The A5414 study will evaluate whether treatment for drug-susceptible pulmonary tuberculosis (TB) can be tailored according to a participant's risk of an unfavorable outcome. Participants will be assigned to lower-risk or higher-risk groups using baseline characteristics and then randomized within each group to receive either standard TB treatment or an investigational rifapentine- and moxifloxacin-containing regimen. The study will evaluate whether shorter treatment durations may be used in lower-risk participants and whether the investigational regimen may improve outcomes in higher-risk participants. Safety and tolerability will also be evaluated.

Start Date30 Oct 2026

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

[+1]

TCTR20260210006

/ Not yet recruitingPhase 4IIT

A Multicentre Randomized Non-inferiority Trial Comparing One-month Daily Rifapentine plus Isoniazid (1HP) versus Three-month Weekly Rifapentine plus Isoniazid (3HP) for Treatment of Latent Tuberculosis Infection in Non-HIV Adults in Rayong Province

Start Date01 Oct 2026

Sponsor / Collaborator-

NCT07656012

/ Not yet recruitingPhase 2IIT

Multi-arm, Open-label, Duration-randomized, Phase IIc Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of Optimized Rifampicin in Combination With Isoniazid, Pyrazinamide, and Ethambutol for the Treatment of Children With Drug-susceptible Tuberculosis

Current tuberculosis (TB) treatment is effective (works well), but it takes a long time to cure TB. This study will evaluate if TB treatment with a higher dose of rifampicin, one of the TB medicines, and shorter TB treatment duration is as effective and safe as the standard, TB treatment (with the usual rifampicin dose and usual duration). This study hopes to find a better shorter treatment that works as well as the current treatment (standard of care). This could benefit children worldwide who are getting TB treatment.
Children 3 months to less than 10 years of age who have drug-susceptible TB (can be successfully treated with standard TB medicines) are eligible for this study.

Start Date01 Oct 2026

Sponsor / Collaborator

University of Wisconsin-Madison

[+1]

100 Clinical Results associated with Isoniazid

100 Translational Medicine associated with Isoniazid

100 Patents (Medical) associated with Isoniazid

25,587

Literatures (Medical) associated with Isoniazid

01 Feb 2027·TISSUE & CELL

Rosmarinic Acid Attenuates Isoniazid-Induced Neurotoxicity by Restoring Mitochondrial Dynamics and Suppressing Oxidative Stress, Ferroptosis, Neuroinflammation, and Apoptosis

Article

Author: Karaarslan, Tuba ; Aykurt, Furkan ; Derelİ, Esra ; Atasever, Aslıhan ; Teki̇n, Samet ; Çelebi̇, Fikret ; Aktaş Şenocak, Esra ; Bolat, İsmail ; Şengül, Emin ; Bolat, Merve ; Laçi̇n, Burak Batuhan

Despite the continued global burden of tuberculosis and the essential role of isoniazid (INH) in first-line antituberculosis therapy, INH-induced neurotoxicity remains a major clinical challenge that compromises treatment adherence, and effective, well-characterized neuroprotective strategies are still lacking. This study investigated the neuroprotective effects of rosmarinic acid (RA) against INH-induced neurotoxicity, evaluating oxidative stress, inflammation, iron metabolism, energy homeostasis, mitochondrial dynamics, ferroptosis, and apoptosis using biochemical, molecular, and histopathological approaches. INH markedly increased malondialdehyde while reducing superoxide dismutase and glutathione, and increased TNF-α, IL-1β, and IL-6 while decreasing IL-10. INH also disturbed iron homeostasis (increased Fe²⁺), impaired energy metabolism (reduced ATP), and disrupted mitochondrial dynamics (increased Drp-1; decreased Mfn-2 and PGC-1α). NF-κB activation was accompanied by increased ACSL4 and decreased GPX4 and FTH1, reflecting ferroptosis, alongside increased Bax, Caspase-3, and Cytochrome c and reduced Bcl-2, indicating mitochondrial apoptosis. RA treatment suppressed oxidative stress, enhanced antioxidant defense, attenuated inflammation, restored iron and energy homeostasis, improved mitochondrial dynamics, and inhibited NF-κB activation, ferroptosis, and apoptosis. These findings demonstrate that RA exerts potent neuroprotective effects against INH-induced brain injury by simultaneously targeting oxidative stress, mitochondrial dysfunction, iron dyshomeostasis, neuroinflammation, ferroptosis, and apoptosis. To our knowledge, this is among the first studies to comprehensively address these interconnected pathways, including ferroptosis and iron dyshomeostasis, in INH-induced neurotoxicity. RA may thus represent a promising therapeutic candidate for preventing INH-induced neurotoxicity.

01 Feb 2027·TALANTA

Design of a red-emitting camphor-derived benzothiazole ratiometric fluorescent probe for hydrazine detection in environmental samples and its versatile imaging applications in live cells, zebrafish and Arabidopsis thaliana

Article

Author: Zhang, Shuo ; Gu, Yue ; Zhao, Mengdi ; Wang, Zhonglong ; Wang, Shifa ; Wang, Mengru

Hydrazine (N₂H₄) has been extensively utilized during industrial production, while its excessive usage presents substantial risks to human health and ecological systems. In this paper, a new red-emitting camphor-derived benzothiazole-based ratiometric fluorescent probe BTMI-AC was synthesized for selectively and sensitively detecting N₂H₄ with the large Stokes shift of 223 nm. BTMI-AC exhibited a remarkable fluorescence emission shift from 506 nm to 613 nm after reaction with N₂H₄, and its ratiometric fluorescence signal ratio (I₆₁₃/I₅₀₆) showed a favorable linear relationship with N₂H₄ concentration with the detection limit as low as 33 nM. The quantitative determination of N₂H₄ in different soil samples was achieved by using BTMI-AC, suggesting its potential application in the on-site monitoring of N₂H₄ pollution in the environment. BTMI-AC was also immobilized onto test strips and hydrogel matrices to fabricate the portable solid-state sensing platforms for rapid and visual detection of gaseous and liquid N₂H₄ through the distinct fluorescence color changes from green to red. Moreover, BTMI-AC was employed for tracking the exogenous concentrations of N₂H₄ in the live cells, zebrafish and Arabidopsis thaliana. Considering that the metabolism of antituberculosis drugs such as isoniazid (INH) may increase N₂H₄ levels by enzyme induction and bring potential biological toxicity risk, BTMI-AC could successfully realize the fluorescence imaging of endogenous N₂H₄ distribution in live cells and zebrafish. We expected that BTMI-AC can offer a sensitive, visual and multi-scenario applicable analytical tool for monitoring N₂H₄ levels in the environmental samples and biological systems.

01 Jan 2027·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Evaluation of dried blood spots relative to peripheral blood mononuclear cells for intracellular tenofovir-diphosphate and emtricitabine-triphosphate assessment using liquid chromatography-tandem mass spectrometry

Article

Author: Lin, Ya-Ting ; Sun, Hsin-Yun ; Su, Yi-Ching ; Cheng, Chih-Ning ; Hung, Chien-Ching ; Liu, Wen-Chun ; Tsai, Chuan-Ching ; Kuo, Ching-Hua

Tenofovir alafenamide/emtricitabine (TAF/FTC) is widely used for HIV treatment and prevention. Their intracellular metabolites, tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP), provide informative measures of drug exposure. Peripheral blood mononuclear cells (PBMCs) are the primary matrix for these measurements; however, their isolation is labor-intensive, limiting clinical applicability. This study evaluated dried blood spots (DBS) for assessing intracellular TFV-DP and FTC-TP exposure relative to PBMCs. Paired PBMC and DBS samples (n = 124) were analyzed using a validated LC-MS/MS method. Moderate correlations were observed between DBS and PBMC concentrations for TFV-DP (r = 0.44, p < 0.0001) and FTC-TP (r = 0.27, p = 0.0025), with stronger correlations in the central 80% of participants based on the DBS-to-PBMC concentration ratios (r = 0.61 and 0.44, respectively). Log-transformed Bland-Altman analysis, with more than 90% of samples falling within the 95% limits of agreement. Additionally, concentration distributions across different virological statuses were similar between DBS and PBMC. DBS samples (n = 44) were also collected at baseline and on day 29 from people with HIV receiving TAF/FTC in combination with isoniazid plus rifapentine (1HP) to demonstrate the applicability of DBS for investigating potential drug-drug interactions (DDIs). In conclusion, the observed moderate correlations between DBS and PBMC concentrations of TFV-DP and FTC-TP suggest that DBS may serve as a feasible sampling approach for population-level assessment of intracellular TFV-DP and FTC-TP exposure. The simplicity of DBS sample collection and handling may facilitate large-scale clinical studies and highlights its potential utility in future clinical research.

News (Medical) associated with Isoniazid

30 Jul 2026

·www.biospace.com

Meitheal Pharmaceuticals Announces FDA Approval of Garzulys™ (insulin aspart-fsan) Injection

FDA approves Garzulys™ (insulin aspart-fsan), a rapid-acting insulin analog to improve glycemic control in adults and pediatric patients with diabetes mellitus Meitheal serves as the U.S. Regulatory Agent for Garzulys and holds exclusive U.S. commercialization rights under its license agreement with Emerge, the BLA holder Approval marks an important milestone in Meitheal’s continued expansion into complex biologics and essential medicines CHICAGO--(BUSINESS WIRE)--Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company headquartered in Chicago and focused on the development and commercialization of generic injectable medicines, biologics, fertility products and branded medicines, today announced that the U.S. Food and Drug Administration (“FDA”) has approved Garzulys™ (insulin aspart-fsan) injection, a biosimilar to NovoLog ® (insulin aspart). Emerge Bioscience Pte. Ltd. (“Emerge”) is the holder of the approved Biologics License Application (BLA) for Garzulys. Meitheal serves as the product’s U.S. Regulatory Agent and holds exclusive U.S. commercialization rights under its license agreement with Emerge. Garzulys is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Garzulys formulations are approved for both subcutaneous and intravenous administration. Please see the Important Safety Information below. Garzulys was developed through a collaboration between Tonghua Dongbao Pharmaceutical Co., Ltd. (“Tonghua Dongbao”) and companies affiliated with Meitheal. Tonghua Dongbao was responsible for drug substance development, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (“NKF”) was responsible for drug product development, Xentria, Inc. (“Xentria”) led the clinical development program, and Meitheal, serving as the U.S. Regulatory Agent, led the U.S. regulatory work supporting FDA approval. Emerge is the BLA holder and is responsible for key supply-chain activities associated with the product. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); The collaboration initiated in 2023 between Tonghua Dongbao and NKF encompasses Garzulys and two additional insulin biosimilar candidates currently in development. Through its exclusive license agreement with Emerge, Meitheal holds exclusive U.S. commercialization rights for Garzulys and the two additional product candidates. “The FDA approval of Garzulys represents an important milestone in Meitheal’s continued expansion beyond our established generic injectable business and into a broader portfolio of biologics and branded products,” said Tom Shea, Chief Executive Officer of Meitheal. “We are making deliberate, long-term investments in the regulatory expertise, commercial infrastructure and strategic partnerships needed to expand patient access to high-quality biologic treatment options. Our leadership of the U.S. regulatory process for Garzulys demonstrates the strength of our platform and the disciplined execution we bring to complex products and global partnerships.” This approval further expands Meitheal’s presence in diabetes care and advances the company’s strategy to build a broader portfolio of biologics and branded products. Since its founding in 2017, Meitheal has developed a diversified U.S. platform supporting more than 80 FDA-approved products across therapeutic areas including anti-infectives, oncology, anesthesia, diabetes, critical care and fertility. INDICATIONS AND USAGE Garzulys™ (insulin aspart-fsan) injection is a rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. IMPORTANT SAFETY INFORMATION FOR GARZULYS™ Garzulys (insulin aspart-fsan) is biosimilar* to NovoLog (insulin aspart). Contraindications Garzulys™ is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Garzulys or one of its excipients. Warnings and Precautions Never Share a Garzulys Prefilled Pen between Patients, even if the needle is changed. Patients using Garzulys vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens. Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed. Hypoglycemia: Hypoglycemia is the most common adverse effect of all insulins, including insulin aspart products. Severe hypoglycemia can cause seizures, may lead to unconsciousness, may be life threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers), or in patients who experience recurrent hypoglycemia. Risk Factors for Hypoglycemia: The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulins, the glucose lowering effect time course of Garzulys may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature. Other factors which may increase the risk of hypoglycemia include changes in meal pattern, changes in level of physical activity, or changes to concomitantly administered medication. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia. Patients and caregivers must be educated to recognize and manage hypoglycemia. Hypoglycemia Due to Medication Errors: To avoid medication errors and accidental mix-ups between Garzulys and other insulin products, instruct patients to always check the insulin label before injection. Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with insulin products, including Garzulys. Hypokalemia: All insulins, including Garzulys, can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentration). Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including Garzulys. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered. Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction: Malfunction of the insulin pump or insulin infusion set or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Patients using insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure. Garzulys continuous subcutaneous infusion route (insulin pump): Do not mix Garzulys with any other insulin or diluent. Adverse Reactions Adverse reactions observed with Garzulys include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus. Drug Interactions Drugs that may increase the risk of hypoglycemia: antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics. Drugs that may decrease the blood glucose lowering effect: atypical antipsychotics, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Drugs that may increase or decrease the blood glucose lowering effect: alcohol, beta-blockers, clonidine, lithium salts, and pentamidine. Drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine. *Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of Garzulys has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. Please see Prescribing Information for Garzulys Additional Patient Information Leaflets are available at or call 1-844-824-8426. ABOUT MEITHEAL PHARMACEUTICALS, INC. Founded in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of generic injectable, biologic, fertility and branded products. Meitheal currently markets more than 80 FDA-approved products across therapeutic areas including anti-infectives, oncology, anesthesia, diabetes, critical care and fertility. Meitheal combines an established U.S. commercial platform with regulatory expertise and strategic development and manufacturing partnerships to support complex pharmaceutical products. Building on its foundation in generic injectables, the company is making deliberate, long-term investments to expand its biologics and branded portfolio and broaden access to high-quality, fairly priced medicines. Meitheal is guided by the traditional Irish principle for which it is named—working together toward a common goal, for the greater good. Learn more at . ABOUT TONGHUA DONGBAO PHARMACEUTICAL CO., LTD. Founded in 1985 and based in Jilin Province, China, Tonghua Dongbao Pharmaceutical Co., Ltd. (“Tonghua Dongbao”) is a biopharmaceutical company specializing in the research, development, manufacturing and commercialization of therapies for diabetes and other endocrine and metabolic diseases. In 1998, Tonghua Dongbao developed China’s first domestically produced recombinant human insulin. The company’s portfolio and pipeline include human insulin, insulin analogs, GLP-1 receptor agonists and other therapies for diabetes and related metabolic conditions. Tonghua Dongbao is publicly listed on the Shanghai Stock Exchange under stock code 600867. ABOUT EMERGE BIOSCIENCE PTE. LTD. Established in 2024 and based in Singapore, Emerge Bioscience Pte. Ltd. (“Emerge”) is a subsidiary of Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (“NKF”) that supports NKF’s international pharmaceutical trading and supply-chain activities. Emerge coordinates with manufacturers, regulatory authorities, logistics providers and commercial partners to support the reliable, compliant and timely delivery of pharmaceutical products and NKF’s broader international growth strategy. ABOUT NANJING KING-FRIEND BIOCHECMICAL PHARMACEUTICAL CO., LTD. Founded in 1986 and headquartered in Nanjing, China, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (“NKF”) is an integrated biopharmaceutical company engaged in the research, development and manufacturing of active pharmaceutical ingredients and finished dosage forms. Building on its established expertise in heparin APIs and sterile injectable products, NKF has expanded its capabilities across generic, biologic and branded products in therapeutic areas including oncology, critical care, fertility and diabetes. NKF supports products and partners in the United States, China, Europe and other global markets and is publicly listed on the Shanghai Stock Exchange under stock code 603707. ABOUT XENTRIA, INC. Established in 2020, Xentria Inc. (“Xentria”) works across life science communities creating innovative and authentic collaborations and partnerships that advance challenging drug development. Xentria, derived from “centrality”, is dedicated to delivering customized approaches to ambitious drug innovation through meaningful patient engagement and effective partnerships. Headquartered in Chicago, Xentria is taking the lead to support surging life sciences initiatives for global audiences, while nurturing diversity, individualism, and sustainability. To learn more about Xentria visit MAT-US-BIO-00002-1 07/2026 Contacts MEDIA CONTACT Meitheal Pharmaceuticals, Inc. John Spilman, VP of Corporate Strategy 773 899 5910 info@meithealpharma.com

License out/inDrug Approval

20 Jul 2026

·www.prnewswire.com

Akagera Medicines Reports Positive First-in-Human Data for Single-Ascending-Dose of AKG-100, Advancing a Potentially Transformative Long-Acting Therapeutic for Drug-Resistant Tuberculosis

Favorable safety and tolerability across all dose levels; pharmacokinetics support the potential for infrequent dosing; multiple-ascending-dose study now underway KIGALI, Rwanda, July 20, 2026 /PRNewswire/ -- Akagera Medicines, Inc., a clinical-stage biopharmaceutical company developing lipid-nanoparticle therapeutics and vaccines for infectious diseases that disproportionately affect the majority world, together with the TASK Clinical Research Center in South Africa, today announced positive results from the single-ascending-dose (SAD) portion of the first-in-human Phase 1 study of AKG-100, the company's investigational long-acting intravenous (IV) therapeutic being developed to transform the treatment of tuberculosis including drug-resistant tuberculosis (DR-TB). The SAD study evaluated single IV doses of AKG-100 across a range of dose levels in 40 healthy volunteers and 15 patients with pulmonary tuberculosis in a 14-day Early Bactericidal Activity (EBA) cohort. AKG-100 was well tolerated at every dose studied, up to and including the highest dose of 850 mg. The overall safety profile was favorable; no participants discontinued due to adverse events and most adverse events were mild and self-limiting. AKG-100 demonstrated a pharmacokinetic profile consistent with a long-acting profile. Following a single dose, drug concentration was maintained above the pre-specified target threshold for at least 14 days following a single administration while the modeled concentration-time profiles support exposure being maintained over 28 days. These findings support the potential for dosing measured in weeks to months rather than every day. If confirmed in later studies, that profile would represent a significant departure from current treatment regimens, which require daily oral dosing for six months or longer and for which adherence over the full course remains one of the central challenges in tuberculosis care. AKG-100 acts through a mechanism that is independent of rifampicin and isoniazid, the backbone of first-line tuberculosis treatment, and we have demonstrated with clinical isolates that it retains its full activity in multidrug-resistant strains. In an exploratory, model-based analysis of the tuberculosis-patient EBA cohort, a single dose of AKG-100 on day 1 was associated with an estimated 3.7 log 10 reduction in bacterial burden by day 14, corresponding to an approximately 99.98% bacterial killing. The analysis also demonstrated a substantial increase in time to culture positivity by Day 14 with a model predicted improvement of approximately 298 hours from baseline. While these are early findings and model-derived signals from single-dose cohorts, they compare favorably with historical early bactericidal activity benchmarks and support continued clinical evaluation. On the strength of these results, the multiple-ascending-dose (MAD) portion of the Phase 1 program is now underway. Dr. Sachin Marulkar, Chief Medical Officer, Akagera Medicines "These first-in-human results are an important milestone for the patients who today face many months of daily treatment for tuberculosis. AKG-100 was well tolerated at every dose we studied, and its pharmacokinetic profile points toward dosing measured in months rather than days. If that profile holds through later studies, it could change what a course of DR-TB treatment looks like, particularly in the settings where the burden of this disease is greatest." Prof. Andreas Diacon, Founder and Chief Scientific Officer, the TASK Group "Akagera's approach to tuberculosis treatment is undoubtedly the most innovative TASK has explored in its 20-year history. Early results with AKG-100 show good tolerability and safety alongside strong bactericidal activity. If follow-up studies are successful, AKG-100 could revolutionize tuberculosis treatment. Beyond being a new antibiotic, AKG-100 has the potential to transform how patients and caregivers experience tuberculosis treatment. Long-acting agents can significantly reduce pill burden, shorten treatment duration, improve compliance, and combat the emergence of resistance." Dr. Daryl Drummond, Co-Founder and Chief Scientific Officer, Akagera Medicines "AKG-100 is built on a lipid-nanoparticle delivery platform with an approved clinical precedent, and this study is the first human evidence that the platform can carry a tuberculosis therapeutic with the long-acting exposure for which it was engineered. Sustaining levels above our target threshold from a single dose, alongside a clean safety readout, is exactly the proof of concept we were looking for as we move into multiple-dose testing." Michael Fairbanks, Co-Founder and Executive Chairman, Akagera Medicines "Tuberculosis is the oldest pandemic we know. It has stalked humankind for nine thousand years under various names: consumption, the white plague, "the captain of all the men of death." It has killed more people than any disease in history, and it still kills more than a million every year. It falls hardest on the people who have the least say over their own medicines. AKAGERA Medicines is majority-owned by the people of Rwanda. The company produced the first human data on a long-acting protocol. We intend to prove that innovations created and owned by the people who bear the greatest burden is the best way to finally end the pandemic." About AKG-100 AKG-100 is Akagera Medicines' lead therapeutic candidate, a long-acting IV treatment for tuberculosis delivered on the company's proprietary lipid-nanoparticle platform. It is designed to provide sustained drug exposure from infrequent dosing and to remain active against strains susceptible or resistant to currently recommended therapy. As a first aim, AKG-100 could help address major barriers in MDR-TB treatment, including adherence challenges, treatment interruptions, and the complexity of current multidrug regimens. About Akagera Medicines Akagera Medicines, Inc. is a clinical-stage biopharmaceutical company developing messenger-RNA and lipid-nanoparticle therapeutics and vaccines for infectious diseases that disproportionately affect the Global South, including tuberculosis, nontuberculous mycobacterial disease, RSV, HIV, Lassa fever, and Malaria, influenzas well as Avian Flu and next generation Mumps vaccines. Founded in 2018 and majority-owned by the Rwanda Social Security Board on behalf of Rwanda's 14 million citizens, the company has partnered with the European Investment Bank, CEPI, the NIH/VRC, and the Gates Foundation. It operates in Kigali, Rwanda, San Francisco, California, and Waltham, Massachusetts, and is building sovereign strategic, scientific, and trials capabilities in Africa. About the TASK Group TASK is a global clinical research organization dedicated to advancing healthcare through innovative and ethical clinical trials. Its origins lie in Cape Town, South Africa, where TASK has conducted many pioneering clinical evaluations of novel tuberculosis antibiotics, vaccines or diagnostics in the past. TASK is covering a variety of therapeutic area at clinical sites in South African and Europe. Forward-Looking Statements This release contains forward-looking statements regarding AKG-100 and its clinical development, including statements about dosing potential and future studies. These statements are based on current expectations and are subject to risks and uncertainties inherent in drug development. Results from early-phase studies may not be predictive of results in later studies, and product candidates that appear promising in early development may fail to demonstrate efficacy or safety in subsequent clinical trials. Akagera Medicines undertakes no obligation to update these statements except as required by law. Media Contact Sachin Marulkar, MD, MPH, MBA Email: [email protected] Akagera Medicines, Inc. SOURCE Akagera Medicines Inc 21% more press release views with Request a Demo

Clinical ResultPhase 1Vaccine

02 Jun 2026

·www.cidrz.org

Strengthening Drug-Resistant Tuberculosis Detection Through Reflex MTB/XDR Testing in Zambia.

The Centre for Infectious Disease Research in Zambia (CIDRZ) successfully presented findings from a study assessing the feasibility and utility of reflex Xpert MTB/XDR testing during the CIDRZ Research Meeting held at its headquarters in Lusaka. The study was conducted as part of a four-week active Drug Resistant tuberculosis case finding surge implemented across 39 high TB burden facilities in five provinces of Zambia. The research evaluated how reflex MTB/XDR testing can support rapid detection of resistance to isoniazid, fluoroquinolones, ethionamide and aminoglycosides among bacteriologically confirmed tuberculosis patients, regardless of rifampicin resistance status. Presenting the findings, Dr. Phallon Mwaba, Deputy Chief of Party for TBLON, said the study analysed programmatic data collected during the May 2025 TB surge and assessed the operational feasibility of integrating reflex MTB/XDR testing into routine diagnostic workflows. Dr Mwaba noted that the findings revealed that 8.5% of bacteriologically confirmed tuberculosis patients had some form of drug-resistant tuberculosis. Importantly, 37.5% of all drug-resistant TB cases identified were non-rifampicin resistant and would likely have been missed using standard rifampicin-centric diagnostics diagnostic methods like the GeneXpert MTB/Rif ultra. He further highlighted that mono-resistance accounted for the majority of drug-resistant TB detected, demonstrating the importance of expanding beyond rifampicin-centric testing approaches in order to improve early detection and treatment of different forms of drug-resistant tuberculosis. The presentation emphasized that reflex MTB/XDR testing proved operationally feasible across primary care, hospital and referral facilities, delivering rapid and actionable results that can support individualized treatment, strengthen drug resistant tuberculosis control efforts and contribute to the elimination of drug-resistant tuberculosis in Zambia.

Clinical 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.

to view more data

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.

to view more data

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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04930744 (METHOD, CTgov)	Phase 2	Pulmonary Tuberculosis \| HIV Infections	112	Ethambutol+Rifampicin+Isoniazid+Pyrazinamide (Standard Tuberculosis Medicines)	ztjvwdoelg = trynykwmed oxexahztnp (lcttavjqwl, aalldbtwti - cubzfasosc) View more	-	06 Aug 2026
				Ethambutol+Rifampicin+Isoniazid+Metformin hydrochoride+Pyrazinamide (Standard Tuberculosis Medicines and Metformin)	ztjvwdoelg = fwbqucmrba oxexahztnp (lcttavjqwl, inudwikiqo - xpvmoowsuu) View more
IAS2026	Not Applicable	Tuberculosis	1,063	3HP (isoniazid-rifapentine)	agymhpqjfe(xcokfyhtzv) = gzovzolpbu ulxhisevty (ldlhavhqsm ) View more	Positive	26 Jul 2026
				INH-based TPT	agymhpqjfe(xcokfyhtzv) = nizkbnkcbk ulxhisevty (ldlhavhqsm ) View more
IAS2026	Not Applicable	Latent Tuberculosis	15	Isoniazid and rifapentine	csjicxvnhi(nlwlpstvic) = zyrmnlbaci gwehnucshh (rrcmrtuyjr ) View more	Positive	26 Jul 2026
NCT05630872 (CTgov)	Phase 2	Tuberculosis \| Pulmonary Tuberculosis	30	TDF/3TC+Dolutegravir+rifapentine+moxifloxacin+isoniazid+pyrazinamide	cazvvfoxds = cldnfgyrod cgpefnivcp (trogsicrnn, myzocpsepu - prxbwxwglo) View more	-	20 Jul 2026
NCT05413551 (CTgov)	Phase 1	Tuberculosis \| Latent Tuberculosis \| Poisoning by isoniazid	78	isoniazid (Rapid Acetylator)	ugwcdtswkn(jlyondychp) = xmqwvcuokp pnswjzaewx (pumguvcykn, vyzqgwdewo - bdvazsfzyb) View more	-	15 Jun 2026
				isoniazid (Intermediate Acetylator)	ugwcdtswkn(jlyondychp) = vfshdhbnoh pnswjzaewx (pumguvcykn, eeqrqixzxi - jbrpjvghhv) View more
NCT00164281 (CTgov)	Phase 4	Tuberculosis \| HIV Infections	1,995	Isoniazid (Continuous Isoniazid Arm)	hriwflfaqr = xcarbbwaqz rsigelafjb (nywvkugyht, rnzxjgmpao - crzchmxeur) View more	-	27 May 2026
				Placebo+Isoniazid (Limited (Placebo) Isoniazid Arm)	hriwflfaqr = yvayygwyrv rsigelafjb (nywvkugyht, zahnaqxxfp - qnxotfwmnh) View more
NCT02457208 (Pubmed \| Trop Med Int Health)	Phase 2	Tuberculosis	61	Standard anti-TB therapy (HIV co-infected)	ftrwxqzvah(xxymeuatwe) = Baseline CRP showed an inverse association after adjustment, but this did not reach statistical significance (OR = 0.98, 95% CI: 0.96-1.00, p = 0.06). rrashennzm (ehticotgch ) View more	Positive	19 May 2026
				Standard anti-TB therapy (Without HIV co-infection)
EHA2026	Not Applicable	Latent Tuberculosis	225	Isoniazid preventive therapy (IPT) (Hematopoietic stem cell transplant recipients with latent TB infection (LTBI))	fctcevyeno(glgjaoekew) = vjvemqwsee xgitighynx (jsfhuqqqpj )	Positive	12 May 2026
				Placebo	-
NCT04703075 (Pubmed \| PLoS Med)	Phase 4	Latent Tuberculosis	500	1 month of rifapentine and isoniazid	pklpfbuxqj(fmztzuyfyr) = czftlizjoy bgyablrrry (iuuibjcrjw ) View more	Negative	10 Feb 2026
				3 months of rifapentine and isoniazid	pklpfbuxqj(fmztzuyfyr) = dajpbeavss bgyablrrry (iuuibjcrjw ) View more
NCT04311502 (Clo-Fast, CTgov)	Phase 2	Tuberculosis \| Pulmonary Tuberculosis \| HIV Infections	104	Ethambutol+Rifapentine+Clofazimine loading dose+Isoniazid+Pyrazinamide (Arm 1: Experimental)	bpsifhomsl(zjssrmleus) = rwkjneyuuk dakxbyafal (tawdautgsg, kxwdwaktwt - xmwthkmrgk) View more	-	27 Aug 2025
				Ethambutol+Rifampicin+Isoniazid+Pyrazinamide (Arm 2: Standard of Care)	bpsifhomsl(zjssrmleus) = ukdaapepwv dakxbyafal (tawdautgsg, dlmfopqkrk - ulpwkzhbaj) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

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

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis