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
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 |
---|---|---|---|---|
XIFAXAN | Salix Pharmaceuticals | N-021361 RX | 2004-05-25 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
xifaxan | New Drug Application | 2023-02-04 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
bacterial infections | — | D001424 | A49 |
diarrhea | HP_0002014 | D003967 | R19.7 |
irritable bowel syndrome | EFO_0000555 | D043183 | K58 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Rifaximin, Xifaxan, Salix Pharms | |||
8642573 | 2029-10-02 | U-1481 | |
8969398 | 2029-10-02 | U-1481 | |
7928115 | 2029-07-24 | U-1121 | |
8829017 | 2029-07-24 | U-1562 | |
8946252 | 2029-07-24 | U-1481 | |
9421195 | 2029-07-24 | U-1481 | |
9629828 | 2029-07-24 | U-1994 | |
10314828 | 2029-07-24 | U-1481 | |
10335397 | 2029-07-24 | U-2579 | |
10709694 | 2029-07-24 | U-2579 | |
8309569 | 2029-07-18 | U-1707, U-1708 | |
10456384 | 2029-02-26 | U-2643, U-2644 | |
10765667 | 2029-02-26 | U-2643, U-2644 | |
11564912 | 2029-02-26 | U-3511, U-3512 | |
8193196 | 2027-09-02 | DS, DP | U-1707, U-1708 |
8518949 | 2026-02-27 | DP | |
8741904 | 2026-02-27 | DP | U-1526, U-1707, U-1708 |
9271968 | 2026-02-27 | DP | |
10703763 | 2026-02-27 | U-1708, U-2847, U-2848 | |
7906542 | 2025-06-01 | DS, DP | |
7915275 | 2025-02-23 | U-1707, U-1708 | |
7045620 | 2024-06-19 | DP | |
7612199 | 2024-06-19 | DS, DP | |
7902206 | 2024-06-19 | DS, DP | |
8158644 | 2024-06-19 | DP | |
8158781 | 2024-06-19 | DP | |
8835452 | 2024-06-19 | DS, DP | |
8853231 | 2024-06-19 | DP |
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 |
---|---|---|---|---|---|---|---|---|---|
Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 6 | 7 | 7 | 4 | 2 | 23 |
Latent tuberculosis | D055985 | Z22.7 | 2 | 2 | 4 | 2 | 1 | 9 | |
Hiv | D006678 | O98.7 | 1 | 1 | 1 | 1 | — | 4 | |
Hiv seropositivity | D006679 | 1 | 1 | — | 1 | — | 2 | ||
Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | — | — | 1 | — | 1 |
Hepatitis | D006505 | HP_0012115 | K75.9 | — | — | — | 1 | — | 1 |
Patient compliance | D010349 | — | — | — | 1 | — | 1 | ||
Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | 1 | — | 1 |
Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | 1 | 4 | 5 | — | — | 8 |
Hiv infections | D015658 | EFO_0000764 | B20 | — | 2 | 2 | — | — | 4 |
Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 1 | — | — | 1 |
Female infertility | D007247 | EFO_0008560 | N97 | — | — | 1 | — | — | 1 |
Female genital tuberculosis | D014384 | EFO_1000935 | — | — | 1 | — | — | 1 | |
Male genital tuberculosis | D014389 | EFO_1001030 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Mycobacterium avium-intracellulare infection | D015270 | EFO_0007386 | — | 1 | — | — | — | 1 | |
Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | 1 | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | RIFAXIMIN |
INN | rifaximin |
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 class | antibiotics (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-ID | 80621-81-4 |
RxCUI | 35619 |
ChEMBL ID | CHEMBL1617 |
ChEBI ID | 75246 |
PubChem CID | 6436173 |
DrugBank | DB01220 |
UNII ID | L36O5T016N (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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