Trulance™ (Plecanatide)

Trulance is a once-daily tablet approved for adults with CIC and is being evaluated for IBS-C. With the exception of a single amino acid, Trulance is structurally related to uroguanylin, a naturally occurring and endogenous human GI peptide. Uroguanylin is thought to act in a pH-sensitive manner, targeting GC-C receptors primarily in the small intestine coinciding with areas of fluid secretion.

Trulance has a boxed warning concerning the risk of serious dehydration in pediatric patients. Trulance is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of plecanatide caused deaths due to dehydration. Use of Trulance should be avoided in patients 6 years to less than 18 years of age. The safety and efficacy of Trulance™ have not been established in pediatric patients less than 18 years of age.

Uroguanylin Analog
Discovery Phase 1 Phase 2 Phase 3 NDA Filings Market
TRULANCE™ (plecanatide)
CIC Discovery Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA Filings Phase in progress
Trulance (plecanatide)
Market Phase not started
IBS-C Discovery Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase in progress
NDA Filings Phase not started
Market Phase not started

For additional safety information, click here for full Prescribing Information including Patient Information and discuss with a healthcare practitioner.

Please also see Medication Guide.

Learn more about our clinical trials for Trulance here.