FDA-Approved Peptides: The Complete List (2026)
10 min · 2026-05-15 · Ercle Editorial
A comprehensive, evidence-grounded list of every FDA-approved peptide and peptide-based drug — what it does, what it's approved for, and how it compares to the compounded versions circulating online.
This is the complete list of FDA-approved peptides as of 2026 — verified against FDA’s drug approval database, not marketing copy. FDA-approved peptides have cleared Phase III clinical trials, demonstrated safety through post-market surveillance, and met cGMP manufacturing standards. Most peptides marketed for longevity and performance have not cleared this bar. The ones below have.
Last verified: May 2026
Contents
- GLP-1 Receptor Agonists
- Growth Hormone Axis
- Metabolic / Endocrine
- Immune Modulation
- Pain / Neurology
- Sexual Function
- Notable Approved Peptides Outside Ercle’s Database
- Compounded vs. FDA-Approved: The Divide
- What FDA Approval Doesn’t Cover
- Bottom Line
What Qualifies as a Peptide Drug?
For this list: any FDA-approved therapeutic compound composed of 2–50 amino acid residues. This includes synthetic analogs of endogenous peptides, cyclic peptides, and stapled peptides. Insulin (51 residues in its two-chain form) and large protein biologics are excluded. GLP-1 analogs are included — they’re peptides.
The Approved List
GLP-1 Receptor Agonists
Semaglutide (Ozempic, Wegovy, Rybelsus) The defining peptide of the 2020s. FDA-approved for T2D (Ozempic, 2017), obesity (Wegovy, 2021), and oral T2D (Rybelsus, 2019). STEP trials: 15–17% body weight reduction. SELECT trial: 20% reduction in major cardiovascular events in non-diabetic overweight patients. Currently the most clinically consequential peptide in use. → Semaglutide profile
Tirzepatide (Mounjaro, Zepbound) FDA-approved for T2D (Mounjaro, 2022) and obesity (Zepbound, 2023). Dual GLP-1/GIP agonist. SURMOUNT-1: up to 22.5% body weight reduction — the highest in any Phase III peptide trial. Superior to semaglutide head-to-head in SURPASS-2. → Tirzepatide profile
Liraglutide (Victoza, Saxenda) FDA-approved for T2D (Victoza, 2010) and obesity (Saxenda, 2014). Daily SC injection; largely displaced by semaglutide’s once-weekly dosing, but LEADER trial (13% CV risk reduction) remains clinically important. → Liraglutide profile
Exenatide (Byetta, Bydureon BCise) The first FDA-approved GLP-1 agonist (Byetta, 2005), derived from Gila monster venom (Exendin-4). 53% sequence homology with human GLP-1 — higher immunogenicity than later agents. Historically significant; largely superseded clinically. → Exenatide profile
Dulaglutide (Trulicity) — FDA-approved 2014. Weekly GLP-1 agonist. REWIND trial showed CV benefit. Not currently in Ercle’s database.
Albiglutide (Tanzeum) — FDA-approved 2014, withdrawn 2018 (commercial, not safety reasons).
Lixisenatide (Adlyxin) — FDA-approved 2016, discontinued in the US 2017.
Growth Hormone Axis
Sermorelin (Geref) FDA-approved for pediatric growth hormone deficiency. Original indication for diagnostic use and short-stature treatment in children; the brand was withdrawn from market. Now widely compounded under 503A pharmacy rules for adult anti-aging and GH optimization. Compounding is legal but exists in a gray zone — Sermorelin remains on the 503A bulk substance list. → Sermorelin profile
Tesamorelin (Egrifta) FDA-approved for HIV-associated lipodystrophy (2010) — specifically abdominal fat accumulation in HIV patients on antiretroviral therapy. A GHRH analog. Compounded versions marketed for general fat loss are off-label and technically violate the clinical rationale for 503A use. → Tesamorelin profile
Metabolic / Endocrine
Pramlintide (Symlin) FDA-approved for T1D and T2D as an adjunct to mealtime insulin (2005). Synthetic amylin analog that slows gastric emptying, suppresses postprandial glucagon, and reduces appetite. Limited clinical adoption due to injection burden alongside insulin. → Pramlintide profile
Gonadorelin (Factrel, Lutrepulse) FDA-approved synthetic GnRH (gonadotropin-releasing hormone). Indicated for primary hypothalamic amenorrhea (pulsatile IV administration) and for diagnostic testing of pituitary function. Not approved for fertility treatment in the same way leuprolide is. Widely compounded. → Gonadorelin profile
Triptorelin (Trelstar, Triptodur) FDA-approved GnRH agonist for advanced prostate cancer (depot formulations). Also used off-label for endometriosis, precocious puberty, and female fertility preservation. Like all GnRH agonists, causes an initial testosterone surge before achieving castrate levels. → Triptorelin profile
Oxytocin (Pitocin, Syntocinon) FDA-approved for labor induction, augmentation of labor, and postpartum uterine atony. Intranasal oxytocin is not FDA-approved despite widespread interest in autism spectrum disorder and social cognition research. Compounded intranasal oxytocin exists in a regulatory gray zone. → Oxytocin profile
Immune Modulation
Thymosin Alpha-1 (Zadaxin) Not FDA-approved in the United States. Approved in 35+ countries (Italy, China) for hepatitis B, hepatitis C, and as an immune adjuvant. Listed here because it’s frequently mischaracterized as “FDA-approved” in US peptide marketing. In the US: unapproved, compounded under 503A — legal but operating on thin regulatory ground. → Thymosin Alpha-1 profile
Pain / Neurology
Ziconotide (Prialt) FDA-approved for severe chronic pain (2004) via intrathecal delivery only. Derived from cone snail venom (Conus magus). Non-opioid mechanism: blocks N-type calcium channels at the spinal cord level. Narrow therapeutic window; requires intrathecal pump. Not a compound you’ll find at a wellness clinic. → Ziconotide profile
Sexual Function
PT-141 / Bremelanotide (Vyleesi) FDA-approved for hypoactive sexual desire disorder (HSDD) in premenopausal women (2019). Melanocortin receptor agonist — acts centrally via MC4R, not on vascular tone like PDE5 inhibitors. Compounded versions are widely available and marketed for both men and women; the off-label male use has no FDA trial support. → PT-141 profile
Notable Approved Peptides Not in Ercle’s Database
These are FDA-approved but currently outside Ercle’s coverage scope:
| Peptide | Brand | Indication | Year |
|---|---|---|---|
| Insulin (lispro, aspart, glargine, etc.) | Humalog, NovoLog, Lantus | Diabetes | 1982+ |
| Glucagon | GlucaGen, Baqsimi | Hypoglycemia | 1960s |
| Octreotide | Sandostatin | Acromegaly, carcinoid | 1988 |
| Vasopressin | Vasostrict | Vasodilatory shock | — |
| Calcitonin (salmon) | Miacalcin | Osteoporosis, hypercalcemia | 1984 |
| Leuprolide | Lupron | Prostate cancer, endometriosis | 1985 |
| Buserelin | Suprefact | Prostate cancer | — |
| Cetrorelix | Cetrotide | Controlled ovarian stimulation | 1999 |
| Ganirelix | Orgalutran | Controlled ovarian stimulation | 1999 |
| Bivalirudin | Angiomax | Anticoagulation | 2000 |
| Eptifibatide | Integrilin | Acute coronary syndrome | 1998 |
| Icatibant | Firazyr | Hereditary angioedema | 2011 |
| Linaclotide | Linzess | IBS-C, CIC | 2012 |
| Plecanatide | Trulance | CIC, IBS-C | 2017 |
| Enfuvirtide | Fuzeon | HIV-1 infection | 2003 |
| Cyclosporine | Restasis, Sandimmune | Immunosuppression | 1983 |
The Compounded vs. Approved Divide
Most peptides discussed in longevity and performance circles — BPC-157, TB-500, GHK-Cu, AOD-9604, Epithalon, Semax, Dihexa — are not FDA-approved and never have been. They exist entirely under 503A compounding rules, research chemical suppliers, or outright unregulated sources.
FDA approval requires:
- Adequate and well-controlled clinical trials demonstrating efficacy for a specific indication
- Demonstrated safety with characterization of adverse events
- Defined manufacturing standards (cGMP) with lot-to-lot consistency
- Post-market surveillance obligations
Compounded peptides skip all of this. That doesn’t automatically make them ineffective or dangerous — but it does mean the evidence base is incomparably thinner, the purity is variable by source, and the legal framework for prescribing is narrow.
The honest position: FDA approval is a high bar that most peptides haven’t cleared because no sponsor has funded the trials — not necessarily because the compounds don’t work.
What “FDA-Approved” Doesn’t Cover
Even approved peptides have limits:
- Semaglutide is approved for obesity and T2D — not longevity, not muscle preservation, not neurodegeneration (despite active trials)
- PT-141 is approved for HSDD in premenopausal women — not men, not postmenopausal women
- Tesamorelin is approved for HIV lipodystrophy — not general abdominal fat or GH optimization
- Sermorelin brand is withdrawn; compounded versions operate under 503A rules with specific limitations
Off-label prescribing is legal and common. But it’s not the same as using a drug for its approved indication, and patients should understand the distinction.
Bottom Line
Fourteen peptides in Ercle’s database carry FDA approval for at least one indication. Dozens more exist in approved form for indications outside our current scope (diabetes, coagulation, HIV). The vast majority of peptides discussed in the longevity and performance space remain unapproved.
Use this list as a baseline for informed conversations with your prescriber — not as a shopping guide.
Research any peptide before you use it → Ercle Peptide Database
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