The largest randomized GHRP-6 trial pepmg found missed its main goal. It gave the peptide intravenously, with EGF, to stroke patients for 7 days.

The trial

COURAGE-2: 188 stroke patients, 7 days of intravenous treatment

GHRP-6 is the hexapeptide His-D-Trp-Ala-Trp-D-Phe-Lys-NH2, a synthetic growth hormone-releasing peptide in the same family as GHRP-2 and Hexarelin .[5] The Center for Genetic Engineering and Biotechnology (CIGB) in Havana has developed it, combined with recombinant EGF, as a neuroprotective treatment for stroke.[3] The Cuban registry calls the product Serendictus.[2]

In COURAGE-2, a multicenter, randomized, open-label Phase III trial, adults within 12 hours of symptom onset and with NIHSS stroke scores of 5 to 20 received either standard care (93 patients) or standard care plus 75 µg of EGF and 5 mg of GHRP-6 intravenously, twice daily for 7 days (95 patients).[1] The trial hypothesized a 20% greater improvement in disability at six months, measured on the modified Rankin scale (mRS).[1] Patients averaged 63.5 years, 110 of the 188 were men, the mean baseline NIHSS score was 9.5, and treatment started on average 7.3 hours after symptoms began.[1]

The positive findings are narrower. In 27 patients with severe strokes (NIHSS 15 or more), the treated group's six-month mRS was 2.6 (95% CI 1.3 to 3.8) against 4.7 (2.6 to 6) in controls, p = 0.03, and the mortality hazard ratio was 0.18 (0.03 to 0.96), p = 0.045.[1] Treated patients with strokes in the middle cerebral artery territory had a greater reduction in infarct volume at 30 days, p = 0.041, and the authors report similar results with an NIHSS threshold of 12.[1] The abstract does not give the subgroup's split between arms or say whether it was planned in advance, and the English registry record pepmg read does not mention a severity subgroup.[1][2] The authors conclude that the result "suggested potential benefit in moderate-to-severe stroke, warranting further studies."[1]

Safety leaned the other way numerically. The abstract reports severe adverse events in 48 of the 188 patients: 30 of 95 treated patients and, by subtraction, 18 of 93 controls, an odds ratio of 1.92 with a 95% confidence interval of 0.981 to 3.767, which includes no difference.[1] The authors judged none of them treatment-related.[1]

Several authors are CIGB researchers, which the paper declares as a potential competing interest.[1] The registry record, registered March 14, 2019, lists a target of 220 patients, against 188 reported, and a primary outcome of mRS at discharge and at 1, 3, 6 and 12 months; the abstract reports results at 3 and 6 months.[2][1] The record still shows recruitment as "Pending" and was last verified in October 2020.[2] The full paper is paywalled, so pepmg read only the abstract.

The trial before it

36 patients, a safety endpoint and a dose that changed

The Phase I/II trial behind COURAGE-2 ran from July 2017 to January 2018 in 11 Cuban hospitals. It assigned 10 patients to EGF plus 3.5 mg GHRP-6, 10 to EGF plus 5 mg GHRP-6, and 16 to standard care, with treatment twice daily for 7 days. Its primary endpoint was safety over six months.[3] Serious adverse events occurred in 9 of 16 controls, 3 of 10 in the lower-dose group and 2 of 10 in the higher-dose group, and the authors reported better neurological and functional outcomes in the treated groups as secondary findings.[3] There were seven deaths in the control group, two in the 5 mg group and none in the 3.5 mg group, all judged unrelated to the study drugs.[3]

Two details limit that trial. The paper reports a protocol deviation: the first six patients missed the treatment window and were put in the control group, against a planned 10 patients per group.[3] And the registry record pepmg read on November 3 lists the higher dose as 7.0 mg of GHRP-6 and a target of 30 patients, while the paper reports 5 mg and 36 patients.[4][3] The trial's GHRP-6 was synthesized by a Barcelona company the paper names as BCN peptide and formulated as a lyophilized intravenous preparation at CIGB.[3]

Other human data

Mostly single doses and hormone tests

A PubMed search for GHRP-6 in human studies tagged as clinical trials returned 40 records, published from 1994 to 2013.[11] Most of their titles describe growth hormone and adrenal hormone responses to GHRP-6 in healthy people and in patients with pituitary, adrenal, thyroid or metabolic conditions. ClinicalTrials.gov listed no study for GHRP-6 or GHRP6 on November 3, 2026.[12]

The best-known clinical use was diagnostic. In a 2000 Lancet study of 125 adults with pituitary disease and 125 healthy controls, one intravenous dose of GHRH (1 µg/kg) plus GHRP-6 (1 µg/kg) produced mean growth hormone peaks of 59.2 µg/L in controls and 4.1 µg/L in patients, with no reported side effects; the authors proposed it as a test for adult growth hormone deficiency.[6]

In nine healthy men given single intravenous doses of 100, 200 and 400 µg/kg, GHRP-6 had a distribution half-life of 7.6 minutes and an elimination half-life of about 2.5 hours; four of the nine showed what the authors call atypical concentration spikes during elimination.[5] Route matters. Oral GHRP-6 at 300 µg/kg raised growth hormone in 7 children with short stature, but the same oral dose in young men left growth hormone, ACTH and cortisol unchanged overnight, while 30 µg/kg intranasally raised growth hormone.[9][8]

GHRP-6 does more than release growth hormone. In a placebo-controlled study in healthy men, four intravenous boluses of 50 µg raised overnight ACTH and more than doubled mean cortisol from 22.00 to 03.00 h, 56.0 versus 25.2 ng/mL.[7] pepmg did not find a published controlled trial of GHRP-6 alone given for weeks for body composition in its PubMed searches. The closest is a 2017 retrospective chart review: of 105 men on testosterone who had been prescribed 100 µg of GHRP-6, GHRP-2 and Sermorelin three times daily, 14 met its strict inclusion criteria, and their mean IGF-1 rose from 159.5 to 239.0 ng/mL over a mean of 134 days.[10] With three secretagogues given together and no control group, it cannot show the effect of GHRP-6.

Status

Not approved, flagged by FDA and left out of the HHS policy

pepmg found no GHRP-6 product in Drugs@FDA, searched through openFDA on November 3, 2026.[16] FDA's NDC directory has one GHRP-6 acetate bulk ingredient listing, from Pure Peptide Pharmaceuticals with a marketing start date of May 1, 2026.[15] FDA says assignment of an NDC number "does not in any way denote FDA approval of the product."[21]

FDA's page on bulk substances that may present significant safety risks lists GHRP-6 under section 503B, the outsourcing-facility pathway, as of September 29, 2023. It says compounded GHRP-6 "may pose risk for immunogenicity for certain routes of administration" and that the limited available data "reveal safety concerns including potential effect on cortisol and increase in blood glucose due to decreases in insulin sensitivity."[13] On FDA's separate 503A nominations list, updated May 14, 2026, GHRP-6 is in category 3, "Bulk Drug Substances Nominated Without Adequate Support."[14]

The HHS enforcement discretion policy published October 30, 2026 covers BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. GHRP-6 is not among them.[17][18][19] pepmg did not check USP monograph status or the 503B nominations list.

The market

5 mg and 10 mg vials, not the trial product

pepmg's November 2, 2026 index shows GHRP-6 at 22 vendors in 32 listings. Seventeen are 10 mg, three of them blends, and 12 are 5 mg.[20] None is the CIGB combination tested in COURAGE-2, which was given intravenously in hospital with EGF.[1][3] The stroke trials and the hormone studies report doses for their own populations and routes. They do not show what a research-shelf vial contains or what it does in a healthy person.

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