CYP2C19 inhibitors(cytochrome P450 family 2 subfamily C member 19 inhibitors), CYP2C8 inhibitors(cytochrome P450 family 2 subfamily C member 8 inhibitors), Cell wall inhibitors

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Drug-Resistant TuberculosisMultidrug resistant pulmonary tuberculosisTuberculosis, Multidrug-Resistant+ [3]

Inactive Indication

Infectious Lung Disorder

Originator Organization

Novartis Pharma AG

Active Organization

Viatris, Inc.

Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.Mylan IRE Healthcare Ltd.

+ [5]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (14 Aug 2019),

Extensively Drug-Resistant TuberculosisTuberculosis

RegulationFast Track (US), Orphan Drug (KR), Orphan Drug (AU)

Structure/Sequence

Molecular FormulaC14H12F3N3O5

InChIKeyZLHZLMOSPGACSZ-NSHDSACASA-N

CAS Registry187235-37-6

Clinical Trials associated with Pretomanid

NCT06441006

/ Not yet recruitingPhase 3IIT

Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis (PRISM-TB)

PRISM-TB is an international, multicenter, open-label, randomized, controlled, pragmatic, stratified medicine, treatment shortening, noninferiority Phase 3 clinical trial for fluoroquinolone-susceptible multidrug-resistant/rifampin-resistant pulmonary tuberculosis (FQ-S MDR/RR-TB).
The trial objective is to evaluate whether stratified medicine treatment strategies for FQ-S MDR/RR-TB, defined by a pre-specified risk stratification algorithm, have noninferior efficacy to a one-size-fits-all control regimen (the local standard-of-care [SOC] regimen consistent with preferred regimen(s) in international guidelines), as measured by TB-related unfavorable outcomes at Week 73.

Start Date15 Jan 2025

Sponsor / Collaborator

The University of California, San Francisco

[+1]

NCT06192160

/ Not yet recruitingPhase 2IIT

A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB).
A5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care [(SOC) isoniazid/rifampicin/pyrazinamide/ethambutol (HRZE)].
The study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of experimental or SOC treatment (based on treatment arm assignment) followed by 18 weeks of SOC treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.

Start Date10 Jan 2025

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

[+1]

NCT03896750

/ RecruitingPhase 1IIT

A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function

This is a Phase 1, open-label, single-dose, sequential group study to compare the safety and pharmacokinetics (PK) of pretomanid in the following groups of participants: 1) participants with severe renal impairment including those with end stage renal disease (ESRD) not on dialysis, and participants with mild or moderate renal impairment, designated as Groups 2, 3, and 4, respectively; and 2) participants with normal renal function matched to the above renal impairment groups, designated as Groups 1A, 1B, and 1C, respectively.
The study will be conducted following a reduced PK study design in Part A. Part A will enroll participants from Group 1A (i.e., 6 healthy matched controls) and Group 2 (i.e., 6 participants with severe renal impairment and ESRD, not on dialysis). A decision to proceed to Part B will be made after the PK of pretomanid, and safety in participants enrolled in Part A have been reviewed. If Part A demonstrates at least a 50% increase in pretomanid area under the plasma concentration-time curve (AUC) in Group 2 (severe renal impairments and ESRD, not on dialysis) relative to the exposures in Group 1A (matched participants with normal renal function), then the reduced PK study will extend to the full PK study to enroll participants into Part B (i.e., to investigate mild and moderate renal impairment). All Part B groups (1B, 1C, 3, and 4) will be enrolled concurrently.
If the reduced PK study shows at least a 50% increase in AUC in patients with severe renal impairment and patients with ESRD not yet on dialysis relative to the matched healthy controls, a "full PK" renal impairment study in patients with all intermediate levels of renal function impairment should be conducted. Otherwise, no further study is recommended.
The approximate patient involvement will be 3 months. The primary objective is to evaluate the PK profiles of pretomanid in plasma and urine after a single oral dose of 200 mg in participants with renal impairment compared to matched healthy controls.

Start Date27 Mar 2024

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with Pretomanid

100 Translational Medicine associated with Pretomanid

100 Patents (Medical) associated with Pretomanid

417

Literatures (Medical) associated with Pretomanid

01 Feb 2025·BIOORGANIC & MEDICINAL CHEMISTRY

Structural toxicity relationship (STR) of linezolid to mitigate myelosuppression and serotonergic toxicity

Review

Author: Patel, Harun ; Shaikh, Matin

Tuberculosis (TB) remains a significant global health challenge, with multidrug-resistant (MDR-TB) and extensively drug-resistant (XDR-TB) strains posing severe threats to treatment efficacy. Linezolid, a key component of the BPaL (Bedaquiline, Pretomanid and Linezolid) regimen, has demonstrated substantial efficacy against MDR-TB and XDR-TB. However, its clinical utility is often limited by side effects such as myelosuppression and monoamine oxidase (MAO) inhibition, linked to its mechanism of action. This perspective centres on the structural toxicity relationship (STR) of Linezolid and its analogues, exploring modifications to the C-ring and C-5 position that aim to reduce these toxicities while maintaining or enhancing antibacterial activity. Several promising analogues have been identified that exhibit reduced myelosuppression and MAO inhibition, highlighting the potential for developing safer Linezolid derivatives. The findings underscore the importance of continued research into the structure toxicity relationships of oxazolidinones to improve the therapeutic profiles of these essential drugs in combating drug-resistant TB.

01 Jan 2025·Microbial Drug Resistance

TB Anywhere, TB Everywhere. The First Case of pre-Extensively Drug Resistant Tuberculosis Treated with BPaL in Italy: Challenges and Opportunities for Transborder Collaboration

Article

Author: Codecasa, Luigi R. ; Riccardi, Niccolò ; Ferrarese, Maurizio ; Repossi, Alice Claudia ; Catalano, Gaia ; Fumagalli, Giovanni

Even if in the past years new effective, safe, and orally administrable drugs are available to create shorter regimens, drug-resistant (DR) tuberculosis (TB) treatment remains a critical issue and a major challenge faced by clinicians worldwide. We present the first case of transborder pulmonary pre-extensively drug-resistant (pre-XDR)-TB treated in Italy with the bedaquiline-pretomanid-linezolid regimen. Diagnosis and treatment were started in Ukraine, and, after a month of treatment, due to the Russo-Ukrainian war, the patient moved to Italy, where the diagnosis was confirmed both by genotypic and phenotypic drug susceptibility tests, and treatment continued. In this short report, we highlight challenges and future opportunities to improve the clinical management of patient with DR-TB.

17 Dec 2024·CLINICAL INFECTIOUS DISEASES

Effectiveness and Safety of Varying Doses of Linezolid With Bedaquiline and Pretomanid in Treatment of Drug-Resistant Pulmonary Tuberculosis: Open-Label, Randomized Clinical Trial

Article

Author: Awasthi, A K ; Rawat, Alok ; Yadav, Sushma ; Chatterjee, Biswarup ; Mukherjee, Rishikesh Nath ; Sisara, Arvind B ; Parmar, Mallik ; Sreedhar, Sreenisha ; Santhanakrishnan, Rameshkumar ; Kumar, Praveen ; Chauhan, Sandeep ; Paul, Dhamodharan ; Kumar, Krishan ; Kumar, Santosh ; Oswal, Vikas S ; Bajpai, Jyoti ; Wala, Grinish Tamaku ; Singla, Neeta ; Jain, Amita ; Jain, Chetan Kumar ; Ramraj, Balaji ; Shilna, A ; Mary, A Stella ; Jain, Vani ; Rathinam, Prabhakaran ; Shamail, Ghazala ; Rana, Dipti ; Kanwar, Renu ; Bhatnagar, Anuj K ; Kumar, Ramesh ; Dave, Jigna D ; Palav, Manasi ; Mehta, Rashi ; Daniel, Bella Devaleenal ; Shanmugam, Sivakumar ; Kumar, Vijay ; Shankar, Shakila ; Padmapriyadarsini, Chandrasekaran ; Ghadage, Amol ; Shete, Vrushali ; Kumaravadivelu, Shanmugapriya ; Nanavare, Manasvi ; Pandey, Rohit Kumar ; Kant, Surya ; Oswal, Vikas ; Singh, Mukesh Kumar ; Rawat, Shivani ; Kumar, Ravinder ; Bhalla, Manpreet ; Ganesan, Mangalambal ; Bisht, Gopal Singh ; Shah, Neha V ; Mittal, Upasana ; Parade, Tejasvi ; Kambli, Santosh ; Jaju, Jyoti ; Jain, Chetankumar D ; Baskaran, Dhivya ; Alavadi, Umesh ; Singla, Rupak ; Meena, Saroj ; Dipakbhai, Gamit Aishwarya ; Sisara, Aravind ; Vadgama, Parul ; Mattoo, Sanjay K ; Mankar, Shubhangi Dhakulkar ; Amanankur ; Padaya, Mamta ; Padmapriyadarsini, C ; Patel, Pranav ; Subhashini, G ; Dewan, Ravindra K ; Bharathi, Jeyadeepa ; Mariappan, Muthu Vijayalakshmi ; Shekh, Nadim

Abstract:

Background:

Treatment of drug-resistant tuberculosis with bedaquiline-pretomanid-linezolid regimen has demonstrated good treatment efficacy. Given linezolid's toxicity profile, prudence suggests reconsidering its dose and duration. We determined the effectiveness and safety of structured dose reduction of linezolid with bedaquiline and pretomanid in adults with pre–extensively drug-resistant (pre-XDR) or treatment-intolerant/nonresponsive multidrug-resistant (MDRTI/NR) pulmonary tuberculosis.

Method:

Adults with pre-XDR or MDRTI/NR pulmonary tuberculosis were enrolled in a multicenter, parallel-group, randomized clinical trial in India. Patients were randomized to 26 weeks of bedaquiline, pretomanid, and daily linezolid, at 600 mg for 26 weeks (arm 1); 600 mg for 9 weeks followed by 300 mg for 17 weeks (arm 2); or 600 mg for 13 weeks followed by 300 mg for 13 weeks (arm 3). Study end points included sustained cure, bacteriological failure, toxicity, and death.

Results:

Of 403 patients enrolled, 255 (63%) were <30 years old, 273 (68%) had prior tuberculosis episodes, and 238 (59%) were malnourished. At the end of treatment, after excluding those with negative baseline cultures, cure was seen in 120 (93%), 117 (94%), and 115 (93%) in arms 1, 2, and 3 respectively. Myelosuppression seen in 85 patients each in arms 1 and 2 and 77 patients in arm 3, not significantly different. Peripheral neuropathy was noticed in 66 patients (30, 17, and 19 in arms 1, 2, and 3) at 10–26 weeks (P = .02). The linezolid dose was reduced because of toxicity in 13, 2, and 4 patients in arms 1, 2, and 3, respectively.

Conclusions:

In adults with pre-XDR or MDRTI/NR pulmonary tuberculosis, structured linezolid dose reduction to 300 mg/d is as effective as the standard 600-mg dose but with fewer cases of peripheral neuropathy when given with bedaquiline and pretomanid.

Clinical Trials Registration:

Clinical Trial Registry of India (CTRI/2021/03/032189)

News (Medical) associated with Pretomanid

06 Nov 2024

·www.tballiance.org

TB Alliance Applauds WHO Prequalification of Macleods Pretomanid Product

NEW YORK (November 6, 2024) — Macleods, a pharmaceutical company headquartered in India, has received prequalification from the World Health Organization (WHO) for its 200mg tablet of pretomanid, which provides an assurance of safety, quality and efficacy for drug-resistant tuberculosis (DR-TB) patients and their healthcare providers. Pretomanid was developed by the nonprofit TB Alliance and is a key component of the BPaL/M regimens, which have shortened the time needed to treat DR-TB to six months. Previously, most DR-TB treatment regimens lasted 9-18 months or sometimes longer. By partnering with Macleods and other predominantly generic manufacturers, TB Alliance aims to expand access to this life-saving treatment through a strategic commercialization approach – helping to deliver on our commitment to ensure an affordable, sustainable and competitive market for all our new TB products. Macleods has agreed to commercialize pretomanid in approximately 140 countries and territories. According to new data from the WHO, an estimated 400,000 people developed DR-TB infections in 2023, with only 176,000 people starting treatment. TB is the world’s deadliest infectious disease. Macleods' new product will accelerate our continued efforts to reliably provide more patients with access to this life-saving regimen. WHO prequalification is a standard for medical products required for procurement by many UN agencies, multilateral organizations like the Global Fund and Stop TB’s Global Drug Facility for supplying low- and middle-income countries. By obtaining WHO pre-qualification for pretomanid, Macleods will be able to service demand for this life saving medicine from these agencies. WHO Global TB Report 2023 TB Alliance and Macleods Announce Commercial Partnership for New Therapy for Highly Drug-Resistant TB

Clinical Study

01 Nov 2024

·www.tballiance.org

Introducing BPaL: Experiences from countries supported under the LIFT-TB project

11/2024 - PLoS One Author(s): D. F. Wares ,M. Mbenga ,V. Mirtskhulava ,M. Quelapio ,A. Slyzkyi ,I. Koppelaar ,S. N. Cho ,U. Go ,J. S. Lee ,J.-K. Jung ,D. Everitt ,S. Foraida ,M. Diachenko ,S. Juneja ,E. Burhan ,A. Totkogonova ,Z. Myint ,I. Flores ,N. A. Lytvynenko ,N. Parpieva ,N. V. Tags: BPaL, MDR-TB, Regimen Change 10/2024 Author(s): Denise Evans, Kamban Hirasen, Clive Ramushu, Lawrence Long, Edina Sinanovic, Francesca Conradie, Pauline Howell, Xavier Padanilam, Hannetjie Ferreira, Ebrahim Variaiva, Shakira Rajaram, Aastha Gupta, Sandeep Juneja, Norbert Ndjeka Tags: Bedaquiline (TMC-207), BPaL, Linezolid, Pretomanid/PA-824, TB Drug Market, TB Market 8/2024 - IJTLD Open Author(s): C. Auer, A. Gupta, C. Malbacius, A. Ghafoor, Y. Kock, O. Medvedieva, P. Hanlon, P. Steinmann, and S. Juneja Tags: BPaL, MDR-TB, TB Drug Market, TB Market 7/2024 - Journal of Clinical Tuberculosis and Other Mycobacterial Diseases Author(s): B. Myrzaliev, M. Ahmatov, A. Duishekeeva, A. Kulzhabaeva, A. Kadyrov, A. Toktogonova, G. Abdulaeva, D.F. Wares , V. Mirtskhulava, M. Mbenga, A. Slyzkyi, S. Foraida, M. Diachenko, S. Juneja, G. Turdumambetova, A. Musaeva, A. Gebha Tags: Bedaquiline (TMC-207), BPaL, Linezolid, MDR-TB, Regimen Change, XDR-TB 6/2024 - The International Journal of Tuberculosis and Lung Disease Author(s): D. Evans, K. Hirasen, D.J. Casalme, M.T. Gler, A. Gupta, S. Juneja Tags: Bedaquiline (TMC-207), BPaL, Linezolid, Pretomanid/PA-824, Regimen Change, TB Drug Market 5/2024 - Lancet Infectious Diseases Author(s): Muge Cevik, MD Lindsay C Thompson, MPhil Caryn Upton, MD Valéria Cavalcanti Rolla Mookho Malahleha, MD Blandina Mmbaga, PhD Nosipho Ngubane, MD Zamzurina Abu Bakar, MD Mohammed Rassool, MD Ebrahim Variava, MD Rodney Dawson, MD Suzanne Staples, DPhil Umes Tags: Clinical Development, Clinical Trial Results, Global Pipeline, MDR-TB, Moxifloxacin, Pretomanid/PA-824, Pyrazinamide 5/2024 - Annals of Clinical Micobiology and Antimicrobials Author(s): Bing Zhao, Huiwen Zheng, Juliano Timm, Zexuan Song, Shaojun Pei, Ruida Xing, Yajie Guo, Ling Ma, Feina Li, Qing Li, Yan Li, Lin Huang, Chong Teng, Ni Wang, Aastha Gupta, Sandeep Juneja, Fei Huang, Yanlin Zhao, Xichao Ou Tags: Drug-Sensitivity Testing, M.tb. Biology, MDR-TB, Pretomanid/PA-824, XDR-TB 1/2024 - PLOS One Author(s): A Gupta, S Juneja, V Babawale, N R Majidovich, N Ndjeka, P T M Nguyen, P Nargiza Nusratovna, D R Omanito, T T Pakasi, Y Terleeva, A Toktogonova, Y Waheed, Z Myint, Z Yanlin, S Sahu Tags: Advocacy, Bedaquiline (TMC-207), BPaL, Linezolid, Moxifloxacin, Policy, Pretomanid/PA-824, TB Burden, TB Drug Market, TB Market 11/2023 - International Journal of Tuberculosis and Lung Disease Author(s): Taneja, R., Nahata, M. C., Scarim, J., Pande, P. G., Scarim, A., Hoddinott, G., Fourie, C. L., Jew, R. K., Schaaf, H. S., Hesseling, A. C., Garcia-Prats, A. J., Inabathina, K. Rao Tags: BENEFIT Kids, Underserved Populations 10/2023 - Clinical and Translational Science Author(s): Paloma Moraga, Paula Prieto, Almari Conradie, Majda Benhayoun, Vicki Rousell, Maria Davy, Uwe Fuhr, Rosa Antonijoan Arbos, Francisco Abad‐Santos, Antonio Portolés, Jolanda Van Duinen, Antonio J. Carcas, Alberto M. Borobia, and the ERA4TB Consortium Tags: Pharmacodynamics, Pharmacokinetics 10/2023 - Clinical Infectious Diseases Author(s): Tasnim Hasan, Ellie Medcalf, Bern-Thomas Nyang'wa, Erica Egizi, Catherine Berry, Matthew Dodd, Salah Foraida, Medea Gegia, Mengchun Li, Fuad Mirzayev, Hannah Morgan, Ilaria Motta, Linh Nguyen, Samuel Schumacher, Tim Schlub, Greg Fox Tags: Bedaquiline (TMC-207), BPaL, Linezolid, MDR-TB, Pretomanid/PA-824 10/2023 - PLOS Global Public Health Author(s): Juliano Timm, Anna Bateson, Priya Solanki, Ana Paleckyte, Adam A Witney, Sylvia A D Rofael, Stella Fabiane, Morounfolu Olugbosi, Timothy D McHugh, Eugene Sun Tags: Bedaquiline (TMC-207), BPaL, Linezolid, Pretomanid/PA-824 9/2023 - International Journal of Tuberculosis and Lung Disease Author(s): Viljoen, L., Acaba, J., Agbassi, Y. J. P., Beko, B., Goslett, C., Hoddinott, G., Kumar, B., Kumar, R. G., McKenna, L., Moses, G., Sachs, T., Seidel, S., von Delft, A. Tags: Advocacy, BENEFIT Kids, Underserved Populations 6/2023 - Indian Journal of Tuberculosis Author(s): Nibedita Rath, Chaitali Nikam, Stephanie Seidel, Anindya Sinha, Vijay Arora Tags: Advocacy, Community Engagement, TB Burden, Underserved Populations 5/2023 - Molecular Pharmaceutics Author(s): Hanh Thuy Nguyen, Tu Van Duong, Sarah Jaw-Tsai, Rebecca Bruning-Barry, Poonam Pande, Rajneesh Taneja, and Lynne S. Taylor Tags: Pretomanid/PA-824, TB Drug Market, Underserved Populations 3/2023 - International Journal of Tuberculosis and Lung Disease Author(s): R Taneja, M C Nahata, J Scarim, P G Pande, A Scarim, G Hoddinott, C L Fourie, R K Jew, H S Schaaf, A J Garcia-Prats, A C Hesseling Tags: Bedaquiline (TMC-207), BENEFIT Kids, Childhood TB, TB Burden, TB Market, Underserved Populations 3/2023 - Antimicrobial Agents and Chemotherapy Author(s): Si-Yang Li, Paul J. Converse, Fabrice Betoudji, Jin Lee, Khisimuzi Mdluli, Anna Upton, Nader Fotouhi, Eric L. Nuermberger Tags: Bedaquiline (TMC-207), BPaL, Clinical Development, Drug Discovery, Linezolid, Preclinical Data, Preclinical Models, Pretomanid/PA-824 3/2023 - International Journal of Infectious Diseases Author(s): Francesca Saluzzo, Juan Espinosa-Pereiro, Stephan Dressler, Ezio Tàvora Dos Santos Filho, Stephanie Seidel, Jesus Gonzalez Moreno, Norbert Heinrich, Adrian Sanchez-Montalva, Daniela Maria Cirillo Tags: Advocacy, Clinical Development, Community Engagement, Trial Design, Underserved Populations 2/2023 - International Journal of Tuberculosis and Lung Disease Author(s): Taneja, R., Nahata, M. C., Scarim, J., Pande, P. G., Scarim, A., Hoddinott, G., Fourie, C. L., Jew, R. K., Schaaf, H. S., Hesseling, A. C., Garcia-Prats, A. J. Tags: BENEFIT Kids, Childhood TB, Clofazamine, Underserved Populations 1/2023 - Journal of Biopharmaceutical Statistics Author(s): James Buchanana, Mengchun Lib, Barbara Hendricksonc, Parul Bhargavad, Satrajit Roychoudhury Tags: Trial Design

03 Sep 2024

·www.tballiance.org

Brazil and Philippines Accelerate Availability of Shorter Drug-Resistant Tuberculosis Treatment

MANILA (September 3, 2024) – A delegation of experts from Brazil’s National TB Program visited Manila recently to collaborate with the Philippines to accelerate implementation of the new drug-resistant TB (DR-TB) treatment, BPaL/M. Through the Manila-based PeerLINC Knowledge Hub, Brazilian officials had in-depth scientific exchange with their peers in the Philippines – one of the first countries in the world to successfully roll out BPaL/M treatment. PeerLINC is supported by TB Alliance and offers countries like Brazil first-in-class peer support, capacity building, and technical assistance to implement the life-saving regimen in their own countries. BPaL/M – a combination of the antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L), with or without moxifloxacin (M) – are six-month DR-TB treatments with a success rate of 90% or greater. BPaL/M is recommended by the World Health Organization (WHO) for the treatment of most forms of DR-TB. Prior to the introduction of these regimens, DR-TB treatment typically consisted of 9-24 months of treatment, with a treatment success rate of approximately 60%. New regimens have the potential to improve DR-TB treatment outcomes and experiences in Brazil, while reducing costs to both health systems and individuals who seek treatment. “Brazil has decided to fast track implementation of BPaL/M,” says Dr. Fernanda Dockhorn. “We had valuable interactions with the PeerLINC team and Philippines Department of Health Disease Prevention and Control Bureau (DPCB) experts to utilize their experience as we deploy this new standard of care in our country. We are thankful to TB Alliance for supporting this interaction and DPCB for their help.” The intensive week-long programme included didactic and hands-on training with experts from PeerLINC, the Philippines Department of Health, the Lung Center of the Philippines, and the National TB Reference Laboratory (NTRL). The PeerLINC team also provides ongoing support and technical assistance as Brazil implements the new treatment regimens. “It is truly heartening and exciting to see this initiative working so well,” said Sandeep Juneja, Senior Vice President of Access at TB Alliance. “We’re seeing countries with substantial TB burdens working with the PeerLINC team and returning home with deeper knowledge, strengthened commitment, and tangible plans to expand and accelerate access to new TB cures that will benefit their people and health systems.” PeerLINC Knowledge Hub operates as a partnership between TB Alliance and the Tropical Disease Foundation, Inc. (TDF), and in close collaboration with the Department of Health (DOH), Philippines, to help countries implement best practices in the treatment of drug-resistant tuberculosis (DR-TB) and speed the worldwide programmatic implementation of innovative, more effective treatments for the disease. The initiative is funded by the Australian Government through the Partnerships for a Healthy Region initiative. Since launching in March 2024, PeerLINC has helped numerous counties define and operationalize plans to expand availability of the BPaL/M, including Brazil, Peru, Nigeria, Rwanda, and Democratic Republic of Congo. About BPaL The BPaL regimen – which combines the antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L) – was designed and clinically studied by TB Alliance. Pretomanid, as part of the BPaL regimen, received its first regulatory approval in August 2019, for use against highly drug-resistant strains of TB. Prior to the initial BPaL clinical trial, less than one-third of drug-resistant TB patients were being successfully treated. Treatment options were limited, expensive, toxic, and lengthy, requiring patients to take more than 20 pills per day for 9-20 months. About PeerLINC The PeerLINC Knowledge Hub provides practical training and technical support to help speed programmatic implementation of innovative, effective TB treatments globally. PeerLINC follows a peer-to-peer model for sharing best practices, experience, tools, and materials by connecting experts from early adopter countries with countries interested in implementing the latest TB treatments. PeerLINC, operates in partnership between the Tropical Disease Foundation, Inc. (TDF) and TB Alliance in close collaboration with the Department of Health, Philippines. PeerLINC Knowledge Hub New PeerLINC Knowledge Hub will Leverage Local Expertise and Experience to Accelerate New, More Effective TB Cures Around the World Australian Government Grants TB Alliance an Award to Help Bolster Clinical Research and Improve Access to New Treatments for Drug-Resistant TB

Drug ApprovalClinical Study

100 Deals associated with Pretomanid

External Link

KEGG	Wiki	ATC	Drug Bank
D10722	Pretomanid	J04	DB05154

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Drug-Resistant Tuberculosis	HK	Shanghai Fosun High Technology (Group) Co., Ltd.	15 Dec 2022
Multidrug resistant pulmonary tuberculosis	KR	Viatris, Inc.	15 Oct 2021
Tuberculosis, Multidrug-Resistant	EU	Mylan IRE Healthcare Ltd.	31 Jul 2020
Tuberculosis, Multidrug-Resistant	IS	Mylan IRE Healthcare Ltd.	31 Jul 2020
Tuberculosis, Multidrug-Resistant	LI	Mylan IRE Healthcare Ltd.	31 Jul 2020
Tuberculosis, Multidrug-Resistant	NO	Mylan IRE Healthcare Ltd.	31 Jul 2020
Extensively Drug-Resistant Tuberculosis	US	Mylan Ireland Ltd.	14 Aug 2019
Tuberculosis	US	Mylan Ireland Ltd.	14 Aug 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Tuberculosis	Phase 3	GE	Global Alliance for TB Drug Development	21 Nov 2017
Pulmonary Tuberculosis	Phase 3	MD	Global Alliance for TB Drug Development	21 Nov 2017
Pulmonary Tuberculosis	Phase 3	RU	Global Alliance for TB Drug Development	21 Nov 2017
Pulmonary Tuberculosis	Phase 3	ZA	Global Alliance for TB Drug Development	21 Nov 2017
Infectious Lung Disorder	Phase 3	ZA	Global Alliance for TB Drug Development	01 Mar 2015
Rifampicin resistant tuberculosis	Phase 1	BR	Global Alliance for TB Drug Development	03 Oct 2023
Rifampicin resistant tuberculosis	Phase 1	IN	Global Alliance for TB Drug Development	03 Oct 2023
Rifampicin resistant tuberculosis	Phase 1	ZA	Global Alliance for TB Drug Development	03 Oct 2023
Rifampicin resistant tuberculosis	Phase 1	TZ	Global Alliance for TB Drug Development	03 Oct 2023
Rifampicin resistant tuberculosis	Phase 1	TH	Global Alliance for TB Drug Development	03 Oct 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04179500 (PaSEM, CTgov)	Phase 2	Multidrug resistant pulmonary tuberculosis \| Tuberculosis, Multidrug-Resistant	26	BPaMZ	uxrxoocikv(hqxxzsjuas) = tbsugsmwrp fzhdjpllsn (towjyuobqy, zzjsswpwqa - xkbqfkrfzr) View more	-	19 Sep 2024
NCT02589782 (TB-PRACTECAL, Pubmed) Manual	Phase 2/3	Extensively Drug-Resistant Tuberculosis	552	rifampicin (Standard care)	ieqxlblnoo(gvksdbygzq) = emiajzvwyb zvwllenuht (laiziozhko ) View more	Positive	01 Feb 2024
				rifampbedaquilinepretomanidlinezolidmoxifloxacin (BPaLM)	ieqxlblnoo(gvksdbygzq) = htdhlrvbzf zvwllenuht (laiziozhko ) View more
NCT03338621 (CTgov)	Phase 2/3	Multidrug resistant pulmonary tuberculosis \| Tuberculosis, Multidrug-Resistant	455	ethambutol+rifampicin+isoniazid+pyrazinamide (Drug Sensitive-TB 2HRZE/4HR)	mllfnqvwnn(ykcqveruir) = hwytpltbyt stklqivlkh (rqxrcgpnez, jcwnxfeftj - ijktexquob) View more	-	08 Nov 2023
				4BPaMZ (Drug Sensitive-TB 4BPaMZ)	mllfnqvwnn(ykcqveruir) = zqyuompucp stklqivlkh (rqxrcgpnez, uvdxxqphpw - pfqrlysfua) View more
NCT02256696 (CTgov)	Phase 2	Pulmonary Tuberculosis	157	PA-824+Rifampin+Isoniazid+Pyrazinamide (Arm 1)	lgbhrbozbc(adfnnfuyen) = ikgpqrpifx srkebvfhjy (faibvlytdw, lfcvppsnap - fncycpdldf) View more	-	18 Jul 2023
				PA-824+Rifabutin+Isoniazid+Pyrazinamide (Arm 2)	lgbhrbozbc(adfnnfuyen) = dqffedmbww srkebvfhjy (faibvlytdw, nhpmspojnm - ecwbwyfdhj) View more
NCT03086486 (ZeNix, CTgov)	Phase 3	Extensively Drug-Resistant Tuberculosis \| Pulmonary Tuberculosis \| Infectious Lung Disorder	181	Placebo Linezolid+Pretomanid+Linezolid+Bedaquiline (1200mg L x 26 Weeks + Pa + B)	yrubfgkdsk(iblcetocak) = axqmheqsue qrehjwvkts (qfvqvhnigq, graejdstpc - ruaizwjbne) View more	-	29 Jun 2023
				Placebo Linezolid+Pretomanid+Linezolid+Bedaquiline (1200 mg L x 9 Weeks + Pa + B)	yrubfgkdsk(iblcetocak) = psfnkqaiel qrehjwvkts (qfvqvhnigq, dbywoquuly - whagdrkloe) View more
NCT03086486 (ZeNix, Pubmed \| N Engl J Med)	Phase 3	Tuberculosis, Multidrug-Resistant	181	Bedaquiline-pretomanid-linezolid with linezolid 1200mg for 26 weeks	lpnzzmfcmk(rnukwwccta) = the linezolid dose was modified (i.e., interrupted, reduced, or discontinued) in 51%, 30%, 13%, and 13% of participants who received bedaquiline-pretomanid-linezolid with linezolid at a dose of 1200 mg for 26 weeks or 9 weeks or 600 mg for 26 weeks or 9 weeks, respectively vgdmyxwnld (bbadouelrf ) View more	Positive	01 Sep 2022
				Bedaquiline-pretomanid-linezolid with linezolid 1200mg for 9 weeks
NCT02256696 (Pubmed \| Antimicrob Agents Chemother)	Phase 1	Tuberculosis	157	Pretomanid + Rifampin	jmaabmxama(fcxwtxinsb) = ajqecefhzo ehfijokesb (wttwbwloai ) View more	-	20 Jan 2021
				Pretomanid + Rifabutin	jmaabmxama(fcxwtxinsb) = onrbabiqgi ehfijokesb (wttwbwloai ) View more
NCT03086486 (ZeNix, IAS2021)	Not Applicable	Tuberculosis	181	Bedaquiline (B)	fnhxfmikiv(tbwslvvxur) = udjrumijzw idrplkeuli (xlryslgkql )	-	01 Jan 2021
NCT02333799 (Nix-TB, Pubmed)	Phase 3	Multidrug resistant pulmonary tuberculosis	109	Bedaquiline (B)	jafkhuppep(kavnxusgdg) = avtvpghsvf clyomkccqx (gwszgvaayt ) View more	-	05 Mar 2020
				Pretomanid (Pa)	sgosvskrft(gwnzqbujcd) = zbgyuokmxc vrlolxwame (pdclbawwzj ) View more
NCT02193776 (NC-005, CTgov)	Phase 2	Pulmonary Tuberculosis	240	PA-824+Bedaquiline+Pyrazinamide (DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide)	pztdoituyn(hwcbmtdfkk) = ucuadweptt xcftbtncio (keeeeatuti, egpaswbkwa - ganyapltwv) View more	-	26 Jul 2019
				PA-824+Bedaquiline+Pyrazinamide (DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide)	pztdoituyn(hwcbmtdfkk) = plnzuvtxgp xcftbtncio (keeeeatuti, yyzzausaob - yfghljhtqj) View more

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