Overview
Persistent forms of tuberculosis (TB) have proven to be a major cause of global morbidity and mortality and a cause for significant concern. Research in recent years has been geared toward the development of novel therapies that target persistent forms of this disease, which have shown resistance to standard therapy regimens. Pretomanid is an antimycobacterial agent that is administered with Bedaquiline and Linezolid to treat resistant forms of pulmonary TB. It was the first TB drug developed by a nonprofit organization, known as TB Alliance, and was granted FDA approval on August 14, 2019. Unlike other therapeutic regimens for the treatment of resistant TB, which may take 18 months or longer and may not be effective, the pretomanid-containing regimen allows for a more efficacious and shorter duration of treatment with fewer drugs.
Background
Persistent forms of tuberculosis (TB) have proven to be a major cause of global morbidity and mortality and a cause for significant concern. Research in recent years has been geared toward the development of novel therapies that target persistent forms of this disease, which have shown resistance to standard therapy regimens. Pretomanid is an antimycobacterial agent that is administered with Bedaquiline and Linezolid to treat resistant forms of pulmonary TB. It was the first TB drug developed by a nonprofit organization, known as TB Alliance, and was granted FDA approval on August 14, 2019. Unlike other therapeutic regimens for the treatment of resistant TB, which may take 18 months or longer and may not be effective, the pretomanid-containing regimen allows for a more efficacious and shorter duration of treatment with fewer drugs.
Indication
Pretomanid is indicated, as part of a combination regimen with bedaquiline and linezolid, for the treatment of adults with pulmonary tuberculosis (TB) that is resistant to isoniazid, rifamycins, a fluoroquinolone and a second-line injectable antibacterial drug or adults with pulmonary TB resistant to isoniazid and rifampin, who are treatment-intolerant or non-responsive to standard therapy.
Associated Conditions
- Pulmonary Rifampicin- and Isoniazid-Resistant Tuberculosis
- Pulmonary Tuberculosis resistant to isoniazid, rifamycins, a fluoroquinolone and a second line injectable antibacterial drug
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/04/01 | Phase 3 | Not yet recruiting | Shenzhen Third People's Hospital | ||
2024/06/24 | N/A | Recruiting | |||
2024/06/04 | Phase 3 | Not yet recruiting | |||
2024/01/05 | Phase 2 | Suspended | |||
2023/11/02 | Phase 2 | Recruiting | |||
2023/09/28 | Phase 2 | Active, not recruiting | |||
2023/08/02 | Phase 2 | Terminated | |||
2023/01/17 | Phase 2 | Active, not recruiting | The Aurum Institute NPC | ||
2022/10/19 | Phase 1 | Recruiting | |||
2021/09/10 | Phase 3 | Active, not recruiting | Tuberculosis Research Centre, India |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Mylan Specialty L.P. | 49502-476 | ORAL | 200 mg in 1 1 | 4/15/2020 | |
Viatris Specialty LLC | 49502-476 | ORAL | 200 mg in 1 1 | 4/15/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 7/31/2020 | ||
Authorised | 7/31/2020 |
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 |
---|---|---|---|---|---|
Pretomanid Tablets | 国药准字HJ20240153 | 化学药品 | 片剂 | 12/1/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
PRETOMANID TABLETS 200MG | N/A | N/A | N/A | 12/15/2022 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |