Overview
Linaclotide is a synthetic 14-amino acid cyclic peptide and first-in-class guanylate cyclase-C (G-CC) agonist. Linaclotide is structurally related to human guanylin and uroguanylin, paracrine peptide hormones that are endogenous activators of GC-C. It is also a homolog of a heat-stable enterotoxin derived from Escherichia coli, the first natural ligand that activates GC-C. Linaclotide is used for the treatment of various types of constipation, including irritable bowel syndrome with constipation. Linaclotide was first approved by the FDA on August 30, 2012. It gained EMA and Health Canada approval on November 26, 2012 and December 3, 2013, respectively. Linaclotide works to improve the symptoms of constipation and gastrointestinal symptoms of conditions involving constipation.
Background
Linaclotide is a synthetic 14-amino acid cyclic peptide and first-in-class guanylate cyclase-C (G-CC) agonist. Linaclotide is structurally related to human guanylin and uroguanylin, paracrine peptide hormones that are endogenous activators of GC-C. It is also a homolog of a heat-stable enterotoxin derived from Escherichia coli, the first natural ligand that activates GC-C. Linaclotide is used for the treatment of various types of constipation, including irritable bowel syndrome with constipation. Linaclotide was first approved by the FDA on August 30, 2012. It gained EMA and Health Canada approval on November 26, 2012 and December 3, 2013, respectively. Linaclotide works to improve the symptoms of constipation and gastrointestinal symptoms of conditions involving constipation.
Indication
Linaclotide is indicated for the treatment of irritable bowel syndrome with constipation in adults. This indication is approved in the US, Canada, and Europe. In the US and Canada, it is also indicated for the treatment of chronic idiopathic constipation in adults. In the US, it is also indicated for the treatment of functional constipation in pediatric patients 6 to 17 years of age.
Associated Conditions
- Functional Constipation (FC)
- Irritable Bowel Syndrome With Constipation (IBS-C)
- Chronic idiopathic constipation (CIC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/25 | Phase 4 | Completed | |||
2024/12/27 | Phase 4 | ENROLLING_BY_INVITATION | Haifeng Lan | ||
2023/03/08 | Phase 2 | Completed | |||
2022/12/15 | Phase 3 | Active, not recruiting | |||
2021/11/30 | Not Applicable | UNKNOWN | Second Affiliated Hospital of Xi'an Jiaotong University | ||
2021/11/26 | Phase 4 | UNKNOWN | |||
2021/11/04 | Phase 1 | Active, not recruiting | |||
2021/03/18 | Phase 3 | UNKNOWN | Jiangsu Hansoh Pharmaceutical Co., Ltd. | ||
2019/10/01 | Phase 2 | Completed | |||
2019/07/19 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Allergan, Inc. | 0456-1202 | ORAL | 290 ug in 1 1 | 9/20/2023 | |
| Allergan, Inc. | 0456-1203 | ORAL | 72 ug in 1 1 | 9/20/2023 | |
| Allergan, Inc. | 0456-1201 | ORAL | 145 ug in 1 1 | 9/20/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/26/2012 | ||
Authorised | 11/26/2012 | ||
Authorised | 11/26/2012 | ||
Authorised | 11/26/2012 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Linaclotide Capsules | 国药准字HJ20190002 | 化学药品 | 胶囊剂 | 10/16/2023 | |
| Linaclotide Capsules | 国药准字HJ20190001 | 化学药品 | 胶囊剂 | 10/16/2023 | |
| Linaclotide Capsules | 国药准字HJ20191007 | 化学药品 | 胶囊剂 | 10/16/2023 | |
| Linaclotide Capsules | 国药准字J20200012 | 化学药品 | 胶囊剂 | 5/14/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CONSTELLA linaclotide 145 microgram hard capsule bottle | 297703 | Medicine | A | 6/18/2019 | |
| CONSTELLA linaclotide 72 microgram hard capsule bottle | 297705 | Medicine | A | 6/18/2019 | |
| CONSTELLA linaclotide 290 microgram hard capsule bottle | 297704 | Medicine | A | 6/18/2019 |