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AboutPricing
Drug ReportsLubiprostone
Lubiprostone
Amitiza, Lubiprostone (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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FDA approval date
EMA approval date
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Study 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
Amitiza, Lubiprostone (discontinued: Lubiprostone)
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 Application2025-09-11
amitzaANDA2025-01-22
lubiprostoneNDA authorized generic2025-09-11
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
irritable bowel syndromeEFO_0000555D043183K58
constipation—D003248K59.0
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
54 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ConstipationD003248—K59.033168936
Irritable bowel syndromeD043183EFO_0000555K58212128
Healthy volunteers/patients—————11—2
Diabetes mellitusD003920EFO_0000400E08-E13———112
ColonoscopyD003113—————2—2
Parkinson diseaseD010300EFO_0002508G20———112
Multiple sclerosisD009103EFO_0003885G35———1—1
SclerosisD012598—————1—1
Inflammatory bowel diseasesD015212EFO_0003767————1—1
Patient satisfactionD017060—————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Opioid-induced constipationD000079689————4—26
SyndromeD013577———12—25
Gastrointestinal diseasesD005767————4——4
Intestinal diseasesD007410—K63.9——4——4
Colorectal neoplasmsD015179————1——1
Drug-related side effects and adverse reactionsD064420—T88.7——1——1
Treatment outcomeD016896————1——1
Liver diseasesD008107EFO_0001421K70-K77——1——1
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.81——1——1
Fatty liverD005234EFO_0003934———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HivD006678—O98.7—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Visceral painD059265——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FibrosisD005355——————22
Cystic fibrosisD003550EFO_0000390E84————22
Type 2 diabetes mellitusD003924EFO_0001360E11————11
Type 1 diabetes mellitusD003922EFO_0001359E10————11
Food diet and nutritionD000066888——————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)Loading
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
RxCUI—
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
No data
Financial
Revenue by drug
$
€
£
â‚£
Amitiza – Sucampo Pharmaceuticals
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Amitiza – Viatris
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Estimated US medical usage
Lubiprostone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,511 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,062 adverse events reported
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