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Last Updated: April 29, 2025

CLINICAL TRIALS PROFILE FOR RIFADIN


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All Clinical Trials for Rifadin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00439166 ↗ Effects of Doxycycline and Rifampicin on Biomarkers of Alzheimer's Disease in the Cerebrospinal Fluid Completed The Physicians' Services Incorporated Foundation Phase 3 2007-02-01 This study will determine if biomarkers found in the cerebrospinal fluid of people with Alzheimer's disease, are affected by treatment with two common antibiotics, doxycycline and rifampicin, suggesting a disease-modifying effect of those treatments.
NCT00439166 ↗ Effects of Doxycycline and Rifampicin on Biomarkers of Alzheimer's Disease in the Cerebrospinal Fluid Completed Hamilton Health Sciences Corporation Phase 3 2007-02-01 This study will determine if biomarkers found in the cerebrospinal fluid of people with Alzheimer's disease, are affected by treatment with two common antibiotics, doxycycline and rifampicin, suggesting a disease-modifying effect of those treatments.
NCT00621309 ↗ Sulforaphane as an Antagonist to Human PXR-mediated Drug-drug Interactions Completed Fred Hutchinson Cancer Research Center Phase 1 2008-03-01 Adverse drug-drug interactions (DDIs) are responsible for approximately 3% of all hospitalizations in the US, perhaps costing more than $1.3 billion per year. One of the most common causes of DDIs is the when one drug alters the metabolism of another. A key enzyme in the liver and intestine, called "cytochrome P450 3A4 (CYP3A4) is generally considered to be the most important drug metabolizing enzyme. The gene for CYP3A4 can be 'turned on' by the presence of certain other drugs, resulting in much higher levels of CYP3A4 in the liver and intestine. Thus, when a drug that induces CYP3A4 is given with or before another drug that is metabolized by 3A4, a 'drug-drug' interaction occurs because the first drug (the inducer) greatly changes the rate at which the second drug (CYP3A4 substrate) is removed from the body. Many drugs increase CYP3A4 activity by binding to a receptor called the Pregnane-X-Receptor (PXR), which is a major switch that controls the expression of the CYP3A4 gene. Using human liver cells we have demonstrated that sulforaphane (SFN), found in broccoli, can block drugs from activating the PXR receptor, thereby inhibiting the switch that causes CYP3A4 induction. The purpose of this project is to determine if SFN can be used to block adverse DDIs that occur when drugs bind to and activate the PXR receptor and subsequently induce CYP3A4 activity. We will recruit 24 human volunteers to participate in the study. This project will determine whether SFN can prevent the drug Rifampin from binding to PXR and increasing CYP3A4 activity in humans following oral administration of SFN (broccoli sprout extract). The rate of removal of a small dose of the drug midazolam will be used to determine the enzymatic activity of CYP3A4 before and following treatment with Rifampin, in the presence or absence of SFN, since midazolam is only eliminated from the bloodstream by CYP3A4. . We predict that SFN will prevent the increase in midazolam clearance (metabolism) that normally follows treatment with the antibiotic, rifampicin. This research is important because it could potentially lead to a simple, cost-effective way of preventing one of the most common causes of adverse drug-drug interactions that occurs today. For example, rifampicin, which is a cheap and effective antibiotic used to treat TB, cannot be used in HIV/AIDS patients because it increases the metabolism of many of the antiretroviral drugs used to treat HIV/AIDS. TB is a major opportunistic infection in AIDS patients, so this is a serious clinical problem, especially in developing countries where more expensive alternative drug therapies are not available. We hypothesize that co-formulation of rifampicin with SFN could block this drug-drug interaction without altering its efficacy, thereby allowing its use in HIV/AIDS patients infected with TB. This is but one example of numerous drug-drug interactions that occur via this mechanism.
NCT00621309 ↗ Sulforaphane as an Antagonist to Human PXR-mediated Drug-drug Interactions Completed National Institute of General Medical Sciences (NIGMS) Phase 1 2008-03-01 Adverse drug-drug interactions (DDIs) are responsible for approximately 3% of all hospitalizations in the US, perhaps costing more than $1.3 billion per year. One of the most common causes of DDIs is the when one drug alters the metabolism of another. A key enzyme in the liver and intestine, called "cytochrome P450 3A4 (CYP3A4) is generally considered to be the most important drug metabolizing enzyme. The gene for CYP3A4 can be 'turned on' by the presence of certain other drugs, resulting in much higher levels of CYP3A4 in the liver and intestine. Thus, when a drug that induces CYP3A4 is given with or before another drug that is metabolized by 3A4, a 'drug-drug' interaction occurs because the first drug (the inducer) greatly changes the rate at which the second drug (CYP3A4 substrate) is removed from the body. Many drugs increase CYP3A4 activity by binding to a receptor called the Pregnane-X-Receptor (PXR), which is a major switch that controls the expression of the CYP3A4 gene. Using human liver cells we have demonstrated that sulforaphane (SFN), found in broccoli, can block drugs from activating the PXR receptor, thereby inhibiting the switch that causes CYP3A4 induction. The purpose of this project is to determine if SFN can be used to block adverse DDIs that occur when drugs bind to and activate the PXR receptor and subsequently induce CYP3A4 activity. We will recruit 24 human volunteers to participate in the study. This project will determine whether SFN can prevent the drug Rifampin from binding to PXR and increasing CYP3A4 activity in humans following oral administration of SFN (broccoli sprout extract). The rate of removal of a small dose of the drug midazolam will be used to determine the enzymatic activity of CYP3A4 before and following treatment with Rifampin, in the presence or absence of SFN, since midazolam is only eliminated from the bloodstream by CYP3A4. . We predict that SFN will prevent the increase in midazolam clearance (metabolism) that normally follows treatment with the antibiotic, rifampicin. This research is important because it could potentially lead to a simple, cost-effective way of preventing one of the most common causes of adverse drug-drug interactions that occurs today. For example, rifampicin, which is a cheap and effective antibiotic used to treat TB, cannot be used in HIV/AIDS patients because it increases the metabolism of many of the antiretroviral drugs used to treat HIV/AIDS. TB is a major opportunistic infection in AIDS patients, so this is a serious clinical problem, especially in developing countries where more expensive alternative drug therapies are not available. We hypothesize that co-formulation of rifampicin with SFN could block this drug-drug interaction without altering its efficacy, thereby allowing its use in HIV/AIDS patients infected with TB. This is but one example of numerous drug-drug interactions that occur via this mechanism.
NCT00621309 ↗ Sulforaphane as an Antagonist to Human PXR-mediated Drug-drug Interactions Completed University of Washington Phase 1 2008-03-01 Adverse drug-drug interactions (DDIs) are responsible for approximately 3% of all hospitalizations in the US, perhaps costing more than $1.3 billion per year. One of the most common causes of DDIs is the when one drug alters the metabolism of another. A key enzyme in the liver and intestine, called "cytochrome P450 3A4 (CYP3A4) is generally considered to be the most important drug metabolizing enzyme. The gene for CYP3A4 can be 'turned on' by the presence of certain other drugs, resulting in much higher levels of CYP3A4 in the liver and intestine. Thus, when a drug that induces CYP3A4 is given with or before another drug that is metabolized by 3A4, a 'drug-drug' interaction occurs because the first drug (the inducer) greatly changes the rate at which the second drug (CYP3A4 substrate) is removed from the body. Many drugs increase CYP3A4 activity by binding to a receptor called the Pregnane-X-Receptor (PXR), which is a major switch that controls the expression of the CYP3A4 gene. Using human liver cells we have demonstrated that sulforaphane (SFN), found in broccoli, can block drugs from activating the PXR receptor, thereby inhibiting the switch that causes CYP3A4 induction. The purpose of this project is to determine if SFN can be used to block adverse DDIs that occur when drugs bind to and activate the PXR receptor and subsequently induce CYP3A4 activity. We will recruit 24 human volunteers to participate in the study. This project will determine whether SFN can prevent the drug Rifampin from binding to PXR and increasing CYP3A4 activity in humans following oral administration of SFN (broccoli sprout extract). The rate of removal of a small dose of the drug midazolam will be used to determine the enzymatic activity of CYP3A4 before and following treatment with Rifampin, in the presence or absence of SFN, since midazolam is only eliminated from the bloodstream by CYP3A4. . We predict that SFN will prevent the increase in midazolam clearance (metabolism) that normally follows treatment with the antibiotic, rifampicin. This research is important because it could potentially lead to a simple, cost-effective way of preventing one of the most common causes of adverse drug-drug interactions that occurs today. For example, rifampicin, which is a cheap and effective antibiotic used to treat TB, cannot be used in HIV/AIDS patients because it increases the metabolism of many of the antiretroviral drugs used to treat HIV/AIDS. TB is a major opportunistic infection in AIDS patients, so this is a serious clinical problem, especially in developing countries where more expensive alternative drug therapies are not available. We hypothesize that co-formulation of rifampicin with SFN could block this drug-drug interaction without altering its efficacy, thereby allowing its use in HIV/AIDS patients infected with TB. This is but one example of numerous drug-drug interactions that occur via this mechanism.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Rifadin

Condition Name

Condition Name for Rifadin
Intervention Trials
Pulmonary Tuberculosis 3
Healthy 3
Cystic Fibrosis 2
HIV 2
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Condition MeSH

Condition MeSH for Rifadin
Intervention Trials
Tuberculosis 7
Tuberculosis, Pulmonary 5
Cystic Fibrosis 2
Neoplasms 2
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Clinical Trial Locations for Rifadin

Trials by Country

Trials by Country for Rifadin
Location Trials
United States 65
South Africa 7
Canada 5
India 4
France 3
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Trials by US State

Trials by US State for Rifadin
Location Trials
California 6
Florida 4
Texas 4
Colorado 4
Washington 4
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Clinical Trial Progress for Rifadin

Clinical Trial Phase

Clinical Trial Phase for Rifadin
Clinical Trial Phase Trials
Phase 4 2
Phase 3 5
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Rifadin
Clinical Trial Phase Trials
Completed 27
Recruiting 4
Unknown status 2
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Clinical Trial Sponsors for Rifadin

Sponsor Name

Sponsor Name for Rifadin
Sponsor Trials
European and Developing Countries Clinical Trials Partnership (EDCTP) 3
University of Washington 3
University of California, San Francisco 3
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Sponsor Type

Sponsor Type for Rifadin
Sponsor Trials
Other 80
Industry 17
NIH 5
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Rifadin (Rifampicin): Clinical Trials Update, Market Analysis, and Projections

Introduction to Rifampicin

Rifampicin, commonly known by the brand name Rifadin, is a crucial antibiotic in the treatment of various bacterial infections, most notably tuberculosis (TB). Its efficacy and safety have been subjects of extensive clinical trials and market analyses.

Clinical Trials Update

Safety and Efficacy of High-Dose Rifampicin Regimens

Recent clinical trials have focused on optimizing the dosing regimen of rifampicin to improve treatment completion rates and reduce adverse events. A phase 2b trial conducted across Canada, Indonesia, and Vietnam compared the safety and treatment completion rates of different rifampicin dosing regimens.

  • Standard Dose: 10 mg/kg daily for 4 months.
  • High-Dose Regimens: 20 mg/kg daily for 2 months and 30 mg/kg daily for 2 months.

The study found that the 20 mg/kg daily regimen for 2 months was as safe as the standard treatment but had lower treatment completion rates. The 30 mg/kg daily regimen for 2 months had significantly worse safety and completion rates compared to the standard and 20 mg/kg regimens[1].

Pharmacokinetic and Pharmacodynamic Analysis

Another study analyzed the pharmacokinetic and pharmacodynamic relationships of rifampicin in a phase 3 clinical trial. This trial evaluated the effect of rifampicin exposure on treatment outcomes, including stable culture conversion and TB-related unfavorable outcomes. The study used population nonlinear mixed-effects models to compare flat-dosing and weight-banded dosing strategies. It concluded that weight-banded dosing may offer better efficacy and safety profiles compared to flat dosing[4].

Treatment Shortening Potential

Research has also explored the potential for shortening TB treatment regimens using higher doses of rifampicin. A study using parametric models to simulate treatment outcomes found that higher rifampicin doses could potentially shorten treatment durations without compromising efficacy. However, this approach must be balanced with the risk of increased adverse events[3].

Market Analysis

Current Market Size and Growth

The rifampicin market was valued at USD 35 billion in 2023 and is projected to reach USD 66.24 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 8.3% from 2024 to 2031. This growth is driven by the increasing prevalence of multidrug-resistant TB and the global efforts to eradicate TB[5].

Market Segmentation

The rifampicin market is segmented based on application (TB treatment, leprosy treatment, meningitis treatment, and prophylaxis against meningococcal disease) and product form (tablets, capsules, oral suspension). Geographically, the market is significant in regions such as Asia-Pacific and North America.

Key Drivers

  • Global TB Epidemic: The ongoing epidemic of TB, particularly drug-resistant forms, drives the demand for rifampicin.
  • Government Initiatives: Government funding and initiatives for TB control programs globally support the market.
  • Technological Advancements: Improvements in medication administration and antibiotic formulations enhance the effectiveness and patient compliance of rifampicin.
  • Collaborations: Collaborations between pharmaceutical firms and healthcare institutions to develop cost-effective treatments also boost market growth[5].

Market Projections

Price Predictions

Analysts predict a positive trend for rifampicin prices in the coming years. By the end of 2025, the price is expected to rise to around €0.1400, with further increases anticipated in 2026 and beyond. By 2028, the price could potentially peak at €0.2800[2].

Market Expansion

The rifampicin market is expected to expand steadily due to its critical role in treating bacterial diseases like TB. The Asia-Pacific and North American regions are anticipated to remain key markets due to their high prevalence of TB and robust healthcare infrastructure.

Safety and Adverse Events

Clinical Trial Findings

The recent phase 2b trial highlighted that higher doses of rifampicin, particularly the 30 mg/kg daily regimen, were associated with a higher risk of adverse events, including grade 3 hepatotoxicity. However, the 20 mg/kg daily regimen for 2 months showed a safety profile comparable to the standard dose but with lower treatment completion rates[1].

Pharmacodynamic Evidence

Studies have also evaluated the relationship between rifampicin exposure and safety outcomes. For instance, a phase 3 trial analyzed the effect of rifampicin exposure on adverse events, including liver enzyme elevations and other serious adverse events. The study recommended a dosing strategy that balances efficacy with safety[4].

Conclusion

Rifampicin remains a cornerstone in the treatment of tuberculosis and other bacterial infections. Ongoing clinical trials are optimizing dosing regimens to enhance safety and efficacy. The market for rifampicin is expected to grow significantly, driven by the global burden of TB and advancements in treatment methods.

Key Takeaways

  • Optimized Dosing: Clinical trials are exploring shorter, higher-dose regimens of rifampicin to improve treatment completion and safety.
  • Market Growth: The rifampicin market is projected to grow at an 8.3% CAGR from 2024 to 2031.
  • Safety Profile: Higher doses of rifampicin may increase the risk of adverse events, but certain regimens show promise in balancing safety and efficacy.
  • Global Impact: The global TB epidemic and government initiatives are key drivers of the rifampicin market.

FAQs

What are the current clinical trials focusing on for rifampicin?

Current clinical trials are focusing on optimizing the dosing regimen of rifampicin to improve treatment completion rates and reduce adverse events, particularly comparing standard doses with higher, shorter-duration regimens.

How is the market for rifampicin expected to grow?

The rifampicin market is expected to grow at an 8.3% CAGR from 2024 to 2031, reaching USD 66.24 billion by 2031, driven by the global burden of TB and advancements in treatment methods.

What are the key drivers of the rifampicin market?

Key drivers include the global TB epidemic, government initiatives for TB control, technological advancements in medication administration, and collaborations between pharmaceutical firms and healthcare institutions.

What are the potential risks associated with higher doses of rifampicin?

Higher doses of rifampicin, particularly the 30 mg/kg daily regimen, have been associated with a higher risk of adverse events, including grade 3 hepatotoxicity.

How do price predictions look for rifampicin in the coming years?

Analysts predict a positive trend for rifampicin prices, with the price expected to rise to around €0.1400 by the end of 2025 and potentially reaching €0.2800 by 2028.

Sources

  1. High-dose, short-duration versus standard rifampicin for tuberculosis preventive treatment: a partially blinded, parallel-arm, non-inferiority, randomised, controlled, phase 2b trial. PubMed.
  2. Rifampicin price prediction 2025/2026 - 2031. BTCDirect.eu.
  3. Potential for Treatment Shortening With Higher Rifampicin Doses. Oxford Academic.
  4. Pharmacokinetic-Pharmacodynamic Evidence From a Phase 3 Trial. Oxford Academic.
  5. Rifampicin Market Size and Projections. Market Research Intellect.

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