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Linzess, Constella(linaclotide)
Constella, 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
Therapeutic Area
MeSH
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Linzess (generic drugs available since 2023-02-07)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Linaclotide
Tradename
Company
Number
Date
Products
LINZESSAbbVieN-202811 RX2012-08-30
3 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
constellation brands hand sanitizerOTC monograph not final2020-05-04
linzessNew Drug Application2020-09-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
constipationHP_0002019D003248K59.0
irritable bowel syndromeEFO_0000555D043183K58
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Linaclotide, Linzess, Abbvie
97083712033-08-16DPU-1515, U-1516
87485732031-10-30U-1515, U-1516
88026282031-10-30DP
106753252031-08-11DP
107025762031-08-11U-1516
89330302031-02-17DPU-1516
73040362026-08-30DS, DPU-1278, U-1516
73717272024-01-28DP
77049472024-01-28DS, DP
77454092024-01-28DS, DP
80805262024-01-28DS, DP
81105532024-01-28U-1278, U-1516
ATC Codes
A: Alimentary tract and metabolism drugs
— A06: Drugs for constipation
— A06A: Drugs for constipation
— A06AX: Other drugs for constipation in atc
— A06AX04: Linaclotide
HCPCS
No data
Clinical
Clinical Trials
44 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Irritable bowel syndromeD043183EFO_0000555K581583320
Diabetes mellitusD003920EFO_0000400E08-E13———1—1
Ulcerative colitisD003093EFO_0000729K51———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ConstipationD003248HP_0002019K59.0111—14
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD01517911———2
Opioid-induced constipationD000079689—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 feedingD0019421————1
DiseaseD004194EFO_0000408R691————1
Barrett esophagusD001471EFO_0000280K22.71————1
Gastroesophageal refluxD005764EFO_0003948K211————1
Abdominal painD015746R10.91————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ColonoscopyD003113————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLINACLOTIDE
INNlinaclotide
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 classpeptides: 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-ID851199-59-2
RxCUI1307404
ChEMBL IDCHEMBL3301675
ChEBI ID68551
PubChem CID16158208
DrugBankDB08890
UNII IDN0TXR0XR5X (ChemIDplus, GSRS)
Target
Agency Approved
GUCY2C
GUCY2C
Organism
Homo sapiens
Gene name
GUCY2C
Gene synonyms
GUC2C, STAR
NCBI Gene ID
2984
Protein name
guanylyl cyclase C
Protein synonyms
Heat-stable enterotoxin receptor, hSTAR, Intestinal guanylate cyclase, STA receptor
Uniprot ID
P25092
Mouse ortholog
Gucy2c (14917)
guanylyl cyclase C (Q8JZQ6)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Linzess - Allergan
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Linzess - Warner Chilcott
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£
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Linzess - AbbVie
$
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,119 documents
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Safety
Black-box Warning
Black-box warning for: Linzess
Adverse Events
Top Adverse Reactions
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29,023 adverse events reported
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