MedPath

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

Overview

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.

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

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/01
Phase 3
Not yet recruiting
Shenzhen Third People's Hospital
2024/06/24
N/A
Recruiting
2024/06/04
Phase 3
Not yet recruiting
2024/01/05
Phase 2
Suspended
2023/11/02
Phase 2
Recruiting
2023/09/28
Phase 2
Active, not recruiting
2023/08/02
Phase 2
Terminated
2023/01/17
Phase 2
Active, not recruiting
The Aurum Institute NPC
2022/10/19
Phase 1
Recruiting
2021/09/10
Phase 3
Active, not recruiting
Tuberculosis Research Centre, India

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Mylan Specialty L.P.
49502-476
ORAL
200 mg in 1 1
4/15/2020
Viatris Specialty LLC
49502-476
ORAL
200 mg in 1 1
4/15/2020

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Pretomanid Tablets
国药准字HJ20240153
化学药品
片剂
12/1/2024

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
PRETOMANID TABLETS 200MG
N/A
N/A
N/A
12/15/2022

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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