Regulatory record
Ipamorelin is not an approved drug. Anywhere. This is the record.
Status: never approved. Banned in sport, WADA S2. Compounding access restricted, 2024. A terse, cited reading of where a research peptide stands with regulators.

The short version
Ipamorelin is a lab-made peptide — a short chain of five amino acids. It tells the pituitary gland (a pea-sized gland under the brain) to release a pulse of growth hormone. Its claim to fame: it does this cleanly, without spiking stress hormones the way older peptides do.
Here is the part this page leads with. No government has ever approved ipamorelin as a medicine. Not the FDA, not anyone. It was tested in one human trial, for slow bowel recovery after surgery, and that trial did not work [3]. It is banned in sports [11]. In 2024 the FDA tightened the rules so compounding pharmacies can no longer freely make it. It is sold only as a "research chemical."
What people report and what the studies actually found — including the downsides — is on the effects page. Despite the word in this site's name, nothing is dosed, dispensed, or sold here.
Status, in one screen
FDA: not approved. No indication. The single Phase 2 trial (postoperative ileus, NCT00672074, n=114) missed its primary endpoint — time to first tolerated meal was 25.3 h with ipamorelin versus 32.6 h placebo, p=0.15 [3]. No Phase 3. No approved use anywhere.
Compounding: restricted. In September 2024 the nominator withdrew ipamorelin acetate, and the FDA removed it from Category 2 of the interim Section 503A bulk-substances list. The agency reviewed it at the October 29, 2024 Pharmacy Compounding Advisory Committee meeting. It is not an approved bulk substance for compounding.
Sport: prohibited at all times under the WADA Prohibited List, category S2 — a growth hormone secretagogue, detectable in urine [11]. Anti-doping labs have even cataloged modified street versions, including a glycine-tagged analog (Gly-Ipamorelin) found in seized material [9][10].
Supply: gray-market. Most available material is research-grade of variable purity from unregulated suppliers, with no pharmaceutical quality assurance.
What ipamorelin actually is
Ipamorelin (Aib-His-D-2-Nal-D-Phe-Lys-NH2) is a synthetic pentapeptide. It is a selective agonist of the GHS-R1a (the ghrelin receptor — the same switch the natural "hunger hormone" flips) on pituitary somatotrophs, the cells that store and release growth hormone. Activate the receptor, get a discrete GH pulse.
The defining trait is selectivity. In its founding 1998 characterization it released GH potently in rat pituitary cells, anaesthetised rats, and conscious swine (swine ED50 2.3 nmol/kg), yet did not raise ACTH or cortisol above the level seen with GHRH even at doses more than 200-fold above its GH ED50 [1]. That clean profile is the whole reason it exists, and the reason it gets paired with GHRH analogs such as CJC-1295, which release GH by a different, complementary route.
It is not the CJC-1295 + ipamorelin blend. This site is about ipamorelin, the single agent. The combination is covered where the research warrants — separately, and labeled as such. Full detail lives in the Ipamorelin research and on the Ipamorelin references page.
Why a regulatory digest, not a store
The marketing for ipamorelin runs far ahead of the evidence. Clinics and online sellers pitch anti-aging, fat loss, and muscle gain. The actual human record is one failed trial and one pharmacokinetic study [2][3]. Everything else is mechanism and short rodent work.
This page logs the gap plainly. Where a number exists, it is cited to the study that measured it. Where human data is absent — long-term safety, the popular subcutaneous protocols, the combination stacks — the line is left openly empty rather than filled with a guess. That is the honest shape of the record, and it is what a reader weighing the regulatory status deserves to see first.