Peptide Registry

Semaglutide (NN9535) is a long-acting synthetic GLP-1 receptor agonist sharing 94% sequence homology with human GLP-1. In FDA-approved products, it is marketed as Ozempic (T2D glycemic control, MACE, and CKD progression reduction), Wegovy injection & tablets (chronic weight management, MACE reduction, and accelerated approval for noncirrhotic MASH with F2–F3 fibrosis), and Rybelsus (oral T2D glycemic control and MACE). The FDA semaglutide shortage ended in February 2025; compounded semaglutide formulations are not FDA-approved.

Tirzepatide (LY3298176) is a synthetic dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. In FDA-approved drug products, it is marketed as Mounjaro (for type 2 diabetes mellitus in adults and pediatric patients aged 10 years and older) and Zepbound (for chronic weight management in qualifying adults, and for moderate-to-severe obstructive sleep apnea in adults with obesity). FDA shortage-based mass-compounding enforcement discretion ended in early 2025; compounded or 'research-grade' tirzepatide formulations are not FDA-approved.

Body Protection Compound-157 (BPC-157; PL-14736) is a synthetic pentadecapeptide reported to be a fragment of a protective gastric protein. It has been investigated primarily in cell culture and animal models of gastrointestinal injury, wound healing, and musculoskeletal repair. BPC-157 is not FDA-approved for any indication. On July 23, 2026, the FDA Pharmacy Compounding Advisory Committee (PCAC) voted 8–6 (with 1 abstention) to recommend adding BPC-157 free base and acetate to the Section 503A Bulk Drug Substances List (contrary to FDA staff recommendations); final FDA rulemaking remains pending. Published human clinical evidence is limited to small exploratory studies and meeting abstracts.

Thymosin Alpha-1 (Tα1; generic name thymalfasin) is a synthetic 28-amino-acid immunomodulatory peptide corresponding to endogenous Tα1. It is authorized in select foreign countries (e.g., Italy as an influenza vaccine adjuvant in immunocompromised adults) under brand names like Zadaxin. It is not FDA-approved in the United States. In December 2024, the FDA Pharmacy Compounding Advisory Committee (PCAC) voted 4–17 against adding Tα1 free base or acetate to the Section 503A Bulk Drug Substances List; compounding nominations were subsequently withdrawn due to safety risks (peptide aggregation, impurities, immunogenicity) and inconsistent clinical evidence.

CJC-1295 is a synthetic 29-amino-acid analog of growth hormone-releasing hormone (GHRH). It exists as two distinct chemical moieties: a short-acting non-DAC peptide (Modified GRF 1-29) and a long-acting derivative conjugated with a Drug Affinity Complex (DAC) that binds serum albumin. CJC-1295 is not FDA-approved for any indication. In December 2024, the FDA Pharmacy Compounding Advisory Committee (PCAC) voted overwhelmingly against adding CJC-1295 substances to the Section 503A Bulk Drug Substances List; compounding nominations were subsequently withdrawn due to safety risks (systemic vasodilatory reactions, heart rate elevation, immunogenicity) and lack of established clinical efficacy.

Ipamorelin (NNC 26-0161) is a synthetic pentapeptide agonist of the ghrelin/growth-hormone secretagogue receptor GHSR-1a. It was evaluated in historical Phase 2 clinical trials for postoperative gastrointestinal recovery following bowel resection, which failed to demonstrate statistically significant efficacy over placebo. Ipamorelin is not FDA-approved for any indication. In October 2024, the FDA Pharmacy Compounding Advisory Committee (PCAC) voted 0–12 against adding ipamorelin free base or acetate to the Section 503A Bulk Drug Substances List, and ipamorelin acetate remains in FDA 503B Category 2 reflecting safety concerns.

TB-500 is a synthetic N-acetylated heptapeptide fragment (residues 17–23: Ac-LKKTETQ-OH) corresponding to the active actin-binding domain of Thymosin Beta-4, distinct from the full-length 43-amino-acid protein (Tβ4). TB-500 is not FDA-approved for any indication. On July 23, 2026, the FDA Pharmacy Compounding Advisory Committee (PCAC) voted 8–6 (with 1 abstention) to recommend adding TB-500 free base and acetate to the Section 503A Bulk Drug Substances List (contrary to FDA staff recommendations); final FDA rulemaking remains pending. Neither human clinical trials nor human pharmacokinetic datasets exist for Ac-LKKTETQ-OH.

Retatrutide (LY3437943) is an investigational, synthetic unimolecular triple agonist targeting the glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), and glucagon (GCG) receptors. Developed by Eli Lilly and Company, it is in Phase 3 clinical trials (TRIUMPH and TRANSCEND programs) for obesity, type 2 diabetes, obstructive sleep apnea, and knee osteoarthritis. Retatrutide is not FDA-approved for any indication, and Lilly plans a U.S. BLA submission in Q1 2027. Under federal law, unapproved retatrutide cannot be used in compounding.

PT-141 (bremelanotide) is a synthetic cyclic heptapeptide analog of α-melanocyte-stimulating hormone (α-MSH). It functions as a non-selective melanocortin receptor agonist (MC1R–MC5R). Bremelanotide is FDA-approved specifically under the brand name Vyleesi (1.75 mg SC autoinjector) for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It is not FDA-approved for men, postmenopausal women, general sexual performance enhancement, or as unapproved compounded preparations.

Selank is a synthetic heptapeptide (Thr-Lys-Pro-Arg-Pro-Gly-Pro) derived from the immunopeptide tuftsin with a C-terminal Pro-Gly-Pro sequence to retard enzymatic degradation. Developed by the Institute of Molecular Genetics of the Russian Academy of Sciences, it is approved in Russia as a 0.15% intranasal anxiolytic solution (LSR-003338/09). Selank is not FDA-approved in the United States, and its 503A bulk compounding nomination for Selank acetate (TP-7) was withdrawn following FDA concerns regarding peptide aggregation, impurities, and immunogenicity.

GHK-Cu is an endogenous copper-binding tripeptide (Gly-His-Lys) present in human plasma and saliva. In preclinical models, GHK-Cu modulates extracellular matrix remodeling, collagen synthesis, and gene expression. GHK-Cu is not FDA-approved. Under FDA's interim compounding policy, non-injectable (topical) GHK-Cu is listed in 503A Category 1 under enforcement discretion; however, injectable (subcutaneous) GHK-Cu is explicitly EXCLUDED from Category 1 following nomination withdrawal and FDA concerns regarding peptide aggregation, impurities, and immunogenicity.

Epithalon (Epitalon) is a synthetic tetrapeptide (Ala-Glu-Asp-Gly) conceptually derived from Epithalamin, a crude bovine pineal gland extract. Preclinical models report telomerase activation, antioxidant upregulation, and melatonin modulation in vitro. Epithalon is not FDA-approved. On July 24, 2026, the FDA Pharmacy Compounding Advisory Committee (PCAC) voted 7–4 to recommend adding Epitalon-related bulk substances to the Section 503A Bulk Drug Substances List (contrary to FDA staff recommendations); final FDA rulemaking remains pending. (Note: Historical geriatric survival studies evaluated crude Epithalamin extract, not synthetic Epitalon.)

Delta Sleep-Inducing Peptide (DSIP, Emideltide) is a synthetic nonapeptide studied historically for sleep architecture and substance withdrawal. Nonclinical research suggests neuromodulatory and opioid-mediated mechanisms, but specific human molecular targets remain unconfirmed. DSIP is not FDA-approved. On July 24, 2026, the FDA Pharmacy Compounding Advisory Committee (PCAC) voted 6–7 (with 1 abstention) against recommending emideltide free base or acetate for inclusion on the Section 503A Bulk Drug Substances List due to weak analytical characterization, unestablished effectiveness, and absent safety datasets.

Melanotan II (MT-II) is a synthetic, lactam-bridged, cyclic heptapeptide analog of endogenous alpha-melanocyte-stimulating hormone (α-MSH). It acts as a non-selective agonist at melanocortin receptors (MC1R, MC3R, MC4R, MC5R). Early small pilot studies evaluated subcutaneous MT-II for skin pigmentation and psychogenic erectile dysfunction. MT-II is not FDA-approved for any indication, and its compounding nomination was withdrawn after placement on FDA's list of bulk substances presenting potential safety risks (Category 2). (Note: The FDA-approved drug for Erythropoietic Protoporphyria is Afamelanotide / Scenesse / Melanotan-I, not Melanotan II.)

AOD-9604 is a synthetic 16-amino-acid peptide fragment corresponding to C-terminal residues 177–191 of human growth hormone (hGH) with an added N-terminal tyrosine residue. Originally developed for obesity management to stimulate lipolysis without hGH-mediated diabetogenic or growth effects, human clinical trials failed to establish efficacy. The pivotal 502-participant 24-week OPTIONS trial found no statistically significant weight loss over placebo. In December 2024, the FDA Pharmacy Compounding Advisory Committee (PCAC) voted unanimously (12–0) against placing AOD-9604 free base or acetate on the Section 503A Bulk Drug Substances List. AOD-9604 is not FDA-approved and lacks human subcutaneous safety or pharmacokinetic datasets.

LL-37 is the 37-amino-acid amphipathic C-terminal active fragment cleaved from the human cathelicidin precursor protein hCAP-18. Serving as a component of innate mucosal immunity, it exhibits broad-spectrum antimicrobial activity, biofilm disruption, and immunomodulatory signaling in vitro. Human clinical development is limited to investigational topical formulations for chronic wound healing (such as venous leg ulcers and diabetic foot ulcers), where Phase 1/2 trials have shown mixed results. LL-37 is not FDA-approved, has no established 503A compounding eligibility, and lacks systemic human safety or pharmacokinetic data.

Dihexa is an experimental synthetic angiotensin-IV-derived peptidomimetic studied in cell and animal models of cognitive impairment and neural injury. It is not FDA-approved, has no established federal 503A compounding authorization, and has not been evaluated in controlled human clinical trials. Its proposed HGF/c-Met signaling mechanism remains uncertain because the primary 2014 mechanistic paper was formally retracted in 2025, while the foundational 2013 pharmacology paper carries a PubMed Expression of Concern. There are no established human doses, administration routes, or clinical safety profiles.

MOTS-c is a 16-amino-acid mitochondrial-derived peptide (MDP) encoded within the 12S rRNA region of the mitochondrial genome. In preclinical models, it acts as a stress-responsive nuclear signaling molecule regulating metabolic homeostasis. On July 24, 2026, the FDA Pharmacy Compounding Advisory Committee (PCAC) voted 7–5 (with 2 abstentions) to recommend adding MOTS-c to the Section 503A Bulk Drug Substances List; however, this advisory vote is non-binding and MOTS-c remains an unapproved drug in the United States pending formal FDA rulemaking. A Phase 2a clinical trial in prediabetes and obesity is actively recruiting (NCT07505745), but human efficacy and safety data for native MOTS-c have not been published.

Semax is a synthetic heptapeptide derived from the ACTH(4-7) fragment (Met-Glu-His-Phe) with a C-terminal Pro-Gly-Pro (PGP) tripeptide attached to enhance metabolic stability. Devoid of adrenal or hormonal activity, Semax is registered in Russia as a prescription intranasal medication (0.1% solution for cognitive/ocular conditions; 1.0% for acute ischemic stroke). While preclinical animal studies demonstrate neurotrophic and gene expression effects, Semax remains an unapproved drug in the United States. On July 24, 2026, the FDA Pharmacy Compounding Advisory Committee (PCAC) voted 8–5 to recommend adding Semax free base and acetate to the 503A Bulk Drug Substances List; however, this non-binding recommendation has not yet been adopted by the FDA into formal rulemaking.

Liraglutide is a synthetic acylated human glucagon-like peptide-1 (GLP-1) receptor agonist sharing 97% sequence homology with native human GLP-1. Engineered with a C-16 fatty acid (palmitic acid) attached via a glutamic acid spacer at Lys26, it binds extensively to serum albumin and resists DPP-4 degradation, enabling once-daily subcutaneous administration (~13-hour half-life). As a first-generation GLP-1 agonist requiring daily dosing, it precedes newer weekly single and multi-receptor agonists (such as Semaglutide, Tirzepatide, and Retatrutide). It is FDA-approved under two distinct brand names: Victoza (for type 2 diabetes in patients ≥10 years old, and major adverse cardiovascular event reduction in adults with T2D and established CVD) and Saxenda (for chronic weight management in adults and pediatric patients ≥12 years weighing >60 kg). The first generic liraglutide (referencing Victoza) was FDA-approved in December 2024. Investigational human trials have explored liraglutide in NASH/MASH, Parkinson's disease, and Alzheimer's disease, though it is not FDA-approved for these conditions.