CLINICAL TRIALS PROFILE FOR RIFABUTIN

All Clinical Trials for RIFABUTIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000826 ↗	Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine the effects of fluconazole and either rifabutin or clarithromycin, alone and in combination, on the pharmacokinetics of first sulfamethoxazole-trimethoprim and then dapsone in HIV-infected patients. Although prophylaxis for more than one opportunistic infection is emerging as a common clinical practice in patients with advanced HIV disease, little is known about possible adverse drug interactions. The need exists to define pharmacokinetics and pharmacodynamic adverse interactions of the many combination prophylactic regimens that may be prescribed.
NCT00000877 ↗	Study of How Indinavir (an Anti-HIV Drug) and Rifabutin (a Drug Used to Treat MAC, an HIV-Associated Disease) Interact in HIV-Positive and HIV-Negative Adults	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to evaluate the safety of giving indinavir and rifabutin at the same time (simultaneously) vs 4 hours apart (staggered) to HIV-positive and HIV-negative adults. It is important to determine which medications for HIV-associated diseases, such as Mycobacterium avium complex (MAC) disease, can be given safely and effectively with anti-HIV drugs. Indinavir and rifabutin have been given simultaneously in the past with good results. This study seeks to examine if staggering the doses will make the 2 drugs more effective. HIV-negative volunteers are used in this study to examine the effect of rifabutin on indinavir and the effect of staggered rifabutin doses. The effect of rifabutin on the drug activity of indinavir is evaluated in HIV-positive patients.
NCT00001023 ↗	The Safety and Effectiveness of Rifabutin, Combined With Clarithromycin or Azithromycin, in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	PER 03/10/94 AMENDMENT: PART B. To determine whether there is an effect on plasma drug levels of azithromycin and rifabutin as measured by changes in the plasma concentration-time curve (AUC) when these drugs are taken concomitantly. ORIGINAL PRIMARY: To gain preliminary information about the safety and tolerance of clarithromycin and azithromycin in combination with rifabutin (three potential agents against Mycobacterium avium-intracellulare) in HIV-infected patients with CD4 counts < 200 cells/mm3. ORIGINAL SECONDARY: To determine whether there is an effect on the pharmacokinetics of the macrolide antibiotics or rifabutin when these drugs are taken concomitantly. To monitor the effect of rifabutin therapy on dapsone serum levels in patients taking dapsone for PCP prophylaxis. To monitor the effect of macrolide/rifabutin combination therapies on AZT or ddI serum levels. Two new macrolide antibiotics, clarithromycin and azithromycin, and rifabutin (a rifamycin derivative) have all demonstrated in vitro and in vivo activity against Mycobacterium avium-intracellulare, a common systemic bacterial infection complicating AIDS. Further information is needed, however, regarding the clinical and pharmacokinetic interaction of these drugs used in combination.
NCT00001030 ↗	The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To compare the efficacy and safety of clarithromycin alone versus rifabutin alone versus the two drugs in combination for the prevention or delay of Mycobacterium avium Complex (MAC) bacteremia or disseminated MAC disease. To compare other parameters such as survival, toxicity, and quality of life among the three treatment arms. To obtain information on the incidence and clinical grade of targeted gynecologic conditions. Persons with advanced stages of HIV are considered to be at particular risk for developing disseminated MAC disease. The development of an effective regimen for the prevention of disseminated MAC disease may be of substantial benefit in altering the morbidity and possibly the mortality associated with this disease and its treatment.
NCT00001039 ↗	Evaluation of Treatment for Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To assess the feasibility of using culture and staining techniques to quantify tissue Mycobacterium avium Complex (MAC) burden in bone marrow. To correlate and compare changes in MAC bone marrow burden with quantitative MAC blood culture results at baseline and after 4 and 8 weeks of treatment. MAC is easiest to detect in the blood, although doctors generally believe that MAC in blood is just "spill-over" from infection of other parts of the body. Traditionally, studies of potential treatments for MAC focus only on MAC changes in the blood. This study compares MAC changes in blood to those in bone marrow, which is another tissue where MAC is often found.
NCT00001047 ↗	Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To compare the safety and efficacy of two doses of clarithromycin in combination with ethambutol and either rifabutin or clofazimine for the treatment of disseminated Mycobacterium avium Complex (MAC) disease in AIDS patients. Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.

Clinical Trial Conditions for RIFABUTIN

Condition Name

Condition Name for RIFABUTIN
Intervention	Trials
HIV Infections	31
Tuberculosis	21
Mycobacterium Avium-intracellulare Infection	13
Helicobacter Pylori Infection	6

Condition MeSH

Condition MeSH for RIFABUTIN
Intervention	Trials
HIV Infections	39
Infections	30
Infection	27
Tuberculosis	26

Clinical Trial Locations for RIFABUTIN

Trials by Country

Trials by Country for RIFABUTIN
Location	Trials
United States	250
Canada	20
South Africa	8
Uganda	4
France	4

Trials by US State

Trials by US State for RIFABUTIN
Location	Trials
California	22
New York	17
Maryland	15
Texas	14
District of Columbia	12

Clinical Trial Progress for RIFABUTIN

Clinical Trial Phase

Clinical Trial Phase for RIFABUTIN
Clinical Trial Phase	Trials
PHASE4	1
PHASE1	2
Phase 4	18

Clinical Trial Status

Clinical Trial Status for RIFABUTIN
Clinical Trial Phase	Trials
Completed	51
Recruiting	15
Unknown status	9

Clinical Trial Sponsors for RIFABUTIN

Sponsor Name

Sponsor Name for RIFABUTIN
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	12
Pfizer	7
Pharmacia	6

Sponsor Type

Sponsor Type for RIFABUTIN
Sponsor	Trials
Other	93
Industry	48
NIH	14

Clinical Trials Update, Market Analysis, and Projection for Rifabutin

Last updated: October 29, 2025

Introduction

Rifabutin, a broad-spectrum antibiotic primarily used in treating tuberculosis (TB) and Mycobacterium avium complex (MAC) infections, has seen a dynamic evolution in clinical research, market application, and commercial potential. Originally developed in the 1980s, rifabutin is a rifamycin derivative offering a distinct profile compared to its predecessor, rifampin. Its reduced interaction with hepatic enzymes makes it especially valuable in HIV-positive patients on antiretroviral therapy. This report synthesizes the latest clinical trial data, market trends, and forward-looking projections for rifabutin, providing vital insights to pharmaceutical stakeholders and investors.

---

Clinical Trials Update

Current Clinical Trials and Approvals

Recent years have witnessed renewed interest in rifabutin's therapeutic potentials beyond its traditional use against TB and MAC. Notably:

• Expanded Indications: Multiple phase II and phase III trials are exploring rifabutin's efficacy in multidrug-resistant TB (MDR-TB) and non-tuberculous mycobacterial (NTM) infections, including Mycobacterium abscessus.

• Combination Regimens: Trials assess rifabutin with novel agents such as bedaquiline, delamanid, and newer macrolides to combat resistant TB strains. For example, the NCT04377294 trial investigates rifabutin combined with bedaquiline in MDR-TB, aiming to shorten treatment duration.

• HIV and Latent TB Infection (LTBI): Several studies evaluate rifabutin-based regimens for LTBI, especially in patients co-infected with HIV, where interactions with antiretrovirals are a concern. The WHO’s 2022 guidelines endorse rifabutin as an alternative in suitable cases [1].

Safety, Tolerability, and Pharmacokinetics

The latest data reflect a favorable safety profile comparable to rifampin, with fewer drug-drug interactions. Recent pharmacokinetic studies demonstrate sustained serum concentrations, informing dosing strategies for resistant strains and co-infected patients.

Regulatory Developments

Although no new drug approvals for rifabutin have been sanctioned recently, the FDA and EMA continue to recognize its importance in multidrug regimens, with ongoing discussions to extend indications, especially for resistant infections.

---

Market Analysis

Current Market Landscape

Rifabutin's global market remains niche but steady, estimated at approximately $150 million in 2022, driven chiefly by high-burden endemic regions such as India, Sub-Saharan Africa, and Southeast Asia. The drug's primary use in treating HIV-associated mycobacterial infections sustains consistent demand, despite competition from newer agents.

Key Market Drivers

• HIV/AIDS Co-infection: With an increasing prevalence of HIV globally, the demand for rifabutin in prophylactic and treatment regimens persists. Its advantage in reducing drug interactions makes it a preferred choice in co-infected patients.

• Resistance Challenges: The rise of MDR-TB and NTM infections is pushing the medical community to explore rifabutin as part of combination therapy, thereby expanding its market. Notably, the WHO's endorsement enhances acceptance.

• Regulatory and Policy Shifts: WHO and national health agencies' guidelines favor rifabutin where applicable, which propels procurement and utilization.

• Supply Chain Dynamics: Limited manufacturing sources, predominantly in India and China, influence pricing and availability, affecting market accessibility.

Market Saturation and Competition

The competitive landscape involves drugs like rifampin, rifapentine, and newer agents like bedaquiline and pretomanid. Rifabutin’s niche is reinforced in specific patient populations; however, its market share faces constraints from these alternatives in general TB treatment.

Emerging Opportunities

• Development of Fixed-Dose Combinations (FDCs): Incorporation into simplified regimens could broaden usage.

• Research on Resistance-Resilient Formulations: Innovations targeting resistant strains offer future growth avenues.

• Global Funding Initiatives: Programs from the Global Fund and GAVI promote access in low-income countries, potentially elevating market size.

---

Market Projection and Future Outlook

Forecast for 2023–2030

The rifabutin market is projected to grow at a CAGR of approximately 4-6% over the next decade, driven by:

• Rising TB and NTM burdens: Especially in Asia-Pacific and African regions. WHO projects TB incidence to decline modestly, but resistant strains will sustain demand for rifabutin-containing regimens.

• Advancements in Clinical Research: Successful trials may expand indications, leading to regulatory approvals that could triple the market size by 2030.

• Strategic Patent Extensions/USDA Regulations: Will impact pricing, access, and adoption.

• Pricing and Reimbursement Policies: Affordability remains crucial; partnerships with global health agencies will influence market penetration.

Barriers to Growth

• Limited Manufacturing Capacity: Affects supply stability and costs.

• Competition from Newer Agents: Limited efficacy against resistant strains compared to experimental agents.

• Regulatory Challenges: Delays in approval for expanded indications could slow market expansion.

• Drug Resistance: Emergence of rifabutin-resistant strains may curtail its utility in certain regions.

---

Conclusion

Rifabutin maintains a vital role in managing complex mycobacterial infections, especially in HIV co-infected populations. Current clinical trials underscore its potential expansion into resistant TB and NTM niches, supported by favorable safety data. While its market is relatively niche, strategic developments, nowych therapies, and global health initiatives suggest a modest but steady growth trajectory. Stakeholders should monitor ongoing research, regulatory shifts, and supply factors to capitalize on emerging opportunities.

---

Key Takeaways

• Clinical pipeline progress supports rifabutin’s use against MDR-TB and NTM, especially in co-infected patients.

• Market demand hinges on its unique safety profile and drug-drug interaction advantages, sustained by HIV/TB co-epidemics.

• Growth projections forecast moderate expansion, contingent on positive trial outcomes and regulatory approvals.

• Competitive landscape remains intense, necessitating innovation and strategic positioning to expand indications.

• Global health initiatives could enhance access and affordability, unlocking new markets in low-resource settings.

---

FAQs

1. What are the main advantages of rifabutin over rifampin?
   Rifabutin exhibits fewer drug-drug interactions, making it more suitable for HIV co-infected patients on antiretroviral therapy, and has a similar or better safety profile.

2. Are there ongoing efforts to expand rifabutin’s approved indications?
   Yes, multiple trials are exploring its efficacy in resistant TB and NTM infections, with potential regulatory consideration pending positive results.

3. How does resistance impact rifabutin’s market potential?
   The emergence of rifabutin-resistant strains could limit its efficacy, emphasizing the need for ongoing surveillance and development of combination therapies.

4. What role do global health organizations play in rifabutin’s market?
   They promote access in endemic regions through funding, guidelines, and procurement initiatives, influencing demand and distribution.

5. What are the primary challenges facing rifabutin’s market growth?
   Manufacturing limitations, competition from newer drugs, resistance issues, and regulatory hurdles present notable barriers.

---

References

[1] World Health Organization. Consolidated guidelines on tuberculosis. 2022.