Reference table
Which peptides in this index are actually approved drugs?
The answer
Ten, and their approvals are narrow: an approval belongs to a product in a stated indication, not to a molecule in every use a seller can imagine for it.
An FDA approval means a specific product completed clinical development — controlled trials in a named indication, a reviewed manufacturing process, and labeling that states what the evidence supports. It is the strongest position a molecule in this index can hold, and it is also the narrowest, because it attaches to a product and an indication rather than to a compound in general.
The consequence for supply is direct. Under section 503A a pharmacy may not compound what is essentially a copy of a commercially available drug unless a prescriber documents a clinical difference for an individual patient, and the FDA has rejected price as such a difference.
Denominator
The rows are the molecules this index files as approved. Where this index's ledger carries no dated approval entry for a product, the record column says so rather than supplying a year; the approved-product column states the products the ledger names.
Rows are read from MOLECULES[] where status is approved, MOLECULES[].approvedProduct, MOLECULES[].route, MOLECULES[].record[] entries stating an approval — the same dated ledger the molecule index renders. No cell on this page is typed by hand.
| Molecule | Approved product | Route | Approval record in this index |
|---|---|---|---|
| Tesamorelin | EGRIFTA WR (2025); EGRIFTA (2010) | Subcutaneous injection | November 2010. FDA approves tesamorelin (EGRIFTA) for the reduction of excess abdominal fat in adults with HIV and lipodystrophy. March 2025. FDA approves EGRIFTA WR, an eight-fold concentrated formulation reconstituted weekly rather than daily; it replaces EGRIFTA SV. |
| Semaglutide | Ozempic, Wegovy, Rybelsus | Subcutaneous injection; oral (Rybelsus) | April 2026. FDA proposes excluding semaglutide from the 503B bulks list, closing the outsourcing-facility route; patient-specific 503A compounding requires a documented clinical need an approved product cannot meet. |
| Tirzepatide | Mounjaro, Zepbound | Subcutaneous injection | this index's ledger carries no dated approval entry for this product |
| Setmelanotide | Imcivree (2020) | Subcutaneous injection | November 2020. FDA approves setmelanotide injection under new drug application 213793, approval dated November 25, 2020, as a Type 1 new molecular entity. Drugs@FDA records the product as Imcivree, a subcutaneous solution containing setmelanotide acetate at a strength of 10 mg base per mL, sponsored by Rhythm and marketed as prescription-only. March 2026. Drugs@FDA records three approved efficacy supplements to the application after the original approval, dated June 16, 2022, December 20, 2024 and March 19, 2026, alongside two labeling supplements. The label in effect on April 1, 2026 indicates the product to reduce excess body weight and maintain weight reduction long term in patients aged four years and older with acquired hypothalamic obesity, and aged two years and older with obesity due to Bardet-Biedl syndrome or to confirmed proopiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency. September 2026. Setmelanotide sits in no category of the 503A bulks list published May 14, 2026 and on no 503B list. An approved product exists, so the question the bulks list answers does not arise for it. |
| PT-141 | Vyleesi (2019) | Subcutaneous injection (single-use autoinjector) | June 2019. FDA approves bremelanotide injection under new drug application 210557, effective June 21, 2019, for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder. The label's limitations of use state that the product is not indicated for hypoactive sexual desire disorder in postmenopausal women or in men, and is not indicated to enhance sexual performance. |
| Liraglutide | Victoza (2010), Saxenda (2014), and approved generics | Subcutaneous injection, once daily | January 2010. FDA approves liraglutide injection as Victoza under new drug application 022341, effective January 25, 2010; the indication is now an adjunct to diet and exercise for glycemic control in type 2 diabetes and reduction of major adverse cardiovascular events in adults with established cardiovascular disease. December 2014. FDA approves a second liraglutide product, Saxenda, under new drug application 206321, effective December 23, 2014, for chronic weight management alongside a reduced-calorie diet and increased physical activity. December 2024. FDA approves the first generic liraglutide injection referencing Victoza, under abbreviated new drug application 215503, effective December 23, 2024. The agency's announcement notes that liraglutide injection and certain other GLP-1 medicines are in shortage. |
| Secretin | ChiRhoStim (2004); Porcine Secretin (2002) | Intravenous, as an approved diagnostic product | April 2002. FDA approves Porcine Secretin under new drug application 021209; the product remains prescription-only. April 2004. FDA approves ChiRhoStim, synthetic human secretin, under new drug application 021256, in 16 microgram and 40 microgram vials for intravenous use. Two earlier secretin products, SecreFlo and Secretin-Ferring, are recorded in Drugs@FDA as discontinued. May 2026. The section 503A bulks list published May 14, 2026 lists Secretin, human 99% in Category 3, the file for substances nominated without adequate support to evaluate. A bulk nomination for a substance that is already the active ingredient of an approved product raises the essentially-a-copy question that section 503A exists to control. |
| Elamipretide | Forzinity (2025) | Subcutaneous injection, once daily | September 2025. FDA approves elamipretide injection under new drug application 215244, approval dated September 19, 2025, as a Type 1 new molecular entity. Drugs@FDA records the product as Forzinity, a subcutaneous solution of elamipretide hydrochloride at 280 mg base per 3.5 mL, sponsored by Stealth BioTherapeutics and marketed as prescription-only. December 2025. The label in effect December 10, 2025 indicates the product to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. The same section states that the indication is approved under accelerated approval on an improvement in knee extensor muscle strength, an intermediate clinical endpoint, and that continued approval may be contingent upon verification of clinical benefit in a confirmatory trial. |
| Afamelanotide | Scenesse (2019) | Subcutaneous implant | October 2019. FDA approves afamelanotide implant under new drug application 210797, approval dated October 8, 2019, as a Type 1 new molecular entity. Drugs@FDA records the product as Scenesse, a 16 mg subcutaneous implant marketed as prescription-only, with one labeling supplement approved August 12, 2024. |
| Dulaglutide | Trulicity (2014) | Subcutaneous injection, once weekly | September 2014. FDA licenses dulaglutide injection under biologics license application 125469, approval dated September 18, 2014, as a Type 1 new molecular entity. Drugs@FDA records the product as Trulicity, a prescription injection in four strengths of 0.75 mg, 1.5 mg, 3 mg and 4.5 mg per 0.5 mL, sponsored by Eli Lilly and Company. |
The approved page states where compounded copies of these products now stand, and the GLP-1 receptor agonists page covers the class where 2026's supply-side changes cut hardest.
Other tables
Evidence reviews
Monographs in this table