Rifabutin
Mycobutin, Rifabutin, Talicia (rifabutin) is a small molecule pharmaceutical. Rifabutin was first approved as Mycobutin on 1992-12-23. It is used to treat mycobacterium avium-intracellulare infection, mycobacterium infections, and pulmonary tuberculosis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| respiratory tract diseases | D012140 |
Trade Name
FDA
EMA
Mycobutin, Rifabutin
CombinationsTalicia
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amoxicillin
+
Omeprazole magnesium
+
Rifabutin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TALICIA | RedHill Biopharma | N-213004 RX | 2019-11-01 | 1 products, RLD, RS |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
AMOXICILLIN / OMEPRAZOLE MAGNESIUM / RIFABUTIN, TALICIA, REDHILL | |||
| 2027-11-01 | GAIN | ||
| 2022-11-01 | NP | ||
ATC Codes
A: Alimentary tract and metabolism drugs
— A02: Drugs for acid related disorders
— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD16: Omeprazole, amoxicillin and rifabutin
J: Antiinfectives for systemic use
— J04: Antimycobacterials
— J04A: Drugs for treatment of tuberculosis
— J04AB: Antibiotics, antitubercular
— J04AB04: Rifabutin
HCPCS
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Clinical
Clinical Trials
90 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 11 | 7 | 5 | 4 | 9 | 35 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 4 | 10 | 2 | 3 | 6 | 23 |
| Infections | D007239 | EFO_0000544 | — | 5 | 1 | 8 | 3 | 3 | 20 |
| Mycobacterium avium-intracellulare infection | D015270 | EFO_0007386 | — | 1 | 3 | 7 | 4 | 5 | 19 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 4 | — | 1 | 1 | 5 | 11 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 3 | 3 | 2 | — | 6 |
| Mycobacterium avium complex | D015269 | — | — | 1 | 1 | 1 | 2 | — | 5 |
| Helicobacter infections | D016481 | EFO_1000961 | — | — | — | 2 | 1 | 2 | 5 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 2 | 1 | 1 | 1 | 4 |
| Gastritis | D005756 | EFO_0000217 | K29.7 | — | — | 1 | 2 | — | 3 |
Show 6 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mycobacterium infections | D009164 | — | A31.9 | — | 4 | 7 | — | 1 | 10 |
| Communicable diseases | D003141 | — | — | 1 | 1 | 5 | — | 2 | 9 |
| Mycoses | D009181 | — | B35-B49 | 1 | — | 1 | — | — | 2 |
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | — | 1 | — | 1 | 2 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | — | 2 | — | — | 2 |
| Nontuberculous mycobacterium infections | D009165 | EFO_0007461 | A31.9 | — | — | 1 | — | 1 | 2 |
| Bronchiectasis | D001987 | — | J47 | — | — | 1 | — | — | 1 |
| Prosthesis-related infections | D016459 | EFO_1001406 | — | — | — | 1 | — | — | 1 |
| Latent tuberculosis | D055985 | — | Z22.7 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv | D006678 | — | O98.7 | 1 | 2 | — | — | — | 3 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | 1 | 1 | — | — | — | 2 |
| Pulmonary sarcoidosis | D017565 | DOID_13406 | D86.0 | 1 | 1 | — | — | — | 2 |
| Coronary disease | D003327 | — | — | — | 1 | — | — | — | 1 |
| Coronary artery disease | D003324 | — | I25.1 | — | 1 | — | — | — | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | 1 | — | — | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | — | — | — | 1 |
| Chlamydophila infections | D023521 | EFO_1000863 | — | — | 1 | — | — | — | 1 |
| Chlamydial pneumonia | D061387 | — | J16.0 | — | 1 | — | — | — | 1 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 1 | — | — | — | 1 |
Show 6 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 8 | — | — | — | — | 8 |
| Bacterial infections | D001424 | — | A49 | 3 | — | — | — | — | 3 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | — | — | — | — | 1 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aids-related opportunistic infections | D017088 | — | — | — | — | — | — | 2 | 2 |
| Aids-related complex | D000386 | EFO_0007137 | B20 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Rifabutin |
| INN | rifabutin |
| Description | Rifabutin (Rfb) is an antibiotic used to treat tuberculosis and prevent and treat Mycobacterium avium complex. It is typically only used in those who cannot tolerate rifampin such as people with HIV/AIDS on antiretrovirals. For active tuberculosis it is used with other antimycobacterial medications. For latent tuberculosis it may be used by itself when the exposure was with drug-resistant TB.
|
| 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(c3C2=O)C2=NC3(CCN(CC(C)C)CC3)NC2=C(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)C4=O |
Identifiers
| PDB | — |
| CAS-ID | 72559-06-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL444633 |
| ChEBI ID | 45367 |
| PubChem CID | 6323490 |
| DrugBank | DB00615 |
| UNII ID | 1W306TDA6S (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Estimated US medical usage
Rifabutin
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Number of persons purchased
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Trends
PubMed Central
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Safety
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No Black-box warning
Adverse Events
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2,456 adverse events reported
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