U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS
Plecanatide (SP-304) is a synthetic, 16-amino acid peptide with 2 disulfide bonds that is a secondin-class guanylate cyclase-C (GC-C) receptor agonist. Plecanatide (brand name Trulance) was approved in January 2017 by the FDA for the treatment of chronic idiopathic constipation (CIC). Plecanatide stimulates intestinal fluid secretions in the gastrointestinal tract to support regular bowel function. Plecanatide, taken orally once daily, works locally in the upper GI tract to stimulate secretion of intestinal fluid and support regular bowel function. Plecanatide is structurally related to human uroguanylin, and similar to uroguanylin, plecanatide functions as a 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 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 cause changes in stool consistency.

Approval Year

TargetsConditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
TRULANCE

Approved Use

TRULANCE is a guanylate cyclase-C agonist indicated in adults for treatment of chronic idiopathic constipation (CIC).

Launch Date

2017
PubMed

PubMed

TitleDatePubMed
Safety and tolerability of plecanatide in patients with chronic idiopathic constipation: long-term evidence from an open-label study.
2018 Apr
Efficacy and safety of plecanatide in treating constipation predominant irritable bowel syndrome.
2018 Feb
Efficacy and Tolerability of Guanylate Cyclase-C Agonists for Irritable Bowel Syndrome with Constipation and Chronic Idiopathic Constipation: A Systematic Review and Meta-Analysis.
2018 Mar
Patents

Sample Use Guides

The recommended adult dosage of TRULANCE (Plecanatide ) is 3 mg taken orally once daily.
Route of Administration: Oral
Stimulation of in vitro cGMP synthesis was assessed by ELISA in T84 cells following treatment with 0.1 mM plecanatide or uroguanylin for 30 minutes at solution pH of 5.5, 6.0, 6.5, and 7.0.
Name Type Language
PLECANATIDE
INN   USAN   WHO-DD  
INN   USAN  
Official Name English
[3-Glutamic acid(D>E)]human uroguanylin (UGN)
Common Name English
L-LEUCINE, L-ASPARAGINYL-L-.ALPHA.-ASPARTYL-L-.ALPHA.-GLUTAMYL-L-CYSTEINYL-L-.ALPHA.-GLUTAMYL-L-LEUCYL-L-CYSTEINYL-L-VALYL-L-ASPARAGINYL-L-VALYL-L-ALANYL-L-CYSTEINYL-L-THREONYLGLYCYL-L-CYSTEINYL-, CYCLIC (4-12),(7-15)-BIS(DISULFIDE)
Common Name English
Plecanatide [WHO-DD]
Common Name English
PLECANATIDE [ORANGE BOOK]
Common Name English
ASN-ASP-GLU-CYS-GLU-LEU-CYS-VAL-ASN-VAL-ALA-CYS-THR-GLY-CYS-LEU CYCLIC (4->12),(7->15)-BIS(DISULFIDE)
Systematic Name English
PLECANATIDE [USAN]
Common Name English
plecanatide [INN]
Common Name English
GUANILIB
Common Name English
SP-304 (SYNERGY)
Code English
PLECANATIDE [MI]
Common Name English
TRULANCE
Brand Name English
Classification Tree Code System Code
NDF-RT N0000185500
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WHO-ATC A06AX07
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Code System Code Type Description
ChEMBL
CHEMBL2103867
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PRIMARY
LACTMED
Plecanatide
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MERCK INDEX
m12023
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DAILYMED
7IK8Z952OK
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INN
9367
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DRUG BANK
DB13170
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RXCUI
1873752
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PUBCHEM
70693500
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CAS
467426-54-6
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EPA CompTox
DTXSID60196933
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WIKIPEDIA
Plecanatide
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NCI_THESAURUS
C167027
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DRUG CENTRAL
5208
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FDA UNII
7IK8Z952OK
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USAN
XX-06
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