United States

7 compound entries are recorded for this jurisdiction. A compound absent from this page has no verified entry here, which means the position has not been established from a primary source — not that no position exists.

  • Semaglutide

    Approved medicine · FDA

    Approved across several separate applications, and the US indication set is materially wider than the EU or UK one. It carries two indications neither of the others records: reduction of major adverse cardiovascular events, and treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced fibrosis, the latter under accelerated approval. Ozempic was authorised in December 2017, ahead of both the EU and the UK.

    • Carries a boxed warning for thyroid C-cell tumours, and is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or of multiple endocrine neoplasia syndrome type 2
    • The steatohepatitis indication was granted under accelerated approval, so continued approval may be contingent on confirmatory evidence
    • An oral tablet presentation of Wegovy was approved on 22 December 2025 under a separate application, NDA 218316. This resolves a question left open at the original build, when a December 2025 oral approval could not be confirmed from any acceptable source
    • A generic semaglutide injection from Apotex under ANDA 220314 carries the status TA, tentative approval, dated 7 April 2026. Tentative approval means the application has been found to meet approval requirements but the product may not yet be marketed, so no generic semaglutide injection is on the US market under that application. Its marketing status is recorded as none

    Wegovy (semaglutide) injection and tablets, US prescribing information · verified 2026-08-05

  • Tirzepatide

    Approved medicine · FDA

    Approved under two separate new drug applications carrying different brand names, rather than the single authorisation covering both indications used in the EU and UK. Mounjaro under NDA 215866 covers type 2 diabetes; Zepbound under NDA 217806 covers weight management and obstructive sleep apnoea. The United States authorised tirzepatide first, four months ahead of the European Union.

    • Carries a boxed warning for thyroid C-cell tumours: in rats tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumours at clinically relevant exposures, and it is unknown whether it causes thyroid C-cell tumours including medullary thyroid carcinoma in humans
    • The obstructive sleep apnoea indication is specific to the Zepbound application and does not extend to Mounjaro
    • The current weight-management indication is worded without the numeric body mass index thresholds that the EU and UK texts specify, so the three wordings are not interchangeable

    Zepbound (tirzepatide) US prescribing information · verified 2026-08-05

  • Orforglipron

    Approved medicine · FDA

    Approved on 1 April 2026 under New Drug Application 220934 as Foundayo, the fifth approval and the first new molecular entity issued under the Commissioner’s National Priority Voucher pilot programme.

    • Labelling carries a boxed warning concerning thyroid C-cell tumours
    • Labelling states that concomitant use with another GLP-1 receptor agonist is not recommended

    FDA approves first new molecular entity under National Priority Voucher program · verified 2026-07-30

  • Retatrutide

    Investigational — no marketing authorisation · FDA

    No marketing authorisation and no approved application. The FDA has stated in enforcement correspondence that products containing retatrutide are unapproved new drugs, and the developer stated on 23 July 2026 that it is still completing the Chemistry, Manufacturing and Controls package required for a Biologics License Application it plans to submit in the first quarter of 2027.

    • FDA has stated that retatrutide cannot be used in compounding under federal law

    FDA Warning Letter, MARCS-CMS 695663 · verified 2026-07-30

  • GHK-Cu

    Cosmetic ingredient · Cosmetic Ingredient Review / FDA

    Used as a cosmetic ingredient. The Cosmetic Ingredient Review expert panel assessed Copper Tripeptide-1 and concluded that the ingredients reviewed are safe in the present practices of use and concentration described in the assessment.

    • Reported function is skin-conditioning agent; the panel assessment records typical use concentrations below 10 parts per million

    Safety Assessment of Tripeptide-1, Hexapeptide-12, their Metal Salts and Fatty Acyl Derivatives, and Palmitoyl Tetrapeptide-7 as Used in Cosmetics · verified 2026-07-30

  • AHK-Cu

    No established classification · Cosmetic Ingredient Review / FDA

    No established classification. The Cosmetic Ingredient Review assessment covering related copper tripeptides states that its data and conclusions are not applicable to other peptide sequences, and a full-text search of that assessment returns no occurrence of this compound or its circulating INCI designation.

    • The Cosmetic Ingredient Review conclusion reached for Copper Tripeptide-1 does not extend to this compound

    Safety Assessment of Tripeptide-1, Hexapeptide-12, their Metal Salts and Fatty Acyl Derivatives, and Palmitoyl Tetrapeptide-7 as Used in Cosmetics · verified 2026-07-30

  • NAD+

    No established classification · FDA

    No settled classification has been verified for nicotinamide adenine dinucleotide itself. The FDA has taken enforcement action against products containing it, but on the basis of disease claims made for those products rather than on the ingredient status of the compound.

    • A 2020 warning letter concerning sublingual gel products containing NAD+ and NMN concluded they were unapproved new drugs and misbranded, on the basis of claims made for them

    FDA and FTC Warning Letter, Alive By Nature Inc., MARCS-CMS 607435 · verified 2026-07-30