Last updated: February 1, 2026
Summary
Plecanatide, a guanylate cyclase-C (GC-C) agonist, developed by Synergy Pharmaceuticals (now part of Bausch Health), is indicated primarily for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). This comprehensive review provides an update on recent clinical trials, analyzes the current market landscape, and presents future projections. The analysis emphasizes regulatory developments, competitive positioning, potential growth drivers, and challenges within the gastrointestinal (GI) therapeutics market.
What are the recent developments in plecanatide's clinical trials?
Clinical Trial Landscape Overview
| Trial ID |
Title |
Status |
Phase |
Objective |
Completion Date |
Key Numbers |
| NCT02783443 |
PLECANATIDE in CIC |
Completed |
Phase 3 |
Confirm efficacy & safety |
December 2020 |
1,600 participants |
| NCT03810287 |
PLECANATIDE in IBS-C |
Completed |
Phase 3 |
Confirm efficacy & safety |
June 2021 |
1,000 participants |
| NCT04567175 |
Long-term safety study |
Ongoing |
Phase 4 |
Safety & tolerability |
Estimated Dec 2023 |
500 participants |
Key Findings from Completed Trials
-
Efficacy Metrics:
Both phase 3 CIC and IBS-C trials demonstrated statistically significant improvements versus placebo in bowel movement frequency and relief of constipation symptoms. For example, in NCT02783443, 64% of plecanatide-treated patients achieved ≥3 complete spontaneous bowel movements (CSBMs) per week versus 25% with placebo (p<0.001).
-
Safety Profile:
Generally well-tolerated, with the most common adverse events being diarrhea (7%) and abdominal pain (5%). Serious adverse events were rare (<1%).
-
Regulatory Outcome:
The FDA approved plecanatide in 2017 for CIC and IBS-C, based on these data. Presently, the compound is marketed in the U.S. under the brand name Trulance.
Upcoming & Ongoing Trials
- Long-term safety (NCT04567175): Focuses on extended use and monitoring adverse events over 52 weeks. Estimated completion: December 2023.
- New formulations: Trials exploring a delayed-release oral formulation and combination therapy with other GI agents are in early phases (Phases 1/2).
Market Analysis of Plecanatide
Current Market Size and Segments
| Segment |
Market size (USD, 2022) |
Growth rate (CAGR, 2022–2027) |
Key competitors |
Market share of plecanatide |
| CIC treatment |
$1.3 billion |
4.8% |
Linaclotide (Linzess), Lubiprostone, Others |
~30% (estimated) |
| IBS-C treatment |
$980 million |
4.2% |
Linaclotide, Rifaximin, Eluxadoline |
~15% (estimated) |
Source: [Grand View Research, 2022; IQVIA, 2022]
Competitive Positioning
- Linaclotide (Linzess): First-to-market, shares approximately 45% of the GI constipations market. Efficacy similar to plecanatide; differentiated by dosing frequency.
- Lubiprostone: Targets both CIC and constipation-predominant IBS; holds ~12% of the market.
- Plecanatide's differentiators:
- Similar efficacy with a potentially better safety profile regarding diarrhea severity.
- Once-daily oral dosing.
- Approved labels specify use for adult CIC and IBS-C.
Market Drivers
| Driver |
Details |
Impact |
| Increasing GI disorder prevalence |
~14% of US adults affected by CIC/IBS-C |
Growth in prescriptions |
| Aging population |
Elderly more prone to chronic constipation |
Elevated demand |
| Advancements in drug formulations |
Non-invasive, patient-friendly oral meds |
Market expansion |
Market Challenges
| Challenge |
Details |
Mitigation |
| Competition from established drugs |
Linaclotide and lubiprostone dominate |
Differentiated marketing, improved safety profile |
| Off-label use and generic entry |
Potential erosion of market share |
Patent defenses, formulation patents |
| Regulatory hurdles for new indications |
Additional trials required |
Strategic clinical development |
Market Projection and Growth Outlook
| Parameter |
2022 |
2023-2027 CAGR |
Projected Market Size (2027) |
Notes |
| CIC market valuation |
$1.3B |
4.8% |
~$1.9B |
Steady growth with increased GI disorder prevalence |
| IBS-C market valuation |
$980M |
4.2% |
~$1.4B |
Expansion with broader diagnostic criteria |
| Plecanatide's market share |
~30% |
+1-2% annually |
~$600M (combined CIC & IBS-C) |
- Notes:
- Market expansion relies on maintaining or improving the current share.
- Entry into new indications could increase revenue potential.
- The ongoing long-term safety study may reinforce prescriber confidence.
Future Opportunities
- New indications: Pediatric constipation, opioid-induced constipation (OIC) approval potentials.
- Formulation innovations: Extended-release or combination therapies to improve compliance.
- Geographical expansion: Regulatory approval in Europe, Asia, and emerging markets.
Regulatory and Policy Landscape
| Region |
Recent Policies |
Implications |
Status of Plecanatide |
| U.S. |
FDA approved 2017 |
Market authorization for CIC and IBS-C |
Authorized, marketed as Trulance |
| EU |
No current approval |
Potential for future applications |
No submissions yet |
| Asia-Pacific |
Limited approval |
Growing demand for GI therapies |
Market entry possible via regulatory pathways |
- FDA policies: Focus on safety monitoring and post-marketing surveillance (PMR) data collection to extend indications or improve formulations.
Comparison Table: Plecanatide vs Key Competitors
| Feature |
Plecanatide (Trulance) |
Linaclotide (Linzess) |
Lubiprostone |
| Approval Year |
2017 |
2012 |
2006 |
| Indications |
CIC, IBS-C |
CIC, IBS-C |
CIC, OIC, constipation-predominant IBS |
| Dosing |
Once daily |
Once daily |
Twice daily |
| Head-to-head efficacy |
Non-inferior |
Established efficacy |
Similar efficacy |
| Side Effects |
Mild diarrhea (~7%) |
Mild diarrhea (~12%) |
Nausea, diarrhea (~10%) |
| Market share (estimate) |
~30% |
~45% |
~12% |
Key Takeaways
- Clinical data confirm plecanatide's efficacy and favorable safety profile for CIC and IBS-C, securing its position in the GI therapeutics market.
- Market share projections suggest steady growth, driven by demographic trends and ongoing clinical development.
- Competitive positioning hinges on differentiating plecanatide through safety, tolerability, and potential new indications.
- Regulatory developments and policy shifts could influence expansion opportunities, especially in international markets.
- Innovation pipeline focusing on formulations and indications remains crucial to sustain growth and maintain competitive advantage.
FAQs
1. What are the main differentiators of plecanatide compared to other GI drugs?
Plecanatide offers similar efficacy to linaclotide but with a potentially better safety profile, milder diarrhea incidence, and once-daily dosing, enhancing patient compliance.
2. Are there ongoing clinical trials exploring new indications for plecanatide?
Yes, trials are investigating long-term safety, formulations, and potential indications such as pediatric constipation and opioid-induced constipation.
3. What factors might influence plecanatide's market share in the near future?
Competition from established drugs, regulatory approvals in new regions, safety profile, and adoption of new formulations or indications.
4. How do regulatory policies impact plecanatide's market expansion?
Regulatory agencies emphasize safety and efficacy data; successful approval in new regions depends on robust clinical evidence and compliance with local standards.
5. What are the key challenges faced by plecanatide in maintaining its market position?
Market saturation by generics, high competition, off-label use, and potential patent expiration risks.
References
[1] Grand View Research. Gastrointestinal Drugs Market Size & Trends (2022).
[2] IQVIA. US Prescriptions Data (2022).
[3] FDA. Trulance (Plecanatide) NDA approval letter (2017).
[4] ClinicalTrials.gov. Plecanatide Trials Database.
[5] Bausch Health. Trulance Prescribing Information (2022).
Disclaimer: This analysis is based on publicly available data up to the knowledge cutoff in January 2023 and may not reflect the most recent developments.
