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Lubiprostone
Amitiza (lubiprostone) is a small molecule pharmaceutical. Lubiprostone was first approved as Amitiza on 2006-01-31. It is used to treat constipation and irritable bowel syndrome in the USA. The pharmaceutical is active against chloride channel protein 2.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Amitiza (generic drugs available since 2021-11-30)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lubiprostone
Tradename
Company
Number
Date
Products
AMITIZASucampo PharmaceuticalsN-021908 RX2006-01-31
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
amitizaNew Drug Application2021-04-12
lubiprostoneNDA authorized generic2023-04-20
lubiprostoneNDA authorized generic2023-04-20
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
Lubiprostone, Amitiza, Sucampo Pharma Llc
80263932027-10-25DP
83386392027-01-23DP
87791872027-01-23DP
87484812025-09-01U-1519, U-1520
77953122024-09-17U-1085
ATC Codes
A: Alimentary tract and metabolism drugs
— A06: Drugs for constipation
— A06A: Drugs for constipation
— A06AX: Other drugs for constipation in atc
— A06AX03: Lubiprostone
HCPCS
No data
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
Healthy volunteers/patients—3——216
Fragile x syndromeD005600Q99.211—1—3
Inborn genetic diseasesD030342EFO_0000508———1—1
HyperlipidemiasD006949EFO_0003774E78.5———1—1
DyslipidemiasD050171HP_0003119———1—1
Hyperlipoproteinemia type vD006954Orphanet_70470E78.3———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypercholesterolemiaD006937HP_0003124—14—27
Cardiovascular diseasesD002318EFO_0000319I98—23—16
Heart diseasesD006331EFO_0003777I51.9—22——4
Coronary diseaseD003327—12——3
Myocardial ischemiaD017202EFO_1001375I20-I25—12——3
Coronary artery diseaseD003324I25.1—12——2
AtherosclerosisD050197EFO_0003914I25.1—21——2
Intermittent claudicationD007383EFO_0003876I73.9——2——2
Peripheral vascular diseasesD016491EFO_0003875I73.9——2——2
Alveolar bone lossD016301—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neurofibromatosis 1D009456Q85.0112——14
Breast neoplasmsD001943EFO_0003869C5012———3
MelanomaD008545—2———2
Prostatic neoplasmsD011471C61—1——12
StrokeD020521EFO_0000712I63.911———2
Cerebrovascular disordersD002561EFO_0003763I60-I69—1———1
Vascular diseasesD014652EFO_0004264I77—1———1
Intracranial arteriosclerosisD002537EFO_1000860I67.2—1———1
Carotid stenosisD016893—1———1
Cerebrotendinous xanthomatosisD019294—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C801————1
Lipid metabolism disordersD0524391————1
PneumoniaD011014EFO_0003106J181————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug interactionsD004347————11
Type 2 diabetes mellitusD003924EFO_0001360E11————11
Autism spectrum disorderD000067877F84.0————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLUBIPROSTONE
INNlubiprostone
Description
Lubiprostone, sold under the brand name Amitiza among others, is a medication used in the management of chronic idiopathic constipation, predominantly irritable bowel syndrome-associated constipation in women and opioid-induced constipation. The drug is owned by Mallinckrodt and is marketed by Takeda Pharmaceutical Company.
Classification
Small molecule
Drug classprostaglandins
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCCCC(F)(F)[C@@]1(O)CC[C@H]2[C@@H](CC(=O)[C@@H]2CCCCCCC(=O)O)O1
Identifiers
PDB—
CAS-ID333963-40-9
RxCUI623033
ChEMBL IDCHEMBL1201134
ChEBI ID—
PubChem CID157920
DrugBankDB01046
UNII ID7662KG2R6K (ChemIDplus, GSRS)
Target
Agency Approved
CLCN2
CLCN2
Organism
Homo sapiens
Gene name
CLCN2
Gene synonyms
NCBI Gene ID
1181
Protein name
chloride channel protein 2
Protein synonyms
chloride channel 2, chloride channel, voltage-sensitive 2
Uniprot ID
P51788
Mouse ortholog
Clcn2 (12724)
chloride channel protein 2 (Q9WUJ9)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Amitiza - Sucampo Pharmaceuticals
$
€
£
₣
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Amitiza - Viatris
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,122 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,470 adverse events reported
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