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
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 | 2024-11-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| irritable bowel syndrome | EFO_0000555 | D043183 | K58 |
| diarrhea | HP_0002014 | D003967 | R19.7 |
| bacterial infections | — | D001424 | A49 |
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 | |
| 11779571 | 2029-02-26 | U-3706 | |
| 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 | DS, 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
205 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 11 | 13 | 9 | 14 | 41 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | 3 | 5 | 11 | 9 | 14 | 41 |
| Hepatic encephalopathy | D006501 | — | K72.91 | 3 | 5 | 10 | 9 | 14 | 40 |
| Fibrosis | D005355 | — | — | — | 14 | 11 | 8 | 10 | 35 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | 2 | 6 | 9 | 7 | 4 | 24 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | 2 | 7 | 5 | 6 | 7 | 23 |
| Syndrome | D013577 | — | — | 2 | 7 | 5 | 5 | 7 | 22 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | 2 | 1 | 4 | 2 | 8 |
| Dysentery | D004403 | EFO_1001869 | — | — | 1 | 2 | 2 | 2 | 6 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | — | 3 | 1 | 1 | 1 | 6 |
Show 30 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Crohn disease | D003424 | EFO_0000384 | K50 | 1 | 7 | 4 | — | — | 11 |
| Peritonitis | D010538 | EFO_0008588 | K65 | — | 2 | 6 | — | 1 | 8 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 4 | 4 | 2 | — | — | 6 |
| Recurrence | D012008 | — | — | — | 1 | 4 | — | 1 | 6 |
| Intestinal diseases | D007410 | HP_0002242 | K63.9 | — | 1 | 2 | — | 2 | 4 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | 1 | 1 | — | 1 | 3 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | — | 1 | 1 | — | 1 | 3 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | 2 | 1 | — | 1 | 3 |
| Abdominal pain | D015746 | HP_0002027 | R10.9 | — | 1 | 1 | — | 2 | 3 |
| Infections | D007239 | EFO_0000544 | — | 1 | 1 | 1 | — | — | 3 |
Show 19 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rosacea | D012393 | — | L71 | — | 3 | — | — | — | 3 |
| Intestinal pseudo-obstruction | D007418 | EFO_1000988 | K56.0 | — | 1 | — | — | 1 | 2 |
| Insulin resistance | D007333 | HP_0000855 | — | — | 1 | — | — | 1 | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 1 | — | — | — | 2 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | 2 | — | — | — | 2 |
| Heart failure | D006333 | HP_0001635 | I50 | — | 1 | — | — | 1 | 2 |
| Constipation | D003248 | HP_0002019 | K59.0 | 1 | 1 | — | — | 1 | 2 |
| Microscopic colitis | D046728 | EFO_1001295 | K52.83 | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | 1 | — | — | — | 1 |
Show 13 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 1 | — | — | — | 1 | 2 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Persian gulf syndrome | D018923 | EFO_0007430 | — | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | — | 1 |
| Graft vs host disease | D006086 | — | D89.81 | 1 | — | — | — | — | 1 |
| Bone marrow transplantation | D016026 | — | — | 1 | — | — | — | — | 1 |
| Waldenstrom macroglobulinemia | D008258 | HP_0005508 | C88.0 | 1 | — | — | — | — | 1 |
| Paraproteinemias | D010265 | — | D47.2 | 1 | — | — | — | — | 1 |
| Monoclonal gammopathy of undetermined significance | D008998 | EFO_1000836 | D47.2 | 1 | — | — | — | — | 1 |
Show 4 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colonic neoplasms | D003110 | — | C18 | — | — | — | — | 2 | 2 |
| Gastrointestinal hemorrhage | D006471 | HP_0002239 | K92.2 | — | — | — | — | 2 | 2 |
| Fever | D005334 | HP_0001945 | R50.9 | — | — | — | — | 1 | 1 |
| Hyperthermia | D000084462 | — | — | — | — | — | — | 1 | 1 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | — | — | — | 1 | 1 |
| Ulcer | D014456 | MPATH_579 | — | — | — | — | — | 1 | 1 |
| Adenocarcinoma | D000230 | — | — | — | — | — | — | 1 | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 1 | 1 |
| Colorectal neoplasms | D015179 | — | — | — | — | — | — | 1 | 1 |
| Bone neoplasms | D001859 | EFO_0003820 | D16 | — | — | — | — | 1 | 1 |
Show 17 more
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 | — |
| ChEMBL ID | CHEMBL1617 |
| ChEBI ID | 75246 |
| PubChem CID | 6436173 |
| DrugBank | DB01220 |
| UNII ID | L36O5T016N (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Estimated US medical usage
Rifaximin
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Trends
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Safety
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Adverse Events
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12,922 adverse events reported
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