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Are there clinical trials for Linaclotide?
Linaclotide has 60 registered clinical trials, including 39 completed interventional studies and trials reaching Phase 4. Its use in humans is supported by established registered clinical evidence.
Trial breakdown
By phase
| Phase 3 | 16 |
| Phase 2 | 14 |
| Not applicable | 11 |
| Phase 4 | 9 |
| Phase 1 | 6 |
| Early Phase 1 | 1 |
By status
| Completed | 41 |
| Unknown status | 5 |
| Terminated | 4 |
| Recruiting | 3 |
| Withdrawn | 2 |
| Active, not recruiting | 2 |
| Not yet recruiting | 2 |
| Enrolling by invitation | 1 |
Active trials
- MRI Parameters as Biomarkers in Cystic Fibrosis (FEMPTO)Not applicable · Not yet recruiting · 12 participants · University of Nottingham · started 2026-09NCT07780344
- Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic FibrosisEarly Phase 1 · Recruiting · 26 participants · University of Nottingham · started 2026-03-09NCT07569419
- "Efficacy and Safety of Linaclotide in Chronic Constipation"Phase 4 · Not yet recruiting · 90 participants · Md Mehedi Shahriar · started 2026-02-20NCT07431957
- Linaclotide for Colonoscopy Bowel PrepPhase 1 / Phase 2 · Recruiting · 10 participants · University of Florida · started 2025-12-01NCT06692673
- Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for ColonoscopyPhase 4 · Enrolling by invitation · 444 participants · Haifeng Lan · started 2024-09-01NCT06748638
- A Study of Virtual Reality and Linaclotide for IBS-CNot applicable · Recruiting · 65 participants · Mayo Clinic · started 2024-05-31NCT05796388
- Linaclotide in Treating Patients With Stages 0-3 Colorectal CancerPhase 2 · Active, not recruiting · 150 participants · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · started 2019-10-30NCT03796884
- Efficacy of Linaclotide in Type II Diabetics With Chronic ConstipationPhase 4 · Active, not recruiting · 23 participants · Texas Tech University Health Sciences Center, El Paso · started 2015-09-01NCT03119584
Most recent registered trials
- MRI Parameters as Biomarkers in Cystic Fibrosis (FEMPTO)Not applicable · Not yet recruiting · 12 participants · University of Nottingham · started 2026-09NCT07780344
- Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic FibrosisEarly Phase 1 · Recruiting · 26 participants · University of Nottingham · started 2026-03-09NCT07569419
- "Efficacy and Safety of Linaclotide in Chronic Constipation"Phase 4 · Not yet recruiting · 90 participants · Md Mehedi Shahriar · started 2026-02-20NCT07431957
- Linaclotide for Colonoscopy Bowel PrepPhase 1 / Phase 2 · Recruiting · 10 participants · University of Florida · started 2025-12-01NCT06692673
- Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for ColonoscopyPhase 4 · Enrolling by invitation · 444 participants · Haifeng Lan · started 2024-09-01NCT06748638
- A Study of Virtual Reality and Linaclotide for IBS-CNot applicable · Recruiting · 65 participants · Mayo Clinic · started 2024-05-31NCT05796388
- Clinical Study of Bowel Preparation Before ColonoscopyNot applicable · Completed · 444 participants · Jinling Hospital, China · started 2023-08-01NCT06091735
- 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 LinaclotidePhase 2 · Completed · 19 participants · AbbVie · started 2023-04-27NCT05760313
- A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional ConstipationPhase 3 · Completed · 123 participants · AbbVie · started 2022-12-29NCT05652205
- GCC Agonist Signal in the Small IntestinePhase 1 · Completed · 43 participants · University of Wisconsin, Madison · started 2022-11-30NCT05107219
- Application of Linaclotide Capsule in Bowel Preparation for Patients at High Risk of Inadequate Bowel PreparationNot applicable · Completed · 720 participants · Zhiguo Liu · started 2022-08-01NCT05379491
- Application of Linaclotide Capsule in Bowel Preparation for ColonoscopyNot applicable · Completed · 1607 participants · Changhai Hospital · started 2022-05-25NCT05291325
Frequently asked questions
Are there clinical trials for Linaclotide?
Linaclotide has 60 registered clinical trials, including 39 completed interventional studies and trials reaching Phase 4. Its use in humans is supported by established registered clinical evidence.
Does a registered trial mean the peptide works?
No. Registration means a study was formally listed before or during the research. It says nothing about the result. A completed trial can find no benefit, and many registered studies are never published.
What is the difference between a registered trial and published evidence?
Registration records that a study exists. Publication reports what it found. This page counts registrations, which is the more complete picture of research activity, but it is not a measure of proven effectiveness.
Why do phases matter?
Phase 1 tests safety in a small group. Phase 2 looks for early signs of effect. Phase 3 tests effectiveness against a comparator in a large group, and is what regulators normally require. Phase 4 studies happen after approval. A compound with only Phase 1 trials has not been shown to work.
Source: ClinicalTrials.gov API v2, U.S. National Library of Medicine. Studies where Linaclotide is registered as an intervention. Last updated 2026-09-23.