Which peptides are FDA-approved? A product-by-product directory.

01 · Continued

Short answer: FDA approves products, not peptide name lists.: more detail

Approval attaches to an application and applicant, active ingredient, dosage form, route, strength or presentation, labeling, and one or more defined indications. An application is a request for FDA to approve a product. An indication is the approved use for a defined group of people. Approval does not attach to every vial, tablet, implant, compounded preparation, or research product that uses the same ingredient word.

That distinction matters because the same active ingredient can appear in products with different brand names, routes, applications, and uses. Semaglutide alone appears in separate approved applications for injection and tablets, with labeling that differs by product. Tirzepatide injection appears in distinct applications, including Mounjaro for type 2 diabetes and Zepbound for chronic weight management and obstructive sleep apnea. The molecule name cannot tell you which approval someone means.

The directory below is a bounded, non-exhaustive set of U.S. products that had identifiable FDA application and labeling records when checked on August 30, 2026. It is an orientation tool, not a treatment recommendation, safety ranking, prescribing guide, or claim that these products are appropriate for a particular person.

02

What this directory counts as a peptide medicine.

FDA does not maintain a single authoritative list called “all approved peptides.” This directory is a selected list, not a complete list of every approved peptide-related medicine. Peptide can describe short amino-acid chains, modified peptide analogues, peptide hormones, and peptide-containing radiopharmaceuticals.

The regulatory pathway does not create a clean scientific boundary. Many products are approved through New Drug Applications (NDAs). Some peptide or protein products use Biologics License Applications (BLAs). Egrifta SV, for example, appears in the Purple Book under BLA 022505.

For a useful and auditable scope, this directory includes selected medicines whose active component is described in FDA labeling or review material as a peptide, peptide analogue, peptide hormone, or radiolabeled peptide analogue. It excludes the much larger therapeutic-protein and insulin landscape, generic duplicates, every strength and presentation, discontinued historical products, diagnostic agents, and most hospital-only peptide products.

Exclusion does not mean a product is unapproved; it means the product is outside this edition's deliberately limited scope.

Every entry names the exact brand, ingredient, application, dosage form, route, and a plain-language summary of the labeled use. A route is how a product enters the body. Use the current FDA application record and approved labeling for the current status, indications, and limitations. Marketing status, warnings, presentations, and indications can change after this review date.

03

Weight, diabetes, heart, and kidney uses.

This is the area most likely to produce approval-transfer errors. “Semaglutide is approved” or “tirzepatide is approved” does not establish which brand, route, or indication is being discussed. These records were checked against FDA application or labeling sources on August 30, 2026.

• Wegovy (semaglutide) injection — NDA 215256; injection solution by the subcutaneous route. Its current label covers long-term weight reduction and maintenance in specified adult and pediatric populations, cardiovascular-event risk reduction in specified adults, and an injection-specific indication for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate-to-advanced fibrosis.
• Wegovy (semaglutide) tablets — NDA 218316; tablet by the oral route. FDA's December 22, 2025 approval letter covers long-term weight reduction and maintenance in specified adults and major cardiovascular-event risk reduction in specified adults. The tablet application is separate from the injection application.
• Ozempic (semaglutide) injection — NDA 209637; injection solution by the subcutaneous route. Its current label covers glycemic control in adults with type 2 diabetes, major cardiovascular-event risk reduction in specified adults, and reduction of specified kidney and cardiovascular outcomes in adults with type 2 diabetes and chronic kidney disease. It is not the Wegovy application.
• Rybelsus and Ozempic tablets (semaglutide) — NDA 213051; tablets by the oral route. Their current shared label covers glycemic control in adults with type 2 diabetes and major cardiovascular-event risk reduction in adults with type 2 diabetes who are at high risk. An oral brand name does not inherit the injection product's entire label.
• Mounjaro (tirzepatide) — NDA 215866; injection solution by the subcutaneous route. The public January 2026 prescribing information covers glycemic control in adults and pediatric patients 10 years and older with type 2 diabetes. In an August 27, 2026 approval letter, FDA approved supplement S-044 to add reduction of cardiovascular death, nonfatal heart attack, and nonfatal stroke in adults with type 2 diabetes at high risk of major adverse cardiovascular events. The same letter approved supplement S-045, which allows a 2.5 mg dose for ongoing glycemic control. FDA's application record says the revised label is not yet posted, so this entry distinguishes the January 2026 label from the August 27 approval letter. Mounjaro is a different product record from Zepbound.
• Zepbound (tirzepatide) — NDA 217806; injection solution by the subcutaneous route. Its current label covers long-term weight reduction and maintenance in specified adults and treatment of moderate-to-severe obstructive sleep apnea in adults with obesity. Mounjaro's diabetes indication and Zepbound's indications are not interchangeable approval claims.

04

Bone health, severe low blood sugar, and HIV-related fat changes.

Approved peptide medicines extend well beyond weight loss. These products also show why a broad goal such as “bone,” “metabolism,” or “fat loss” is not enough to identify an approved use.

• Forteo (teriparatide) — NDA 021318; solution in a prefilled delivery device by the subcutaneous route. Its current label covers defined high-fracture-risk osteoporosis populations, including certain postmenopausal women, men with primary or hypogonadal osteoporosis, and people with osteoporosis associated with sustained systemic glucocorticoid therapy.
• Baqsimi (glucagon) — NDA 210134; single-dose nasal powder by the intranasal route. Its current label covers treatment of severe hypoglycemia in adults and pediatric patients one year and older with diabetes. This emergency-rescue indication is not a general metabolic-health claim.
• Egrifta SV (tesamorelin) — BLA 022505; a licensed biological product supplied as lyophilized powder for subcutaneous injection after preparation. Its current label covers reduction of excess abdominal fat in adults with HIV and lipodystrophy. The label specifically says it is not indicated for weight-loss management and describes it as weight neutral.

05

Sexual health and rare light-sensitivity uses.

Melanocortin-related products are another place where shared receptor biology can tempt overgeneralization. These approvals are narrow and product-specific.

• Vyleesi (bremelanotide) — NDA 210557; solution in a single-dose autoinjector by the subcutaneous route. Its current label covers acquired, generalized hypoactive sexual desire disorder in premenopausal women when the label's defining conditions are met. It is not indicated for men, postmenopausal women, or enhancement of sexual performance.
• Scenesse (afamelanotide) — NDA 210797; a 16 mg bioresorbable implant placed subcutaneously. Its current label covers increasing pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria. That rare-disease approval does not establish tanning, cosmetic pigmentation, or the safety of other melanocortin products.

06

Severe pain, critical care, tumors, and acromegaly.

Several peptide medicines are used in highly supervised settings. Listing them here should not be read as an invitation to compare them with wellness products; their routes and indications make the clinical context explicit.

• Prialt (ziconotide) — NDA 021060; solution for intrathecal infusion. Its current label covers severe chronic pain in adults for whom intrathecal therapy is warranted and who are intolerant of or refractory to specified other treatments. Intrathecal administration is not interchangeable with an injection under the skin.
• Giapreza (angiotensin II) — NDA 209360; solution for intravenous infusion after dilution. Its current label covers increasing blood pressure in adults with septic or other distributive shock.
• Vasostrict (vasopressin) — NDA 204485; injection solution, including forms requiring dilution and premixed presentations, by the intravenous route. Its current label covers increasing blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
• Lutathera (lutetium Lu 177 dotatate) — NDA 208700; radiolabeled somatostatin-analogue solution by the intravenous route. Its current label covers somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors in adults and pediatric patients 12 years and older.
• Mycapssa (octreotide) — NDA 208232; delayed-release capsule by the oral route. Its current label covers long-term maintenance treatment in people with acromegaly who have responded to and tolerated octreotide or lanreotide. It does not make every octreotide formulation orally interchangeable.

07

Approval does not spread to a molecule, route, or goal.

An approval statement should survive a simple substitution test. If the brand, application number, dosage form, route, population, or indication changes, the original statement may no longer be true. Wegovy tablets and Wegovy injection have separate NDAs. Ozempic injection and oral semaglutide products do not share every use. Mounjaro and Zepbound contain tirzepatide but have distinct applications and labels.

The same rule applies beyond metabolic products. Egrifta SV's HIV-lipodystrophy indication does not become general weight management. Scenesse's EPP indication does not become a cosmetic tanning approval. Vyleesi's defined HSDD indication does not become approval for sexual performance. A provider or seller should be able to identify the exact marketed product and show that its claim appears in that product's current label.

FDA approval also does not mean risk-free, suitable for everyone, superior to alternatives, or approved for every use a clinician might lawfully consider. This directory answers a regulatory identity question. Benefit-risk decisions belong to the label, the patient's clinical context, and a qualified prescriber—not to a list ordered by popularity.

08

Compounded and research-labeled products do not inherit approval.

FDA states that compounded drugs are not FDA-approved and are not reviewed by the agency for safety, effectiveness, or quality before marketing. Compounding can serve a legitimate patient-specific need under applicable law, but a compounded preparation is not the branded product named in an NDA or BLA. Matching an ingredient word on an invoice or vial is not proof of the same formulation, manufacturing controls, stability, delivery system, or label.

A “research use only” label does not establish an approved drug product. An online vial labeled semaglutide, tirzepatide, tesamorelin, bremelanotide, afamelanotide, or another peptide does not become an approved medicine because an approved product contains a related active ingredient. FDA has separately warned about unapproved GLP-1 products, salt forms that differ from the active ingredients in approved products, dosing errors, fraudulent labeling, and counterfeit supply.

The approval check is product-specific: What is the brand? Which applicant and application? What dosage form and route? Which labeled indication? If those answers do not point to the same FDA record, the approval claim has not been established. Authenticity and lawful supply-chain questions are separate checks; an approval record alone cannot prove that a package in hand is genuine.

09

How to check an approval and keep this directory current.

Start with Drugs@FDA for NDA and ANDA products and the Purple Book for licensed biological products. Search the proprietary name and active ingredient. Then open the application record and latest label. Confirm the application number, applicant, dosage form, route, marketing status, indications and limitations, and label revision date.

FDA notes that Drugs@FDA is updated daily, so it should outrank a clinic page, seller page, search snippet, or undated list.

For negative claims, absence from one search is not enough. Check name variants, exact active ingredient, both Drugs@FDA and the Purple Book, and FDA enforcement or compounding materials. This article therefore avoids claiming that it has cataloged every approved or unapproved peptide. It reports the bounded records actually audited.

This directory follows the site's published review cadence and immediate re-review triggers for a material FDA approval, withdrawal, safety communication, or label expansion. Each revision must preserve the application-level audit trail and review date. If an entry cannot be reconciled to a current official record, it will be marked cannot confirm or removed until the conflict is resolved.