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Lanreotide regulatory status

Current status of Lanreotide 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 Lanreotide?

Regulatory: FDA approvedWADA: Not WADA prohibitedVerified: Verified Sep 23, 2026
FDA and compounding
FDA approved as Somatuline Depot in August 2007 for acromegaly, December 2014 for unresectable gastroenteropancreatic neuroendocrine tumors, and September 2017 for carcinoid syndrome. A generic lanreotide injection was approved in December 2021. Compounding is not permitted beyond patient specific exceptions because approved products exist.
WADA
Not WADA prohibited
Access path
  1. Prescription from an endocrinologist or oncologist, dispensed by a specialty pharmacy or administered in clinic.
  2. Not available through compounding or telehealth peptide clinics.

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

How has the status of Lanreotide changed over time?

  1. FDA

    FDA approves Somatuline Depot (lanreotide) for acromegaly

    FDA approved lanreotide injection (Somatuline Depot), a somatostatin analog, for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery or radiotherapy.

    Regulatory: FDA approvedSource: Drugs@FDA: Somatuline Depot (lanreotide) NDA 022074

Sources

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

  1. [1]FDA prescribing information for Somatuline Depot (lanreotide) injection, via DailyMedFDA, 2024
  2. [2]WADA Prohibited ListWADA, 2026
  3. [3]Drugs@FDA: Somatuline Depot (lanreotide) NDA 022074FDA, 2007