Pretomanid
- Generic Name
- Pretomanid
- Brand Names
- 普瑞尼, 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
A PAN-USR TB Multi-Center Trial
- Conditions
- Pulmonary Tuberculosis
- Interventions
- First Posted Date
- 2025-04-01
- Last Posted Date
- 2025-04-01
- Lead Sponsor
- Shenzhen Third People's Hospital
- Target Recruit Count
- 610
- Registration Number
- NCT06905522
Safety and Efficacy Evaluation of <Dovprela Tablets 200 mg> by Post-marketing Surveillance
- First Posted Date
- 2024-06-24
- Last Posted Date
- 2024-06-24
- Lead Sponsor
- Viatris Inc.
- Target Recruit Count
- 100
- Registration Number
- NCT06471088
- Locations
- 🇰🇷
Viatris, Seoul, Korea, Republic of
Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis
- Conditions
- Tuberculosis, MDRTuberculosis, PulmonaryTuberculosis, Multidrug-Resistant
- Interventions
- Drug: Control Arm FQ-S MDR/RR-TB regimen, designed according to latest WHO guidelines
- First Posted Date
- 2024-06-04
- Last Posted Date
- 2025-03-05
- Lead Sponsor
- University of California, San Francisco
- Target Recruit Count
- 690
- Registration Number
- NCT06441006
- Locations
- 🇲🇩
Institute of Phthisiopneumology Chiril Dragniuc, Chisinau, Moldova, Republic of
🇲🇳National Center for Communicable Diseases, Ulaanbaatar, Mongolia
🇵🇪Hospital Nacional Hipólito Unanue, Lima, Peru
Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
- Conditions
- Pulmonary Tuberculosis
- Interventions
- First Posted Date
- 2024-01-05
- Last Posted Date
- 2025-04-23
- Target Recruit Count
- 315
- Registration Number
- NCT06192160
- Locations
- 🇧🇼
12701, Gaborone CRS, Gaborone, Botswana
🇧🇷12201, Hospital Nossa Senhora da Conceicao CRS, Porto Alegre, Brazil
🇧🇷12101, Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS, Rio De Janeiro, Brazil
Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB
- Conditions
- Pulmonary Tuberculosis
- Interventions
- First Posted Date
- 2023-11-02
- Last Posted Date
- 2024-10-16
- Lead Sponsor
- University College, London
- Target Recruit Count
- 2500
- Registration Number
- NCT06114628
- Locations
- 🇿🇦
TASK Eden, George, South Africa
🇹🇿NIMR Mbeya, Mbeya, Tanzania
🇿🇦TASK Brooklyn, Cape Town, South Africa
Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis
- Conditions
- Pulmonary TBPulmonary TuberculosisDrug Sensitive Tuberculosis
- Interventions
- First Posted Date
- 2023-09-28
- Last Posted Date
- 2025-02-17
- Lead Sponsor
- Global Alliance for TB Drug Development
- Target Recruit Count
- 300
- Registration Number
- NCT06058299
- Locations
- 🇵🇭
Care Clinical Trial Group Inc., Dasmariñas, Philippines
🇬🇪National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia
🇵🇭Tropical Disease Foundation, Makati City, Philippines
Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis
- Conditions
- Pulmonary Tuberculosis
- Interventions
- Drug: Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS)Drug: Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS)Drug: Isoniazid, Rifampicin, Pyrazinamide, Ethambutol (HRZE)
- First Posted Date
- 2023-08-02
- Last Posted Date
- 2025-02-25
- Lead Sponsor
- Bill & Melinda Gates Medical Research Institute
- Target Recruit Count
- 93
- Registration Number
- NCT05971602
- Locations
- 🇵🇭
Lung Center of the Philippines, Quezon City, Philippines
🇿🇦The Aurum Institute (Tembisa CRS), Johannesburg, South Africa
🇿🇦Perinatal HIV Research Unit (PHRU), Klerksdorp, South Africa
A Pan-TB Regimen Targeting Host and Microbe
- Conditions
- Tuberculosis
- Interventions
- Combination Product: Rifafour
- First Posted Date
- 2023-01-17
- Last Posted Date
- 2024-10-07
- Lead Sponsor
- The Aurum Institute NPC
- Target Recruit Count
- 352
- Registration Number
- NCT05686356
- Locations
- 🇲🇿
Instituto Nacional de Saúde, Maputo, Mozambique
🇿🇦Clinical HIV Research Unit, Durban, South Africa
🇿🇦The Aurum Institute: Tembisa Clinical Research Centre, Tembisa, Gauteng, South Africa
Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis
- Conditions
- Rifampicin Resistant TuberculosisTuberculosis
- Interventions
- Drug: Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB)
- First Posted Date
- 2022-10-19
- Last Posted Date
- 2025-05-08
- Target Recruit Count
- 72
- Registration Number
- NCT05586230
- Locations
- 🇧🇷
Site 5071, Instituto de Puericultura e Pediatria Martagao Gesteira CRS, Rio De Janeiro, Brazil
🇮🇳Site 31441, BJMC CRS, Pune, India
🇿🇦Site 31976, PHRU Matlosana CRS, Klerksdorp, North West Province, South Africa
Modified BPaL Regimen for Managing Pre-XDR TB and MDR (TI/NR) TB in India
- Conditions
- Treatment Intolerant Multidrug-Resistant Pulmonary TBNon-responsive Multidrug-Resistant Pulmonary TBPre-Extensively Drug-Resistant Pulmonary TB
- Interventions
- First Posted Date
- 2021-09-10
- Last Posted Date
- 2024-01-03
- Lead Sponsor
- Tuberculosis Research Centre, India
- Target Recruit Count
- 400
- Registration Number
- NCT05040126
- Locations
- 🇮🇳
S N Medical College, Agra, Uttarpradesh, India
Drug Development Updates
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