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Linaclotide official document review · version 1

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Inside the official reviews

Reviewed 2026-09-19 · Preserved version 1

What a constipation responder meant

In the original FDA chronic idiopathic constipation review, response required at least three complete spontaneous bowel movements per week and at least one more than baseline, during at least nine of twelve weeks. This is a defined trial threshold, not a claim that every symptom resolved. FDA PDF pp. 30 ↗

More findings, study links and document coverage

Benefit was demonstrated over a limited interval

Two placebo-controlled phase 3 trials, LIN-MD-01 and MCP-103-303, supported the constipation finding. FDA noted low absolute responder proportions despite statistically significant differences, and no efficacy-durability data beyond sixteen weeks in that submission. FDA PDF pp. 30 ↗

Diarrhea mattered to tolerability

Diarrhea was the most common adverse event and reason for discontinuation in the reviewed clinical program. Most cases were mild or moderate; this does not mean treatment was well tolerated by every participant. FDA PDF pp. 30 ↗

Separate the clinical programs

The combined file also contains a separate adult irritable bowel syndrome with constipation review. These selected pages appraise the original chronic idiopathic constipation account, not the IBS-C evidence or later pediatric extensions. FDA PDF pp. 17, 267, 30 ↗

Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.

Document coverage

Selected sections read in 1 of 23 inventoried documents; 22 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.

Selected English EMA PDFs from the retained September 15, 2026 title-matched document feed, plus independently retrieved FDA approval-package documents where listed. Candidate entries are not verified product/application matches. This is a bounded inventory, not a complete FDA, national or worldwide source search. EMA inventory source ↗

Inspect documents, application identities and source pins

Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.

Remaining work

  • Read the separate IBS-C clinical review and later pediatric approval documents.
  • Reconcile longer-term efficacy and safety reports with the original short-term trials.

Open versioned document coverage and study pins →

Public beta · Selective source coverageNot medical advice · No dosing or purchasing guidance