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 complete
NDA Filings Phase in progress
Market Phase not started

For additional safety information, click here for full Prescribing Information. For Medication Guide, click here.

Learn more about our clinical trials for Trulance here.