Drugs / Rifabutin
Rifabutin
also known as
BV100 · MYCOBUTIN · RBT · Ansamycin · LM 427 · RFB · rifabutin capsules · Rifabutin component of talicia · +4 more
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
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News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2026-04-30 | RedHill Biopharma Limited | Results RedHill's RHB-204 Demonstrates Comparable MAP Killing Efficacy to RHB-104 - Important Step in RHB-204 Development for MAP-related Crohn's Disease redhillbio.com ↗ |
| 2023-09-18 | RedHill Biopharma Limited | Regulatory RedHill Announces FDA sNDA Approval for Talicia® redhillbio.com ↗
RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced the U.S. Food and Drug Administration's (FDA) approval of its supplemental new drug application (sNDA) for Talicia[3], allowing a change to a more flexible three times daily (TID), taken at least 4 hours apart with food, dosing regimen for H. pylori eradication. |
| 2023-08-01 | RedHill Biopharma Limited | Regulatory RedHill Biopharma Announces Talicia Approved in the United Arab Emirates and First Commercial Order Outside the U.S. redhillbio.com ↗
RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced that its partner, Gaelan Medical LLC ("Gaelan Medical"), a wholly owned subsidiary of the Ghassan Aboud Group (GAG), has received marketing approval from the United Arab Emirates (UAE) Ministry of Health for Talicia (omeprazole magnesium, amoxicillin and rifabutin)[3]. |
| 2023-05-09 | RedHill Biopharma Limited | Results RedHill Publishes New Talicia® Data on Generic Non-Bioequivalence in AP&T and Presents New Dosing Data at Digestive Disease Week redhillbio.com ↗
The PBPK modeling data we have presented supports bioequivalence between Talicia TID and Q8H dosing regimens for H. pylori eradication therapy showing that the overall exposures are comparable for all three Talicia-containing drugs, amoxicillin, rifabutin, and omeprazole. |
| 2022-11-04 | RedHill Biopharma Limited | Results RedHill Presents New Talicia® Data Analyses at Obesity Week 2022 redhillbio.com ↗ |
| 2022-10-26 | RedHill Biopharma Limited | Results RedHill Presents New Talicia® and Movantik® Data Analyses at ACG 2022 redhillbio.com ↗
This study used Physiologically-Based Pharmacokinetic (PBPK) modeling to compare intragastric rifabutin concentrations with Talicia (low-dose rifabutin 50 mg) administered every 8 hours (Q8H) vs. rifabutin 150 mg (the generically available dose) administered twice daily (BID) or 300 mg administered once daily (QD). |
| 2022-07-12 | RedHill Biopharma Limited | Results RedHill Announces New H. pylori and COVID-19 Data Publication and Presentations at Leading Upcoming Scientific Conferences redhillbio.com ↗
Helicobacter pylori Eradication by Low-Dose Rifabutin Triple Therapy (Talicia®) is Unaffected by High Body Mass Index |
| 2022-05-25 | RedHill Biopharma Limited | Results RedHill Presents New Talicia® Data Analyses at DDW 2022 redhillbio.com ↗ |
| 2021-12-02 | RedHill Biopharma Limited | Results RedHill Biopharma Data Published in GastroHep Shows Consistent Efficacy of Talicia Irrespective of Patient BMI redhillbio.com ↗
Talicia maintained high efficacy across all BMI groups compared to the active comparator including in obese and severely obese patients (P<0.0001). |
| 2021-10-25 | RedHill Biopharma Limited | Results RedHill Biopharma Presents New Talicia® and Movantik® Data Analyses at ACG 2021 redhillbio.com ↗
today announced the presentation of four new analyses of Phase 3 Talicia® (omeprazole magnesium, amoxicillin and rifabutin)1 and Movantik® (naloxegol)2 data at the ACG 2021 Annual Scientific Meeting, taking place October 22-27, 2021. |
| 2021-01-06 | RedHill Biopharma Limited | Regulatory RedHill Biopharma's RHB-204 Granted FDA Fast Track Designation for NTM Disease redhillbio.com ↗
RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or “the Company”), a specialty biopharmaceutical company, today announced that RHB-204 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its development as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC) – a rare disease for which there is no FDA-approved first-line therapy. |
| 2020-10-26 | RedHill Biopharma Limited | Results RedHill Biopharma Presents New Data from Talicia®’s Phase 3 Studies at ACG 2020 Focused on Achieving Successful First-Line Treatment in H. pylori Eradication redhillbio.com ↗ |
| 2020-05-05 | RedHill Biopharma Limited | Results RedHill Biopharma Announces Publication of Talicia® Pivotal Phase 3 Study Results in Annals of Internal Medicine redhillbio.com ↗
Results demonstrated the added rifabutin benefit with 83.8% eradication of H. pylori infection with Talicia vs. 57.7% in the active comparator arm (ITT analysis, p<0.0001), showing a 26.1% benefit with Talicia. |
| 2019-11-04 | RedHill Biopharma Limited | Regulatory RedHill Biopharma Announces FDA Approval of Talicia® for Treatment of H. pylori in Adults redhillbio.com ↗ |
| 2019-10-28 | RedHill Biopharma Limited | Results RedHill Biopharma to Present New Phase 3 Data on RHB-105 and RHB-104 at the American College of Gastroenterology 2019 Annual Meeting redhillbio.com ↗
The abstract discusses the positive Phase 3 ERADICATE Hp2 study results, concluding that RHB-105 (Talicia) was found to be safe, effective and well-tolerated in H. pylori eradication, and not affected by clarithromycin or metronidazole resistance. |
| 2019-07-03 | RedHill Biopharma Limited | Regulatory RedHill Biopharma Announces FDA Acceptance of New Drug Application for Talicia® redhillbio.com ↗
RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on gastrointestinal diseases, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Talicia® (RHB-105)1 for H. pylori infection. |
| 2019-05-07 | RedHill Biopharma Limited | Regulatory RedHill Biopharma Submits New Drug Application for Talicia® for H. pylori Infection redhillbio.com ↗
The NDA was submitted under the 505(b)(2) regulatory pathway. |
| 2018-12-03 | RedHill Biopharma Limited | Results RedHill Biopharma Announces Positive Top-Line Results from Confirmatory Phase 3 Study with TALICIA® for H. pylori Infection redhillbio.com ↗
The ERADICATE Hp2 study successfully met its primary endpoint with a high degree of statistical significance, demonstrating 84% eradication of H. pylori infection with TALICIA® versus 58% in the active comparator arm in the intent-to-treat (ITT) population (p<0.0001). |
| 2017-05-04 | RedHill Biopharma Limited | Results RedHill Biopharma Announces Poster Presentation of the Positive RHB-105 Phase III Results for H. pylori Infection at Digestive Disease Week 2017 redhillbio.com ↗
The study results demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105. |
| 2016-06-22 | RedHill Biopharma Limited | Results RedHill Biopharma Announces Publication Demonstrating Potential Efficacy of RHB-104 for Crohn's Disease Associated with MAP Infection redhillbio.com ↗
The results of the study demonstrated that the RHB-104 active components, in their individual concentrations or in dual combinations, were not as effective against all microorganisms, compared to the triple combination at minimum inhibitory concentrations level. |
All press releases naming this drug 20 releases
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 ↗ “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 ↗ |
| 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 |