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Rifaximin
Xifaxan (rifaximin) is a small molecule pharmaceutical. Rifaximin was first approved as Xifaxan on 2004-05-25. It is used to treat bacterial infections, diarrhea, and irritable bowel syndrome in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Xifaxan
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Rifaximin
Tradename
Company
Number
Date
Products
XIFAXANSalix PharmaceuticalsN-021361 RX2004-05-25
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
xifaxanNew Drug Application2023-02-04
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bacterial infections—D001424A49
diarrheaHP_0002014D003967R19.7
irritable bowel syndromeEFO_0000555D043183K58
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Rifaximin, Xifaxan, Salix Pharms
86425732029-10-02U-1481
89693982029-10-02U-1481
79281152029-07-24U-1121
88290172029-07-24U-1562
89462522029-07-24U-1481
94211952029-07-24U-1481
96298282029-07-24U-1994
103148282029-07-24U-1481
103353972029-07-24U-2579
107096942029-07-24U-2579
83095692029-07-18U-1707, U-1708
104563842029-02-26U-2643, U-2644
107656672029-02-26U-2643, U-2644
115649122029-02-26U-3511, U-3512
81931962027-09-02DS, DPU-1707, U-1708
85189492026-02-27DP
87419042026-02-27DPU-1526, U-1707, U-1708
92719682026-02-27DP
107037632026-02-27U-1708, U-2847, U-2848
79065422025-06-01DS, DP
79152752025-02-23U-1707, U-1708
70456202024-06-19DP
76121992024-06-19DS, DP
79022062024-06-19DS, DP
81586442024-06-19DP
81587812024-06-19DP
88354522024-06-19DS, DP
88532312024-06-19DP
ATC Codes
A: Alimentary tract and metabolism drugs
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07A: Intestinal antiinfectives
— A07AA: Antibiotics, intestinal
— A07AA11: Rifaximin
D: Dermatologicals
— D06: Antibiotics and chemotherapeutics for dermatological use
— D06A: Antibiotics for topical use
— D06AX: Other antibiotics for topical use in atc
— D06AX11: Rifaximin
HCPCS
No data
Clinical
Clinical Trials
48 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A196774223
Latent tuberculosisD055985Z22.7224219
HivD006678O98.71111—4
Hiv seropositivityD00667911—1—2
Opioid-related disordersD009293EFO_0005611F11———1—1
HepatitisD006505HP_0012115K75.9———1—1
Patient complianceD010349———1—1
Renal insufficiencyD051437HP_0000083N19———1—1
Chronic kidney failureD007676EFO_0003884N18.6———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pulmonary tuberculosisD014397EFO_1000049A15145——8
Hiv infectionsD015658EFO_0000764B20—22——4
Diabetes mellitusD003920EFO_0000400E08-E13——1——1
Female infertilityD007247EFO_0008560N97——1——1
Female genital tuberculosisD014384EFO_1000935——1——1
Male genital tuberculosisD014389EFO_1001030——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mycobacterium avium-intracellulare infectionD015270EFO_0007386—1———1
PregnancyD011247EFO_0002950Z33.111———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—2————2
Drug interactionsD0043471————1
Mycobacterium tuberculosisD0091691————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SilicotuberculosisD012830J65————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRIFAXIMIN
INNrifaximin
Description
Rifaximin is a semisynthetic member of the class of rifamycins and non-systemic gastrointestinal site-specific broad spectrum antibiotic. Used in the treatment of traveller's diarrhoea, hepatic encephalopathy and irritable bowel syndrome. It has a role as a gastrointestinal drug, an orphan drug and an antimicrobial agent. It is a member of rifamycins, an acetate ester, a lactam, an organic heterohexacyclic compound, a macrocycle, a semisynthetic derivative and a cyclic ketal.
Classification
Small molecule
Drug classantibiotics (rifamycin derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CO[C@H]1/C=C/O[C@@]2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)/C(C)=C\C=C\[C@H](C)[C@H](O)[C@@H](C)[C@@H](O)[C@@H](C)[C@H](OC(C)=O)[C@@H]1C
Identifiers
PDB—
CAS-ID80621-81-4
RxCUI35619
ChEMBL IDCHEMBL1617
ChEBI ID75246
PubChem CID6436173
DrugBankDB01220
UNII IDL36O5T016N (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,196 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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261 adverse events reported
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