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Molecule

Plecanatide

Guanylate Cyclase-C Agonist
Available on requestGastroenterology
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Plecanatide is a guanylate cyclase-C agonist indicated in adults for the treatment of chronic idiopathic constipation (CIC). It is available as tablets for oral use. MedsAcross supplies Plecanatide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Guanylate Cyclase-C Agonist, Guanylate Cyclase Activators
ATC classification
A06AX07 Plecanatide · Laxatives, subgroup A06A, subgroup A06AX
US FDA first approval
19 January 2017
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII 7IK8Z952OKRxCUI 1873752CAS 467426-54-6DrugBank DB13170Q28559278

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

TRULANCE is indicated in adults for the treatment of: chronic idiopathic constipation (CIC). irritable bowel syndrome with constipation (IBS-C). TRULANCE is a guanylate cyclase-C agonist indicated in adults for treatment of: chronic idiopathic constipation (CIC). irritable bowel syndrome with constipation (IBS-C).

Source: US FDA prescribing information

How it works

Plecanatide is a structural analog of human uroguanylin, and similarly 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 extracellular cGMP has been associated with a 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.

Source: US FDA prescribing information

Dosing overview

The recommended adult dosage of TRULANCE is CIC: 3 mg taken orally once daily. IBS-C: 3 mg taken orally once daily. Administration Instructions: Take with or without food. Swallow tablets whole. For patients who have difficulty swallowing tablets whole or those with a nasogastric or gastric feeding tube, see full prescribing information with instructions for crushing the tablet and administering with applesauce or water.

Source: US FDA prescribing information

Contraindications

TRULANCE is contraindicated in: Patients less than 6 years of age due to the risk of serious dehydration. Patients with known or suspected mechanical gastrointestinal obstruction. Patients less than 6 years of age due to the risk of serious dehydration.

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (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. Avoid use of TRULANCE in patients 6 years to less than 18 years of age. The safety and effectiveness of TRULANCE have not been established in patients less than 18 years of age. Diarrhea: Patients may experience severe diarrhea. If severe diarrhea occurs, suspend dosing and rehydrate the patient. Risk of Serious Dehydration in Pediatric Patients TRULANCE is contraindicated in patients less than 6 years of age. The safety and effectiveness of TRULANCE in patients less than 18 years of age have not been established.

Source: US FDA prescribing information

Storage

Store at room temperature, 20 to 25°C (68 to 77°F), excursions permitted to 15 to 30°C (59 to 86°F). Protect from moisture.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Plecanatide, sorted by availability.

MedicineManufacturerRegisterAvailability
Trulance Immediate release 3 mg tabletOralSalix PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 19 January 2017Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Plecanatide in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Plecanatide available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Plecanatide and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Plecanatide have?

The catalogue lists 1 brand names for Plecanatide, including Trulance Immediate release.

Is Plecanatide approved by the US FDA?

Yes. The US FDA first approved Plecanatide on 19 January 2017, according to Drugs@FDA.

Does Plecanatide need cold chain shipping?

No listed presentation of Plecanatide is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Plecanatide in?

Plecanatide is classified under ATC code A06AX07 (Plecanatide).

References

  1. Trulance Immediate release prescribing information (Salix Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 4 April 2024

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