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+ [4]

Inactive Indication

Infectious Lung Disorder

Originator Organization

Novartis Pharma AG

Active Organization

Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.

Viatris, Inc.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

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

394

Literatures (Medical) associated with Pretomanid

01 Dec 2024·Journal of Clinical Tuberculosis and Other Mycobacterial Diseases

Pharmacology of emerging drugs for the treatment of multi-drug resistant tuberculosis

Review

Author: Johnson, Tanner M ; Rivera, Christina G ; Zeuli, John D ; Lee, Grace

Mycobacterium tuberculosis (TB) remains the leading cause of infection-related mortality worldwide. Drug resistance, need for multiple antimycobacterial agents, prolonged treatment courses, and medication-related side effects are complicating factors to TB cure. The introduction of treatment regimens containing the novel agents bedaquiline, pretomanid, and linezolid, with or without moxifloxacin (BPaL-M or BPaL, respectively) have substantially reduced TB-related morbidity and mortality and are associated with favorable rates of treatment completion and cure. This review summarizes key information on the pharmacology and treatment principles for moxifloxacin, bedaquiline, delamanid, pretomanid, linezolid, and tedizolid in the treatment of multi-drug resistant TB, with recommendations provided to address and attenuate common adverse effects during treatment.

01 Nov 2024·DRUG RESISTANCE UPDATES

Widespread loss-of-function mutations implicating preexisting resistance to new or repurposed anti-tuberculosis drugs

Article

Author: Gorman, Bria M ; Gorman, Bria M. ; Elghraoui, Afif ; Thosar, Nachiket ; Modlin, Samuel J ; Modlin, Samuel J. ; Conkle-Gutierrez, Derek ; Valafar, Faramarz

BACKGROUND:

Five New or Repurposed Drugs (NRDs) were approved in the last decade for treatment of multi-drug resistant tuberculosis: bedaquiline, clofazimine, linezolid, delamanid, and pretomanid. Unfortunately, resistance to these drugs emerged faster than anticipated, potentially due to preexisting resistance in naïve strains. Previous investigations into the rapid emergence have mostly included short variants. For the first time, we utilize de novo-assembled genomes, and systematically include Structural Variations (SV) and heterogeneity to comprehensively study this rapid emergence. We show high prevalence of preexisting resistance, identify novel markers of resistance, and lay the foundation for preventing preexisting resistance in future drug development.

METHODS:

First, a systematic literature review revealed 313 NRD resistance variants in 13 genes. Next, 409 globally diverse clinical isolates collected prior to the drugs' programmatic use (308 were multidrug resistant, 106 had de novo assembled genomes) were utilized to study the 13 genes comprehensively for conventional, structural, and heterogeneous variants.

FINDINGS:

We identified 5 previously reported and 67 novel putative NRD resistance variants. These variants were 2 promoter mutations (in 8/409 isolates), 13 frameshifts (21/409), 6 SVs (9/409), 35 heterogeneous frameshifts (32/409) and 11 heterogeneous SVs (12/106). Delamanid and pretomanid resistance mutations were most prevalent (48/409), while linezolid resistance mutations were least prevalent (8/409).

INTERPRETATION:

Preexisting mutations implicated in resistance to at least one NRD was highly prevalent (85/409, 21 %). This was mostly caused by loss-of-function mutations in genes responsible for prodrug activation and efflux pump regulation. These preexisting mutations may have emerged through a bet-hedging strategy, or through cross-resistance with non-tuberculosis drugs such as metronidazole. Future drugs that could be resisted through loss-of-function in non-essential genes may suffer from preexisting resistance. The methods used here for comprehensive preexisting resistance assessment (especially SVs and heterogeneity) may mitigate this risk during early-stage drug development.

01 Nov 2024·IJTLD OPEN

Experience of piloting BPaLM/BPaL for DR-TB care at selected sites in Pakistan

Article

Author: Khan, M.A. ; Foraida, S. ; Juneja, S. ; Khan, N. ; Zafar, F. ; Khan, A.W. ; Muzaffar, N. ; Ghafoor, A. ; Gupta, A. ; Shahid, S. ; Fatima, R. ; Ismail, A.

BACKGROUNDPakistan ranks fourth globally in terms of high drug-resistant TB (DR-TB) burden, with approximately one-third of cases resistant to fluoroquinolones. Bedaquiline, pretomanid, linezolid and moxifloxacin (BPaLM/BPaL) offers an opportunity for most DR-TB patients to benefit from a shorter, all-oral, well-tolerated and more effective treatment.METHODSWe conducted a retrospective cohort study to pilot the BPaLM/BPaL regimen at four selected sites in two provinces of Pakistan, i.e. Punjab and Khyber Pakhtunkhwa. Data were extracted and analysed using electronic medical records from the program. Descriptive statistics, survival analysis and binary logistic regression analysis were employed.RESULTSA total of 116 patients took treatment between October 2022 and February 2023. The treatment success rate was 96%, with 3% deaths and <1% loss to follow-up. Patients typically completed treatment in 26.2–26.7 weeks for BPaLM and BPaL, respectively. No serious adverse events were observed. The most common side effects included QTcF prolongation (BPaLM: 55%, BPaL: 84%), haematological events (BPaLM: 32%, BPaL: 34%), and gastrointestinal problems (BPaLM: 36%, BPaL: 25%).CONCLUSIONThe BPaLM/BPaL regimens for DR-TB are highly effective with minimal adverse events and feasible to implement in routine program circumstances.

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

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

25 Mar 2024

·www.prnewswire.com

New PeerLINC Knowledge Hub will Leverage Local Expertise and Experience to Accelerate New, More Effective TB Cures Around the World

Hub will focus on supporting global use of new treatments that effectively treated drug-resistant TB in 98% of Filipino participants MANILA, Australia, March 24, 2024 /PRNewswire/ -- TB Alliance's new Peer-to-Peer Learning for Innovative Cures (PeerLINC) Knowledge Hub launched today in Manila, with funding from the Australian Government through the Partnerships for a Healthy Region initiative. PeerLINC, operating in partnership between TB Alliance and the Tropical Disease Foundation, Inc. (TDF), and in close collaboration with the Department of Health, Philippines, will help countries implement best practices in the treatment of drug-resistant tuberculosis (DR-TB) to help speed the worldwide programmatic implementation of innovative, more effective treatments for the disease, starting with the World Health Organization (WHO)-recommended six-month, all-oral BPaL/M regimens, composed of the antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L), with or without moxifloxacin (M). PeerLINC will provide practical training and technical assistance to countries to support this objective, via experts from the Philippines and the Department of Health, including Lung Center of the Philippines and the National TB Reference Laboratory (NTRL). The Philippines has successfully and rapidly deployed new treatments through participation in TB Alliance's Leveraging Innovation for Faster TB Treatment (LIFT-TB) initiative. "TB Alliance works to minimize the gap between research and access, ensuring people anywhere in the world can have access to new treatments as soon as possible, maximizing the number of lives and livelihoods saved," said Sandeep Juneja, Senior Vice President of Market Access at TB Alliance. "PeerLINC will make training and knowledge on new treatments available swiftly and efficiently to ensure their rapid adoption and roll out. We are proud to launch PeerLINC in the Philippines with DOH and TDF and establish the first Knowledge Hub on the introduction of new DR-TB regimens, and we are grateful for the support of Australia in helping make this a reality." "It is important for the Philippines to share our knowledge and experience in using the BPaL/M regimens," said Dr. Mamel Quelapio, TDF Board of Trustees member and Programmatic Implementation Lead at PeerLINC. "DOH's leadership through the Disease Prevention and Control Bureau in partnership with TDF and TB Alliance in the LIFT-TB initiative has led to improved outcomes and treatment experiences for people. We are eager to help new treatments reach far and wide." The BPaL/M regimens combine the antibiotics bedaquiline (B), pretomanid (Pa), linezolid (L) with or without moxifloxacin (M). The BPaL regimen was first clinically studied by TB Alliance and the BPaL/M regimens are now recommended by WHO as the standard of care treatment for the vast majority of people with DR-TB. Prior to the initial study of the BPaL regimen, global treatment success rates for DR-TB were less than 50% and treatment options were limited, expensive, toxic, and lengthy – requiring individuals to take more than 14,000 pills over the course of treatment, which could last from nine months to two years or longer. Data to date reveals treatment success rates of 90% or higher with BPaL/M, in addition to reduced treatment duration and approximately 95% lower pill burden. TB Alliance's LIFT-TB initiative, which is co-funded by GDEF/KOICA, the South Korean Development agency, helped accelerate implementation of the regimen in the Philippines, Indonesia, Kyrgyzstan, Myanmar, Ukraine, Uzbekistan, and Vietnam. Interim data from these countries shows an average success rate of 92.5%, with the Philippines program reporting a 98% cure rate. Several key high-burden countries around the world, including the early adopting LIFT-TB countries, are now rolling out BPaL/M in their national programs. However, some countries have moved more slowly. Leveraging a group of experts and the experience garnered from those who have rapidly and successfully implemented the BPaL/M regimens, PeerLINC will focus on assisting other countries in doing the same. "In the Philippines, the new regimen exceeded all expectations," said Dr. Irene Flores, Medical Officer of the Jose B. Lingad Memorial Medical Center and Head of PeerLINC. "Every country with drug-resistant TB can benefit from widespread implementation of the best available TB treatment. With BPaL/M, we see a path toward transforming DR-TB treatment for everybody, anywhere in the world." "I tried everything before I was given BPaL as part of the research program," said Joegene Mangilaya, a participant from the Philippines who was treated with the BPaL regimen. "I was losing hope that I'd be cured, but shortly after I started on this new regimen, my body felt stronger and I had a new hope for my health and future. It is important to speed the availability of life-saving new therapies everywhere they are needed – the work of PeerLINC will help save lives." PeerLINC will offer support such as advice, assistance, training materials, tools, guides, and other materials to TB programs, clinicians, lab specialists, and community organizations, all delivered through peer-to-peer learning models. Trainings will be provided in-person in the Philippines or in the beneficiary country or remotely through virtual meetings. The expert team from PeerLINC will continue to guide countries after trainings, as they work to implement the regimens. A delegation from Peru is scheduled to visit PeerLINC in April 2024 and will be the first to receive training on BPaL/M from PeerLINC and its partners in the DOH. "We are excited to visit the PeerLINC Knowledge Hub and work with experts from the early implementers of the short, highly effective treatments for drug-resistant tuberculosis," said Dr. Valentina Alarcón, Executive Director at the Directorate of Tuberculosis Prevention and Control - MINSA Peru. "The communities affected by resistant tuberculosis in Peru deserve the best possible experiences and treatment schemes and we are taking measures to access the BPaL and BPaL/M regimens and make them available to people throughout Peru in a timely and rapid manner. Our experience with PeerLINC will help us achieve those goals." About TB TB is a difficult infection to cure, requiring patients to take a combination of medicines for at least four to six months. Even after symptoms disappear, medicines still need to be taken so that the disease can be fully eradicated. The scope and intensity of TB globally is in large part fueled by antiquated and inadequate TB drugs. Novel drug regimens are urgently needed to bring the TB pandemic under control. About BPaL The BPaL regimen—which combines the antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L)—was first 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 around the world 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 TB Alliance TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia's Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Foreign, Commonwealth and Development Office (United Kingdom), Cystic Fibrosis Foundation, Germany's Federal Ministry of Education and Research through KfW, Global Disease Eradication Fund (South Korea), Global Health Innovative Technology Fund, Irish Aid, Korea International Cooperation Agency, National Institute of Allergy and Infectious Diseases, South Korea's Ministry of Foreign Affairs, Unitaid, and the United States Agency for International Development. For more information, please visit: . Contact: Jessica Wiggs, +1 (646) 616-8613 / [email protected] SOURCE TB Alliance

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	duxouacpwt(ynzhrmzlcl) = luyetlbhsi fyqnlkmsxa (fouesrhmxu, nxtmktqcwk - bplmvrflya) View more	-	19 Sep 2024
NCT02589782 (TB-PRACTECAL, Pubmed) Manual	Phase 2/3	Extensively Drug-Resistant Tuberculosis	552	rifampicin (Standard care)	jpvuzgroni(ehouexgaky) = bbliccgtel iwumrsukod (yhqvxxwbxt ) View more	Positive	01 Feb 2024
				rifampbedaquilinepretomanidlinezolidmoxifloxacin (BPaLM)	jpvuzgroni(ehouexgaky) = qgzghsjskw iwumrsukod (yhqvxxwbxt ) View more
NCT03338621 (CTgov)	Phase 2/3	Multidrug resistant pulmonary tuberculosis \| Tuberculosis, Multidrug-Resistant	455	ethambutol+rifampicin+isoniazid+pyrazinamide (Drug Sensitive-TB 2HRZE/4HR)	oegvbnlizf(qtpwzyihex) = nyhjwbdyyn decqodljpt (qdgiyxlsjl, uabmargkxi - sawbckvvsk) View more	-	08 Nov 2023
				4BPaMZ (Drug Sensitive-TB 4BPaMZ)	oegvbnlizf(qtpwzyihex) = enuhhdfkpy decqodljpt (qdgiyxlsjl, oygsoaxqsl - wqkrywgovg) View more
NCT02256696 (CTgov)	Phase 2	Pulmonary Tuberculosis	157	PA-824+Rifampin+Isoniazid+Pyrazinamide (Arm 1)	nmduihgnkf(fhrxhuxgqf) = acvumegjhm uwplgutlxc (jwmfkbikpb, jczpdxclfw - mgyeygwqic) View more	-	18 Jul 2023
				PA-824+Rifabutin+Isoniazid+Pyrazinamide (Arm 2)	nmduihgnkf(fhrxhuxgqf) = hiyhzxblhe uwplgutlxc (jwmfkbikpb, myqtkqgnwo - alyvgwikil) 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)	wprdgbrrtn(kfmkymadwl) = hvxkpmmuen lcwsigyvlq (lxjisjqifo, aoyxzglsgp - bosczdqukz) View more	-	29 Jun 2023
				Placebo Linezolid+Pretomanid+Linezolid+Bedaquiline (1200 mg L x 9 Weeks + Pa + B)	wprdgbrrtn(kfmkymadwl) = yaufgzrcpy lcwsigyvlq (lxjisjqifo, byrwutlgej - nhfjgvschs) View more
NCT03086486 (ZeNix, Pubmed \| N Engl J Med)	Phase 3	Tuberculosis, Multidrug-Resistant	181	Bedaquiline-pretomanid-linezolid with linezolid 1200mg for 26 weeks	lhybrxcedz(gdjbqqnmjs) = 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 odwyihfcdl (wwjfzaybec ) 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	rnqqdzosmj(qurffbqyfn) = eierluespx kogzvdiwvt (lfsyeyfyps ) View more	-	20 Jan 2021
				Pretomanid + Rifabutin	rnqqdzosmj(qurffbqyfn) = herjztrfkc kogzvdiwvt (lfsyeyfyps ) View more
ZeNix (IAS2021)	Not Applicable	Tuberculosis	181	Bedaquiline (B)	dofsvgvktk(obbjjlxcwl) = gbursbdpbs bvezqmeuel (exehcgyjhw )	-	01 Jan 2021
NCT02333799 (Nix-TB, Pubmed)	Phase 3	Multidrug resistant pulmonary tuberculosis	109	Bedaquiline (B)	muiysfljbl(nnmwqmssbl) = ckhfqontna uosxytsjjr (pbdgfqfawj ) View more	-	05 Mar 2020
				Pretomanid (Pa)	czedvgbmqb(alclqeysnn) = upcdjfljdz xixddpueou (hwyibpmgvc ) 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)	pvdxphfedy(qfpazzozsm) = eclrpapeuv zrfbpuuaaj (uzcgnsuvgk, ptancirylz - nncjzqsmit) View more	-	26 Jul 2019
				PA-824+Bedaquiline+Pyrazinamide (DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide)	pvdxphfedy(qfpazzozsm) = qixgxvuewm zrfbpuuaaj (uzcgnsuvgk, sjkqyonzun - nictaxaezc) View more

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis