Dr. Grey AI

Linaclotide (Linzess)

Peptide

Linaclotide is a 14-amino acid peptide guanylate cyclase-C (GC-C) agonist. FDA-approved 2012 for chronic idiopathic constipation (CIC) and IBS-C. Phase 3: 33.7% FDA responder rate vs 13.9% placebo in IBS-C. Improves bowel frequency, stool consistency, and abdominal pain. Doses: 72-145 mcg (CIC), 290 mcg (IBS-C) once daily.

Quick Answer

What it is

Linaclotide is a 14-amino acid peptide guanylate cyclase-C (GC-C) agonist. FDA-approved 2012 for chronic idiopathic constipation (CIC) and IBS-C.

Key findings

  • Grade A: FDA Responder Rate IBS-C (Constipation-Predominant Irritable Bowel Syndrome (IBS-C))
  • Grade A: Abdominal Pain Relief (Constipation-Predominant Irritable Bowel Syndrome (IBS-C))
  • Grade A: Complete Spontaneous BM (Constipation)

Safety

No specific caution or interaction language was detected in the current summary/outcome notes.

⚠️ Research Notice

This peptide information is for educational and research purposes only. Peptides may not be FDA-approved for human use and may only be legally available for research purposes. Consult qualified healthcare professionals before considering any peptide compounds.

ℹ️ Quick Facts: Linaclotide (Linzess)

Quick Facts: Linaclotide (Linzess)

  • Best Evidence:Grade A
  • Conditions Studied:2
  • Research Outcomes:9
  • Grade A Findings:4
  • Grade B Findings:2
  • Key Effect:Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
A4
B2
C2
D1
2 conditions · 9 outcomes

Detailed Outcomes

|
A
FDA Responder Rate IBS-C
Phase 3: 33.6-33.7% FDA responders vs 13.9-21.0% placebo (P<0.0001). Dual endpoint: ≥30% pain improvement + ≥1 CSBM increase for ≥50% of weeks. Effect maintained over 26 weeks.
large↑Improves
A
Abdominal Pain Relief
Significant improvement in worst abdominal pain scores vs placebo. Pain relief observed within first week. cGMP-mediated visceral analgesia independent of bowel effects. No rebound worsening on discontinuation.
large↓Improves
A
Complete Spontaneous BM
Significant increase in CSBMs/week vs placebo. Phase 3 CIC: ≥3 CSBMs/week with ≥1 increase from baseline achieved in significantly more patients. Improved stool consistency and reduced straining.
large↑Improves
A
Abdominal Bloating
Phase 3b: Significant reduction in moderate-to-severe bloating. Improved quality of life and global assessment. Both 145 and 290 mcg doses effective for bloating symptom relief.
large↓Improves
B
GI Protection
10 human trials support this finding. Human clinical trial data available.
moderate↑Improves
B
Safety/Tolerability
8 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.
moderate↑Improves
C
Anti-Cancer Activity
3 preclinical studies support this finding. Primarily preclinical evidence.
small↑Improves
D
Liver Protection
2 preclinical studies support this finding. Primarily preclinical evidence.
small↑Improves

Research Citations (49)

Linaclotide combined with polyethylene glycol for bowel preparation in colonoscopy: a systematic review and meta-analysis of randomized controlled trials.
(2026)
PMID: 41168471
Efficacy and Safety of Linaclotide as an Adjunct to Polyethylene Glycol in Bowel Preparation: A Meta-Analysis.
(2025)
PMID: 40955723
Efficacy and safety of pharmacological therapies for functional constipation in children: a systematic review and meta-analysis.
(2025)
PMID: 41101321
Safety and efficacy of linaclotide as an adjuvant for bowel preparation: A systematic review and meta-analysis.
(2025)
PMID: 41203453
ESPGHAN/NASPGHAN guidelines for treatment of irritable bowel syndrome and functional abdominal pain-not otherwise specified in children aged 4-18 years.
(2025)
PMID: 40444524
Management of Chronic Constipation: A Comprehensive Review.
(2025)
PMID: 37952945
Combined linaclotide and polyethylene glycol electrolyte for colonoscopy preparation: a network meta-analysis of 14 randomized controlled trials.
(2025)
PMID: 40528061
Efficacy and safety of linaclotide in treating functional constipation in paediatric patients: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial
(2024)
PMID: 38211604
Efficacy and safety of linaclotide in treatment-resistant chronic constipation: A multicenter, open-label study
(2024)
PMID: 39370607
Safety and efficacy of linaclotide in children aged 7-17 years with irritable bowel syndrome with constipation.
(2024)
PMID: 38504394

Related Peptides

Plecanatide (Trulance)

Peptide

2 shared conditions · 8 outcomes

Plecanatide is a 16-amino acid synthetic uroguanylin analog and guanylate cyclase-C agonist. FDA-approved 2017 for CIC, 2018 for IBS-C. Phase 3: 21% durable CSBM responders vs 10.2% placebo in CIC (P<0.001). 30% overall responders vs 17.8% placebo in IBS-C. Lower diarrhea rate (5%) than linaclotide. Dose: 3 mg once daily.