Plecanatide

Summary

Plecanatide (CHEMBL2103867) is an approved protein (ATC A06AX07) targeting GUCY2C; indicated across 2 conditions including constipation disorder and irritable bowel syndrome.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Protein
• ATC class: A06AX07
• Targets: 1 (GUCY2C)
• Indications: 2 conditions
• Clinical trials: 14
• Chemistry: 1681.9 Da · C65H104N18O26S4

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2103867
Name	Plecanatide
Type	Protein
Max phase	4
FDA approved	yes
PubChem CID	70693500
ATC	A06AX07
Molecular formula	C65H104N18O26S4
Molecular weight	1681.9
InChIKey	NSPHQWLKCGGCQR-DLJDZFDSSA-N

SMILES: C[C@H]1C(=O)N[C@H]2CSSC[C@@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@@H](CSSC[C@H](NC(=O)CNC(=O)[C@@H](NC2=O)[C@@H](C)O)C(=O)N[C@@H](CC(C)C)C(=O)O)C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N1)C(C)C)CC(=O)N)C(C)C)CC(C)C)CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CC(=O)N)N

IUPAC name: (2S)-2-[[(1R,4S,7S,10S,13S,16R,19S,22S,25R,32S,38R)-10-(2-amino-2-oxoethyl)-25-[[(2S)-4-carboxy-2-[[(2S)-3-carboxy-2-[[(2S)-2,4-diamino-4-oxobutanoyl]amino]propanoyl]amino]butanoyl]amino]-22-(2-carboxyethyl)-32-[(1R)-1-hydroxyethyl]-4-methyl-19-(2-methylpropyl)-3,6,9,12,15,18,21,24,30,33,36-undecaoxo-7,13-di(propan-2-yl)-27,28,40,41-tetrathia-2,5,8,11,14,17,20,23,31,34,37-undecazabicyclo[14.13.13]dotetracontane-38-carbonyl]amino]-4-methylpentanoic acid

Also known as: Guanilib, Plecanatida, Plecanatide, SP-304, SP-304 (SYNERGY), Trulance, PLECANATIDE

Patent coverage: 216 distinct patent families (477 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 420 (88%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
GUCY2C	Guanylyl cyclase-C	Agonist		0%	P25092

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): GUCY2C.

Top Reactome pathways

2 total, by targets touching each:

Pathway	Targets	Genes
Digestion	1	GUCY2C
Intestinal infectious diseases	1	GUCY2C

Dominant GO biological processes

GO term	Targets
cGMP biosynthetic process	1
receptor guanylyl cyclase signaling pathway	1
response to toxic substance	1
intracellular signal transduction	1
regulation of cell population proliferation	1
protein phosphorylation	1
cyclic nucleotide biosynthetic process	1

Indications & clinical

Indications

2 indications (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
constipation disorder	4	MONDO:0002203	HP:0002019
irritable bowel syndrome	3	MONDO:0005052	EFO:0000555

Clinical trials

Total trials: 14.

Phase distribution

Phase	Trials
PHASE3	7
PHASE2	4
PHASE2/PHASE3	1
PHASE1	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT01429987	PHASE2/PHASE3	COMPLETED	The Plecanatide Chronic Idiopathic Constipation (CIC) Study
NCT01919697	PHASE3	COMPLETED	Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
NCT01982240	PHASE3	COMPLETED	12-Week Study of Plecanatide for CIC (The CIC3 Study)
NCT02122471	PHASE3	COMPLETED	12-Week Study of Plecanatide for CIC (The National CIC3 Study)
NCT02387359	PHASE3	COMPLETED	The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
NCT02493452	PHASE3	COMPLETED	Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)
NCT02706483	PHASE3	COMPLETED	Long Term Safety Study of Plecanatide
NCT05151328	PHASE3	COMPLETED	Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation
NCT01053962	PHASE2	COMPLETED	SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation
NCT01722318	PHASE2	COMPLETED	The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
NCT03120520	PHASE2	COMPLETED	An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation
NCT03596905	PHASE2	COMPLETED	Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT05107219	PHASE1	COMPLETED	GCC Agonist Signal in the Small Intestine
NCT03551873	Not specified	COMPLETED	A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).