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 Date01 Nov 2024

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 Date15 Sep 2024

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

[+1]

NCT06114628 / RecruitingPhase 2IIT

A Seamless Phase 2B/C Platform Trial to Evaluate Multiple Regimens and Durations of Treatment in Pulmonary Tuberculosis

The UNITE4TB consortium is a group of universities and pharmaceutical companies funded by the European Union. This consortium are carrying out a trial to find better and faster ways to treat tuberculosis (TB). The standard treatment for TB takes 24 weeks and uses four drugs. The consortium want to find new treatments that are faster but just as safe and effective.
In the trial, two new drugs will be used, BTZ-043 and GSK3036656, along with the drugs that are already used to treat TB in a variety of combinations (11 different combinations initially). These new drugs have worked well in tests with animals and have reduced the amount of TB bacteria in people's sputum/phlegm when used alone for two weeks. These new drugs will be used in combination with other TB drugs for a longer time (up to 16 weeks) in people with TB. The UNITE4TB consortium want to see if they work well and are safe.
This trial will take place at sites across the world and will involve people with TB of the lungs that would usually respond well to the standard treatment. But the new treatments being tested might also work for people with drug resistant TB, that's harder to treat.
The trial has two parts. In the first part, different combinations of drugs will be tried on up to 700 people for 16 weeks. These combinations will be compared to the standard 24-week treatment to see which ones work the best and are safe.
In the second part, the best combinations from the first part will be taken to try to find out what the best length of time is to give the treatment for. These combinations will be tried on up to 1800 people giving them either 8, 10, 12, 14 or 16 weeks treatment. The investigators will follow these people for a total of 72 weeks to make sure the treatment is working.
The UNITE4TB consortium hope that this trial will find new treatments that are fast, safe, and effective for both regular TB and resistant TB. If it works, it can then be tested again in a bigger trial to be sure.

Start Date09 Jan 2024

Sponsor / Collaborator

University College London

[+22]

100 Clinical Results associated with Pretomanid

100 Translational Medicine associated with Pretomanid

100 Patents (Medical) associated with Pretomanid

348

Literatures (Medical) associated with Pretomanid

01 Feb 2024·The Lancet. Respiratory medicine

Bedaquiline, pretomanid, and linezolid with or without moxifloxacin for tuberculosis

Letter

Author: Dasgupta, Shom ; Goswami, Neela D ; Labuda, Sarah M ; Seaworth, Barbara

01 Feb 2024·The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease

Cost-effectiveness of pretomanid-based regimen for highly drug- resistant TB in a low-burden setting

Article

Author: Wang, Y ; You, J H S ; Fekadu, G

BACKGROUNDRecent clinical findings reported improvement in the treatment outcomes of highly resistant TB (HDR-TB) with the pretomanid (Pa) based regimen. This study aimed to evaluate the cost-effectiveness of the Pa-based regimen for HDR-TB treatment from the perspective of the healthcare sector in the United States.METHODSA lifelong decision-analytic model was constructed to simulate potential treatment outcomes of 1) the bedaquiline-Pa-linezolid (BPaL) regimen, and 2) the bedaquiline-linezolid (B-L) based regimen in a hypothetical cohort of adult patients with HDR-TB. Primary model outputs were TB-related direct medical costs, quality-adjusted life-years (QALYs) and incremental cost per QALY gained (ICER).RESULTSIn the base-case analysis, the BPaL regimen gained 3.0054 QALYs and saved costs by USD60,433 when compared to the B-L-based regimen. In the probabilistic sensitivity analysis, the BPaL regimen gained higher QALYs at a lower cost in 80.3% of the time, and gained higher QALYs at a higher cost with ICER less than the willingness-to-pay (WTP) threshold (100,000 USD/QALY) in 19.0% of the simulations. The probability of the BPaL regimen being cost-effective was higher than the B-L-based regimen throughout the variation of WTP.CONCLUSIONBPaL therapy is likely the cost-effective option for HDR-TB treatment from the US healthcare sector perspective.

01 Feb 2024·British journal of clinical pharmacology

Model‐based dose optimization framework for bedaquiline, pretomanid and linezolid for the treatment of drug‐resistant tuberculosis

Article

Author: van Hasselt, J G Coen ; van der Graaf, Piet H ; Mehta, Krina ; Guo, Tingjie

Aims:

Bedaquiline, pretomanid and linezolid (BPaL) combination treatment against Mycobacterium tuberculosis is promising, yet safety and adherence concerns exist that motivate exploration of alternative dosing regimens. We developed a mechanistic modelling framework to compare the efficacy of the current and alternative BPaL treatment strategies.

Methods:

Pharmacodynamic models for each drug in the BPaL combination treatment were developed using in vitro time‐kill data. These models were combined with pharmacokinetic models, incorporating body weight, lesion volume, site‐of‐action distribution, bacterial susceptibility and pharmacodynamic interactions to assemble the framework. The model was qualified by comparing the simulations against the observed clinical data. Simulations were performed evaluating bedaquiline and linezolid approved (bedaquiline 400 mg once daily [QD] for 14 days followed by 200 mg three times a week, linezolid 1200 mg QD) and alternative dosing regimens (bedaquiline 200 mg QD, linezolid 600 mg QD).

Results:

The framework adequately described the observed antibacterial activity data in patients following monotherapy for each drug and approved BPaL dosing. The simulations suggested a minor difference in median time to colony forming unit (CFU)‐clearance state with the bedaquiline alternative compared to the approved dosing and the linezolid alternative compared to the approved dosing. Median time to non‐replicating‐clearance state was predicted to be 15 days from the CFU‐clearance state.

Conclusions:

The model‐based simulations suggested that comparable efficacy can be achieved using alternative bedaquiline and linezolid dosing, which may improve safety and adherence in drug‐resistant tuberculosis patients. The framework can be utilized to evaluate treatment optimization approaches, including dosing regimen and duration of treatment predictions to eradicate both replicating‐ and non‐replicating bacteria from lung and lesions.

News (Medical) associated with Pretomanid

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

24 Mar 2024

·www.prnewswire.com

Australian Government Grants TB Alliance an Award to Help Bolster Clinical Research and Improve Access to New Treatments for Drug-Resistant TB

AUD 17 Million Grant over 5 Years Will Fund Next-Generation TB Cures CANBERRA, Australia, March 24, 2024 /PRNewswire/ -- The Australian Government, through the Partnerships for a Healthy Region initiative, has announced a new AUD 17 million grant to support work with TB Alliance through its Product Development and Access Partnerships program. The funding will contribute toward the completion of the NC-009 Pan-Phase 2 clinical trial and also help establish and sustain the Peer-to-Peer Learning for Innovative Cures (PeerLINC) Knowledge Hub in Manila, which will disseminate best practices to help speed the programmatic implementation of innovative, effective tuberculosis treatments, including the World Health Organization (WHO) recommended six-month, all-oral BPaL/M regimens for drug-resistant tuberculosis (DR-TB). "Drug-resistant TB is an increasing threat to the health and well-being both in Australia and in our neighbouring countries, and in many low- and middle-income countries around the world," said the Hon. Pat Conroy, Minister for International Development and the Pacific. "We are proud of our continued support of the work of TB Alliance, and to help in the rollout of the BPaL/M regimens and to support the development of the next generation of new TB treatments. These are important steps in the effort to end TB as a major health threat by 2030." PeerLINC, which will operate in partnership between TB Alliance and the Tropical Disease Foundation, Inc., will provide practical training, guidance, technical support, field experience, tools, and materials to national TB programs covering a wide range of topics including clinical management, diagnostics, drug safety monitoring, programmatic management, community engagement, and health economics. PeerLINC will continue to guide countries after completion of initial training, as countries work to implement and integrate the BPaL/M regimens into their national tuberculosis programs. The NC-009 trial, which launched in November 2023, will evaluate the safety and efficacy of a combination of a new experimental compound, TBAJ-876, with pretomanid and linezolid, components of the BPaL regimen. This new combination has the potential to shorten and improve treatment for both drug-sensitive and drug-resistant tuberculosis (TB). Results from preclinical and Phase 1 studies presented at the Union Conference showed that TBAJ-876, when compared to bedaquiline (an approved TB medicine in the same drug class), eliminated TB bacteria faster and had a potentially improved safety profile. "Australia has long been a leader in the global health community, and we greatly appreciate their unwavering support in the battle to end TB," said Dr. Mel Spigelman, President and CEO of TB Alliance. "This funding will contribute both to rapidly expanding access to improved treatments, and also to developing the next generation of even more effective TB cures. This award exemplifies the sort of global commitment and political will needed if we hope to, one day, end the TB pandemic." 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

Phase 1Phase 2

16 Nov 2023

·www.prnewswire.com

TB Alliance Launches Five-Country Phase 2 Clinical Trial Evaluating Next-Generation TB Drug

Early results presented at the Union World Conference on Lung Health suggest promise of new compound to fight tuberculosis that will be tested as part of Phase 2 trial The first participant has been dosed in this partially double-blind study to evaluate the safety and efficacy of what has the potential to be a "universal regimen" to treat TB PARIS, Nov. 16, 2023 /PRNewswire/ -- TB Alliance launched a new Pan-Phase 2 clinical trial incorporating elements of Phase 2a, b and c, identified as NC-009, to evaluate the safety and efficacy of a combination of a new experimental compound, TBAJ-876, with pretomanid and linezolid, components of TB Alliance's BPaL regimen. This regimen has the potential to shorten and improve treatment for both drug-sensitive and drug-resistant tuberculosis (TB)—one of the world's deadliest infectious diseases. Results from preclinical and Phase 1 studies presented at the Union Conference showed that the new compound, when compared with bedaquiline (a TB medicine in the same drug class), eliminated TB bacteria faster and had a potentially safer profile. "A 'universal' TB medicine needs to be highly effective while causing very few adverse effects; initial Phase 1 trial results show that TBAJ-876 could possibly move the needle in this direction," said Dr. Mel Spigelman, President and CEO of TB Alliance. "If we can develop a regimen that is composed of novel compounds with minimal pre-existing resistance that is both highly potent and safe, it could blur the distinction between drug-sensitive and drug-resistant TB allowing for treatment of virtually all patients with active TB with the same regimen." The new trial, NC-009, will test different doses of TBAJ-876 in combination with pretomanid and linezolid against the current standard of care for drug-sensitive TB—isoniazid, rifampicin, pyrazinamide, and ethambutol (HRZE). Another arm of the trial will also test pretomanid and linezolid in combination with bedaquiline (BPaL), a regimen recommended by the World Health Organization to treat some forms of drug-resistant TB, against drug-sensitive TB. The study aims to enroll 300 participants with drug-sensitive TB at 21 clinical trial sites in five countries: Georgia, Philippines, South Africa, Tanzania, and Uganda. "To truly get ahead of the tuberculosis pandemic in all of its forms, we need to continually innovate," said Dr. Francesca Conradie, Principal Investigator for the NC-009 clinical trial in South Africa. "Recent innovations in drug-resistant TB therapy have been enormously important, but we need to continue to develop shorter, simpler, and more people-friendly cures, including in drug-sensitive TB where there hasn't been a new drug approved in more than 50 years." New Experimental Compound TBAJ-876 is a diarylquinoline, a category of antibiotic that targets a key enzyme of the tuberculosis bacteria involved in energy production. Bedaquiline, a TB drug approved for the treatment of drug-resistant TB by the US FDA in 2012, is in the same diarylquinoline drug class. At the Union Conference in Paris, data were presented—showing that the new experimental compound has the potential to become an important component in TB regimens moving forward: In in vitro studies, TBAJ-876 demonstrated anti-mycobacterial activity approximately 10-fold greater than bedaquiline. In mouse models of TB, TBAJ-876, together with pretomanid and linezolid, cured infections with shorter treatment durations than HRZE and BPaL regimens. TBAJ-876 also demonstrates greater activity against TB strains resistant to bedaquiline (Rv0678 mutants), suggesting it will also be more effective in treating these emerging strains. In preclinical studies, TBAJ-876 showed the potential to be safer than bedaquiline, including low potential for QT prolongation. In Phase 1 studies involving 165 healthy subjects, few, generally mild, adverse events were observed. 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 all traces of 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 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. Previously, less than two-thirds of drug-resistant TB patients around the world had been 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: Jess Wiggs, [email protected], +1 240 425 7117 SOURCE TB Alliance

Phase 1Phase 2Drug ApprovalClinical Result

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
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
Drug-Resistant Tuberculosis	NDA/BLA	CN	Mylan Ireland Ltd.	12 Dec 2023
Drug-Resistant Tuberculosis	NDA/BLA	CN	Shenyang Hongqi Pharmaceutical Co., Ltd.	12 Dec 2023
Drug-Resistant Tuberculosis	NDA/BLA	CN	Mylan Laboratories Ltd.	12 Dec 2023
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
Multidrug resistant pulmonary tuberculosis	Phase 3	GE	Global Alliance for TB Drug Development	01 Feb 2015
Multidrug resistant pulmonary tuberculosis	Phase 3	KE	Global Alliance for TB Drug Development	01 Feb 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03338621 (CTgov)	Phase 2/3	Multidrug resistant pulmonary tuberculosis \| Tuberculosis, Multidrug-Resistant	455	ethambutol+rifampicin+isoniazid+pyrazinamide (Drug Sensitive-TB 2HRZE/4HR)	ejxsrcwqxe(oamfqnlmee) = uqxiaiapad vvlnxmnljn (igssefpmgy, klwelclgno - glhykbnhlf) View more	-	08 Nov 2023
				4BPaMZ (Drug Sensitive-TB 4BPaMZ)	ejxsrcwqxe(oamfqnlmee) = vjvzjlkxle vvlnxmnljn (igssefpmgy, jzmgovunxs - rclyxbdnxt) View more
NCT02256696 (CTgov)	Phase 2	Pulmonary Tuberculosis	157	PA-824+Rifampin+Isoniazid+Pyrazinamide (Arm 1)	leoxjlhiyf(aupanwreqm) = roibqvjany rzhirbhrbs (keluyfrhzq, vbivfckvgl - vsmbqysyam) View more	-	18 Jul 2023
				PA-824+Rifabutin+Isoniazid+Pyrazinamide (Arm 2)	leoxjlhiyf(aupanwreqm) = guihiiqqzv rzhirbhrbs (keluyfrhzq, xncbaspckg - pyamgodbun) View more
NCT03086486 (CTgov)	Phase 3	Infectious Lung Disorder \| Extensively Drug-Resistant Tuberculosis \| Pulmonary Tuberculosis	181	Placebo Linezolid+Pretomanid+Linezolid+Bedaquiline (1200mg L x 26 Weeks + Pa + B)	zmhamcpehc(nehyxlkrbg) = xvoycptkcj aqgurkhdjc (xbwnhfarxa, crcvuehyyl - bezcuikuzl) View more	-	29 Jun 2023
				Placebo Linezolid+Pretomanid+Linezolid+Bedaquiline (1200 mg L x 9 Weeks + Pa + B)	zmhamcpehc(nehyxlkrbg) = cxzpgnekci aqgurkhdjc (xbwnhfarxa, jretmzgekw - munusfatkz) View more
NCT03086486 (ZeNix, Pubmed \| Br Dent J)	Phase 3	Drug-Resistant Tuberculosis	181	Bedaquiline-pretomanid-linezolid with linezolid 1200mg for 26 weeks	syrcaoquvc(agzesiajkg) = 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 mhejcoxipf (shbfpkjljv ) 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	rsgjeshhnq(olmdfafocq) = jckvhimwls goqmtpoawn (mrgwpbtdzh ) View more	-	20 Jan 2021
				Pretomanid + Rifabutin	rsgjeshhnq(olmdfafocq) = khmbbiwryx goqmtpoawn (mrgwpbtdzh ) View more
ZeNix (IAS2021)	Not Applicable	Tuberculosis	181	Bedaquiline (B)	ikymxfpxuu(lmgicclcsr) = zvnspoidqy mblozrldmc (qzgdzybjun )	-	01 Jan 2021
NCT02333799 (Nix-TB, Pubmed)	Phase 3	Multidrug resistant pulmonary tuberculosis	109	Bedaquiline (B)	ahhewziywe(buybaihbkr) = aomjeqqdxd webqunchng (xsliumsnjr ) View more	-	05 Mar 2020
				Pretomanid (Pa)	zcxjcgdnsz(mywlkucxvf) = tcckpxfuff qnbegjngoa (emicwcubhf ) View more
NCT02193776 (CTgov)	Phase 2	Pulmonary Tuberculosis	240	PA-824+Bedaquiline+Pyrazinamide (DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide)	xzxikokorh(glydymjkdw) = axjgzualrr igaesvnuza (ccpbhrwpqo, wwipkdhjup - fnfetcenur) View more	-	26 Jul 2019
				PA-824+Bedaquiline+Pyrazinamide (DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide)	xzxikokorh(glydymjkdw) = bspzossclw igaesvnuza (ccpbhrwpqo, wylziruzza - oezhwzyzlq) View more
NCT02342886 (CTgov)	Phase 3	Multidrug resistant pulmonary tuberculosis	284	PA-824+Moxifloxacin+Pyrazinamide (DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide)	mlzivoxsue(xdsirfixcs) = pkwxxcuxsq nnjosgghob (jmtbvxnwpc, bzqobaujmu - tqflzgtizv) View more	-	26 Mar 2019
				PA-824+Moxifloxacin+Pyrazinamide (DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide)	mlzivoxsue(xdsirfixcs) = jmvgytiime nnjosgghob (jmtbvxnwpc, ymzozeaojv - lgnrpwmjlr) View more
NCT00567840 (CTgov)	Phase 2	Pulmonary Tuberculosis	69	PA-824 (PA-824 200 mg)	cfzwjjdivf(bczsggpkdx) = rspkzjrdtj qwgcgighlt (nbtfewsryw, qoepqbcddx - ikerzwzwoz) View more	-	04 Apr 2017
				PA-824 (PA-824 600 mg)	cfzwjjdivf(bczsggpkdx) = kezabidbmz qwgcgighlt (nbtfewsryw, vaqlkeyesw - efejyybruj) View more

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