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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR SIRTURO


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All Clinical Trials for Sirturo

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02193776 ↗ A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis. Completed Global Alliance for TB Drug Development Phase 2 2014-10-23 The purpose of this study is to determine the mycobactericidal activity of combinations of bedaquiline (J), moxifloxacin (M), PA-824 (Pa) and pyrazinamide (Z) regimens during 8 weeks of treatment.
NCT02409290 ↗ The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB Active, not recruiting Institute of Tropical Medicine, Belgium Phase 3 2016-04-01 Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. With the incident rate of MDR-TB on the rise, there is a need to investigate optimal treatment regimens using effective drugs.
NCT02409290 ↗ The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB Active, not recruiting Liverpool School of Tropical Medicine Phase 3 2016-04-01 Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. With the incident rate of MDR-TB on the rise, there is a need to investigate optimal treatment regimens using effective drugs.
NCT02409290 ↗ The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB Active, not recruiting Medical Research Council Phase 3 2016-04-01 Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. With the incident rate of MDR-TB on the rise, there is a need to investigate optimal treatment regimens using effective drugs.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sirturo

Condition Name

Condition Name for Sirturo
Intervention Trials
Extensively Drug-Resistant Tuberculosis 5
Tuberculosis 5
Tuberculosis, Multidrug-Resistant 5
Tuberculosis, Pulmonary 3
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Condition MeSH

Condition MeSH for Sirturo
Intervention Trials
Tuberculosis 15
Tuberculosis, Multidrug-Resistant 10
Tuberculosis, Pulmonary 9
Extensively Drug-Resistant Tuberculosis 5
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Clinical Trial Locations for Sirturo

Trials by Country

Trials by Country for Sirturo
Location Trials
South Africa 25
Uzbekistan 6
Uganda 4
Georgia 4
United States 4
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Trials by US State

Trials by US State for Sirturo
Location Trials
Washington 1
Texas 1
New York 1
Colorado 1
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Clinical Trial Progress for Sirturo

Clinical Trial Phase

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

Clinical Trial Status for Sirturo
Clinical Trial Phase Trials
Recruiting 5
Active, not recruiting 4
Completed 4
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Clinical Trial Sponsors for Sirturo

Sponsor Name

Sponsor Name for Sirturo
Sponsor Trials
Wits Health Consortium (Pty) Ltd 5
Global Alliance for TB Drug Development 5
THINK TB & HIV Investigative Network 4
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Sponsor Type

Sponsor Type for Sirturo
Sponsor Trials
Other 100
Industry 6
NIH 4
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SIRTURO (Bedaquiline): Clinical Trials Update, Market Analysis, and Projections

Introduction to SIRTURO

SIRTURO, also known by its generic name bedaquiline, is a crucial medication in the fight against tuberculosis (TB), particularly for cases of multidrug-resistant tuberculosis (MDR-TB). Developed by Janssen Pharmaceutical Companies of Johnson & Johnson, SIRTURO has been a significant advancement in TB treatment, especially given its novel mechanism of action.

Clinical Trials Update

Phase III Trial Suspension for MAC-LD

In a recent development, a Phase III trial for SIRTURO in treating mycobacterium avium complex-associated lung disease (MAC-LD) was suspended. This trial, conducted at 30 sites in Japan, aimed to compare SIRTURO with rifamycin when used in combination with clarithromycin and ethambutol. The suspension led to a drop in the drug's Likelihood of Approval (LoA) from 60% to 33% and a decrease in its Phase Transition Success Rate (PTSR) from 68% to 38%[1].

STREAM Stage 2 Study

On a more positive note, Janssen submitted Phase 3 study data from the STREAM Stage 2 study to both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). This study evaluated the efficacy and safety of an all-oral bedaquiline-containing regimen for MDR-TB, comparing it to a nine-month injectable-based regimen. The results, published in The Lancet, supported the traditional approval of SIRTURO in the U.S. and full approval in the European Union[4].

Market Analysis

Global TB Drugs Market

The global tuberculosis drugs market is projected to grow significantly, driven by the rising prevalence of MDR-TB and HIV-TB co-infections. According to Grand View Research, the TB drugs market is expected to reach USD 1.38 billion by 2025, growing at a CAGR of 5.2% during the forecast period. India, with its high incidence of TB and MDR-TB cases, is a key market for these drugs[2].

SIRTURO's Market Position

SIRTURO has become a core component of World Health Organization (WHO)-recommended treatment guidelines for drug-resistant TB. As of the latest updates, more than 700,000 courses of SIRTURO have been delivered to 159 countries, including those with the highest burdens of TB. The drug's widespread adoption is a testament to its efficacy and the commitment of Johnson & Johnson to global health initiatives[4].

Regulatory Approvals

FDA and EMA Approvals

Recently, Johnson & Johnson received FDA and European Commission approvals for SIRTURO to treat pulmonary TB resistant to rifampicin and isoniazid. These approvals mark a significant milestone, transitioning SIRTURO from accelerated and conditional approvals to standard marketing authorizations. This change removes previous label restrictions and solidifies SIRTURO's position as a standard treatment option for MDR-TB[5].

Safety and Efficacy

Clinical Benefits

SIRTURO has demonstrated significant clinical benefits in treating MDR-TB. The main study and follow-up studies have shown that SIRTURO increases the number of patients who test negative for TB bacteria and shortens the time to sputum culture conversion. The European Medicines Agency has concluded that SIRTURO's benefits outweigh its risks, which include liver toxicity and QT-prolongation, both of which are clinically manageable[3].

Safety Concerns

Despite its efficacy, SIRTURO has been associated with an increased risk of death in some trials. A placebo-controlled trial showed a higher mortality rate in the SIRTURO treatment group compared to the placebo group, although no discernible pattern could be identified. This has led to the recommendation that SIRTURO should only be used in patients when an effective treatment regimen cannot otherwise be provided[4].

Market Projections

Growth Drivers

The market for SIRTURO and other TB drugs is expected to grow driven by several factors:

  • Rising Prevalence of MDR-TB: The increasing incidence of MDR-TB globally, particularly in regions like India, will drive the demand for effective treatments.
  • HIV-TB Co-infections: The high rate of HIV-TB co-infections in certain regions will also contribute to the market growth.
  • Global Health Initiatives: Efforts by organizations like the WHO and pharmaceutical companies to make TB treatments more accessible will further boost the market[2].

Competitive Landscape

SIRTURO's market position is strengthened by its inclusion in WHO-recommended treatment guidelines and its widespread adoption. However, the market is also seeing the introduction of generic versions of bedaquiline, which could impact the pricing and market share of SIRTURO. Johnson & Johnson's decision not to enforce patents for SIRTURO in 134 low- and middle-income countries will facilitate greater access to the drug but may also introduce competition from generic manufacturers[4].

Key Takeaways

  • Clinical Trials: The suspension of the Phase III trial for MAC-LD has impacted SIRTURO's approval likelihood, but positive results from the STREAM Stage 2 study support its traditional and full approvals.
  • Market Growth: The global TB drugs market is projected to reach USD 1.38 billion by 2025, driven by the rising prevalence of MDR-TB and HIV-TB co-infections.
  • Regulatory Approvals: Recent FDA and EMA approvals have solidified SIRTURO's position as a standard treatment for MDR-TB.
  • Safety and Efficacy: SIRTURO has demonstrated significant clinical benefits but also carries safety concerns that need to be managed.
  • Market Projections: The market is expected to grow due to rising MDR-TB cases, HIV-TB co-infections, and global health initiatives.

FAQs

What is SIRTURO used for?

SIRTURO (bedaquiline) is used as part of combination therapy to treat pulmonary tuberculosis (TB) that is resistant to rifampicin and isoniazid, particularly in cases of multidrug-resistant TB (MDR-TB)[4].

What was the outcome of the STREAM Stage 2 study?

The STREAM Stage 2 study compared an all-oral bedaquiline-containing regimen to a nine-month injectable-based regimen for MDR-TB. The results supported the efficacy and safety of the all-oral regimen and were instrumental in securing traditional and full approvals from regulatory bodies[4].

Why was the Phase III trial for MAC-LD suspended?

The Phase III trial for treating mycobacterium avium complex-associated lung disease (MAC-LD) was suspended, leading to a decrease in SIRTURO's Likelihood of Approval and Phase Transition Success Rate. However, the exact reasons for the suspension are not detailed in the available sources[1].

What are the safety concerns associated with SIRTURO?

SIRTURO is associated with an increased risk of death, liver toxicity, and QT-prolongation. These risks are clinically manageable, but the drug should only be used when an effective treatment regimen cannot otherwise be provided[4].

How has Johnson & Johnson facilitated access to SIRTURO?

Johnson & Johnson has granted the Stop TB Partnership’s Global Drug Facility a license to tender, procure, and supply generic versions of SIRTURO for low- and middle-income countries. The company has also announced that it will not enforce patents for SIRTURO in 134 of these countries[4].

Sources

  1. Clinical Trials Arena: "Janssen's Sirturo hit a slump with suspension for Phase III trial in ...", July 22, 2021.
  2. Business Insider: "TB Drugs Market Size Worth $1.38 Billion by 2025 | CAGR: 5.2%", July 18, 2018.
  3. European Medicines Agency: "Sirturo | European Medicines Agency (EMA)".
  4. Johnson & Johnson: "Janssen Submits Phase 3 Study Data to the European Medicines Agency and U.S. Food and Drug Administration for SIRTURO® (bedaquiline)", November 7, 2023.
  5. Pharmaceutical Technology: "Johnson & Johnson gains FDA and EC approvals for TB treatment", July 3, 2024.

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