GHRP is short for “Growth Hormone Releasing Peptide” and is in the category of drugs known as Growth Hormone Secretagogues (GHS). These peptides actually stimulate the body’s natural release of the naturally occurring growth hormone (GH), primarily by stimulating the pituitary gland to produce more GH. The GHRPs of most interest are GHRP-2, GHRP-6, Hexarelin, and Ipamorelin. These GHS drugs differ in their receptor binding affinities and clinical effects.
Almost everyone can agree that they do not want to suffer the bodily decay associated with aging. Growing older is accepted as a natural part of our lives, so long as we still are able to feel and act youthful. This basic human desire is as old as mankind itself and has led many to search for the so called “Fountain of Youth” throughout human history. This age-old conundrum has spawned many industries, mostly legitimate, but some obviously a bit “shady”, that basically target our desire to maintain our youth. Recently, an increase has been taking place in the use of these Peptides medications and drugs (GHRP drugs) by anti-aging and men’s health clinics across the USA to achieve this end.
What is the Background and History of these GHRPs?
GHRPs were first described and documented in scientific literature in 1984, highlighting their GH releasing effects on human pituitary tissues. Soon after, studies identified many non-pituitary derived effects suggesting tissue specific receptors. GHRPs have been shown to be potent ghrelin receptor agonists. Ghrelin, a peptide hormone mainly secreted by the stomach, has been identified as the endogenous ligand of the GH secretagogue receptor (GHS-R) and has a potent GH releasing effect. In addition, ghrelin stimulates food intake and promotes an increase in body mass by a GH-independent action. All of this data suggests that ghrelin plays an important role in the regulation of an individual’s metabolic balance.
Additionally, early cell culture and animal studies identified non-GH related cytoprotective effects of GHRP that included cardioprotective effects with Hexarelin and GHRP-6, plus additional anti-inflammatory effects associated with GHRP-2. Other animal studies have linked the GHRPs with hepatoprotective effects as well. This class of drugs has demonstrated what’s been called “tantalizing potential” in numerous treatment areas, but so far there remains a lack of any conclusive efficacy and safety results derived from well designed human trials. Currently, GHRP6 and its synthetic analogs are only approved for uses in the clinical diagnosis of different forms of Dwarfism.
What are the Current Clinical Uses of GHRPs?
There is currently no approved therapeutic use of GHRPs in the United States. The anabolic and cytoprotective effects demonstrated in animal models, plus the anecdotal human use reports, have caught the attention of many with an interest in the body building and anti-aging arenas. A market for injectable GHRPs has rapidly grown with the incorporation of these drugs into men’s health clinics and websites. Many websites promote GHRPs to “help reduce undesirable symptoms of aging such as decreased libido, hormone imbalance, decreased metabolism, increased cholesterol and weight gain.” The prescribers in these clinics often order a combination of GHRPs customized to the client’s particular needs. These prescriptions /orders are often filled by compounding pharmacies that utilize bulk ingredients (APIs) in this process.
What Is the FDA’s Current View on GHRPs?
The FDA, although both being aware and concerned of this activity, had not, up until recently, taken any action. That has changed dramatically in the past few months. Recently, a few 503a pharmacies have received warning letters from the FDA regarding the compounding of Growth Hormone Releasing Peptide 2 (GHRP-2), Growth Hormone Releasing Peptide 6 (GHRP-6) and chromium picolinate (aka Peptides) as these APIs are (as stated in the FDA warning letter) “not the subject of an applicable USP or NF monograph, are not components of an FDA-approved human drug, and do not appear on the 503A bulks list.” In other words, the FDA is stating that these bulk ingredients are not FDA approved for human use as a drug and, therefore, are not permitted to be prescribed, compounded, or dispensed within the USA as such.
Most experts expect that the FDA will “ramp up” and increase their enforcement and subsequently expand the number of administrative actions taken against compounding pharmacies. So far there have been two FDA warning letters issued to date. The concern is that this can escalate to litigation and, potentially, consent decrees.
Who Can Help With GHRP Related Issues?
If your pharmacy compounds GHRP related drugs (aka Peptides), we urge you to contact Healthcare Consultants now to discuss both your risk exposure to FDA actions and the potential risk mitigation strategies that are available. Our team includes experts in sterile and non-sterile compounding, FDA law, and 503b cGMP.
About HealthCare Consultants
From major hospitals and healthcare systems to individual community pharmacies, HCC has been the nationally renowned pharmacy consultant firm of choice for over 29 years now. We work with businesses of every size – from the corner drug store to national corporations and organizations – with only one goal in mind: to improve your pharmacy’s business operations. We can assist with expert advice in any area of your pharmacy business or practice.
We urge you to contact us today to see how our Pharmacy Consulting services can help you improve your business now, plus be ready for the future. With a full-time staff of in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all pharmacy settings. Contact us online or call us today at 800-642-1652 for a free consultation.