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Approval Is Indication-Specific
FDA-approved peptide medicine directory
A transparent, scope-defined reference to peptide-based medicines with U.S. FDA-approved products. Approval applies only to the product’s labeled indication, formulation and route—not to generalized “anti-aging,” performance or wellness claims.
2025–2026 semaglutide changes now reflected
The directory now recognizes Wegovy’s adult oral tablet formulation, its accelerated-approval MASH indication for eligible adults using the injection, and the March 2026 approval of Wegovy HD 7.2 mg for certain adults. Exact product, route, dose and indication still control.
Directory Methodology
Why this directory defines its scope
The FDA databases classify products by application and active ingredient—not by one universal “peptide” tag. Scientific databases also disagree about where a peptide ends and a protein begins. This directory includes peptide and peptide-analog active ingredients with clear outpatient clinical relevance; it groups insulins as one class, excludes antibodies and most large therapeutic proteins, and does not imply that every product is currently marketed. That methodology is more accurate than claiming an undefined “complete list.”
Metabolic
Endocrine & Bone
Reproductive
Gastrointestinal
Cardio & Blood
Neurology & Rare Disease
Quantitative Examples
What “efficacy” looks like in controlled trials
These outcomes cannot be compared head-to-head across different trials, populations or indications. They illustrate why named trials, doses, time periods and comparators matter.
| Medicine & trial | Population | Selected result | Boundary |
|---|---|---|---|
| Semaglutide 2.4 mg · STEP 1 Primary trial | Adults with overweight/obesity without diabetes | Mean body-weight change at 68 weeks: −14.9% with semaglutide vs −2.4% with placebo, with lifestyle intervention. | Group average; individual response and tolerability vary. |
| Tirzepatide · SURMOUNT-1 Primary trial | Adults with obesity/overweight without diabetes | Mean change at 72 weeks: −15.0%, −19.5% and −20.9% at 5, 10 and 15 mg vs −3.1% placebo. | Different dose groups; GI adverse effects were common. |
| Liraglutide 3 mg · SCALE Primary trial | Adults with obesity/overweight without diabetes | Mean weight loss at 56 weeks was about 8.4 kg vs 2.8 kg with placebo. | Daily injection plus lifestyle intervention. |
| Tesamorelin Phase 3 extension | Adults with HIV-associated abdominal fat accumulation | Visceral adipose tissue reduction was sustained at approximately 18% over 52 weeks in continuing treatment. | Not approved for general obesity or routine “visceral fat” treatment. |
Category 01
Metabolic, diabetes & weight management
| Active ingredient | FDA-approved use, summarized | Critical boundary | Current label |
|---|---|---|---|
| Insulin products (class) | Glycemic control in diabetes; indications differ by product and age. | High-alert medicines; dosing errors can cause severe hypoglycemia, brain injury or death. | DailyMed |
| Pramlintide | Adjunct to mealtime insulin in selected patients with type 1 or type 2 diabetes. | Not a general weight-loss drug; severe hypoglycemia risk with insulin. | DailyMed |
| Exenatide | Improvement of glycemic control in type 2 diabetes. | Product-specific renal and GI warnings; not interchangeable with other GLP-1 drugs. | DailyMed |
| Liraglutide | Type 2 diabetes and, under a different product/dose, chronic weight management. | Brand, dose and indication matter; not all liraglutide products share every indication. | DailyMed |
| Lixisenatide | Glycemic control in adults with type 2 diabetes. | Marketing availability may change; approval does not equal current supply. | DailyMed |
| Semaglutide | Product-specific indications include type 2 diabetes, cardiovascular risk reduction, chronic weight management and, for Wegovy injection, eligible adults with noncirrhotic MASH and F2–F3 fibrosis. Wegovy is also approved as an adult oral tablet; a 7.2 mg injection is approved for certain adults. | Formulation and indication are not interchangeable. Compounded versions are not FDA-approved copies; salt forms and dosing errors raise concerns. | DailyMed |
| Tirzepatide | Type 2 diabetes and, under Zepbound, chronic weight management plus moderate-to-severe obstructive sleep apnea in adults with obesity. | Not the same as retatrutide; compounded tirzepatide is not FDA-approved. Current labeling includes postmarketing intestinal obstruction and severe constipation, including fecal impaction. | DailyMed |
| Setmelanotide | Chronic weight management for specific rare genetic obesity conditions confirmed by criteria in labeling. | Not approved for common obesity; genetic diagnosis is central. | DailyMed |
| Glucagon | Treatment of severe hypoglycemia; some products also have diagnostic use. | Emergency rescue product—not a wellness or fat-loss peptide. | DailyMed |
Category 02
Endocrine, pituitary & bone
| Active ingredient | FDA-approved use, summarized | Critical boundary | Current label |
|---|---|---|---|
| Cosyntropin | Diagnostic testing of adrenal cortical function. | A diagnostic peptide, not an “adrenal fatigue” treatment. | DailyMed |
| Corticotropin | Label-specific inflammatory, neurologic and endocrine indications. | Complex product with significant steroid-like adverse effects. | DailyMed |
| Octreotide | Acromegaly and symptom control in certain severe secretory tumors; product-specific indications. | Can affect glucose, gallbladder, thyroid and cardiac function. | DailyMed |
| Lanreotide | Acromegaly and certain gastroenteropancreatic neuroendocrine tumors. | Oncology/endocrine medicine, not general longevity therapy. | DailyMed |
| Pasireotide | Selected patients with Cushing disease or acromegaly, depending on product. | Hyperglycemia and liver/cardiac monitoring can be important. | DailyMed |
| Tesamorelin | Reduction of excess abdominal fat in adults with HIV and lipodystrophy. | Not FDA-approved for general obesity, anti-aging or bodybuilding. | DailyMed |
| Teriparatide | Osteoporosis in specific high-risk patients. | Not a general “bone-building” supplement; duration and cancer-risk considerations apply. | DailyMed |
| Abaloparatide | Osteoporosis in selected patients at high fracture risk. | Prescription bone therapy with hypercalcemia and orthostatic concerns. | DailyMed |
| Calcitonin-salmon | Product-specific bone indications. | Benefits, risks and current product availability require label review. | DailyMed |
| Desmopressin | Product-specific treatment of central diabetes insipidus, nocturia, enuresis or bleeding disorders. | Hyponatremia can be severe or fatal; formulation and route matter. | DailyMed |
| Vasopressin | Vasodilatory shock in adults who remain hypotensive despite fluids and catecholamines. | Critical-care vasopressor—not outpatient peptide therapy. | DailyMed |
Category 03
Reproductive & hormone signaling
| Active ingredient | FDA-approved use, summarized | Critical boundary | Current label |
|---|---|---|---|
| Leuprolide | Product-specific uses in prostate cancer, endometriosis, fibroids and central precocious puberty. | Strong endocrine effects; indication and depot formulation are not interchangeable. | DailyMed |
| Goserelin | Selected prostate and breast cancers and endometriosis. | Requires diagnosis-specific monitoring. | DailyMed |
| Histrelin | Product-specific use in prostate cancer or central precocious puberty. | Long-acting implant; requires procedure and follow-up. | DailyMed |
| Nafarelin | Endometriosis and central precocious puberty. | Nasal GnRH agonist; adherence and endocrine effects matter. | DailyMed |
| Triptorelin | Product-specific use in prostate cancer or central precocious puberty. | Depot strengths and schedules differ. | DailyMed |
| Cetrorelix | Prevention of premature LH surge in controlled ovarian stimulation. | Fertility-treatment indication; not a general hormone optimizer. | DailyMed |
| Ganirelix | Prevention of premature LH surge during controlled ovarian stimulation. | Protocol-driven fertility medicine. | DailyMed |
| Oxytocin | Obstetric indications including medically indicated induction or augmentation of labor and postpartum bleeding control. | Hospital/obstetric drug with potentially life-threatening misuse. | DailyMed |
| Bremelanotide | Acquired, generalized hypoactive sexual desire disorder in certain premenopausal women. | Not approved for men, performance enhancement or nonspecific low libido. | DailyMed |
Category 04
Gastrointestinal peptides
| Active ingredient | FDA-approved use, summarized | Critical boundary | Current label |
|---|---|---|---|
| Linaclotide | Product-specific treatment of IBS with constipation and chronic idiopathic constipation. | Contraindicated in very young children; dehydration risk is important. | DailyMed |
| Plecanatide | Chronic idiopathic constipation and IBS with constipation in adults. | Pediatric boxed warning/contraindication applies. | DailyMed |
| Teduglutide | Short bowel syndrome in patients dependent on parenteral support. | Requires specialized monitoring, including neoplasia and fluid considerations. | DailyMed |
Category 05
Cardiovascular, blood & diagnostic imaging
| Active ingredient | FDA-approved use, summarized | Critical boundary | Current label |
|---|---|---|---|
| Bivalirudin | Anticoagulation in selected patients undergoing PCI. | Bleeding-risk hospital medicine. | DailyMed |
| Eptifibatide | Acute coronary syndrome and PCI-related indications. | Potent antiplatelet peptide with serious bleeding risk. | DailyMed |
| Angiotensin II | Increase blood pressure in adults with septic or distributive shock. | ICU vasopressor with thrombosis risk. | DailyMed |
| Nesiritide | Selected patients with acutely decompensated heart failure and dyspnea at rest/minimal activity. | Hospital use; approval does not imply routine current use. | DailyMed |
| Gallium Ga-68 dotatate | PET localization of somatostatin receptor-positive neuroendocrine tumors. | Diagnostic radiopharmaceutical. | DailyMed |
| Lutetium Lu-177 dotatate | Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. | Radiopharmaceutical therapy with marrow, kidney and radiation risks. | DailyMed |
Category 06
Neurology, immune & rare disease
| Active ingredient | FDA-approved use, summarized | Critical boundary | Current label |
|---|---|---|---|
| Ziconotide | Severe chronic pain requiring intrathecal therapy in selected patients. | Intrathecal specialist drug with major neuropsychiatric risks. | DailyMed |
| Icatibant | Acute attacks of hereditary angioedema in adults. | Not for general swelling or allergy symptoms. | DailyMed |
| Enfuvirtide | Combination antiretroviral treatment of HIV-1 in treatment-experienced patients with ongoing replication. | Specialist antiviral; not an immune “boosting” peptide. | DailyMed |
| Afamelanotide | Increase pain-free light exposure in adults with erythropoietic protoporphyria and phototoxic reactions. | Implant for a rare disease; not the same as Melanotan II tanning products. | DailyMed |
| Vosoritide | Increase linear growth in certain pediatric patients with achondroplasia and open growth plates. | Pediatric rare-disease indication; blood-pressure monitoring matters. | DailyMed |
| Pegcetacoplan | Product-specific complement-mediated indications including PNH or geographic atrophy. | Different formulations/routes have different risks and indications. | DailyMed |
| Zilucoplan | Generalized myasthenia gravis in selected antibody-positive adults. | Complement inhibitor with serious infection precautions. | DailyMed |
Methodology:
Peptide/peptide-analog active ingredients with outpatient
clinical relevance; insulins grouped; large proteins and
antibodies excluded.
Verify:
FDA Drugs@FDA and NIH DailyMed before relying on any status or
label.
Important Context
FDA-approved does not mean right for every patient.
Approval establishes a benefit-risk profile for a defined indication and population. It does not replace diagnosis, contraindication screening, informed consent, monitoring or individualized prescribing.
Evidence, Then Individualization
Understand the label. Discuss your own risk.
Use this directory to ask informed questions—not to self-prescribe or purchase medication online.