2" OR "pralmorelin" OR "growth hormone releasing peptide-2" OR "growth hormone-releasing peptide 2" OR "KP-102" — returning 260 indexed records, 160 carrying the Humans MeSH term, 59 under "clinical trial"[Publication Type] and 43 under "randomized controlled trial"[Publication Type]. All 59 clinical-trial titles were retrieved through esummary and read. In the same run the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. Source
- Pihoker C, Kearns GL, French D, Bowers CY. Pharmacokinetics and pharmacodynamics of growth hormone-releasing peptide-2: a phase I study in children. J Clin Endocrinol Metab. 1998 Apr;83(4):1168-72. PMID 9543135
- Mericq V, Cassorla F, Salazar T, Avila A, Iñiguez G, Bowers CY, et al. Effects of eight months treatment with graded doses of a growth hormone (GH)-releasing peptide in GH-deficient children. J Clin Endocrinol Metab. 1998 Jul;83(7):2355-60. PMID 9661608
- Laferrère B, Hart AB, Bowers CY. Obese subjects respond to the stimulatory effect of the ghrelin agonist growth hormone-releasing peptide-2 on food intake. Obesity (Silver Spring). 2006 Jun;14(6):1056-63. PMID 16861611
- Chihara K, Shimatsu A, Hizuka N, Tanaka T, Seino Y, Katofor Y. A simple diagnostic test using GH-releasing peptide-2 in adult GH deficiency. Eur J Endocrinol. 2007 Jul;157(1):19-27. PMID 17609397
- US Food and Drug Administration, openFDA Drugs@FDA endpoint. Absence probe run 2026-09-01: a search by active-ingredient name returned no records for GHRP-2 or for pralmorelin. In the same run and the same query form, bremelanotide returned one application and liraglutide returned fourteen, and a deliberately invented ingredient name returned none — a positive and a negative control beside the zero. Source
- US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full 2026-09-01: GHRP-2 appears in Category 3 and in neither Category 1 nor Category 2. Source
- US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026. Read 2026-09-01: the Category 2 table lists Growth hormone releasing peptide-2 (GHRP-2) for injectable and nasal routes of administration under the 503B policy, date added September 29, 2023. Source