Unapproved; reviewed by FDA pcac in 2026
BPC-157 (free base/acetate)
What it is
Marketed for gut, tendon or wound healing. FDA evaluated ulcerative-colitis
claims; there is no FDA-approved BPC-157 product.
Known risks
Unknown human safety, immunogenicity and impurity/aggregation risk. FDA staff
found insufficient characterization, safety and efficacy support; adverse reports
do not prove causality.
Unapproved; reviewed by FDA pcac in 2026
TB-500 / thymosin-beta-4 fragments
What it is
Marketed for wound or musculoskeletal healing. TB-500 products may not be
chemically identical to full thymosin beta-4.
Known risks
FDA identified absence of human clinical exposure data for the nominated
substances and potential injectable immunogenicity/quality risks.
Unapproved; reviewed by FDA pcac in 2026
KPV
What it is
Alpha-MSH-derived tripeptide marketed for inflammation, gut or skin conditions.
Known risks
FDA staff found no human PK/PD, exposure or clinical studies; safety and
immunogenicity are unknown.
Unapproved; reviewed by FDA pcac in 2026
MOTS-c
What it is
Mitochondrial-derived peptide marketed for metabolism, exercise, obesity or
longevity.
Known risks
FDA staff found no human clinical exposure studies for the nominated substances;
systemic and long-term risks are unknown.
Unapproved; reviewed by FDA pcac in 2026
Semax
What it is
ACTH-derived peptide marketed for cognition, migraine or neuroprotection.
Known risks
Unknown product quality and long-term safety; FDA staff noted possible
antithrombotic properties as a bleeding concern and limited human PK data.
Unapproved
Selank
What it is
Peptide marketed for anxiety, cognition or stress; no FDA-approved product.
Known risks
Human evidence, interactions, dosing reliability and long-term safety are
insufficient; compounded/online quality is uncertain.
Unapproved; reviewed by FDA pcac in 2026
Epitalon
What it is
Tetrapeptide marketed for sleep, aging or “telomere” effects.
Known risks
FDA staff found no adequate human PK or clinical safety evidence; cancer,
endocrine and long-term risks are unknown.
Unapproved; reviewed by FDA pcac in 2026
Emideltide / DSIP
What it is
“Delta sleep-inducing peptide” marketed for sleep or withdrawal.
Known risks
Reported transient headache, nausea and vertigo; hypotension occurred in older IV
research. Subcutaneous safety is not established.
503a category 1 for non-injectable routes: not FDA approved
GHK-Cu
What it is
Copper-binding tripeptide marketed for skin/hair or wound care. FDA’s Category 1
entry applies only to non-injectable routes and means “under evaluation,” not
approval.
Known risks
Irritation, allergy and uncertain absorption/quality; injectable use is outside
the Category 1 entry and has additional infection/immunogenicity risk.
Unapproved
CJC-1295 (with or without DAC)
What it is
Long-acting GHRH analogue marketed to raise growth hormone/IGF-1; chemical
versions differ.
Known risks
Edema, joint/carpal-tunnel symptoms, glucose intolerance, headache, possible
intracranial hypertension and theoretical tumor-growth risk; product purity is
uncertain.
503b category 2: may present significant safety risks; unapproved
Ipamorelin
What it is
Growth-hormone secretagogue peptide marketed for recovery, sleep or body
composition.
Known risks
Unknown long-term safety/quality; possible edema, headache, glucose effects,
increased appetite and GH/IGF-1-related risks.
503b category 2: may present significant safety risks; unapproved (ghrp-2:
injectable and nasal routes)
GHRP-2 and GHRP-6
What it is
GH secretagogue peptides marketed for growth, appetite, recovery or body
composition.
Known risks
Insufficient nomination support; possible glucose, appetite, edema and endocrine
effects plus injectable quality/immunogenicity risks.
No current FDA-approved product; historical products discontinued
Sermorelin
What it is
GHRH analogue marketed by peptide clinics for GH deficiency, sleep or anti-aging.
Known risks
GH/IGF-1-related risks, injection reactions and uncertain compounded quality;
“formerly approved” is not the same as a currently approved product.
No current FDA-approved product; historical products discontinued
Gonadorelin
What it is
Synthetic gonadotropin-releasing hormone (GnRH) peptide; the human products once
approved by the FDA are discontinued, and products sold today are not an approved
medicine.
Known risks
Content, purity and long-term safety of the products sold today are unknown;
effects on reproductive hormones, injection reactions and hypersensitivity belong
with the care team.
Unapproved
Hexarelin
What it is
Synthetic growth hormone–releasing peptide (research code EP-23905; FDA substance
name examorelin). There is no FDA-approved product, and products sold today are
not an approved medicine.
Known risks
Content, purity and long-term safety of the products sold today are unknown;
effects on hormones and blood sugar, injection reactions and hypersensitivity
belong with the care team.
503a category 1: under evaluation; not FDA approved
NAD+ (injection or IV infusion)
What it is
Nicotinamide adenine dinucleotide (NAD, coenzyme I), a coenzyme found widely in
nature that carries electrons in many enzyme reactions; given from compounding
pharmacies or clinics as an injection or IV infusion, not as an FDA-approved
product. Not the same as oral NAD+ precursor supplements.
Known risks
Injection and infusion reactions, sterility and quality of compounded products;
any new symptom during or after an infusion belongs with the care team.
Unapproved
AOD-9604 / hGH fragment 176–191
What it is
Growth-hormone fragment marketed for fat loss.
Known risks
Human long-term safety, endocrine effects, impurities and dosing reliability are
uncertain.
Unapproved
IGF-1 LR3
What it is
Long-acting IGF-1 analogue marketed for muscle growth or recovery; distinct from
FDA-approved mecasermin.
Known risks
Potential severe hypoglycemia, edema, organ/tissue growth and tumor-related risk;
product purity and potency are unknown.
503a category 3 for mgf; unapproved
MGF / PEG-MGF
What it is
IGF-1 splice-product fragments marketed for muscle/tendon repair.
Known risks
Unknown systemic, growth-promoting, glucose, immunogenicity and impurity risks.
Unapproved in the united states
Thymosin alpha-1 / thymalfasin
What it is
Immune-modulating peptide approved in some countries and marketed for infection,
cancer support or “immune optimization.”
Known risks
Fever/flu-like symptoms, immune effects, interactions and injectable quality risk;
long-term safety for wellness use is unclear.
503a category 2: significant safety concerns; unapproved
Kisspeptin-10
What it is
Reproductive-neuroendocrine peptide marketed for fertility, testosterone or
libido.
Known risks
FDA identified significant safety concerns for compounding; endocrine
overstimulation, pregnancy/fertility consequences and unknown product quality are
concerns.
503a and 503b category 2: may present significant safety risks; unapproved: not a
peptide
Ibutamoren (MK-677)
What it is
Oral ghrelin-receptor agonist often sold as a “peptide” for GH release, sleep or
muscle gain.
Known risks
FDA identified significant safety concerns; appetite/weight gain, edema, glucose
intolerance and other GH/IGF-1-related risks are concerns.
503a category 1: under evaluation; not FDA approved
Vasoactive intestinal peptide / aviptadil
What it is
Neuropeptide marketed or studied for pulmonary/inflammatory uses.
Known risks
Low blood pressure, flushing, diarrhea, tachycardia and unknown inhaled/injectable
quality or immunogenicity.
503a category 3: unapproved
Cibinetide / ARA-290
What it is
Erythropoietin-derived tissue-protective peptide studied for
neuropathy/inflammation.
Known risks
Insufficient information for FDA to evaluate the compounding nomination;
long-term, immune and product-quality risks are unknown.
503a category 3: unapproved
Thymulin acetate
What it is
Thymic peptide marketed for immune or inflammatory conditions.
Known risks
Insufficient supporting information; endocrine/immune, infection and injectable
quality risks are unknown.
Unapproved
LL-37
What it is
Antimicrobial host-defense peptide marketed for infection, immunity or wound
healing.
Known risks
Can be pro-inflammatory/cytotoxic; systemic effects, immune reactions, impurities
and dosing are not established.
Unapproved
Melanotan II
What it is
Melanocortin analogue sold for tanning or sexual effects; not the same as approved
afamelanotide or bremelanotide products.
Known risks
Nausea, flushing, spontaneous erections/priapism, BP/HR effects and
darkening/changing moles; counterfeit/impurity risk.
Unapproved
Follistatin products / gene-peptide mixtures
What it is
Marketed to inhibit myostatin and increase muscle.
Known risks
Unknown potency, immune/tumor/reproductive effects and irreversible risks for
gene-based products; contamination risk.
Experimental / unapproved
PNC-27, humanin and FOXO4-DRI
What it is
Research peptides marketed online for cancer killing, mitochondrial health or
senolysis/longevity.
Known risks
Human dose, distribution, interactions, immune effects, cancer risk and
manufacturing quality are unknown.
503a category 1: under evaluation; not blanket FDA approval
Glutathione (tripeptide), compounded routes
What it is
Antioxidant tripeptide marketed for wellness, skin lightening or respiratory uses;
approved-drug status and compounding status depend on product/route.
Known risks
Route-specific allergy, bronchospasm, infection/contamination and impurity risks;
IV/inhaled use needs medical oversight.
Unapproved: on the FDA list of bulk drug substances that may present significant
safety risks
Dihexa
What it is
Warning-only entry. No FDA-approved product; listed by FDA as “Dihexa acetate”
among bulk drug substances for compounding that may present significant safety
risks. Kept in the catalog only so that a patient can name it and Aiden can track
it neutrally with its source.
Known risks
FDA has not identified any human exposure data on drug products containing dihexa
acetate administered via any route of administration, and lacks important
information regarding any safety issues, including whether it would cause harm if
administered to humans. Product purity and quality are unknown.
Unapproved: sarm; cannot be legally marketed as a dietary supplement or drug
(FDA)
Ostarine / enobosarm (MK-2866)
What it is
Selective androgen receptor modulator (SARM), sold online as MK-2866 or enobosarm
to build muscle mass and strength, often as a “dietary supplement” or “for
research use only”. Ostarine has been authorized for investigation as a new drug,
so FDA treats a product containing it as an unapproved new drug, not a dietary
supplement.
Known risks
FDA: life-threatening reactions, including liver injuries that required
hospitalization; SARMs also have the potential to cause increased risk of heart
attack or stroke, psychosis/hallucinations, sleep disturbances, sexual
dysfunction, liver injury and acute liver failure, infertility, pregnancy
miscarriage and testicular shrinkage. Products are often sold without any warning;
content and purity are unknown.
Unapproved: sarm; cannot be legally marketed as a dietary supplement or drug
(FDA)
Ligandrol (LGD-4033)
What it is
Selective androgen receptor modulator (SARM), sold online as LGD-4033 to build
muscle mass and strength, often as a “dietary supplement” or “for research use
only”. FDA warning letters call products marketed this way unapproved new drugs.
Known risks
FDA: life-threatening reactions, including liver injuries that required
hospitalization; SARMs also have the potential to cause increased risk of heart
attack or stroke, psychosis/hallucinations, sleep disturbances, sexual
dysfunction, liver injury and acute liver failure, infertility, pregnancy
miscarriage and testicular shrinkage. Products are often sold without any warning;
content and purity are unknown.
Unapproved: sarm; cannot be legally marketed as a dietary supplement or drug
(FDA)
Testolone (RAD-140)
What it is
Selective androgen receptor modulator (SARM), sold online as RAD-140 to build
muscle mass and strength, often as a “dietary supplement” or “for research use
only”. FDA warning letters call products marketed this way unapproved new drugs.
Known risks
FDA: life-threatening reactions, including liver injuries that required
hospitalization; SARMs also have the potential to cause increased risk of heart
attack or stroke, psychosis/hallucinations, sleep disturbances, sexual
dysfunction, liver injury and acute liver failure, infertility, pregnancy
miscarriage and testicular shrinkage. Products are often sold without any warning;
content and purity are unknown.
Unapproved: sarm; cannot be legally marketed as a dietary supplement or drug
(FDA)
Andarine (S-4)
What it is
Selective androgen receptor modulator (SARM), sold online as S-4 to build muscle
mass and strength, often as a “dietary supplement” or “for research use only”. FDA
warning letters call products marketed this way unapproved new drugs; FDA also
found andarine in a product labeled as a dietary supplement.
Known risks
FDA: life-threatening reactions, including liver injuries that required
hospitalization; SARMs also have the potential to cause increased risk of heart
attack or stroke, psychosis/hallucinations, sleep disturbances, sexual
dysfunction, liver injury and acute liver failure, infertility, pregnancy
miscarriage and testicular shrinkage. Products are often sold without any warning;
content and purity are unknown.
Unapproved: sarm; cannot be legally marketed as a dietary supplement or drug
(FDA)
YK-11
What it is
Substance sold online among SARMs (sellers also call it a “myostatin inhibitor”)
to build muscle mass and strength, often as a “dietary supplement” or “for
research use only”. FDA warning letters call products marketed this way unapproved
new drugs.
Known risks
FDA: life-threatening reactions, including liver injuries that required
hospitalization; SARMs also have the potential to cause increased risk of heart
attack or stroke, psychosis/hallucinations, sleep disturbances, sexual
dysfunction, liver injury and acute liver failure, infertility, pregnancy
miscarriage and testicular shrinkage. Products are often sold without any warning;
content and purity are unknown. FDA tested a bodybuilding product that listed
YK-11 after a report of a stroke in a person who used it; the product also
contained an undeclared anabolic steroid.
Unapproved new drug (FDA): not a sarm, sold with sarms
Cardarine (GW501516)
What it is
Not a SARM, but sold online with them as “Cardarine GW501516” for fat loss and
energy, often “for research use only”. FDA warning letters list it among products
marketed as SARMs and call them unapproved new drugs; no FDA-approved product
contains it.
Known risks
No FDA-approved product and no FDA review of its safety. FDA lists it among
products marketed as SARMs, about which FDA has safety concerns: life-threatening
reactions, including liver toxicity, and a potential increased risk of heart
attack and stroke. Product content and purity are unknown.