Pretomanid

Generic Name: Pretomanid

Brand Names: 普瑞尼, Dovprela (previously Pretomanid FGK)

Drug Type: Small Molecule

Chemical Formula: C_₁₄H_₁₂F_₃N_₃O_₅

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

Clinical Trials

Pretomanid in Adults With Hepatic Impairment

Phase 1

Terminated

Conditions: Tuberculosis

Interventions: Drug: PA-824

First Posted Date: 2015-04-21

Last Posted Date: 2025-03-05

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 14

Registration Number: NCT02422524

Locations: 🇺🇸
Saint Louis University Center for Vaccine Development, Saint Louis, Missouri, United States
🇺🇸
Duke University School of Medicine - Duke Clinical Research Institute - Duke Clinical Research Unit, Durham, North Carolina, United States

Shortening Treatment by Advancing Novel Drugs

Phase 3

Completed

Conditions: Tuberculosis, Pulmonary, Multi Drug-resistant
Tuberculosis, Pulmonary, Drug Sensitive

Interventions: Drug: HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)
Drug: Moxifloxacin
Drug: PA-824
Drug: HR (rifampicin plus isoniazid combination tablets)
Drug: Pyrazinamide

First Posted Date: 2015-01-21

Last Posted Date: 2019-03-26

Lead Sponsor: Global Alliance for TB Drug Development

Target Recruit Count: 284

Registration Number: NCT02342886

Locations: 🇹🇿
Kilimanjaro National Institute for Medical Research, Mwanza, Tanzania
🇿🇦
TASK, Bellville, Cape Town, South Africa
🇺🇬
Uganda CWRU Research Collaboration, Kampala, Uganda

and more 23 locations

A Phase 3 Study Assessing Safety and Efficacy of Bedaquiline Plus PA-824 Plus Linezolid in Subjects With Drug Resistant Pulmonary Tuberculosis

Phase 3

Completed

Conditions: Pulmonary Tuberculosis

Interventions: Drug: Bedaquiline
Drug: PA-824
Drug: Linezolid

First Posted Date: 2015-01-07

Last Posted Date: 2024-08-09

Lead Sponsor: Global Alliance for TB Drug Development

Target Recruit Count: 109

Registration Number: NCT02333799

Locations: 🇿🇦
Task Applied Science - Brooklyn Chest Hospital, Ysterplaat, Cape Town, South Africa
🇿🇦
King DinuZulu Hospital Complex, Sydenham, Durban, South Africa
🇿🇦
Sizwe Tropical Disease Hospital, Sandringham, Johannesburg, South Africa

Assessing PA-824 for Tuberculosis (the APT Trial)

Phase 2

Completed

Conditions: Pulmonary Tuberculosis

Interventions: Drug: PA-824
Drug: Rifampin
Drug: Rifabutin
Drug: Pyrazinamide
Drug: Ethambutol
Drug: Isoniazid

First Posted Date: 2014-10-06

Last Posted Date: 2023-07-18

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 157

Registration Number: NCT02256696

Locations: 🇿🇦
University of Cape Town Lung Institute, Cape Town, South Africa

A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis.

Phase 2

Completed

Conditions: Tuberculosis

Interventions: Drug: PA-824
Drug: isoniazid, rifampicin, pyrazinamide and ethambutol combination tablet
Drug: bedaquiline
Drug: pyrazinamide
Drug: moxifloxacin

First Posted Date: 2014-07-18

Last Posted Date: 2019-07-26

Lead Sponsor: Global Alliance for TB Drug Development

Target Recruit Count: 240

Registration Number: NCT02193776

Locations: 🇿🇦
Klerksdorp Tshepong Hospital, Jouberton, Klerksdorp, South Africa
🇿🇦
The Aurum Institute: Tembisa Hospital, Tembisa, Gauteng, South Africa
🇹🇿
NIMR-Mbeya Medical Research Centre (MMRC), Mbeya, Tanzania

and more 7 locations

Evaluation of the Pharmacokinetic Interaction Between PA-824 and Midazolam

Phase 1

Completed

Conditions: Tuberculosis

Interventions: Drug: Midazolam
Drug: PA-824

First Posted Date: 2013-01-15

Last Posted Date: 2019-09-12

Lead Sponsor: Global Alliance for TB Drug Development

Target Recruit Count: 14

Registration Number: NCT01768273

Locations: 🇺🇸
MDS Pharma Services, Lincoln, Nebraska, United States

Effect of PA-824 and of PA-824 Plus Moxifloxacin on the QTc Interval in Healthy Volunteers

Phase 1

Completed

Conditions: Tuberculosis

Interventions: Drug: Moxifloxacin
Drug: PA-824
Other: Placebo

First Posted Date: 2012-08-28

Last Posted Date: 2014-11-14

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 74

Registration Number: NCT01674218

Locations: 🇺🇸
Quintiles Phase I Services - Overland Park, Overland Park, Kansas, United States

Evaluating the Safety and Drug Interaction of PA-824, an Investigational Tuberculosis Medication, Together With Efavirenz, Ritonavir-Boosted Lopinavir, or Rifampin

Phase 1

Completed

Conditions: Tuberculosis

Interventions: Drug: PA-824
Drug: Lopinavir/Ritonavir (LPV/r)
Drug: Efavirenz (EFV)
Drug: Rifampin (RIF)

First Posted Date: 2012-04-05

Last Posted Date: 2021-11-05

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 52

Registration Number: NCT01571414

Locations: 🇺🇸
Ucsf Hiv/Aids Crs, San Francisco, California, United States
🇺🇸
Johns Hopkins University CRS, Baltimore, Maryland, United States
🇺🇸
Ohio State University CRS, Columbus, Ohio, United States

and more 1 locations

Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001)

Phase 2

Completed

Conditions: Pulmonary Tuberculosis

Interventions: Drug: Pyrazinamide
Drug: PA-824
Drug: Rifafour
Drug: TMC207
Drug: Moxifloxacin

First Posted Date: 2010-10-07

Last Posted Date: 2017-02-28

Lead Sponsor: Global Alliance for TB Drug Development

Target Recruit Count: 85

Registration Number: NCT01215851

Locations: 🇿🇦
Centre for Tuberculosis Research Innovation, UCT Lung Institute, Cape Town, South Africa
🇿🇦
Task Applied Science, Karl Bremer Hospital, Cape Town, South Africa

Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010)

Phase 2

Completed

Conditions: Pulmonary Tuberculosis

Interventions: Drug: Rifafour e-275 mg
Drug: PA-824

First Posted Date: 2009-07-22

Last Posted Date: 2019-09-20

Lead Sponsor: Global Alliance for TB Drug Development

Target Recruit Count: 69

Registration Number: NCT00944021

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