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AboutPricing
Drug ReportsLinaclotide
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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5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Linzess (discontinued: Linaclotide)
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 final2020-05-06
linzessNew Drug Application2023-06-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
irritable bowel syndromeEFO_0000555D043183K58
constipationHP_0002019D003248K59.0
Agency Specific
FDA
EMA
Expiration
Code
LINACLOTIDE, LINZESS, ABBVIE
2026-06-12I-921
Patent Expiration
Patent
Expires
Flag
FDA Information
Linaclotide, Linzess, Abbvie
97083712033-08-16DPU-1515, U-1516, U-3644
87485732031-10-30U-1515, U-1516
88026282031-10-30DP
106753252031-08-11DP
107025762031-08-11U-1516, U-3644
89330302031-02-17DPU-1516, U-3644
73040362026-08-30DS, DPU-1278, U-1516, U-3644
73717272024-01-28DP
77049472024-01-28DS, DP
77454092024-01-28DS, DP
80805262024-01-28DS, DP
81105532024-01-28U-1278, U-1516, U-3644
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
56 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ConstipationD003248HP_0002019K59.0—13—15
Irritable bowel syndromeD043183EFO_0000555K58——2—13
SyndromeD013577————2——2
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
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)Loading
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
RxCUI—
ChEMBL IDCHEMBL3301675
ChEBI ID68551
PubChem CID16158208
DrugBank—
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
No data
Financial
Revenue by drug
$
€
£
â‚£
Linzess – Allergan
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Linzess – Warner Chilcott
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Linzess – AbbVie
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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
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,346 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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