Pretomanid
- Generic Name
- Pretomanid
- Brand Names
- ๆฎ็ๅฐผ, Dovprela (previously Pretomanid FGK)
- Drug Type
- Small Molecule
- Chemical Formula
- C14H12F3N3O5
- CAS Number
- 187235-37-6
- Unique Ingredient Identifier
- 2XOI31YC4N
- 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
Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid
- First Posted Date
- 2020-03-16
- Last Posted Date
- 2024-07-24
- Lead Sponsor
- Global Alliance for TB Drug Development
- Target Recruit Count
- 48
- Registration Number
- NCT04309656
- Locations
- ๐บ๐ธ
Worldwide Clinical Trials Early Phase Services, LLC, San Antonio, Texas, United States
Economic Evaluation of New MDR TB Regimens
- Conditions
- Multi-drug Resistant TuberculosisExtensively Drug-Resistant TuberculosisPulmonary Tuberculoses
- Interventions
- First Posted Date
- 2019-12-20
- Last Posted Date
- 2024-04-22
- Lead Sponsor
- Medecins Sans Frontieres, Netherlands
- Target Recruit Count
- 73
- Registration Number
- NCT04207112
- Locations
- ๐ฟ๐ฆ
THINK Clinical Trial Unit, Hillcrest, Durban, KwaZulu-Natal, South Africa
๐ฟ๐ฆKing DinuZulu Hospital, Durban, KwaZulu-Natal, South Africa
๐ง๐พRepublican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital, Minsk, Belarus
A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis
- Conditions
- Tuberculosis, PulmonaryTuberculosis, Multidrug-ResistantTuberculosisTuberculosis, MDRDrug-Resistant Tuberculosis
- Interventions
- First Posted Date
- 2019-11-27
- Last Posted Date
- 2025-01-17
- Lead Sponsor
- Global Alliance for TB Drug Development
- Target Recruit Count
- 26
- Registration Number
- NCT04179500
- Locations
- ๐ฟ๐ฆ
CHRU, Sizwe Tropical Diseases Hospital, Johannesburg, South Africa
๐ฟ๐ฆIsango Lethemba TB Research Unit Empilweni TB Hospital, Port Elizabeth, South Africa
๐ฟ๐ฆThe Aurum Institute: Rustenburg Clinical Research Centre, Rustenburg, South Africa
PRACTECAL-PKPD Sub Study
- Conditions
- Multi-drug Resistant TuberculosisExtensively Drug-Resistant TuberculosisPulmonary Tuberculosis
- Interventions
- First Posted Date
- 2019-09-09
- Last Posted Date
- 2021-05-14
- Lead Sponsor
- Medecins Sans Frontieres, Netherlands
- Target Recruit Count
- 240
- Registration Number
- NCT04081077
- Locations
- ๐ง๐พ
Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital, Minsk, Belarus
๐ฟ๐ฆKing DinuZulu Hospital, Durban, KwaZulu-Natal, South Africa
๐ฟ๐ฆTHINK Clinical Trial Unit, Hillcrest, Durban, KwaZulu-Natal, South Africa
Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial
- Conditions
- Multidrug Resistant Tuberculosis
- Interventions
- Drug: Directly observed therapy (DOT)
- First Posted Date
- 2019-05-08
- Last Posted Date
- 2024-05-29
- Lead Sponsor
- Medecins Sans Frontieres, Netherlands
- Target Recruit Count
- 137
- Registration Number
- NCT03942354
- Locations
- ๐ง๐พ
Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital, Minsk, Belarus
๐บ๐ฟSh Alimov Republican Specialised Scientific-Practical Medical Centre for Phthysiology and Pulmonology Hospital, Tashkent, Uzbekistan
๐ฟ๐ฆHelen Jospeh Hospital, Johannesburg, South Africa
Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function
- First Posted Date
- 2019-04-01
- Last Posted Date
- 2025-05-06
- Target Recruit Count
- 12
- Registration Number
- NCT03896750
- Locations
- ๐บ๐ธ
Advanced Pharma - Miami, Miami, Florida, United States
๐บ๐ธSaint Louis University Center for Vaccine Development, Saint Louis, Missouri, United States
๐บ๐ธAlliance for Multispecialty Research, LLC - Knoxville, Knoxville, Tennessee, United States
Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
- Conditions
- Tuberculosis, PulmonaryTuberculosis, Multidrug-ResistantTuberculosis, MDRTuberculosisDrug-Resistant Tuberculosis
- Interventions
- First Posted Date
- 2017-11-09
- Last Posted Date
- 2024-03-07
- Lead Sponsor
- Global Alliance for TB Drug Development
- Target Recruit Count
- 455
- Registration Number
- NCT03338621
- Locations
- ๐ฟ๐ฆ
University of Cape Town Lung Institute, Cape Town, South Africa
๐ฟ๐ฆMadibeng Centre for Research, Brits, South Africa
๐ฟ๐ฆCHRU, Empilweni TB Hospital, Port Elizabeth, South Africa
A Study of the Safety, Tolerability, and Absorption, Metabolism, and Excretion of PA-824 in Healthy Adult Male Subjects.
- First Posted Date
- 2017-06-28
- Last Posted Date
- 2018-08-02
- Lead Sponsor
- Global Alliance for TB Drug Development
- Target Recruit Count
- 6
- Registration Number
- NCT03202693
- Locations
- ๐บ๐ธ
Covance Clinical Research Unit, Madison, Wisconsin, United States
Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis
- Conditions
- Tuberculosis, Multidrug-ResistantXDR-TBExtensively Drug-Resistant TuberculosisTuberculosis, PulmonaryTuberculosisTuberculosis, MDRPre-XDR-TB
- Interventions
- First Posted Date
- 2017-03-22
- Last Posted Date
- 2023-06-29
- Lead Sponsor
- Global Alliance for TB Drug Development
- Target Recruit Count
- 181
- Registration Number
- NCT03086486
- Locations
- ๐ฟ๐ฆ
Tshepong Hospital, Klerksdorp, North - West, South Africa
๐ฒ๐ฉInstitute of Phthisiopneumology Chiril Draganiuc, Chisinau, Moldova, Republic of
๐ท๐บMoscow City Research and Practice Tuberculosis Treatment Centre, Moscow, Russian Federation
Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)
- Conditions
- Tuberculosis, Multidrug-ResistantExtensively Drug-Resistant TuberculosisTuberculosis, Pulmonary
- Interventions
- Drug: Locally accepted standard of care which is consistent with the WHO recommendations for the treatment of M/XDR-TB.
- First Posted Date
- 2015-10-28
- Last Posted Date
- 2024-05-01
- Lead Sponsor
- Medecins Sans Frontieres, Netherlands
- Target Recruit Count
- 552
- Registration Number
- NCT02589782
- Locations
- ๐ฟ๐ฆ
King DinuZulu Hospital, Durban, KwaZulu-Natal, South Africa
๐บ๐ฟRepublican TB Hospital No. 2, Nukus, Karakalpakstan, Uzbekistan
๐ง๐พRepublican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital, Minsk, Belarus
Drug Development Updates
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