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Is Orforglipron Legal? FDA, Compounding and WADA Status

Orforglipron's FDA status, compounding rules and anti-doping status, with a dated timeline of every change we track.

Medically reviewed by Juan Pablo Frías, MD · · DisclosureOral small-molecule GLP-1 agonistUpdated
FDA status
Approved (Foundayo, Apr 2026)
1 Apr 2026
PCAC vote
Not reviewed
not on the Jul 2026 PCAC agenda
WADA
Not listed
2026 Prohibited List
Not legal adviceStatus reflects public FDA and WADA records on the date shown. Rules differ by country and state.

Current status

FDA approved (Foundayo, Apr 2026)

Orforglipron is FDA approved (Foundayo, Apr 2026). Products sold as research chemicals are not the approved drug and are not checked by the FDA.

Orforglipron: regulatory status by country
CountryStatusSource
United StatesApprovedApproved by FDA as Foundayo (orforglipron), Eli Lilly, 1 April 2026, for chronic weight management in adults (label quote).api.fda.govchecked 2 Oct 2026

Timeline

  1. Orforglipron approved as FoundayoApproval
Every peptide on the FDA tracker

Compounding and research-use sellers

  • Category 2 is the FDA's list of bulk substances it flagged as raising significant safety concerns. Compounding pharmacies are not expected to compound from them while they are on it.
  • The Pharmacy Compounding Advisory Committee (PCAC) advises the FDA on which substances belong on the 503A bulks list that pharmacies may compound from. Its votes are advice; the FDA decides.
  • "Research use only" products are sold outside these rules and are not checked by the FDA for identity, purity or dose.

Sport and drug testing

Not on the WADA Prohibited List

GLP-1 and GIP agonists are not named anywhere on the 2026 list. This one is an approved medicine, so the catch-all S0 (which only covers drugs with no approval anywhere) does not apply to it.

Outside the US

Rules differ by country. What each regulator's own records show, with the date we checked:

Orforglipron: regulatory status by country
CountryStatusSource
United KingdomApprovedListed on emc as Foundayo (orforglipron), Eli Lilly and Company Limited.medicines.org.ukchecked 2 Oct 2026
CanadaNo approved product foundNo product found in a Health Canada Drug Product Database search for ingredient "orforglipron" on 2 Oct 2026.health-products.canada.cachecked 2 Oct 2026
AustraliaNo approved product foundNo approved product found in an ARTG search for "orforglipron" on 2 Oct 2026.tga.gov.auchecked 2 Oct 2026
European UnionNo centrally authorised EU medicine foundEMA medicines list, searched 2 Oct 2026ema.europa.euchecked 2 Oct 2026

Common questions

Is Orforglipron FDA approved?

Orforglipron is FDA approved (Foundayo, Apr 2026). Products sold as research chemicals are not the approved drug and are not checked by the FDA.

Is Orforglipron legal to buy?

As an approved drug it requires a prescription in the US. Products sold online as research chemicals "not for human use" are not the approved drug.

Is Orforglipron banned by WADA?

No. GLP-1 and GIP agonists are not named anywhere on the 2026 list. This one is an approved medicine, so the catch-all S0 (which only covers drugs with no approval anywhere) does not apply to it.

More on Orforglipron

DosageDoses used in published studies, with the source for each.Side effectsWhat labels and studies report, and what is unknown.ResultsStudy outcomes and when they were measured.PricePrice per mg and per week from dated listings. No vendor links.For weight lossWhat research says about Orforglipron for weight loss.

Sources

  1. 1FDA approves first new molecular entity under National Priority Voucher program (Foundayo, orforglipron), 1 Apr 2026U.S. Food and Drug Administration · 2026fda.govAccessed 2 Oct 2026
  2. 2World Anti-Doping Code International Standard Prohibited List 2026World Anti-Doping Agency · 2026wada-ama.orgAccessed 2 Oct 2026
  3. 3United States: Approved by FDA as Foundayo (orforglipron), Eli Lilly, 1 April 2026, for chronic weight management in adults (label quote).U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
  4. 4United Kingdom: Listed on emc as Foundayo (orforglipron), Eli Lilly and Company Limited.Electronic Medicines Compendium (UK) · 2026medicines.org.ukAccessed 2 Oct 2026
  5. 5Canada: No product found in a Health Canada Drug Product Database search for ingredient "orforglipron" on 2 Oct 2026.Health Canada · 2026health-products.canada.caAccessed 2 Oct 2026
  6. 6Australia: No approved product found in an ARTG search for "orforglipron" on 2 Oct 2026.Therapeutic Goods Administration (Australia) · 2026tga.gov.auAccessed 2 Oct 2026
  7. 7EMA medicines export (centrally authorised medicines) (searched 2 Oct 2026)European Medicines Agency · 2026ema.europa.euAccessed 2 Oct 2026
  8. 8Orforglipron approved as FoundayoFDA · 2026fda.govAccessed 2 Oct 2026

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