vialauditThe Roundup
CAGRILINTIDE·US LEGAL STATUS·LAST CHECKED 12 OCT 2026

Is Cagrilintide legal?

Not as a drug. Cagrilintide has no FDA approval, so selling it for human use breaks federal drug law, and a 'research use only' label does not protect a seller whose site signals human use. It is not a controlled substance, and possessing it is not a federal crime. Pharmacies cannot compound it.

RESEARCH-LABELLED SALE
Unapproved drug
PHARMACY COMPOUNDING
No
PRESCRIPTION
No approved product
WADA 2026
Prohibited (S0)

DESCRIBES THE LAW · NOT LEGAL ADVICE · NO DOSING INFORMATION

Federal, compounding and sport status

CHECKED 12 OCT 2026

Federal status

FDA approval
investigational
Indications: obesity (monotherapy + CagriSema combo); T2DM
DEA scheduling
not scheduled
503A compounding
FDA interim category: Not in any FDA category
503A Bulks List: not on list
Not eligible: no FDA approval (Novo Nordisk's CagriSema application is pending), no monograph, not on the 503A Bulks List. Ohio's Board of Pharmacy names it as a research-use-only drug found in clinics.
FDA Warning Letters
  • Dec 10, 2024 — Summit Research Peptides (cited: cagrilintide) · LETTER ↗
  • Dec 10, 2024 — Xcel Research LLC (cited: cagrilintide, semaglutide) · LETTER ↗
Shortage status
not currently on shortage list
Sale framing
Research-use-only posture: FDA has rejected RUO defense for cagrilintide in 2024 warning letters (Xcel, Summit). Same posture as retatrutide.
Personal possession: Not federally scheduled; not criminally possessed at federal level. Enforcement is on sellers.

Sport-body status

WADA 2026
prohibited · class S0 · in and out of competition
Not named. With no government approval yet, it falls under S0. That would change if CagriSema is approved. WADA's 2027 List, in force from 1 Jan 2027, now names 'peptides' among the S0 examples; the status does not change.
USADA
NCAA
unknown

What we couldn’t verify

State rules

1 STATE
pharmacy board enforcement · Ohio

Ohio's Board of Pharmacy names cagrilintide among the research-use-only drugs its inspectors find in clinics and says such drugs are unlawful for prescriber clinics and med spas to possess.

Cagrilintide in Ohio

In the other states we found nothing that names Cagrilintide; federal law applies.

What changed at the last check

4 CHANGES
DateFieldWasNowWhy
12 Oct 2026WADA 20272027 List not yet publishedprohibited (S0), unchangedWADA published the 2027 List on 21 Sep 2026. It adds 'peptides' to the S0 examples of substances with no approval for human therapeutic use. Status unchanged. source ↗
12 Oct 2026WADA 2026prohibited (S2)prohibited (S0)Not named. With no government approval yet, it falls under S0. That would change if CagriSema is approved. source ↗
12 Oct 2026AL state noteAlabama AG enforcement framework against research grade GLP 1/peptide IV clinics reaches cagrilintide containing researcremovedRemoved. The entry described a AL action that does not name Cagrilintide; it applied federal-level or class-wide facts by analogy. source ↗
12 Oct 2026OH state notenoneaddedOhio's Board of Pharmacy names cagrilintide among the research-use-only drugs its inspectors find in clinics and says such drugs are unlawful for prescriber clinics and med spas to possess. source ↗

Questions

3 ANSWERS
Is Cagrilintide legal in the US?

Not as a drug. Cagrilintide has no FDA approval, so selling it for human use breaks federal drug law, and a 'research use only' label does not protect a seller whose site signals human use. It is not a controlled substance, and possessing it is not a federal crime. Pharmacies cannot compound it.

Can a pharmacy compound Cagrilintide?

Not eligible: no FDA approval (Novo Nordisk's CagriSema application is pending), no monograph, not on the 503A Bulks List. Ohio's Board of Pharmacy names it as a research-use-only drug found in clinics.

Is Cagrilintide banned in sport?

Yes. It is prohibited at all times under WADA 2026 class S0. Not named. With no government approval yet, it falls under S0. That would change if CagriSema is approved. WADA's 2027 List, in force from 1 Jan 2027, now names 'peptides' among the S0 examples; the status does not change.

Sources

9 DOCUMENTS
  1. FDA approval record
  2. DEA controlled-substance schedules
  3. FDA 503A compounding position
  4. FDA warning letter to Summit Research Peptides, 10 Dec 2024
  5. FDA warning letter to Xcel Research LLC, 10 Dec 2024
  6. WADA 2026 Prohibited List
  7. Ohio Board of Pharmacy, 'Ten common prescriber clinic and medical spa violations' (updated 8 Dec 2025)
  8. Source for: WADA 2027
  9. Source for: AL state note
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