Linzess, Constella(linaclotide)
Constella, Linaclotide, Linzess (linaclotide) is a protein pharmaceutical. Linaclotide was first approved as Linzess on 2012-08-30. It is used to treat constipation and irritable bowel syndrome in the USA. It has been approved in Europe to treat irritable bowel syndrome. The pharmaceutical is active against guanylyl cyclase C.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Linzess (discontinued: Linaclotide)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| constellation brands hand sanitizer | OTC monograph not final | 2020-05-06 |
| linzess | New Drug Application | 2023-06-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| irritable bowel syndrome | EFO_0000555 | D043183 | K58 |
| constipation | — | D003248 | K59.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LINACLOTIDE, LINZESS, ABBVIE | |||
| 2026-06-12 | I-921 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Linaclotide, Linzess, Abbvie | |||
| 9708371 | 2033-08-16 | DP | U-1515, U-1516, U-3644 |
| 8748573 | 2031-10-30 | U-1515, U-1516 | |
| 8802628 | 2031-10-30 | DP | |
| 10675325 | 2031-08-11 | DP | |
| 10702576 | 2031-08-11 | U-1516, U-3644 | |
| 8933030 | 2031-02-17 | DP | U-1516, U-3644 |
| 7304036 | 2026-08-30 | DS, DP | U-1278, U-1516, U-3644 |
| 7371727 | 2024-01-28 | DP | |
| 7704947 | 2024-01-28 | DS, DP | |
| 7745409 | 2024-01-28 | DS, DP | |
| 8080526 | 2024-01-28 | DS, DP | |
| 8110553 | 2024-01-28 | U-1278, U-1516, U-3644 | |
HCPCS
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Clinical
Clinical Trials
56 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Constipation | D003248 | — | K59.0 | 1 | 12 | 16 | 4 | 8 | 41 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | 1 | 5 | 9 | 3 | 8 | 26 |
| Syndrome | D013577 | — | — | — | 5 | 9 | 3 | 5 | 22 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | 1 | — | 1 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | — | — | 1 | — | 1 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | — | 1 | — | 1 |
| Gastrointestinal hemorrhage | D006471 | — | K92.2 | — | — | — | 1 | — | 1 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | — | — | 1 | — | 1 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 1 | 1 | — | — | — | 2 |
| Opioid-induced constipation | D000079689 | — | — | — | 1 | — | — | — | 1 |
| Adenoma | D000236 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Breast feeding | D001942 | — | — | 1 | — | — | — | — | 1 |
| Disease | D004194 | EFO_0000408 | R69 | 1 | — | — | — | — | 1 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | 1 | — | — | — | — | 1 |
| Digestive system neoplasms | D004067 | — | — | 1 | — | — | — | — | 1 |
| Barrett esophagus | D001471 | EFO_0000280 | K22.7 | 1 | — | — | — | — | 1 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colonoscopy | D003113 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Linaclotide |
| INN | linaclotide |
| Description | Linaclotide is a fourteen-membered heterodetic cyclic peptide consisting of Cys, Cys, Glu, Tyr, Cys, Cys, Asn, Pro, Ala, Cys, Thr, Gly, Cys and Tyr residues joined in sequence and cyclised by three disulfide bonds: between Cys(1) and Cys(6), between Cys(2) and Cys(10), and between Cys(5) and Cys(13). Used for treatment of irritable bowel syndrome accompanied by constipation. It has a role as a guanylate cyclase 2C agonist. |
| Classification | Protein |
| Drug class | peptides: gastrointestinal functions; normalizing agent |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@@H]1NC(=O)[C@@H]2CCCN2C(=O)[C@H](CC(N)=O)NC(=O)[C@@H]2CSSC[C@H](N)C(=O)N[C@H]3CSSC[C@H](NC1=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)NCC(=O)N[C@H](C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)O)CSSC[C@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CCC(=O)O)NC3=O)C(=O)N2 |
Identifiers
| PDB | — |
| CAS-ID | 851199-59-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3301675 |
| ChEBI ID | 68551 |
| PubChem CID | 16158208 |
| DrugBank | — |
| UNII ID | N0TXR0XR5X (ChemIDplus, GSRS) |
Target
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Linzess – Allergan
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Linzess – Warner Chilcott
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Linzess – AbbVie
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Tabular view
Estimated US medical usage
Linaclotide
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
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Additional graphs summarizing 1,376 documents
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Safety
Black-box Warning
Black-box warning for: Linzess
Adverse Events
Top Adverse Reactions
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13,713 adverse events reported
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