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Trulance (PLECANATIDE)

Salix · FDA-approved approved Recombinant protein Quality 65/100

Trulance works by stimulating the guanylate cyclase-C receptor to increase fluid secretion in the intestines.

Plecanatide (Trulance), marketed by Salix, is a chronic idiopathic constipation treatment that stimulates the guanylate cyclase-C receptor to increase intestinal fluid secretion. Its key competitive advantage lies in its mechanism of action and the patent protection until 2028, which provides a strong barrier to entry. The primary risk is the presence of multiple same-class competitors, including linaclotide, lubiprostone, and prucalopride, all of which have varying degrees of patent protection and market presence.

At a glance

Generic namePLECANATIDE
SponsorSalix
Drug classGuanylate Cyclase-C Agonist [EPC]
TargetTumor necrosis factor
ModalityRecombinant protein
Therapeutic areaOncology
PhaseFDA-approved
First approval2017

Mechanism of action

Plecanatide is structural analog of human uroguanylin, and similarly to uroguanylin, plecanatide functions as guanylate cyclase-C (GC-C) agonist. Both plecanatide and its active metabolite bind to GC-C and act locally on the luminal surface of the intestinal epithelium. Activation of GC-C results in an increase in both intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP). Elevation of extracellular cGMP has been associated with decrease in the activity of pain-sensing nerves in animal models of visceral pain. Elevation of intracellular cGMP stimulates secretion of chloride and bicarbonate into the intestinal lumen, mainly through activation of the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel, resulting in increased intestinal fluid and accelerated transit. In animal models, plecanatide has been shown to increase fluid secretion into the gastrointestinal (GI) tract, accelerate intestinal transit, and c

Approved indications

Boxed warnings

Common side effects

Key clinical trials

Patents

PatentExpiryType

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results
FDA Orange BookPatents + exclusivity

Competitive intelligence

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