Linaclotide
Treatment for Irritable Bowel Syndrome
Typical Dosage: 290 mcg orally once daily (IBS-C) or 145 mcg orally once daily (CIC)
Effectiveness
68%
Safety Score
75%
Clinical Trials
26
Participants
10K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
75
DangerousModerateSafe
Treatment Details
Dosage Range
290 mcg orally once daily (IBS-C) or 145 mcg orally once daily (CIC)
Time to Effect
1-2 weeks
Treatment Duration
Long-term (chronic)
Evidence Quality
HIGHNumber Needed to Treat (NNT)
6(Treat 6 patients to see 1 additional successful outcome)
Number Needed to Harm (NNH)
5(Treat 5 patients to see 1 additional serious adverse event)
Confidence Score
90%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$20,000
Monitoring:$300
Side Effect Mgmt:$200
Total Annual:$20,500
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
GOODICER
$85,000/QALY
QALYs Gained
0.08
Outcome-Based Costs
Cost per Responder
$58,571
Cost per Remission
$136,667
Comparison vs Lubiprostone
Cost Difference
+$5,000/year
More expensive
QALY Difference
+0.03 QALYs
Better outcomes
Dominance
No dominance
Prescription Access Economics
Annual Societal Loss per Patient
$16,010
Cost of prescription-only barriers (visits, time, admin, price premium)
Physician Visit Cost
$250/year
Time Cost
$120/year
Travel + wait time
Insurance Admin Cost
$40/year
Prior auth, claims
Rx Price
$20,000/year
Potential OTC Price
$4,000/year
Estimated if OTC available
Early Treatment Benefit
+0.05 QALYs
From faster OTC access
Risk Assessment
Misuse Risk
LOWMissed Diagnosis Risk
MODERATELinaclotide Outcomes
for Irritable Bowel Syndrome
Efficacy Outcomes
Overall Effectiveness
+68%
Response Rate
+35%
Remission Rate
+15%
Common Side Effects
Diarrhea
+20%
Abdominal pain
+7%
Flatulence
+6%
Active Clinical Trials
1 active trial recruiting for Linaclotide in Irritable Bowel Syndrome
A Study of Virtual Reality and Linaclotide for IBS-C
NCT05796388RECRUITINGNA
65 participants
INTERVENTIONAL
Jacksonville, United States
Started: May 31, 2024
Completed Clinical Trials
15 completed trials for Linaclotide in Irritable Bowel Syndrome
Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBS
NCT00258193COMPLETEDPHASE2
36 participants
INTERVENTIONAL
Rochester, United States
Started: Jan 1, 2006
A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically
NCT02220348COMPLETEDPHASE1
7 participants
INTERVENTIONAL
Iowa City, United States +1 more
Started: Jul 31, 2014
An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
NCT00765999COMPLETEDPHASE3
1.56K participants
INTERVENTIONAL
Birmingham, United States +117 more
Started: Oct 31, 2008
An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation
NCT02590432COMPLETEDPHASE4
828 participants
INTERVENTIONAL
Anniston, United States +78 more
Started: Nov 1, 2015
Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT00460811COMPLETEDPHASE2
420 participants
INTERVENTIONAL
Huntsville, United States +84 more
Started: Apr 1, 2007
An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
NCT00730171COMPLETEDPHASE3
1.74K participants
INTERVENTIONAL
Birmingham, United States +115 more
Started: Sep 1, 2008
A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT03573908COMPLETEDPHASE3
614 participants
INTERVENTIONAL
Huntsville, United States +78 more
Started: Jun 20, 2018
A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome
NCT01714843COMPLETEDPHASE2
559 participants
INTERVENTIONAL
Hokkaido, Japan +3 more
Started: Aug 10, 2012
Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome
NCT02316899COMPLETEDPHASE3
500 participants
INTERVENTIONAL
Aichi, Japan +60 more
Started: Oct 21, 2014
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT02559206COMPLETEDPHASE2
759 participants
INTERVENTIONAL
Huntsville, United States +70 more
Started: Oct 22, 2015
Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)
NCT04026113COMPLETEDPHASE3
438 participants
INTERVENTIONAL
Birmingham, United States +114 more
Started: Oct 1, 2019
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT00938717COMPLETEDPHASE3
805 participants
INTERVENTIONAL
Birmingham, United States +106 more
Started: Jul 1, 2009
Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients
NCT02078323COMPLETEDNA
39 participants
INTERVENTIONAL
Augusta, United States
Started: Feb 1, 2014
A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT01880424COMPLETEDPHASE3
1.72K participants
INTERVENTIONAL
Huntsville, United States +81 more
Started: Jul 1, 2013
Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
NCT03471728COMPLETED
2.48K participants
OBSERVATIONAL
Aichi, Japan +46 more
Started: Oct 2, 2017
Showing 20 of 26 total trials