Pretomanid

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.

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
A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis	2025/08/17	NCT07126639	Not Applicable	Not yet recruiting	Wuhan Pulmonary Hospital
A PAN-USR TB Multi-Center Trial	2025/04/01	NCT06905522	Phase 3	Not yet recruiting	Shenzhen Third People's Hospital
Safety and Efficacy Evaluation of <Dovprela Tablets 200 mg> by Post-marketing Surveillance	2024/06/24	NCT06471088	N/A	Recruiting	Viatris Inc.
Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis	2024/06/04	NCT06441006	Not Applicable	Not yet recruiting	University of California, San Francisco
Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis	2024/01/05	NCT06192160	Phase 2	Suspended	National Institute of Allergy and Infectious Diseases (NIAID)
Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB	2023/11/02	NCT06114628	Phase 2	Recruiting	University College, London
Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis	2023/09/28	NCT06058299	Phase 2	Active, not recruiting	Global Alliance for TB Drug Development
Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis	2023/08/02	NCT05971602	Phase 2	Terminated	Bill & Melinda Gates Medical Research Institute
A Pan-TB Regimen Targeting Host and Microbe	2023/01/17	NCT05686356	Phase 2	Active, not recruiting	The Aurum Institute NPC
Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis	2022/10/19	NCT05586230	Phase 1	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)

FDA Drug Approvals

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

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Dovprela (previously Pretomanid FGK)	Mylan IRE Healthcare Limited,Mylan IRE Healthcare Limited,Unit 35/36 Grange Parade,Baldoyle Industrial Estate,Dublin 13,IRELAND	Authorised	7/31/2020

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
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
PRETOMANID TABLETS 200MG	N/A	FOSUN INDUSTRIAL CO., LIMITED	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.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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