TRULANCE (plecanatide)
TRULANCE is indicated for the treatment of Chronic Idiopathic Constipation; Irritable Bowel Syndrome.
How TRULANCE Works
Plecanatide is a structural analog of human uroguanylin that functions as a guanylate cyclase-C (GC-C) agonist. It acts locally on the luminal surface of the intestinal epithelium to increase concentrations of cyclic guanosine monophosphate (cGMP). Intracellular cGMP elevation stimulates the secretion of chloride and bicarbonate into the intestinal lumen via the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel, resulting in increased fluid and accelerated transit. Additionally, elevation of extracellular cGMP is associated with decreased activity of pain-sensing nerves, reducing visceral hypersensitivity.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-01-19
- Patent Cliff
- 2034
- Routes
- ORAL
- Dosage Forms
- TABLET
TRULANCE Approval History
What TRULANCE Treats
2 indicationsTRULANCE is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Idiopathic Constipation
- Irritable Bowel Syndrome
TRULANCE 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 [see Contraindications (4) , Use in Specific Populations (8.4) ] . Avoid use of TRULANCE in patients 6 years to less than 18 years of age [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ] . The safety and effectiveness of TRULAN...
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 [see Contraindications (4) , Use in Specific Populations (8.4) ] . Avoid use of TRULANCE in patients 6 years to less than 18 years of age [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ] . The safety and effectiveness of TRULANCE have not been established in patients less than 18 years of age [see Use in Specific Populations (8.4) ] . WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS See full prescribing information for complete boxed warning. TRULANCE is contraindicated in patients less than 6 years of age; in young juvenile mice, plecanatide caused death due to dehydration. ( 4 , 8.4 ) Avoid use of TRULANCE in patients 6 years to less than 18 years of age. ( 5.1 , 8.4 ) The safety and effectiveness of TRULANCE have not been established in patients less than 18 years of age. ( 8.4 )
TRULANCE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to TRULANCE
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05107219 | NCI-2021-11620 NCI-2021-11620, UWI21-06-01 | Ph 1 | completed | GCC Agonist Signal in the Small Intestine |
| NCT03596905 (IBS-C) results posted | SP304202-14 | Ph 2 | completed | Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C) |
| NCT05151328 | NC011901 | Ph 3 | completed | Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation |
| NCT02706483 IBS-C results posted | SP304203-06 | Ph 3 | completed | Long Term Safety Study of Plecanatide |
| NCT01982240 results posted | SP304203-00 | Ph 3 | completed | 12-Week Study of Plecanatide for CIC (The CIC3 Study) |
| NCT03120520 results posted | SP304202-13 | Ph 2 | completed | An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation |
| NCT01919697 results posted | SP304203-01 | Ph 3 | completed | Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC) |
| NCT02387359 IBS-C results posted | SP304203-04 | Ph 3 | completed | The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C) |
| NCT02493452 IBS-C results posted | SP304203-05 | Ph 3 | completed | Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C) |
| NCT01429987 results posted | SP304-20210 SP-SP30420210 | Ph 2, Ph 3 | completed | The Plecanatide Chronic Idiopathic Constipation (CIC) Study |
| NCT02122471 CIC results posted | SP304203-03 | Ph 3 | completed | 12-Week Study of Plecanatide for CIC (The National CIC3 Study) |
| NCT01722318 CIBS results posted | SP304-20212 | Ph 2 | completed | The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TRULANCE FDA Label Details
Indications & Usage
FDA Label (PDF)TRULANCE is indicated for the treatment of Chronic Idiopathic Constipation; Irritable Bowel Syndrome.
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 [see Contraindications (4) , Use in Specifi...
TRULANCE Patents & Exclusivity
Patents (10 active)
Pro Intelligence Preview
Deep insights for TRULANCE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 12 active patents
Trial Analysis
- • 12 total trials
- • Stage: Declining
Competitive Landscape
- • 10 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment