NDAORALCAPSULE
Approved
Aug 2012
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Mechanism of Action
Guanylate Cyclase Activators
Pharmacologic Class:
Guanylate Cyclase-C Agonist
Clinical Trials (5)
A Study of Virtual Reality and Linaclotide for IBS-C
Started May 2024
65 enrolled
Irritable Bowel Syndrome With Constipation
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
Started Apr 2023
19 enrolled
Functional Constipation
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
Started Dec 2022
123 enrolled
Functional Constipation (FC)Chronic Idiopathic Constipation (CIC)
Evaluate the Safety of Linaclotide in IBS-C Patients in China
Started Sep 2020
3,028 enrolled
Irritable Bowel Syndrome-IBS
Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
Started Nov 2019
381 enrolled
Irritable Bowel Syndrome With ConstipationFunctional Constipation
Loss of Exclusivity
LOE Date
Feb 16, 2034
96 months away
Patent Expiry
Feb 16, 2034
Exclusivity Expiry
May 4, 2029
Patent Records (5)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 7304036 | Aug 30, 2026 | SubstanceProduct | U-1516 |
| 7304036*PED | Feb 28, 2027 | — | |
| 8933030 | Feb 17, 2031 | Product | — |
| 10675325 | Aug 11, 2031 | Product | — |
| 10702576 | Aug 11, 2031 | U-3644 |