Rifabutin

Overview

A broad-spectrum antibiotic that is being used as prophylaxis against disseminated Mycobacterium avium complex infection in HIV-positive patients.

Indication

For the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.

Associated Conditions

Helicobacter Pylori Infection
Mycobacterium avium complex infection
Tuberculosis (TB)
Late phase Tuberculosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults	2025/07/15	NCT07066722	Not Applicable	Not yet recruiting	ViiV Healthcare
Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extremely Refractory Helicobacter Pylori Infection: an Exploratory Study	2024/12/12	NCT06731023	N/A	Not yet recruiting	Xiuli Zuo
Rescue Therapy for Helicobacter Pylori Infection	2023/05/25	NCT05874544	Phase 4	Recruiting	Shanghai Jiao Tong University School of Medicine
Short-course Regimens for the Treatment of Pulmonary Tuberculosis	2023/03/13	NCT05766267	Phase 2	Recruiting	Centers for Disease Control and Prevention
Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100	2023/01/13	NCT05684705	Phase 1	Completed	BioVersys AG
A Study to Assess Effect of BV100 on the Pharmacokinetics of Midazolam in Healthy Participants	2022/09/13	NCT05537090	Phase 1	Completed	BioVersys AG
A Study to Assess the Phamacokinetics of BV100 in Participants with Varying Degrees of Hepatic Impairment	2022/09/13	NCT05537142	Phase 1	Completed	BioVersys AG
Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels	2022/07/14	NCT05458102	Phase 1	Terminated	Gilead Sciences
Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BV100 in Healthy Male Subjects	2021/10/21	NCT05087069	Phase 1	Completed	BioVersys SAS
Pharmacokinetics and Safety of BV100 Administered as Single Intravenous Infusion to Subjects With Renal Impairment	2021/10/20	NCT05086107	Phase 1	Completed	BioVersys AG

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Rifabutin	Greenstone LLC	59762-1350	ORAL	150 mg in 1 1	2/24/2023
Rifabutin	Mylan Pharmaceuticals Inc.	59762-1350	ORAL	150 mg in 1 1	2/24/2023
rifabutin	Lupin Pharmaceuticals, Inc.	68180-285	ORAL	150 mg in 1 1	11/30/2023
Mycobutin	Pfizer Laboratories Div Pfizer Inc	0013-5301	ORAL	150 mg in 1 1	11/1/2021
Rifabutin	ANI Pharmaceuticals, Inc.	70954-041	ORAL	150 mg in 1 1	12/21/2021
Rifabutin	Novitium Pharma LLC	70954-041	ORAL	150 mg in 1 1	12/21/2021
Rifabutin	Marlex Pharmaceuticals, Inc.	10135-738	ORAL	150 mg in 1 1	3/2/2023
Talicia	RedHill Biopharma Ltd	57841-1150	ORAL	12.5 mg in 1 1	9/22/2021
Mycobutin	Department of State Health Services, Pharmacy Branch	55695-010	ORAL	150 mg in 1 1	3/11/2016
Mycobutin	REMEDYREPACK INC.	70518-3731	ORAL	150 mg in 1 1	3/28/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
MYCOBUTIN Rifabutin 150mg capsule blister pack	55038	Pfizer Australia Pty Ltd	Medicine	A	5/2/2000

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MYCOBUTIN	Pfizer Canada Ulc	02063786	Capsule - Oral	150 MG	12/31/1995

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ANSATIPIN 150 MG CÁPSULAS DURAS	Binesa 2002 S.L.	60228	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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BioVersys Reports Strong Survival Benefit in Phase 2 Trial of BV100 for Carbapenem-Resistant Acinetobacter Infections

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• BioVersys will present Phase 2 clinical trial results showing BV100 plus polymyxin B demonstrated substantial survival benefit compared to best available therapy in patients with ventilator-associated bacterial pneumonia caused by carbapenem-resistant Acinetobacter baumannii. • BV100, an intravenous formulation of rifabutin with a novel mechanism targeting RNA-polymerase in Gram-negative bacteria, was generally safe and well-tolerated in critically ill patients, positioning it as a potential breakthrough therapy. • The company will showcase eight presentations at ESCMID Global 2025, including data showing BV100's potent efficacy in lung models and high penetration into epithelial lining fluid, supporting its development for treating deadly CRAB infections that affect over one million patients globally.

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