U.S. label record. The cited DailyMed label identifies Plecanatide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗
Review source snapshots checked September 15, 2026 · Integrity checked September 15, 2026.
Three selected publications report four randomized phase 3 trials in adults with chronic idiopathic constipation or irritable bowel syndrome with constipation.↗↗↗
What the reviewed sources report
The trials found more participants met prespecified bowel-response endpoints with plecanatide than placebo. Diarrhea occurred more often with active treatment; these 12-week studies do not establish comparative superiority to other medicines.↗↗↗
What remains unresolved?
What do current labels establish about pediatric restrictions and serious diarrhea?↗↗↗
How durable are outcomes beyond the randomized treatment periods?↗↗↗
The cited label covers chronic idiopathic constipation and IBS with constipation in adults. Pediatric effectiveness and safety have not been established. Label: 1, 8.4 ↗
Which safety limits matter?
The boxed warning concerns serious dehydration in pediatric patients. The product is contraindicated below age six and the label advises avoiding use at ages six through seventeen. Known or suspected mechanical gastrointestinal obstruction is also contraindicated; severe diarrhea can occur. Label: 1, 4, 5, 8.4, boxed warning ↗
Label edition and source pins
U.S. product labeling hosted by the National Library of Medicine. This account concerns this product and label edition; other formulations and jurisdictions require their own records.
Label ZIP SHA-256: 0d42da0dc89f9dad302f67bcff3df820d6dffe4743c9999083d93df18c88c534. Extracted XML SHA-256: 3ff2626593747b7b8c7e3c379036fec8f8a4f83a19229be9997b73801ed43470.
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 ↗
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.
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.
Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.
Identity/name search without publication-type filtering; primary human reports, extensions, combinations and other reports require separate eligibility decisions. Known selected reports were recovered.
126 retrieved · 3 included · 0 excluded · 123 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
"plecanatide"[Title/Abstract] OR "Trulance"[Title/Abstract]
Full-text appraisal and screening of unassessed records remain open.
Registry comparison, additional aliases and references, and regulator reconciliation require separate checks.
Showing 25 of 126 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
PubMed 29545635 — include: Selected human report; abstract and record metadata reviewed. Study families: plecanatide-PMID29545635-registry-linkage-unresolved.
PubMed 29147135 — include: Selected human report; abstract and record metadata reviewed. Study families: NCT02122471.
PubMed 28169285 — include: Selected human report; abstract and record metadata reviewed. Study families: NCT01982240.
PubMed 42319080 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42694017 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42283961 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42242129 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 39950440 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41604554 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42038325 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41744084 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41644188 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 40471839 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41017482 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41214272 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41101321 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41625191 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41625190 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41625188 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 40379573 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 40603244 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41098936 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 40843382 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 40571893 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 40723050 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
FDA search
Active-ingredient name query in openFDA Drugs@FDA. Returned application identities include salt forms and combination products; exact indications, approval conditions, supplements and marketing status require document-level review.
1 retrieved · 1 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Zero results describe this query response only, not absence of FDA approval or worldwide nonapproval.
This endpoint does not inventory every label, advisory proceeding, safety communication or regulatory document. Application inclusion does not establish current marketing or approval of every use.
Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
FDA NDA208745 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: PLECANATIDE.
EMA search
Local matching in the pinned EMA medicines feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local matching in the pinned EMA documents feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local matching in the pinned EMA orphans feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov search
ClinicalTrials.gov name/alias discovery, including cited product names. Matches may concern combinations, background references or different formulations; identity and outcomes need screening.
15 retrieved · 0 included · 0 excluded · 15 awaiting a decision · 0 full-text appraisals
Registration is not evidence that a study succeeded, that results were published, or that a use is approved.
Other registries, unregistered studies and additional aliases remain outside this query.
Showing 15 of 15 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov NCT07723924 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT02493452 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01429987 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01919697 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT02706483 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT02387359 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03120520 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03551873 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01053962 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT02122471 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT05107219 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03596905 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01982240 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT05151328 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01722318 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
Read the full Human Evidence Review
Supervised synthesis
What do selected human studies report about Plecanatide?
Three selected publications report four randomized phase 3 trials in adults with chronic idiopathic constipation or irritable bowel syndrome with constipation.123
Bottom line from this bounded source set
The trials found more participants met prespecified bowel-response endpoints with plecanatide than placebo. Diarrhea occurred more often with active treatment; these 12-week studies do not establish comparative superiority to other medicines.123
Reviewed study record
Chronic idiopathic constipation: first phase 3 trial
Design
Randomized, double-blind, placebo-controlled trial over 12 weeks with two active groups.1
Population
1,394 adults with chronic idiopathic constipation were randomized.1
Outcomes reported
Durable bowel-response rates were 21.0% and 19.5% in active groups versus 10.2% with placebo. Diarrhea occurred in 5.9% and 5.7% versus 1.3%.1
Limitations
The endpoint combines frequency and persistence of response. Results concern the enrolled adults and short follow-up, not all constipation causes.1
Reviewed study record
Chronic idiopathic constipation: second phase 3 trial
1,337 adults were allocated across two active groups and placebo.2
Outcomes reported
Durable responder rates were 20.1% and 20.0% versus 12.8%. Diarrhea occurred in 3.2% and 4.5% versus 1.3%.2
Limitations
This is a separate trial from the first constipation report. Patient diaries and the defined responder threshold need full-report appraisal.2
Reviewed study record
Irritable bowel syndrome with constipation: two trials
Design
Two randomized, double-blind, placebo-controlled phase 3 trials over 12 weeks.3
Population
2,189 adults were randomized across both trials; 1,879 completed.3
Outcomes reported
Combined pain-and-bowel response was more frequent in active groups in each trial. Diarrhea occurred in about 4% of active-group participants versus 1% with placebo and sometimes led to withdrawal.3
Limitations
The publication contains two studies and uses an endpoint different from the chronic-constipation trials. Cross-trial response percentages are not treatment rankings.3
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1038/ajg.2016.611. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1177/1756283x17734697. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1038/s41395-018-0026-7. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
Explore status sources, recent additions, and coverage gaps
Living status brief
What is the current status of Plecanatide?
U.S. label record. The cited DailyMed label identifies Plecanatide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗
The cited status sources were checked through July 22, 2026. This answer changes only through the profile’s visible version and correction history.
PeptideScanner currently has no selected safety records connected to this profile. That is a collection gap, not evidence that no such records exist.
PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.
This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.
2 exact source-declared trial-publication links connect selected NCT and PMID records. Open the exact graph →
PhasesPhase 2 3Phase 3 1
Status at observationCompleted 3Active, not recruiting 1
A phase value is unavailable here for 8 selected records; this is not counted as “no phase.”
A status value is unavailable here for 8 selected records; this is not counted as a trial status.
PubMed bibliography
Publication composition
2 of 16 selected PubMed records include attributed title, venue, publication date, and publication-type fields.
Publication typesJournal Article 2Research Support, Non-U.S. Gov't 2Clinical Trial, Phase III 1Multicenter Study 1Randomized Controlled Trial 1
Bibliography fields unavailable here for 14 selected records; the records remain visible as metadata observations.
Regulatory and publication surfaces
What is structurally connected?
Drugs@FDA applications
1
FDA Federal Register documents
3
DailyMed SPL versions
14
Canonical profile
Published
Profile structured data
Published
Linked dated records
46
Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.
These links come only from structured NCT and PMID identifiers declared by PubMed or ClinicalTrials.gov. They do not summarize the publications or establish findings.
PeptideScanner retained ClinicalTrials.gov record NCT01982240 at 2026-07-30T20:42:14.439Z. Its registry update date was 2019-12-26, and PeptideScanner's reviewed identity mapping was plecanatide.
PeptideScanner retained ClinicalTrials.gov record NCT03120520 at 2026-07-30T20:44:36.699Z. Its registry update date was 2019-10-04, and PeptideScanner's reviewed identity mapping was plecanatide.
DailyMed lists Structured Product Labeling version 1 for the reviewed Plecanatide label family with a published date of 2019-06-19. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.
These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.
These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.
Evidence summary
What the cited records say
The cited DailyMed label identifies Plecanatide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗
This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.
PeptideScanner retained ClinicalTrials.gov record NCT07723924 at 2026-08-10T18:10:03.859Z. Its registry update date was 2026-07-23, and PeptideScanner's reviewed identity mapping was plecanatide.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41604554 at 2026-08-10T18:13:40.573Z. PubMed recorded a metadata revision date of 2026-07-14 and an Entrez history date of 2026-01-28. PeptideScanner associated this retained record with the identity slug plecanatide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41625188 at 2026-07-30T16:25:14.231Z. PubMed recorded a metadata revision date of 2026-02-04 and an Entrez history date of 2026-02-02. PeptideScanner associated this retained record with the identity slug plecanatide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41625190 at 2026-07-30T16:25:14.232Z. PubMed recorded a metadata revision date of 2026-02-04 and an Entrez history date of 2026-02-02. PeptideScanner associated this retained record with the identity slug plecanatide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 28255961 at 2026-07-30T16:30:57.042Z. PubMed recorded a metadata revision date of 2026-01-27 and an Entrez history date of 2017-03-04. PeptideScanner associated this retained record with the identity slug plecanatide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 38594429 at 2026-07-30T16:31:15.180Z. PubMed recorded a metadata revision date of 2026-01-27 and an Entrez history date of 2024-04-09. PeptideScanner associated this retained record with the identity slug plecanatide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained ClinicalTrials.gov record NCT03596905 at 2026-07-30T18:18:33.534Z. Its registry update date was 2025-12-31, and PeptideScanner's reviewed identity mapping was plecanatide.↗
PeptideScanner retained ClinicalTrials.gov record NCT05151328 at 2026-07-30T18:42:56.581Z. Its registry update date was 2024-07-11, and PeptideScanner's reviewed identity mapping was plecanatide.↗
DailyMed lists Structured Product Labeling version 15 for the reviewed Plecanatide label family with a published date of 2024-04-05. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.↗
DailyMed lists Structured Product Labeling version 14 for the reviewed Plecanatide label family with a published date of 2023-04-06. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.↗
DailyMed lists Structured Product Labeling version 13 for the reviewed Plecanatide label family with a published date of 2023-03-14. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.↗
DailyMed lists Structured Product Labeling version 12 for the reviewed Plecanatide label family with a published date of 2023-03-08. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.↗