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Linaclotide regulatory status

Current status of Linaclotide 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 Linaclotide?

Regulatory: FDA approvedWADA: Not WADA prohibitedVerified: Verified Sep 27, 2026
FDA and compounding
FDA approved prescription drug (Linzess, approved August 30, 2012 for IBS-C and chronic idiopathic constipation; pediatric functional constipation indication added in 2023). It is commercially available, so it is not eligible for routine compounding and is not on any 503A bulks list. Not a research chemical.
WADA
Not WADA prohibited
Access path
  1. Prescription from a licensed provider (in person or telehealth) filled at a retail pharmacy as Linzess.
  2. Not available through compounding pharmacies or as a research chemical.

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

How has the status of Linaclotide changed over time?

  1. FDA

    FDA approves Linzess (linaclotide) for IBS-C and chronic constipation

    FDA approved linaclotide capsules (Linzess), a guanylate cyclase-C agonist peptide, for irritable bowel syndrome with constipation and chronic idiopathic constipation in adults.

    Regulatory: FDA approvedSource: Drugs@FDA: Linzess (linaclotide) NDA 202811

Sources

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

  1. [1]FDA prescribing information for Linzess (linaclotide) capsules, via DailyMedFDA, 2026
  2. [2]WADA Prohibited ListWADA, 2026
  3. [3]Drugs@FDA: Linzess (linaclotide) NDA 202811FDA, 2012