Delving into the Latest Updates on Pretomanid with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Pretomanid (USAN/INN), 普瑞玛尼

+ [5]

Target

CYP2C19 x CYP2C8

Mechanism

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

+ [2]

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

RegulationSpecial Review Project (CN), Fast Track (US), Orphan Drug (KR)

Login to view timeline

Structure/Sequence

Molecular FormulaC14H12F3N3O5

InChIKeyZLHZLMOSPGACSZ-NSHDSACASA-N

CAS Registry187235-37-6

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

Login to view more data

100 Translational Medicine associated with Pretomanid

Login to view more data

100 Patents (Medical) associated with Pretomanid

Login to view more data

423

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: Shaikh, Matin ; Patel, Harun

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

01 Jan 2025·The Lancet Microbe

Safety, bactericidal activity, and pharmacokinetics of the antituberculosis drug candidate BTZ-043 in South Africa (PanACEA-BTZ-043–02): an open-label, dose-expansion, randomised, controlled, phase 1b/2a trial

Article

Author: P J Phillips, Patrick ; Diacon, Andreas ; Dreisbach, Julia ; Adegnika, Ayola Akim ; Arnolds, Shakeera ; Heinrich, Norbert ; Makkan, Heeran ; Aldana, Brian H ; Gerbach, Sina ; Koele, Simon ; Sabi, Issa ; Sloan, Derek ; Bateson, Anna ; Zumba, Tresphory ; Wildner, Leticia ; Chibunu, Nyasige ; Adegbite, Bayode Romeo ; Beattie, Trevor ; Kloss, Florian ; Solanki, Priya ; Sabiiti, Wilber ; Mokaba, Lucia ; Sithole, Jane ; Dawson, Rodney ; Hunt, Robert ; Gross – Demel, Petra ; Grobusch, Martin Peter ; Sebe, Modulakgotla ; Svensson, Elin ; Aldana, Brian ; Liyoyo, Alphonce ; Rassool, Mohammed ; Matt, Leoni ; Noren᷉a, Ivan ; McHugh, Timothy D ; Svensson, Elin M ; Gong, Xue ; Hoelscher, Michael ; Fuhr, Uwe ; Schultz, Susanne ; Razid, Alia ; Sam, Noel ; Mukoka, Madalo ; Minja, Lilian Tina ; Mtafya, Bariki ; Diacon, Andreas H ; Mhimbira, Francis ; Boeree, Martin J ; Muraro Wildner, Leticia ; Mbeya, Benno ; Wallis, Robert ; Brake, Lindsey te ; Sasamalo, Mohamed ; Sanne, Ian ; Gross-Demel, Petra ; Crook, Angela ; Mpagama, Stellah ; Paramo Diaz, Laura ; Semvua, Hadija ; Mouhdad, Chaima ; Aarnoutse, Rob ; Lutchmun, Wandini ; Kirenga, Bruce ; Ntinginya, Nyanda Elias ; Gillespie, Stephen ; Mangu, Chacha ; Boeree, Martin ; Aarnoutse, Rob E ; Mdluli, John ; Reither, Klaus ; Friedrich, Sven ; Khosa, Celso ; Wagnerberger, Larissa ; Timana, Isabel ; Churchyard, Gavin ; de Jager, Veronique ; McHugh, Timothy Daniel ; Phillips, Patrick ; Stemkens, Ralf ; Madikizela, Namhla ; Nliwasa, Marriott ; Jugheli, Levan ; Kibiki, Gibson ; Narunsky, Kim ; Manyama, Christina ; te Brake, Lindsey

BACKGROUNDThe broad use of bedaquiline and pretomanid as the mainstay of new regimens to combat tuberculosis is a risk due to increasing bedaquiline resistance. We aimed to assess the safety, bactericidal activity, and pharmacokinetics of BTZ-043, a first-in-class DprE1 inhibitor with strong bactericidal activity in murine models.METHODSThis open-label, dose-expansion, randomised, controlled, phase 1b/2a trial was conducted in two specialised tuberculosis sites in Cape Town, South Africa. Adults aged 18-64 years with newly diagnosed pulmonary tuberculosis sensitive to rifampicin and isoniazid, who weighed at least 40 kg, had a positive sputum smear graded at least 1+, were HIV negative, and had no history of hypertension or other substantial comorbidities were admitted to hospital. In stage 1 (multiple-ascending dose phase 1b with an adaptive continual reassessment method), the starting dose of BTZ-043 was 250 mg, with planned dose increments of 250 mg up to 2000 mg, and cohorts of three participants were enrolled sequentially. In stage 2 (phase 2a dose-expansion stage), participants were randomly assigned (3:3:3:2) to receive one of three doses of oral BTZ-043 (decided after stage 1) or standard of care (isoniazid, rifampicin, pyrazinamide, and ethambutol) using sealed opaque envelopes. The BTZ-043 groups also received oral dolutegravir (a third of participants) or a probe drug cocktail (caffeine [probe for CYP1A2], tolbutamide [CYP2C9], dextromethorphan [CYP2D6], midazolam [CYP3A4], and digoxin [P-glycoprotein]; two-thirds of participants). Study staff and participants were not masked, but laboratory staff were masked to treatment assignment. The primary outcome was to assess the safety and tolerability of BTZ-43 over 14 days of dosing by evaluation of adverse events in the safety analysis population. Secondary outcomes were bactericidal activity, measured by time to positivity (TTP) and colony-forming unit (CFU) count; pharmacokinetics (stage 2; including the food effect on BTZ-043); and drug-drug interactions with CYP450 enzymes, P-glycoprotein, and dolutegravir. This study is registered with ClinicalTrials.gov, NCT04044001 (completed).FINDINGSIn stage 1, 61 patients were assessed for eligibility and 24 were enrolled into seven dose cohorts between Nov 13, 2019, and Aug 13, 2020. Dose escalations were performed safely up to 1750 mg of BTZ-043 with three participants per dose cohort (and two dose cohorts for the highest dose). In stage 2, 151 patients were assessed for eligibility and 54 were enrolled and randomly assigned between Feb 2, 2021, and Feb 9, 2022, to receive 250, 500, and 1000 mg of BTZ-043 or standard of care. 66 (85%) of 78 participants were male and 12 (15%) were female. The most frequently observed adverse events were nausea (12 [8%] of 154), headache (11 [7%]), dizziness (11 [7%]), and vomiting (eight [5%]). Most participants had adverse events of mild (46 [60%] of 77 participants) or moderate (22 [29%]) severity. Transient increases in alanine aminotransferase were observed in both stages, which declined again despite continued dosing and were classified as signs of adaptation of hepatic metabolism rather than hepatotoxicity. The worsening of pre-existing anaemia and QTcF interval prolongation in one individual each were rated as possibly related to the study drug. One patient died before the first scheduled dose of BTZ-043 500 mg due to a pulmonary embolism. In stage 1, bactericidal activity measured as CFU counts on solid media was highest at doses 750-1500 mg; in stage 2, all doses of BTZ-043 showed 14-day bactericidal activity, highest at 1000 mg on solid media (log₁₀ CFU/mL per day -0·115 [95% CI -0·162 to -0·069]) and TTP estimates were highest at 500 mg in liquid media (log₁₀ h per day 0·015 [0·010 to 0·019]). BTZ-043 pharmacokinetics showed increased exposure with high-fat food versus fasting (area under the curve [AUC]_0-last geometric mean ratio 4·13 [90% CI 1·65 to 10·30] for BTZ-043; 2·99 [1·39 to 6·41] for BTZ-043_total [BTZ-043 plus metabolite 2]; and 1·25 [0·66 to 2·39] for metabolite 1). When taken with a standard breakfast, BTZ-043_total AUC showed a dose-proportional increase up to 33 200 ng/mL × h (range 12 500 to 48 200) at 1000 mg. The maximum concentration (C_max) increased to 5060 ng/mL (2450 to 8020); and median half-life was 3·72 h (2·45 to 6·60). Probe drug evaluations showed bioequivalence (ie, 90% CI of the AUC_0-infinity geometric mean ratio from administration to day 14 entirely within the range of 80 to 125%) for caffeine (100·0% [90% CI 86·3 to 115·9]), digoxin (113·4% [105·9 to 121·5]), and dolutegravir (106·1% [91·5 to 122·9]). Dextromethorphan (116·2% [104·6 to 129·1]), tolbutamide (252·7% [230·7 to 276·9]), and midazolam (77·0% [69·2 to 85·6]) did not meet the bioequivalence criterion.INTERPRETATIONBased on a small sample size, BTZ-043 is a promising antituberculosis drug candidate with favourable safety and good bactericidal activity. Larger follow-up studies are needed to detect any less frequent safety signals, further explore drug-drug interactions, identify the best dose, and evaluate efficacy in combination with other drugs.FUNDINGEDCTP2 programme; German Ministry for Education and Research; German Center for Infection Research; InfectControl; Bavarian Ministry for Science and the Arts; Swiss State Secretariat for Education, Research, and Innovation; and Nederlandse Organisatie voor Wetenschappelijk Onderzoek.

19

News (Medical) associated with Pretomanid

15 Jan 2025

·www.tballiance.org

Historically Successful Global Access Campaign for Pretomanid and BPaL-based Regimens Continues with Major Milestones in BRICS Countries

January 15, 2025 Throughout 2024, one of TB Alliance’s foremost priorities has been ensuring that pretomanid and BPaL-based regimens reach all people with drug-resistant TB (DR-TB) around the world. To meet this challenge, TB Alliance has been working with and empowering a diverse set of stakeholders to help scale access to this treatment more quickly and widely than had been achieved for a TB therapy in the modern era. We are heartened to share an update on approval and programmatic implementation milestones in the five BRICS countries, four of which are among the world’s ten highest DR-TB burden countries. South Africa continues to make dramatic progress against DR-TB South Africa is a prime example of what a country can achieve when they truly commit to tackling DR-TB. Between 2015 and 2022, South Africa reduced its DR-TB burden by nearly 80%. Following first approval of pretomanid, South Africa rapidly implemented the BPaL Clinical Access Programme (BCAP), which helped inform local implementation. Working with the National TB Programme and a local partner, TB Alliance helped develop a national implementation plan. South Africa is firmly on the path toward full national implementation of BPaL-based regimens launched on September 1, 2023. By November 2024, more than 5,000 individuals had been enrolled on the treatments. At least 90% of all individuals who are eligible for these regimens are now receiving them. Brazil rolls out BPaL/M following visit to PeerLINC Knowledge Hub Brazil, a leader in implementing health innovations and making them rapidly available to all who need them in the country, began rolling out BPaL/M in December 2024. This follows a training and capacity building visit by a delegation of TB experts and policymakers from the Brazilian National TB Program to the PeerLINC Knowledge Hub in Manila. PeerLINC is a collaboration between TB Alliance and the Tropical Disease Foundation, Inc. (TDF) and works closely with the Department of Health, Philippines and provides practical training, technical support and peer-to-peer thought partnership to NTPs to develop implementation plans and help speed programmatic implementation of new TB technologies. India issues national guidelines; initiates BPaL rollout With the largest DR-TB burden of any country in the world, India was one of the first countries in the world to approve pretomanid and the BPaL regimen. However, the path from approval to national implementation requires many steps. Upon approval, a study on BPaL was conducted by Indian researchers under India’s National TB Elimination Programme to generate local evidence and confirm the global clinical trial results of the regimen. Having completed this study, India updated its national treatment guidelines in December 2024 to include BPaL/M. National and regional trainings have been rolled out rapidly by the Central TB Division which will enable roll-out of BPaL/M under programmatic settings. Russia approves pretomanid/BPaL One of only three countries in the world that reports 30,000 or more cases of DR-TB annually, Russia is a key high DR-TB burden country with a complex and independent approval process for new medicines. Regulatory approval for pretomanid and BPaL was granted in December 2024. Plans to make pretomanid available in the country have commenced. China approves pretomanid/BPaL With the world’s fourth-highest DR-TB burden, pretomanid and BPaL could prove to be a crucial tool to speed up China’s intention to eliminate DR-TB and build on the country’s efforts that have already led to a reduction in overall DR-TB burden by approximately 50% over the previous decade. In December 2024, pretomanid and BPaL received regulatory approval in China and TB Alliance is working closely with national stakeholders including the China Anti-Tuberculosis Association and the manufacturer in the country to ensure rapid roll-out of the regimen. PeerLINC Knowledge Hub Mylan Secures DCGI Approval in India for Pretomanid, a Treatment for Highly Drug-Resistant Forms of Tuberculosis

Drug ApprovalClinical Study

13 Jan 2025

·www.drugs.com

Shorter Treatment Regimens Recommended for Tuberculosis

MONDAY, Jan. 13, 2025 -- In a clinical practice guideline issued by the American Thoracic Society and published in the January issue of the American Journal of Respiratory and Critical Care Medicine , updated recommendations are presented for the treatment of tuberculosis (TB) in children and adults. Jussi J. Saukkonen, M.D., from the Boston Veterans Administration Health Care System, and colleagues updated clinical practice guidelines for TB treatment in children and adults in settings in which mycobacterial cultures, molecular and phenotypic drug susceptibility tests, and radiographic studies are available on a regular basis. The evidence was reviewed and recommendations made. The authors note that new recommendations for drug-susceptible TB include use of a novel four-month regimen for individuals with pulmonary TB and a shortened four-month regimen, instead of the six-month regimen, for nonsevere TB in children. Use of novel regimens containing bedaquiline, pretomanid, and linezolid with or without moxifloxacin are included as recommendations for drug-resistant TB. For adolescents aged 14 years and older and adults with rifampin-resistant pulmonary TB, a six-month bedaquiline, pretomanid, and linezolid regimen is as efficacious and safe as the current 15-month or longer regimen. "There has been a quest and concerted effort to develop shorter treatments for TB, after decades of little drug development," Saukkonen said in a statement. "With recent studies we have been able to shorten the regimen durations for both drug-susceptible and drug-resistant TB for most patients, down to four and six months, respectively." Several authors disclosed ties to the biopharmaceutical industry. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Phase 3

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

100 Deals associated with Pretomanid

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D10722	Pretomanid	J04	DB05154

R&D Status

Approved

10 top approved records.

Login

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	NO	Mylan IRE Healthcare Ltd.	31 Jul 2020
Tuberculosis, Multidrug-Resistant	LI	Mylan IRE Healthcare Ltd.	31 Jul 2020
Tuberculosis, Multidrug-Resistant	EU	Mylan IRE Healthcare Ltd.	31 Jul 2020
Tuberculosis, Multidrug-Resistant	IS	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.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Drug-Resistant Tuberculosis	NDA/BLA	CN	Mylan Laboratories Ltd.	12 Dec 2023
Drug-Resistant Tuberculosis	NDA/BLA	CN	Mylan Ireland Ltd.	12 Dec 2023
Multidrug resistant pulmonary tuberculosis	Phase 2	GE	Global Alliance for TB Drug Development	01 Feb 2015
Multidrug resistant pulmonary tuberculosis	Phase 2	PH	Global Alliance for TB Drug Development	01 Feb 2015
Multidrug resistant pulmonary tuberculosis	Phase 2	MY	Global Alliance for TB Drug Development	01 Feb 2015
Multidrug resistant pulmonary tuberculosis	Phase 2	ZA	Global Alliance for TB Drug Development	01 Feb 2015
Multidrug resistant pulmonary tuberculosis	Phase 2	TZ	Global Alliance for TB Drug Development	01 Feb 2015
Multidrug resistant pulmonary tuberculosis	Phase 2	ZM	Global Alliance for TB Drug Development	01 Feb 2015
Multidrug resistant pulmonary tuberculosis	Phase 2	KE	Global Alliance for TB Drug Development	01 Feb 2015
Multidrug resistant pulmonary tuberculosis	Phase 2	UG	Global Alliance for TB Drug Development	01 Feb 2015

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02589782 (TB-PRACTECAL, Pubmed) Manual	Phase 2/3	Extensively Drug-Resistant Tuberculosis	552	rifampicin (Standard care)	lalgnndrbp(kzekvllvzb) = rexkwsbluk cogxzygfdt (lxtzlmuxhj ) View more	Positive	01 Feb 2024
				rifampbedaquilinepretomanidlinezolidmoxifloxacin (BPaLM)	lalgnndrbp(kzekvllvzb) = kgzomsgerf cogxzygfdt (lxtzlmuxhj ) View more
NCT03338621 (SimpliciTB, CTgov)	Phase 2/3	Multidrug resistant pulmonary tuberculosis \| Tuberculosis, Multidrug-Resistant	455	ethambutol+rifampicin+isoniazid+pyrazinamide (Drug Sensitive-TB 2HRZE/4HR)	pbxgqqopvl(krhtcbfjvv) = udftdzniwp jpihzrqfob (wkpoaqetbk, kzjcmxwbsi - ujkhhdyhbs) View more	-	08 Nov 2023
				4BPaMZ (Drug Sensitive-TB 4BPaMZ)	pbxgqqopvl(krhtcbfjvv) = xxxqycufjf jpihzrqfob (wkpoaqetbk, nhkzmxmubs - uybnresopb) View more
NCT02256696 (CTgov)	Phase 2	Pulmonary Tuberculosis	157	PA-824+Rifampin+Isoniazid+Pyrazinamide (Arm 1)	liqcgyoguy(lqmtgphbvt) = bdmatuetjd bqivqqplrr (nebxhywrov, ooybptgvwk - ssdnmginex) View more	-	18 Jul 2023
				PA-824+Rifabutin+Isoniazid+Pyrazinamide (Arm 2)	liqcgyoguy(lqmtgphbvt) = wchxfduvwo bqivqqplrr (nebxhywrov, aeurccgzpp - hlybhvdfho) 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)	pxqjknlexs(lkedpunbii) = cqdpqpqije pzjppizxqr (dzoplucost, xilrvdzelb - lqtukurvrb) View more	-	29 Jun 2023
				Placebo Linezolid+Pretomanid+Linezolid+Bedaquiline (1200 mg L x 9 Weeks + Pa + B)	pxqjknlexs(lkedpunbii) = pujciqytxx pzjppizxqr (dzoplucost, wxandgwdyi - bshszkvvsn) View more
NCT02256696 (Pubmed \| Antimicrob Agents Chemother)	Phase 1	Tuberculosis	157	Pretomanid + Rifampin	pjtcknxpzo(uesuekkpki) = nifatxfjps kmkgdxsiny (drfawuybga ) View more	-	20 Jan 2021
				Pretomanid + Rifabutin	pjtcknxpzo(uesuekkpki) = iemapvbjst kmkgdxsiny (drfawuybga ) View more
NCT02333799 (Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 3	Pulmonary Tuberculosis	109	bedaquiline+pretomanid+linezolid	imwaxgqwrw(lestdislgv) = aaespiajfn ndvswkkjmd (scdxafwipx ) View more	Positive	05 Mar 2020
NCT02333799 (Nix-TB, Pubmed)	Phase 3	Multidrug resistant pulmonary tuberculosis	109	Bedaquiline (B)	(cknthoxogb) = cgceqgzrmv vvcmvvwfif (tyilxhiweg ) View more	-	05 Mar 2020
				Pretomanid (Pa)	lfkbfbxsnu(hvzkybrnyi) = polfkhccug upngymtvxs (krzqmsfexw ) 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)	uhywlthspa(kqqzovuezr) = cuqjssacds jmzlprojgd (adwprrmqxj, epedtejdmx - fwmihkswsj) View more	-	26 Jul 2019
				PA-824+Bedaquiline+Pyrazinamide (DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide)	uhywlthspa(kqqzovuezr) = lfobyjavkc jmzlprojgd (adwprrmqxj, wownozgglk - wdyvwdyufv) View more
NCT02342886 (STAND, CTgov)	Phase 3	Multidrug resistant pulmonary tuberculosis	284	PA-824+Moxifloxacin+Pyrazinamide (DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide)	bydomrpqjk(mbtxygvhba) = flnffaspry ljdnohgbuq (tnvdcsyadp, fhppktcnax - butekfoyes) View more	-	26 Mar 2019
				PA-824+Moxifloxacin+Pyrazinamide (DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide)	bydomrpqjk(mbtxygvhba) = qjhxexbsit ljdnohgbuq (tnvdcsyadp, bdqxrqrtac - krsqhaskff) View more
NCT00567840 (CTgov)	Phase 2	Pulmonary Tuberculosis	69	PA-824 (PA-824 200 mg)	cdpzecchyy(eowqhfyeht) = foexdnuviv nckolulbcq (xncbguvuxc, upqeebluww - ddgnylqipm) View more	-	04 Apr 2017
				PA-824 (PA-824 600 mg)	cdpzecchyy(eowqhfyeht) = bfgtdfthpn nckolulbcq (xncbguvuxc, xelnrnsvtg - rxbrorscrd) View more