Rifabutin
Small molecule targets CYP3A4 via activation
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | MYCOBUTIN | — | 1992-12-23 | fda.gov ↗ |
Trials 78 · started per year
Also used as a comparator or background therapy in 12 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT01169038 Comparator | Jul → Nov 2010 | pulmonary sarcoidosis | Vanderbilt University | Completed | No outcome recorded |
| Phase 1 | NCT00646776 Comparator | Apr → Aug 2008 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT04553406 Comparator | Dec 2020 → Jan 2021 | Mycobacterium avium complex disease, pulmonary non-tuberculous mycobacterial infection | Spero Therapeutics | Terminated | No outcome recorded |
| Phase 2 | NCT03891901 Background | Oct 2020 → Aug 2022 | tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT03618108 Comparator | Apr 2018 → Nov 2020 | chlamydia infectious disease, coronary atherosclerosis | Cadrock Pty. Ltd. | Terminated | No outcome recorded |
| Phase 2 | NCT00869518 Comparator | Jul 2009 → Dec 2010 | HIV infectious disease, staphylococcus aureus infection | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04630145 Comparator | Jan 2021 → Nov 2024 | Mycobacterium avium complex disease | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04652284 Comparator | May 2021 → May 2023 | Helicobacter pylori infectious disease, bacterial gastritis, primary bacterial infectious disease | Rabin Medical Center | Unknown | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT07585461 Comparator | Apr 2026 → Dec 2028 expected | AIDS-related disorder, Mycobacterium avium complex disease | Shanghai Public Health Clinical Center | Not yet recruiting | No outcome recorded |
| — | NCT07130253 Comparator | Aug 2025 → Jun 2028 expected | Helicobacter pylori infectious disease | National Taiwan University Hospital | Not yet recruiting | No outcome recorded |
| — | NCT01344148 Background | Feb 2009 → Jun 2011 | AIDS | Shanghai Public Health Clinical Center | Unknown | No outcome recorded |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 94 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rifabutin | “A is amoxicillin (1000 mg thrice daily), B is colloidal bismuth subcitrate (120 mg thrice daily), M is metronidazole (500 mg thrice daily), P is a proton pump inhibitor, i.e.,...” NCT06687473 ↗83“BV100 (rifabutin for infusion) is being developed as an IV formulation for the treatment of serious infections due to Acinetobacter baumannii, including nosocomial pneumonia...” NCT07580586 ↗ “Rifabutin (Rb) is added to the bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) regimen for first 8 weeks and continued for next 9 weeks with bedaquiline (B or...” NCT05766267 ↗ “Current guidelines recommend a macrolide-based triple therapy consisting of a macrolide (azithromycin or clarithromycin), ethambutol, and a rifamycin (typically rifabutin).” NCT07585461 ↗ “The intended dose is RHB-105 (12.5 mg rifabutin, 250 mg amoxicillin, and 10 mg omeprazole capsules) 4 capsules every eight hours, equivalent to a total daily dose of:” NCT01980095 ↗ “RHB-105 is an 'all-in-one' combination oral capsule consisting of combination therapy of Amoxicillin, Omeprazole and Rifabutin; as well as separate Riboflavin” NCT03198507 ↗ “To investigate the pharmacokinetics (PK) of rifabutin in subjects with hepatic impairment after single intravenous (IV) infusion of BV100” NCT05537142 ↗ “Mycobutin capsules contain the antimycobacterial agent rifabutin, which is a semisynthetic ansamycin antibiotic derived from rifamycin S.” NCT01259219 ↗ “Optional rifampin 600 mg or rifabutin 300 mg orally once daily may be added to the SOC regimen for up to 28 days.” NCT04553406 ↗ “Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin quadruple therapy” NCT07130253 ↗ “to anti-MAP RHB-104 (clarithromycin 95 mg, rifabutin 45 mg, and clofazimine 10 mg per capsule) (n = 166)” PMID 39199994 ↗ Jul 2024 “Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD.” NCT01169038 ↗ “Anti-Tb Therapy: 2HREZ-4HRifb(H:Isoniazid，R:Rifampicin，E:Ethambutol，Z：pyrazinamide，Rifb:Rifabutin)” NCT01344148 ↗ “Each capsule contains clarithromycin 158.3mg; rifabutin 40mg; clofazimine 13.3mg.” NCT04616924 ↗ “BV100 (rifabutin for infusion) is being developed as an intravenous formulation” PMID 41770249 ↗ Mar 2026 “Part A - Group 1: BV100 (rifabutin for infusion) plus low dose polymyxin B” NCT07326540 ↗ “moxifloxacin, pasiniazid, rifabutin, ethambutol, and pyrazinamide” PMID 29519716 ↗ Mar 2018 “95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine” NCT01717664 ↗ “Rifabutin for Infusion plus Polymyxin B for Injection” NCT05685615 ↗ “R is rifabutin (150 mg twice daily)” NCT06687499 ↗ “rifampicin, rifabutin, isoniazid” NCT03237182 ↗ “Rifabutin” NCT02099240 ↗ |
| Known as | Ansamycin | ChEMBL registry synonym — accepted as the source's own label CHEMBL444633 ↗ |
| Known as | BV100 | “BV100 (rifabutin for infusion) is being developed as an IV formulation for the treatment of serious infections due to Acinetobacter baumannii, including nosocomial pneumonia...” NCT07580586 ↗8“BV100 (rifabutin for infusion) is being developed as an intravenous formulation” PMID 41770249 ↗ Mar 2026 |
| Known as | LM 427 | ChEMBL registry synonym — accepted as the source's own label CHEMBL444633 ↗ |
| Known as | MYCOBUTIN | “A Single-centre Open-label Study in Healthy Adult Volunteers to Determine the Effects of Steady-state TPV/RTV (500 mg/200 mg) on the Single-dose Pharmacokinetics of Rifabutin...” NCT02251171 ↗2“An Open-Label Randomized Pharmacokinetic/Pharmacodynamic Study of Mycobutin (Rifabutin) or Rifabutin in Combination With Myambutol (Ethambutol) for Prophylaxis of Mycobacterium...” NCT00002343 ↗ “Study to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Rifabutin (MYCOBUTIN®) in HIV+ Patients” NCT02184078 ↗ |
| Known as | RBT | “The overall aim of the project is to evaluate rifabutin (RBT) as a replacement for rifampicin (RMP), for the combined treatment of tuberculosis and HIV infection.” NCT00651066 ↗2“evaluate rifabutin (RBT) as a replacement for rifampicin (RMP)” NCT00640887 ↗ “Group B: Rifampicin (RFP) or Rifabutin (RBT) + CAM + EB” NCT04630145 ↗ |
| Known as | RFB | “Rifabutin (RFB), a moderate CYP3A inducer” PMID 40957819 ↗ Sep 2025 |
| Known as | rifabutin capsules | “rifabutin capsules” NCT02331823 ↗ |
| Known as | Rifabutin component of talicia | ChEMBL registry synonym — accepted as the source's own label CHEMBL444633 ↗ |
| Known as | Rifabutin for Infusion | “BV100 (rifabutin for infusion) is being developed as an intravenous formulation for treating serious or life-threatening infections due to carbapenem-resistant Acinetobacter...” PMID 41770249 ↗ Mar 2026 |
| Known as | Rifabutina | ChEMBL registry synonym — accepted as the source's own label CHEMBL444633 ↗ |
| Known as | Rifabutine | ChEMBL registry synonym — accepted as the source's own label CHEMBL444633 ↗ |
| Known as | Rifb | “Anti-Tb Therapy: 2HREZ-4HRifb(H:Isoniazid，R:Rifampicin，E:Ethambutol，Z：pyrazinamide，Rifb:Rifabutin)” NCT01344148 ↗ |
| Action | Activate | “Based on the reduced exposure of maraviroc observed in this study, increasing the dose of maraviroc may be studied to normalize its moderately reduced exposure following...” PMID 31647836 ↗ Oct 2019 |
| Modality | Small molecule | “rifamycin derivative” NCT00001023 ↗ |
| Route | Oral | “their oral administration is staggered” NCT00000877 ↗ |
| Target | CYP3A4 | “Based on the reduced exposure of maraviroc observed in this study, increasing the dose of maraviroc may be studied to normalize its moderately reduced exposure following...” PMID 31647836 ↗ Oct 2019 |