Phase I/II Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV

This study aims to find the proposed dose of Rifapentine (RPT) taken once daily with Isoniazid (INH) for 28 days to prevent tuberculosis (TB). The study will take place at multiple locations and children under 13 years old will be divided into two groups: one group will include children without HIV, and the other group will include children with HIV who are on antiretroviral treatment. Up to 144 children will participate, and participants in each group will be followed for 24 weeks.

Start Date15 May 2026

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

[+1]

NCT07069582

/ Not yet recruitingPhase 1IIT

Plasma and Breastmilk Exposures to Antituberculosis Drugs in Breastfeeding Women: an Open-label, Randomized, Six-arm, Single-dose, Pharmacokinetic Study

This study is a sub-study of the SSTARLET trial (NCT06498414). The overall aim is to assess the pharmacokinetic profiles after taking a single dose of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in breastfeeding women and the excretion of these drugs in breast milk, with the hope of including breastfeeding women in future clinical trials of TPT, including expanding the inclusion criteria of the SSTARLET trial. In this study, healthy breastfeeding women who fulfill the eligibility criteria will be enrolled from several primary health care centers in Bandung, which will be referred to the TB Research Clinic of the Universitas Padjadjaran, Bandung, Indonesia. Ten participants will be randomized to each of the following six study arms:
* Arm A: Single-dose rifampicin at 10 mg/kg body weight (RIF10).
* Arm B: Single-dose rifampicin at 20 mg/kg body weight (RIF20).
* Arm C: Single-dose isoniazid at 5 mg/kg body weight (INH5).
* Arm D: Single-dose levofloxacin at 10-15 mg/kg body weight (LFX10-15).
* Arm E: Single-dose rifapentine at 10 mg/kg body weight (RPT10).
* Arm F: Single-dose bedaquiline at 400 mg (BDQ400).

Start Date01 Apr 2026

Sponsor / Collaborator

Universitas Padjadjaran

ChiCTR2600116528

/ Not yet recruitingNot ApplicableIIT

Research on key technologies and strategies for preventive intervention of key populations with latent tuberculosis infection

Start Date01 Dec 2025

Sponsor / Collaborator-

100 Clinical Results associated with Isoniazid

100 Translational Medicine associated with Isoniazid

100 Patents (Medical) associated with Isoniazid

25,580

Literatures (Medical) associated with Isoniazid

01 Jun 2026·TALANTA

Integrated electrochemical platform modified with a carbon black–cerium oxide nanocomposite for the simultaneous sensing of rifampicin and isoniazid in biological and environmental samples

Article

Author: Cincotto, Fernando Henrique ; Nossol, Edson ; da Silva, Michele Verena Conceição Oliveira ; de Oliveira, Gustavo Zanon de Moraes Goes ; de Faria, Lucas Vinicius ; Santelli, Ricardo Erthal ; Lopes, Claudio Sabbatini Capella ; Silva, Francisco Walison Lima ; Ribeiro, Emerson Schwingel

Tuberculosis is a major infectious disease with high global mortality, and its first-line drugs, rifampicin (RIF) and isoniazid (INZ), are associated with serious adverse effects and public health risks when improperly administered, due to toxicity, environmental residues, and the potential induction of mycobacterial resistance. Low-cost, rapid analytical methods with simple instrumentation, particularly electrochemical approaches using screen-printed carbon electrodes (SPCE), are highly desirable for detecting these drugs. In this work, a novel electrochemical method for the simultaneous quantification of RIF and INZ was developed employing linear sweep voltammetry (LSV) as the analytical technique. As an electrochemical platform, a miniaturized and portable carbon-integrated substrate system was modified via drop-casting using a nanocomposite based on carbon black (CB) with cerium oxide (CeO₂), which was comprehensively characterized using structural, morphological, and electrochemical analyses. Importantly, this CB/CeO₂ material offered a drastic synergic effect for improving the electrochemical response of both antibiotics. The voltammetric strategy provided wide linear ranges for INZ (3.66 to 343.0 μmol L^-1) and RIF (0.611 to 57.3 μmol L^-1) with limits of detection of 0.638 μmol L^-1 and 0.0390 μmol L^-1, respectively. In addition, the sensor exhibited excellent fabrication reproducibility with RSD <4.76 %, as well as high selectivity for the analyte, making SPCE/CB/CeO₂ applicable to tap water, human urine, and synthetic human serum, with satisfactory recoveries ranging from 96.9 to 106 % demonstrating its potential for monitoring aquatic and biological matrices.

01 Apr 2026·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

The first reported case of combined occlusion of branch retinal artery and vein secondary to disseminated mycobacterium kansasii infection

Article

Author: Lin, Binwu ; Qin, Lin ; Luo, Baohua ; Pang, Long ; Luo, Yanhua

BACKGROUND:

Combined occlusion of branch retinal artery and vein in young patient is rare and indicates a high risk of underlying systemic disease. Retinal arteriovenous occlusion secondary to Mycobacterium kansasii (M. kansasii) infection has never been reported.

CASE PRESENTATION:

A 37-year-old woman, previously healthy and with nothing remarkable in her family history, presented to the ophthalmology clinic due to a 1-week history of blurred vision and inferior shadow of her right eye. She had been experiencing coughing with phlegm for one month prior to the eye symptoms. Upon examination, it was found that she had a simultaneous occlusion of branch retinal artery and branch retinal vein. Laboratory investigations revealed significant inflammation and hypercoagulability. Computed tomography revealed abnormally intense metabolic activity affecting the lungs, mediastinum, spleen, nasopharynx, neck, and bones. After three months, M. kansasii was identified through DNA sequencing of pathological tissue sections, leading to a diagnosis of disseminated M. kansasii infection. Although the medications (Rifampin, Isoniazid, Ethambutol, Clarithromycin) were administered according to standardized diagnostic and therapeutic guidelines as soon as the diagnosis was made, the patient was unable to complete the full course of medications due to her inability to tolerate the side effects of the medications. The patient's condition eventually worsened and resulted in death.

CONCLUSIONS:

This is the first case of M. kansasii-associated hypercoagulability resulting in retinal arteriovenous occlusion. Disseminated Mycobacterium kansasii (DMK) infection is a rare but serious disease that can affect multiple organ systems. Rare retinal arteriovenous occlusion in young patients is often indicative of systemic disease and requires thorough evaluation to avoid misdiagnosis.

01 Mar 2026·Journal of Infection and Public Health

The genetic diversity of drug resistance in Mycobacterium tuberculosis strains from the Tibetan Plateau

Article

Author: Zhu, Bin ; Li, Shangshi ; Xu, Huan ; Shi, Li ; Ding, Sijuan ; Li, Maoshi ; Yu, Xiaohui ; Xia, Anyue ; Feng, Dongfang ; Luo, Jie

OBJECTIVE:

This study aimed to characterize the genetic diversity of drug resistance in Mycobacterium tuberculosis (MTB) isolates from the Tibetan Plateau, elucidate the molecular epidemiological profile of tuberculosis (TB) in this high-altitude region, and offer a molecular basis to guide improved diagnostic, therapeutic, and preventive strategies.

METHODS:

A total of 169 clinical MTB isolates were collected from the General Hospital of Xizang Military Command between January 2024 and April 2025. Drug resistance-associated mutations were identified via targeted gene sequencing.

RESULTS:

Among the 169 isolates, the overall rate of genotypic resistance was 20.71 %, comprising mono-resistance (14.79 %), poly-resistance (1.78 %), and multidrug-resistance (MDR, 4.14 %). Retreated patients exhibited a higher resistance rate than newly treated cases (26.09 % vs. 14.29 %), with MDR exclusively identified in the retreatment group. Resistance to streptomycin was most prevalent (8.28 %), followed by isoniazid (7.69 %) and rifampicin (7.10 %). The predominant mutations observed were rpsL K43R and katG S315T. No mutations conferring resistance to second-line drugs were detected.

CONCLUSION:

The substantial burden of drug-resistant TB on the Tibetan Plateau-particularly streptomycin resistance-underscores the critical need for implementing precision diagnostics and optimizing therapeutic regimens.

News (Medical) associated with Isoniazid

19 Feb 2026

·www.biospace.com

BioVersys and Partners’ Phase 2a Tuberculosis Trial Results Published in New England Journal of Medicine

Data from Phase 2a study demonstrated the first clinical proof of concept for alpibectir in combination with ethionamide (AlpE) in the treatment of patients with tuberculosis. The results, published in the prestigious New England Journal of Medicine, underscore the significant potential of AlpE to shape the future of TB treatment. BASEL, Switzerland, Feb. 19, 2026 (GLOBE NEWSWIRE) -- BioVersys AG (SIX: BIOV), a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multidrug-resistant (MDR) bacteria, announced today the publication of promising clinical proof of concept results in the prestigious New England Journal of Medicine from the Phase 2a clinical trial of AlpE in patients with pulmonary TB. 1 Tuberculosis is one of the leading causes of death by infectious diseases globally, and many existing treatments are becoming less effective due to growing drug resistance. Alpibectir, a small molecule acting through a novel mode of action, represents a totally new concept of overcoming resistance by potentiating the activity of an existing antibiotic, ethionamide (Eto), and was identified in a successful public-private collaboration with GSK, the Pasteur Institute of Lille and the University of Lille. The Phase 2a bEto-TB clinical trial was conducted in South Africa through a consortium of three partners, TASK, GSK and BioVersys, and was completed in April 2024. AlpE delivered a promising clinical proof of concept in a 7-day early bactericidal activity (EBA) study, conducted in patients with pulmonary tuberculosis. AlpE seeks to offer a replacement for isoniazid (INH) in the current first-line regimen or to be added as a novel bactericidal drug to future regimens including those of TB meningitis. The clinical development of AlpE has been strongly supported by several European Union grants and public private partnerships, including the EU Innovative Medicines Initiative 2 (IMI2), TRIC-TB project and UNITE4TB project, and the European & Developing Countries Clinical Trials Partnership (EDCTP2 programme), bEto-TB project. Dr. Glenn Dale, Chief Development Officer of BioVersys: “We are very pleased to see the favorable safety, tolerability and pharmacokinetics pro AlpE, and even more so for the promising signals of efficacy delivered from this Phase 2a clinical trial. These data give us real encouragement for the further Phase 2 studies in UNITE4TB, run by our partner GSK, where AlpE is being studied in combination with first line TB drugs. We are also excited as we plan to initiate a Phase 2 trial in meningeal TB later this year.” Michelle Nderu, Project Officer, EDCTP Association: “The bEto-TB trial demonstrates the power of sustained investment in global health research. The development of AlpE reflects not only scientific innovation but also the strength of collaborative partnerships. With support from EDCTP2, these results bring us a step closer to delivering shorter, safer and more effective treatment options for people living with TB.” Prof. Andreas Diacon, Founder and Chief Scientist at TASK: “At TASK we are grateful to our study participants whose collaboration allows yet another novel antibiotic to move a step forward. This study has shown that ethionamide, an established, low-cost and safe antibiotic, becomes more potent and better tolerated by the addition of alpibectir. The AlpE combination is now on its way to become part of drug combinations that treat tuberculosis patients with and without resistance to other drugs, and it appears particularly suitable for patients with tuberculosis meningitis where better treatments are direly needed.” Dr. David Barros-Aguirre, Head of Global Health Medicines R&D, GSK: “TB remains one of the world’s deadliest infectious diseases, and tackling drug resistance is one of the biggest challenges we face. That’s why innovation is essential. The Phase 2a results for AlpE mark an exciting step forward, demonstrating the potential of novel approaches to strengthen existing therapies. We are proud to collaborate with BioVersys, TASK and partners, to advance research aimed at transforming TB care for patients globally, particularly in lower-income countries where the disease remains most prevalent.” About bEto-TB This project brings a new anti-TB molecule, BVL-GSK098, to the current drug armamentarium. BVL-GSK098 greatly augments the activity of, and overcomes resistance to, the well-established second line drug Eto at a lower and well-tolerated dose. The objectives of this consortium are to determine the early bactericidal activity (EBA) of the combination of BVL-GSK098 and various doses of Eto. We will also evaluate the comparative anti-TB activity of bEto to that of standard dose INH and thus explore the potential for bEto as a replacement of INH in the current first-line regimen or to add a novel bactericidal drug to future regimens. The programme has previously received funding from the EU IMI 2 JU (TRIC-TB) and the Wellcome Trust. Project description website: X: Statements or views expressed in this release are those of the respective organizations or persons and the European & Developing Countries Clinical Trials Partnership is not responsible for any use of the information contained herein. About tuberculosis (TB) Tuberculosis (TB) remains one of the leading causes of death worldwide. It is caused by the bacterial pathogen Mycobacterium tuberculosis (Mtb). According to the WHO Global Tuberculosis Report 2025, an estimated 10.7 million people developed TB in 2024, and approximately 1.23 million died from TB. Drug resistance continues to pose a major challenge. There were about 390,000 people who developed rifampicin-resistant TB (RR-TB) or multidrug-resistant TB (MDR-TB) in 2024. MDR-TB remains a public health crisis and a health security threat, with global treatment success rates at only 71%. The major burden of TB is concentrated within 30 high TB burden countries, accounting for 87% of the global total in 2024. Of those, the top eight countries for TB cases worldwide were, India (25%), Indonesia (10%), the Philippines (6.8%), China (6.5%), Pakistan (6.3%), Nigeria (4.8%), the Democratic Republic of the Congo (3.9%) and Bangladesh (3.6%). Globally, 8.3 million people were reported as newly diagnosed with TB in 2024, Significantly, it remains that 3.2% of new TB cases and 16% of previously treated cases are MDR/RR-TB. About EDCTP The vision of the European & Developing Countries Clinical Trials Partnership (EDCTP) is to reduce the individual, social, and economic burden of poverty-related infectious diseases in sub-Saharan Africa. EDCTP funds collaborative clinical research that accelerates the development of accessible, suitable, and affordable medical interventions (drugs, vaccines, and diagnostics) to identify, prevent or treat infectious diseases, including emerging and re-emerging diseases. EDCTP’s approach integrates research with the development of African clinical research capacity and networking. EDCTP2 is supported by the European Union under Horizon 2020, its Framework Programme for Research and Innovation. For more information, visit . About TASK TASK is a social enterprise committed to developing, testing, and progressing novel medicines, vaccines, and diagnostics in various medical therapeutic areas, most notably in anti-tuberculosis drugs, aimed at improving global health care. Since its inception in 2005, TASK has grown exponentially and diversified into six distinct independent clinical research sites; a mycobacteriology bio-safety level 3 laboratory; a phase I to II clinical trial hospital with twenty-four beds; two registered dispensing pharmacies; a data management centre; regulatory, quality control and compliance office and a clinical research training academy. Over the last 15 years TASK has completed multiple research projects, many of global significance, and contributed to progressing the scientific field of TB medicine and vaccine development, most notably with early bactericidal activity (EBA) studies and clinical trials that in part led to the registration of bedaquiline. Find us at and follow us on Twitter @taskapplied. About BioVersys BioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 3), and tuberculosis (alpibectir, Phase 2, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland. BioVersys contact Hernan Levett , CFO, Tel. +41 61 633 22 50; Mail: hernan.levett@bioversys.com For media: media@bioversys.com Website: X: LinkedIn: The bEto-TB project (grant reference: RIA2019AMR-2657) is part of the EDCTP2 programme supported by the European Union. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning BioVersys and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioVersys to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioVersys is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. 1 The Revival of Ethionamide by Alpibectir (BVL-GSK098), Michel Pieren et a l , 2026;

Phase 2Clinical ResultPhase 3Microbial therapy

27 Jan 2026

·www.prnewswire.com

New Survey Highlights Pill-Splitting Challenges in Parkinson's Disease Treatment

ALPHARETTA, Ga., Jan. 27, 2026 /PRNewswire/ -- Avion Pharmaceuticals, an Alora Pharmaceuticals subsidiary company focused on advancing treatment for Parkinson's disease, is proud to announce the findings from a recently published study examining the real-world practice of splitting carbidopa/levodopa tablets. The article, Practices and Perceptions Around Splitting of Carbidopa/Levodopa Tablets: A Survey of Patients and Neurologists, appears in Neurodegenerative Disease Management and reports that people living with Parkinson's disease often split immediate-release carbidopa/levodopa tablets to manage motor symptoms, a practice that becomes more common, burdensome, and imprecise as the disease progresses. The study, led by Drs. Ramon L. Rodriguez, Stuart H. Isaacson, Yasar Torres-Yaghi, Rajesh Pahwa, and Ahmad Al-Sabbagh, highlights ongoing challenges related to dosing precision, treatment complexity, and quality of life for people living with Parkinson's disease. To better understand these challenges, researchers conducted surveys among 101 people living with Parkinson's disease and caregivers, as well as 120 neurologists, including movement disorder specialists. Across respondents, motor symptoms were reported to have a substantial impact on quality of life, particularly in the later stages of the disease. Among surveyed patients with longer disease duration, more advanced disease, and greater difficulty controlling motor fluctuations, pill splitting was more commonly reported. Of those surveyed that reported splitting pills in half, only 27% find pill splitting easy and of those surveyed who fragmented their pills further beyond a half, just 18% find it accurate.1 "These survey findings reinforce what we hear consistently from patients and clinicians - that dosing flexibility and precision become increasingly important as Parkinson's disease progresses," said Art Deas, Chief Executive Officer of Alora Pharmaceuticals. "DHIVY was developed to address this challenge. It is the first and only functionally scored immediate release carbidopa/levodopa tablet, designed to allow a single tablet to be divided into smaller, more precise segments that are easy to snap, supporting individualized dosing without the need for traditional pill splitting."2-4 Neurologists participating in the survey also reported growing dissatisfaction with available treatment options as Parkinson's disease progresses. Physicians estimated that approximately 45% of their patients split carbidopa/levodopa tablets based on medical recommendation, while nearly 22% do so independently without physician guidance. Overall, the findings underscore the importance of continued collaboration among patients, caregivers, and healthcare providers to address evolving treatment needs and help reduce treatment burden as Parkinson's disease advances. About DHIVY DHIVY® (carbidopa and levodopa) tablets are indicated for the treatment of Parkinson's disease. DHIVY is a functionally scored tablet designed to allow division into smaller dose segments. Patients should take DHIVY exactly as prescribed.2 See ISI below. About Alora Pharmaceuticals Alora Pharmaceuticals is dedicated to improving the lives of individuals with neurological disorders through innovative therapeutic solutions and patient-centered support. Headquartered in Alpharetta, GA, the company focuses on advancing treatments that make real differences in daily care. About the Study The full study, "Practices and perceptions around splitting of carbidopa/levodopa tablets: a survey of patients and neurologists," is available in Neurodegenerative Disease Management (DOI: 10.1080/17582024.2025.2577054). © 2026 Alora Pharmaceuticals, LLC. All rights reserved. DHIVY® is a registered trademark of Avion Pharmaceuticals, LLC. References: 1. Rodriguez R., Isaacson S., Torres-Yaghi Y, Pahwa - full-view-affiliation-4 R. Holecek D, Al-Sabbagh A. Practices and perceptions around splitting of carbidopa/levodopa tablets: a survey of patients and neurologists. Neurodegenerative Disease Management, 2025 Dec 3:1-7. doi: 10.1080/17582024.2025.2577054 2. DHIVY. Package insert. Avion Pharmaceuticals, LLC; 2022. 3. Beach D. Accu-Break's innovative tablet technology – 2016 advancements. ONdrugDelivery Magazine. 2016;69:39-40. 4. Center for Drug Evaluation and Research, Food and Drug Administration. Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation. US Department of Health and Human Services; 2013. IMPORTANT SAFETY INFORMATION & INDICATION DHIVY is contraindicated in patients Currently taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine, linezolid, and tranylcypromine) or have recently (within 2 weeks) taken a nonselective MAO inhibitor. Hypertension can occur if these drugs are used concurrently. With known hypersensitivity to any component of DHIVY. Taking DHIVY may result in falling asleep while engaged in normal activities, even without warning and as late as 1 year or later after starting DHIVY. This may affect your ability to drive or operate machinery, resulting in accidents. Do not do anything that requires alertness until you know how DHIVY affects you. Tell your healthcare provider about any sleep medicines you take or if you have a sleep disorder and discuss any episodes of drowsiness or sleepiness you experience while taking DHIVY. Talk to your healthcare provider before you change the dose or stop taking DHIVY, as this may result in serious side effects. Call your healthcare provider immediately if you develop withdrawal symptoms such as fever, confusion, or severe muscle stiffness. Tell your healthcare provider if you have any heart conditions, especially if you have had a heart attack or irregular heartbeats. Your heart function should be monitored during the time period your DHIVY dose is first adjusted. Treatment with DHIVY may cause hallucinations or abnormal thoughts and behaviors. Be sure to tell your healthcare provider if you experience excessive suspicion; seeing, hearing, or feeling things that are not real; confusion; agitation; aggressive behavior; and disorganized thinking. Treatment with DHIVY may also cause intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and other intense urges, as well as the inability to control those urges. Uncontrolled sudden movements of the face, arms, legs, or trunk may appear or get worse during treatment with DHIVY. This may mean your dosage of DHIVY or other Parkinson's medications needs to be adjusted. Tell your healthcare provider if you have ever had a peptic ulcer or glaucoma, as treatment with DHIVY may worsen these conditions. DHIVY also may cause abnormal blood or urine test results. Some patients taking DHIVY may experience depression or suicidal thoughts. Tell your healthcare provider if you have thoughts of suicide. The most common side effects that may appear with DHIVY include uncontrolled sudden movements and nausea. Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using DHIVY with certain other medicines, including MAO inhibitors, isoniazid, iron supplements, medicines for high blood pressure or those that increase or decrease dopamine levels, or metoclopramide, may cause serious side effects. Notify your healthcare provider if you become pregnant or intend to become pregnant during DHIVY therapy or if you intend to breastfeed or are breastfeeding an infant. INDICATION DHIVY is a prescription medication that contains a combination of carbidopa and levodopa for the treatment of Parkinson's disease, Parkinson's disease caused by infection or inflammation of the brain, or Parkinson's disease–like symptoms that may result from carbon monoxide or manganese poisoning. You may report side effects to Avion Pharmaceuticals, LLC at 1-888-612-8466 or to the FDA at 1-800-FDA-1088. Please click here for full Prescribing Information. NP-4069-v1 (v1.2) SOURCE Alora Pharmaceuticals, LLC 21% more press release views with Request a Demo

19 Dec 2025

·www.drugs.com

High-Dose Rifampin Not Beneficial for Tuberculosis Meningitis

FRIDAY, Dec. 19, 2025 -- No benefit of high-dose versus standard-dose rifampin is seen among adults with tuberculosis meningitis, according to a study published online Dec. 17 in the New England Journal of Medicine . David B. Meya, M.B., Ch.B., Ph.D., from Makerere University in Uganda, and colleagues conducted a randomized, placebo-controlled clinical trial involving adults with tuberculosis meningitis in Indonesia, South Africa, and Uganda to examine whether high-dose rifampin could improve survival outcomes. Participants with and without HIV coinfection were randomly assigned to receive eight weeks of standard daily isoniazid , rifampin (10 mg/kg body weight), ethambutol, and pyrazinamide plus either additional rifampin (for a cumulative dose of 35 mg/kg; high-dose group) or matched placebo (standard-dose group; 249 and 250 participants, respectively). The researchers found that 109 (44.6 percent) and 100 participants (40.7 percent) in the high-dose and standard-dose groups, respectively, died during six months of follow-up (hazard ratio, 1.17; 95 percent confidence interval, 0.89 to 1.54). The median time to death was 13 and 24 days in the high-dose and standard-dose groups, respectively, among those who died within six months. Drug-induced liver injury occurred in 8.0 and 4.4 percent of participants in the high-dose and standard-dose groups, with no deaths from drug-induced liver injury. "It was, of course, disappointing that this is not the solution. But these are important results -- we now know we need to take a different path. That’s how science works," coauthor Reinout van Crevel, M.D., Ph.D., from the University of Oxford in the United Kingdom, said in a statement. One coauthor disclosed financial ties to the biopharmaceutical industry. Abstract/Full Text (subscription or payment may be required)

Clinical ResultClinical Study

100 Deals associated with Isoniazid

External Link

KEGG	Wiki	ATC	Drug Bank
D00346	Isoniazid	J04AC01	DB00951

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pulmonary Tuberculosis	Japan	Alfresa Pharma Corp.	25 Feb 1986
Tuberculosis	United States	Sandoz, Inc.	29 Sep 1952

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Leg Ulcer	Phase 2	Denmark	Pharma 2100 ApS	01 Apr 2008

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04703075 (Pubmed \| PLoS Med)	Phase 4	Latent Tuberculosis	500	1 month of rifapentine and isoniazid	pecgifyxlh(uilrkmavha) = amqjtulzkn gyvmlwpeox (zpchnygens ) View more	Negative	10 Feb 2026
				3 months of rifapentine and isoniazid	pecgifyxlh(uilrkmavha) = xlrdjksxxl gyvmlwpeox (zpchnygens ) View more
NCT04311502 (Clo-Fast, CTgov)	Phase 2	Tuberculosis \| Pulmonary Tuberculosis \| HIV Infections	104	Ethambutol+Rifapentine+Clofazimine loading dose+Isoniazid+Pyrazinamide (Arm 1: Experimental)	azfjwkkjvc(rqcyhdunlm) = bsgviskwxf rnqewgqhme (naeoxmhoqt, qcotldxzrr - akiasbdopc) View more	-	27 Aug 2025
				Ethambutol+Rifampicin+Isoniazid+Pyrazinamide (Arm 2: Standard of Care)	azfjwkkjvc(rqcyhdunlm) = adkabevwea rnqewgqhme (naeoxmhoqt, qqeiylrcgq - jbdchympwf) View more
NCT06041919 (CTgov)	Phase 2	Pulmonary Tuberculosis	20	RESP301 (1 (Active))	lwecmomcxi(skjwysmtzs) = qjergbvsfu mskrnbsbnx (kgpbkaxpfm, dmnjaeifsl - vtkkvdolfv) View more	-	15 Jul 2025
				ethambutol+rifampicin+isoniazid+pyrazinamide (2 (Control))	lwecmomcxi(skjwysmtzs) = ksdsdepfxv mskrnbsbnx (kgpbkaxpfm, awafxjagkn - icolpkvevg) View more
NCT04703075 (CTgov)	Phase 4	Tuberculosis \| Pulmonary Tuberculosis	531	Rifapentine+INH (Arm A: 1HP)	bdcmkciwyr = knjamqirie grasiabjfe (cfehscvfbs, bsjtznhlcr - qwaupwreme) View more	-	19 Jun 2025
				Rifapentine+INH (Arm B: 3HP)	bdcmkciwyr = kxaispjler grasiabjfe (cfehscvfbs, ccoxukvnzr - dxwhjkstwu) View more
NCT03474198 (TRUNCATE-TB, Pubmed \| Lancet Infect Dis)	Phase 2/3	Pulmonary Tuberculosis	675	Standard Treatment (rifampicin, isoniazid, pyrazinamide, and ethambutol)	ilgaghxqko(hvwnntjmpi) = gsdtzwrtrn bjxrddppnh (qjxwwlbgyd ) View more	Negative	01 May 2025
				High-dose rifampicin and linezolid	ilgaghxqko(hvwnntjmpi) = utycfmdabb bjxrddppnh (qjxwwlbgyd ) View more
NCT05592223 (CTgov)	Phase 1	Tuberculosis	20	BCG Vaccine USP+Isoniazid (BCG Challenged-Isoniazid Treated)	aennzdcsts(ybdxfagzlc) = vomacfyphb aczotfwsvm (vkgiyrmmov, 40,516) View more	-	25 Mar 2025
				BCG Vaccine USP (BCG Challenged-Isoniazid Untreated)	aennzdcsts(ybdxfagzlc) = ccifcywwed aczotfwsvm (vkgiyrmmov, 92) View more
NCT01582711 (TBTC Study 33 \| iAdhere, CTgov)	Phase 3	Latent Tuberculosis	1,002	rifapentine+isoniazid (3HP Directly Observed Therapy (DOT))	pgzjrqlzqq = cjnlzvidnc ytlzztlqnk (ltzqqmoyfa, hedtslzopl - qvqbdjrxwv) View more	-	13 Mar 2025
				Self Administered Therapy (SAT)+rifapentine+isoniazid (3HP Self Administered Therapy (SAT))	pgzjrqlzqq = qiranyyfjg ytlzztlqnk (ltzqqmoyfa, axkcxdosuh - aytdlysnsm) View more
NCT03510468 (CTgov)	Phase 1	-	51	Tenofovir alafenamide+Rifapentine+Pyridoxine+Isoniazid (INH)	oilgkherpn(woroweomlm) = hnmesbdhmf ezamkuxbwz (fzztpqxugs, 64) View more	-	25 Oct 2023
NCT01494038 (TB APPRISE, Pubmed \| Lancet Child Adolesc Health)	Phase 4	HIV Infections Bacille Calmette-Guérin (BCG) vaccination \| HIV positive \| probable tuberculosis	956	Immediate isoniazid preventive therapy	chmpdjsuvk(itxhfmfles) = kyzvmqsrqs wmrdnhmlkk (zvkngdzcal, 4 - 8)	Positive	01 Oct 2023
				Deferred treatment	chmpdjsuvk(itxhfmfles) = fjbauzvyeh wmrdnhmlkk (zvkngdzcal, 4 - 8)
NCT03891901 (IMPACT-TB, CTgov)	Phase 2	Tuberculosis	24	Rifabutin+Imatinib+Isoniazid (Cohort 1a: Imatinib (50 mg) + Rifabutin + Isoniazid)	anquywqmka(tzdscnicyk) = qqbdvfgtcc aqhhjcynki (kxnijsrjlh, 933) View more	-	28 Sep 2023
				Rifabutin+Imatinib+Isoniazid (Cohort 1b: Imatinib (100 mg) + Rifabutin + Isoniazid)	anquywqmka(tzdscnicyk) = saxkhqxekc aqhhjcynki (kxnijsrjlh, 480) View more

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