At a glance
- Linaclotide is an FDA-approved drug, marketed as Linzess, Linaclotide (first approval: August 30, 2012).
- PubMed lists 482 publications mentioning it, including 45 randomized controlled trials and 16 animal-only studies.
- ClinicalTrials.gov lists 60 registered studies testing it (7 active).
- FDA's adverse event system (FAERS) holds 27,759 reports mentioning it; 10,214 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA202811 | LINZESS | Approved, marketed | August 30, 2012 | ABBVIE |
| ANDA209564 | LINACLOTIDE | Approved, discontinued | February 9, 2021 | MYLAN |
| ANDA209611 | LINACLOTIDE | Approved, discontinued | February 7, 2023 | AUROBINDO PHARMA |
| ANDA211255 | LINACLOTIDE | Approved, marketed | September 24, 2026 | ACTAVIS LABS FL |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Research progress on bowel preparation regimens before colonoscopy: a narrative review.
- Efficacy of Tenapanor in Patients With or Without Prior Use of IBS-C Prescription Medications: A Post-hoc Analysis of Phase 3 Clinical Trials.
- Development and internal validation of a prediction model for suboptimal bowel preparation in individuals aged ≤50 years undergoing colonoscopy.
- Pharmacotherapy of Irritable Bowel Syndrome with Constipation in Children: An Update on Clinical Progress and Successes.
- Effect of Age and Age-Defined Menopausal Status on Linaclotide Efficacy and Safety in Adults With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation: Post Hoc Analyses of Phase 2b/3 Studies.
- Efficacy and Safety of Linaclotide in Pediatric Patients of Functional Constipation: A Meta-analysis of Randomized Controlled Trials.
- Patients' Real-World Experiences With Pharmacologic Therapies for Irritable Bowel Syndrome With Constipation: A Mixed-Methods Analysis and Classification of Social Media and E-Forum Posts.
- Efficacy of linaclotide as adjunct for bowel preparation in patients with chronic constipation: a pre-specified analysis of the APPLE trial.
- Resolving conformational polymorphism in disulfide-rich peptide drugs.
- Rapid and comprehensive identification of the metabolic soft spots of peptide drugs with highly cross-linked disulfide bonds by integrating established proteomic workflow with a product ion filtering strategy.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 60
- Active
- 7
- With posted results
- 24
Conditions studied
Show 40 more studies
All 60 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 27,759
- Serious
- 10,214
- With death outcome
- 1,126
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
Change history
No changes since monitoring began on October 30, 2026.