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 antimycobacteri...

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 no...

Associated Conditions
Pulmonary Rifampicin- and Isoniazid-Resistant Tuberculosis, Pulmonary Tuberculosis resistant to isoniazid, rifamycins, a fluoroquinolone and a second line injectable antibacterial drug
Associated Therapies
-

Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis

First Posted Date
2024-06-04
Last Posted Date
2024-12-05
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

and more 7 locations

Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

First Posted Date
2024-01-05
Last Posted Date
2024-11-13
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
315
Registration Number
NCT06192160
Locations
🇺🇬

12401, Joint Clinical Research Centre (JCRC)/Kampala CRS, Kampala, Uganda

🇲🇼

30301, Blantyre CRS, Blantyre, Malawi

🇲🇼

12001, Malawi CRS, Lilongwe, Malawi

and more 21 locations

Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis

First Posted Date
2023-09-28
Last Posted Date
2024-08-13
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

and more 19 locations

A Pan-TB Regimen Targeting Host and Microbe

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

and more 4 locations

Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis

First Posted Date
2022-10-19
Last Posted Date
2024-02-07
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
72
Registration Number
NCT05586230
Locations
🇮🇳

Site 31441, BJMC CRS, Pune, India

🇿🇦

Site 31976, PHRU Matlosana CRS, Klerksdorp, North West Province, South Africa

🇧🇷

Site 5071, Instituto de Puericultura e Pediatria Martagao Gesteira CRS, Rio De Janeiro, Brazil

and more 4 locations

Modified BPaL Regimen for Managing Pre-XDR TB and MDR (TI/NR) TB in India

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

Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid

Phase 1
Completed
Conditions
Interventions
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
🇺🇸

Worldwide Clinical Trials Early Phase Services, LLC, San Antonio, Texas, United States

Economic Evaluation of New MDR TB Regimens

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
🇿🇦

THINK Clinical Trial Unit, Hillcrest, Durban, KwaZulu-Natal, South Africa

🇿🇦

King DinuZulu Hospital, Durban, KwaZulu-Natal, South Africa

🇧🇾

Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital, Minsk, Belarus

and more 4 locations

A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis Volunteers

First Posted Date
2019-11-27
Last Posted Date
2023-09-13
Lead Sponsor
Global Alliance for TB Drug Development
Target Recruit Count
26
Registration Number
NCT04179500
Locations
🇿🇦

CHRU, Sizwe Tropical Diseases Hospital, Johannesburg, South Africa

🇿🇦

Isango Lethemba TB Research Unit Empilweni TB Hospital, Port Elizabeth, South Africa

🇿🇦

The Aurum Institute: Rustenburg Clinical Research Centre, Rustenburg, South Africa

and more 1 locations

PRACTECAL-PKPD Sub Study

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
🇧🇾

Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital, Minsk, Belarus

🇿🇦

King DinuZulu Hospital, Durban, KwaZulu-Natal, South Africa

🇿🇦

THINK Clinical Trial Unit, Hillcrest, Durban, KwaZulu-Natal, South Africa

and more 2 locations
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