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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

PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis

Phase 2
Completed
Conditions
Pulmonary Tuberculosis
Interventions
First Posted Date
2007-12-05
Last Posted Date
2017-05-15
Lead Sponsor
Global Alliance for TB Drug Development
Target Recruit Count
69
Registration Number
NCT00567840
Locations
🇿🇦

Tiervlei Trials Center, Stellenbosch University, Cape Town, Cape Province, South Africa

🇿🇦

University of Cape Town Lung Institute, Cape Town, Cape Province, South Africa

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

Completed
Conditions
HIV Infections
Interventions
Drug: darunavir/ritonavir dosage #1
Drug: TAF w/cobicistat
Drug: elvitegravir/cobicistat
Drug: darunavir/cobicistat
Drug: atazanavir/cobicistat
Drug: lopinavir/ritonavir dosage #1
Drug: atazanavir/ritonavir/tenofovir dosage #1
Drug: lopinavir/ritonavir dosage #2
Drug: indinavir/ritonavir dosage #1
Drug: atazanavir/ritonavir dosage #1
Drug: tipranavir/ritonavir
Drug: darunavir/ritonavir dosage #4
Drug: indinavir/ritonavir dosage #2
Drug: darunavir/ritonavir dosage #2
Drug: lopinavir/ritonavir dosage #3
Drug: lopinavir/ritonavir dosage #4
Drug: tenofovir/atazanavir/ritonavir dosage #2
Drug: atazanavir/ritonavir dosage #2
Drug: darunavir/ritonavir dosage #3
Drug: levoflaxacin
Drug: ethionamide/prothionamide
Drug: terizidone/cycloserine
Drug: para-aminosalicylic acid (PAS)
First Posted Date
2002-08-01
Last Posted Date
2022-07-22
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
1578
Registration Number
NCT00042289
Locations
🇺🇸

Usc La Nichd Crs, Los Angeles, California, United States

🇿🇦

Wits RHI Shandukani Research Centre CRS, Johannesburg, Gauteng, South Africa

🇺🇸

Boston Medical Center Ped. HIV Program NICHD CRS, Boston, Massachusetts, United States

and more 59 locations
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