Success Metrics

Clinical Success Rate
95.0%

Based on 19 completed trials

Completion Rate
95%(19/20)
Active Trials
2(8%)
Results Posted
63%(12 trials)
Terminated
1(4%)

Phase Distribution

Ph phase_1
2
8%
Ph phase_3
11
42%
Ph not_applicable
3
12%
Ph phase_2
5
19%
Ph phase_4
4
15%

Phase Distribution

2

Early Stage

5

Mid Stage

15

Late Stage

Phase Distribution25 total trials
Phase 1Safety & dosage
2(8.0%)
Phase 2Efficacy & side effects
5(20.0%)
Phase 3Large-scale testing
11(44.0%)
Phase 4Post-market surveillance
4(16.0%)
N/ANon-phased studies
3(12.0%)

Highest Phase Reached

Phase 4

Trial Status & Enrollment

Completion Rate

95.0%

19 of 20 finished

Non-Completion Rate

5.0%

1 ended early

Currently Active

2

trials recruiting

Total Trials

26

all time

Status Distribution
Active(2)
Completed(19)
Terminated(1)
Other(4)

Detailed Status

Completed19
unknown4
Active, not recruiting2
Terminated1

Development Timeline

Analytics

Development Status

Total Trials
26
Active
2
Success Rate
95.0%
Most Advanced
Phase 4

Trials by Phase

Phase 12 (8.0%)
Phase 25 (20.0%)
Phase 311 (44.0%)
Phase 44 (16.0%)
N/A3 (12.0%)

Trials by Status

active_not_recruiting28%
completed1973%
terminated14%
unknown415%

Recent Activity

Clinical Trials (26)

Showing 20 of 26 trialsScroll for more
NCT03796884Phase 2

Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer

Active Not Recruiting
NCT05760313Phase 2

A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide

Completed
NCT05107219Phase 1

GCC Agonist Signal in the Small Intestine

Active Not Recruiting
NCT05652205Phase 3

A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation

Completed
NCT04026113Phase 3

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)

Completed
NCT03471728

Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)

Completed
NCT01714843Phase 2

A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

Completed
NCT02809105Phase 3

A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation

Completed
NCT02316899Phase 3

Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

Completed
NCT04110145Phase 2

Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation

Completed
NCT05134584Phase 4

Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Unknown
NCT02837783Phase 4

A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)

Terminated
NCT05137145Not Applicable

Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation

Unknown
NCT04804267Phase 3

Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic Constipation

Unknown
NCT02220348Phase 1

A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically

Completed
NCT03573908Phase 3

A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Completed
NCT02559206Phase 2

Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Completed
NCT02590432Phase 4

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

Completed
NCT00765999Phase 3

An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

Completed
NCT02078323Not Applicable

Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients

Completed

Drug Details

Intervention Type
DRUG
Total Trials
26