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Octreotide regulatory status

Current status of Octreotide in the United States: FDA approved. In sport: Not WADA prohibited. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of Octreotide?

Regulatory: FDA approvedWADA: Not WADA prohibitedVerified: Verified Sep 23, 2026
FDA and compounding
FDA approved as Sandostatin injection in 1988 (acromegaly, carcinoid tumors, VIPomas), Sandostatin LAR depot in 1998, Bynfezia Pen in 2020, and Mycapssa oral capsules in 2020 for acromegaly. Generic octreotide injection and generic depot products are available. Compounding is limited to patient specific needs because approved products exist.
WADA
Not WADA prohibited
Access path
  1. Prescription from an endocrinologist, oncologist, or gastroenterologist filled at a specialty pharmacy, or administered in clinic for the depot.
  2. Not available through compounding or telehealth peptide clinics.

Full Octreotide page: evidence, dosing in the literature, and sources

How has the status of Octreotide changed over time?

No dated regulatory event has been recorded for Octreotide. That usually means no FDA, PCAC, Federal Register, or WADA action has named it specifically. Category-wide actions are listed on the tracker hub.

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for Octreotide and the source of each dated event.

  1. [1]FDA prescribing information for Sandostatin (octreotide acetate) injection, via DailyMedFDA, 2026
  2. [2]WADA Prohibited ListWADA, 2026
  3. [3]FDA prescribing information for Sandostatin LAR Depot (octreotide acetate), via DailyMedFDA, 2025
  4. [4]FDA prescribing information for Mycapssa (octreotide) delayed-release capsules, via DailyMedFDA, 2025