Plecanatide

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.

• TRULANCE is indicated in adults for the treatment of: chronic idiopathic constipation (CIC). irritable bowel syndrome with constipation (IBS-C).ICD-10: K58.9, K59.00

• TRULANCE is contraindicated in: Patients less than 6 years of age due to the risk of serious dehydration [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ] . Patients with known or suspected mechanical gastrointestinal obstruction.contraindicated

The recommended adult dosage of TRULANCE is CIC: 3 mg taken orally once daily. ( 2.1 ) IBS-C: 3 mg taken orally once daily. ( 2.1 ) Administration Instructions ( 2.2 ): 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. 2.1 Recommended Dosage The recommended dosage of TRULANCE for the treatment of CIC and IBS-C is 3 mg taken orally once daily. 2.2 Preparation and Administration Instructions Take TRULANCE with or without food [see Clinical Pharmacology (12.3) ] . If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not take two doses at the same time. Swallow a tablet whole for each dose. For adult patients with swallowing difficulties, TRULANCE tablets can be crushed and administered orally either in applesauce or with water or administered with water via a nasogastric or gastric feeding tube. Mixing TRULANCE crushed tablets in other soft foods or in other liquids has not been tested. Oral Administration in Applesauce: In a clean container, crush the TRULANCE tablet to a powder and mix with 1 teaspoonful of room temperature applesauce. Consume the entire tablet-applesauce mixture immediately. Do not store the mixture for later use. Oral Administration in Water: Place the TRULANCE tablet in a clean cup. Pour approximately 30 mL of room temperature water into the cup.

Diarrhea: Patients may experience severe diarrhea. If severe diarrhea occurs, suspend dosing and rehydrate the patient. ( 5.2 ) 5.1 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. In young juvenile mice (human age equivalent of approximately 1 month to less than 2 years), plecanatide increased fluid-secretion into the intestines as a consequence of stimulation of guanylate cyclase-C (GC-C), resulting in mortality in some mice within the first 24 hours, apparently due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than patients 6 years of age and older to develop severe diarrhea and its potentially serious consequences. Avoid the use of TRULANCE in patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in younger mice and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of TRULANCE in patients 6 years to less than 18 years of age [see Contraindications (4) , Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ] . 5.2 Diarrhea Diarrhea was the most common adverse reaction in four placebo-controlled clinical trials, two in patients with CIC and two in patients with IBS-C.

Most common adverse reaction (≥2%) is diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Demographic characteristics were comparable between the TRULANCE and placebo groups in all studies [see Clinical Studies (14) ] . Chronic Idiopathic Constipation (CIC) The safety data described below reflect data from 1,733 adult patients with CIC randomized in two double-blind, placebo-controlled clinical trials (Study 1 and Study 2) to receive placebo or 3 mg of TRULANCE once daily for 12 weeks. Most Common Adverse Reactions Table 1 provides the incidence of adverse reactions reported in at least 2% of CIC patients in the TRULANCE-treated group and at an incidence that was greater than in the placebo group. Table 1: Most Common Adverse Reactions a in Two Placebo-Controlled Trials of TRULANCE [Study 1 and Study 2] in Patients with CIC Adverse Reaction TRULANCE, 3 mg (N = 863) % Placebo (N = 870) % a: Reported in at least 2% of TRULANCE-treated patients with CIC and at an incidence greater than placebo.

8.1 Pregnancy Risk Summary Plecanatide and its active metabolite are negligibly absorbed systemically following oral administration [see Clinical Pharmacology (12.3) ] and maternal use is not expected to result in fetal exposure to the drug. The available data on TRULANCE use in pregnant women are not sufficient to inform any drug-associated risks for major birth defects and miscarriage. In animal developmental studies, no effects on embryo-fetal development were observed with oral administration of plecanatide in mice and rabbits during organogenesis at doses much higher than the recommended human dosage. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Pregnant mice and rabbits were administered plecanatide during the period of organogenesis. There was no evidence of harm to embryo-fetal development at oral doses up to 800 mg/kg/day in mice and 250 mg/kg/day in rabbits.

Metabolism

Absorption Plecanatide was minimally absorbed with negligible systemic availability following oral administration. Concentrations of plecanatide and its active metabolite in plasma were below the limit of quantitation in the majority of analyzed plasma samples after an oral TRULANCE dose of 3 mg.

• Jan 19, 2017NDANDA208745Salix

1. 1Diarrhoea37020%
2. 2Nausea1698.9%
3. 3Constipation1598.4%
4. 4Drug Ineffective1598.4%
5. 5Fatigue1125.9%
6. 6Abdominal Distension1055.5%
7. 7Abdominal Pain Upper1025.4%
8. 8Headache1005.3%
9. 9Abdominal Pain975.1%
10. 10Pain975.1%
11. 11Dizziness945.0%
12. 12Dyspnoea723.8%
13. 13Muscle Spasms713.7%
14. 14Product Use In Unapproved Indication713.7%
15. 15Abdominal Discomfort703.7%

The 10 most recently updated of 14 ClinicalTrials.gov registrations naming Plecanatide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• GCC Agonist Signal in the Small Intestine
  Completed · Phase 1 · Interventional · 43 enrolled · University of Wisconsin, Madison
  NCT05107219updated 2026-04-07
• Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)
  Completed · Phase 2 · Interventional · 218 enrolled · Bausch Health Americas, Inc.
  NCT03596905updated 2025-12-31
• Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation
  Completed · Phase 3 · Interventional · 648 enrolled · Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
  NCT05151328updated 2024-07-11
• Long Term Safety Study of Plecanatide
  Completed · Phase 3 · Interventional · 2,272 enrolled · Bausch Health Americas, Inc.
  NCT02706483updated 2020-08-18
• SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation
  Completed · Phase 2 · Interventional · 84 enrolled · Bausch Health Americas, Inc.
  NCT01053962updated 2020-01-02
• 12-Week Study of Plecanatide for CIC (The CIC3 Study)
  Completed · Phase 3 · Interventional · 1,394 enrolled · Bausch Health Americas, Inc.
  NCT01982240updated 2019-12-26
• A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®
  Completed · Observational · 7 enrolled · Bausch Health Americas, Inc.
  NCT03551873updated 2019-11-22
• An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation
  Completed · Phase 2 · Interventional · 124 enrolled · Bausch Health Americas, Inc.
  NCT03120520updated 2019-10-04
• Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
  Completed · Phase 3 · Interventional · 2,370 enrolled · Bausch Health Americas, Inc.
  NCT01919697updated 2019-07-02
• The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
  Completed · Phase 3 · Interventional · 1,054 enrolled · Bausch Health Americas, Inc.
  NCT02387359updated 2019-06-14

Frequently asked questions

How does Plecanatide work?

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.

What is Plecanatide used for?

According to FDA labeling, Plecanatide carries indications including: TRULANCE is indicated in adults for the treatment of: chronic idiopathic constipation (CIC). irritable bowel syndrome with constipation (IBS-C).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Plecanatide?

Plecanatide is classified as Other drugs for constipation, Guanylate Cyclase-C Agonist, Chloride Channel Activators, Guanylate Cyclase Activators, Increased Gastric Motility, Small Intestine Fluid/Electrolyte Secretion Alteration.

What are the brand names for Plecanatide?

Plecanatide is marketed under brand names including Trulance.

What are the contraindications for Plecanatide?

Plecanatide labeling lists contraindications including: TRULANCE is contraindicated in: Patients less than 6 years of age due to the risk of serious dehydration [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ] . Patients with known or suspected mechanical gastrointestinal obstruction.. Always consult the full prescribing information and a clinician.