Plecanatide official document review · version 1
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Inside the official reviews
Reviewed 2026-09-19 · Preserved version 1
The primary endpoint required sustained response
The 2016 FDA clinical review defines a weekly responder as having at least three complete spontaneous bowel movements and at least one more than baseline. Overall response required nine of twelve weeks, including three of the final four weeks. FDA PDF pp. 109 ↗
More findings, study links and document coverage
The effect was statistically supported but modest
Two placebo-controlled phase 3 trials supported the original adult chronic idiopathic constipation submission. The reviewer described a modest benefit rather than universal symptom resolution; the main comparison covered twelve weeks. FDA PDF pp. 51, 54 ↗
Diarrhea was the principal adverse reaction
The review’s benefit-risk assessment identifies diarrhea as the main treatment-related concern. A favorable regulatory assessment does not establish freedom from adverse effects. FDA PDF pp. 53, 54 ↗
The original adult evidence has a defined boundary
This document evaluates the original adult constipation application. It does not by itself establish pediatric benefit or summarize the later irritable bowel syndrome indication. FDA PDF pp. 40, 54 ↗
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 1 inventoried documents; 0 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.
Trulance: FDA 2016 selected approval-package clinical review ↗
Selected sections reviewed · fda-trulance-medical-2016 · Document/feed date: 2016-10-06
Independently retrieved FDA approval-package PDF. The displayed date belongs to the selected review, not the entire compilation or a current label.
Verified: Trulance · NDA 208745 · Document dated 2016-10-06. Identity checked on PDF pp. 40.
Identity and selected clinical design, efficacy, safety and benefit-risk sections only. One-based PDF file pages; unlisted pages have not been appraised. The date identifies the selected review within any compiled approval package.
Retrieved 2026-09-19. Read PDF pages: 2, 40, 51, 53, 54, 109 of 244. SHA-256:
5d4ca0fe7be0c7fc07b9bae510ffd755ac37118a81e72913dc5781d227c8fb77.
Remaining work
- Appraise the later IBS-C approval and longer-term safety reports separately.
- Verify trial-level denominators, missing-data analyses and linked publications before adding detailed effect estimates.