Trial reportDigestive diseases and sciences2013
Plecanatide, an oral guanylate cyclase C agonist acting locally in the gastrointestinal tract, is safe and well-tolerated in single doses.
Trial report in Digestive diseases and sciences, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
44 citing papers in PubMed, 98 citations in OpenAlex.
- Plecanatide Improves Abdominal Bloating and Bowel Symptoms of Irritable Bowel Syndrome with Constipation.Digestive diseases and sciences · 2024Trial
- A Randomized Phase III Clinical Trial of Plecanatide, a Uroguanylin Analog, in Patients With Chronic Idiopathic Constipation.The American journal of gastroenterology · 2017Trial
- Review
- Pharmacological management of childhood constipation: Bridging today's gaps with tomorrow's therapies.World journal of clinical pediatrics · 2026Review
- Advance in peptide-based drug development: delivery platforms, therapeutics and vaccines.Signal transduction and targeted therapy · 2025Review
- Assessing real-world safety of plecanatide: a pharmacovigilance study based on the FDA adverse event reporting system.Frontiers in pharmacology · 2024Article
- An Update of Pharmacological Management in Children with Functional Constipation.Paediatric drugs · 2023Review
- On the Utility of Chemical Strategies to Improve Peptide Gut Stability.Journal of medicinal chemistry · 2022Article
- Guanylate cyclase-C agonists as peripherally acting treatments of chronic visceral pain.Trends in pharmacological sciences · 2022Review
- Cyclic peptide drugs approved in the last two decades (2001-2021).RSC chemical biology · 2022Review
- GUCY2C as a biomarker to target precision therapies for patients with colorectal cancer.Expert review of precision medicine and drug development · 2021Article
- Management of functional constipation in children and adults.Nature reviews. Gastroenterology & hepatology · 2020Review
- Benefit-Risk Assessment of Plecanatide in the Treatment of Chronic Idiopathic Constipation.Drug safety · 2019Review
- Update on Pharmacotherapy for Irritable Bowel Syndrome.Current gastroenterology reports · 2019Review
- Profile of plecanatide in the treatment of chronic idiopathic constipation: design, development, and place in therapy.Clinical and experimental gastroenterology · 2019Review
- Pharmacokinetics of Toxin-Derived Peptide Drugs.Toxins · 2018Review
- Review
- 2017 FDA Peptide Harvest.Pharmaceuticals (Basel, Switzerland) · 2018Review
- Plecanatide: a new guanylate cyclase agonist for the treatment of chronic idiopathic constipation.Therapeutic advances in gastroenterology · 2018Review
- Clinical utility of plecanatide in the treatment of chronic idiopathic constipation.International journal of general medicine · 2018Review
Corrections and comments
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Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposePlecanatide, an analogue of uroguanylin, activates the guanylate cyclase C (GC-C) receptor found on the GI mucosal epithelial cells, leading to secretion of fluid, facilitating bowel movements. Plecanatide is being investigated as a potential treatment for constipating GI disorders. The aim of this investigation was to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single doses of plecanatide in healthy volunteers.
methodsA total of 72 healthy volunteers at a single site were randomized in 9 cohorts to receive oral plecanatide or placebo from 0.1 to 48.6 mg. Plasma PK samples were collected pre-dose and post-dose. PD assessments included time to first stool, stool frequency, and stool consistency using the Bristol Stool Form Scale. All adverse events were documented.
resultsPlecanatide was safe and well-tolerated at all dose levels. A total of 17 of 71 subjects (23.9%) reported 25 treatment-emergent adverse events (TEAEs) during the study. The number of TEAEs reported by subjects who received plecanatide or placebo was comparable (24.5 vs. 22.2%, respectively). There were no dose-related increases in TEAEs or any SAEs reported. No measurable systemic absorption of oral plecanatide was observed at any of the oral doses studied, utilizing an assay sensitive down to 1 ng/mL.
conclusionsPlecanatide, an oral GC-C agonist, acting locally within the GI tract without measurable systemic exposure, was safe and well-tolerated in single doses up to 48.6 mg. The study was not powered for statistical analyses, but trends in PD parameters supported continued clinical development.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.