ambroxol oral / Generic mfg. - LARVOL DELTA

A DECADE OF EVOLUTION: MANAGING CHRONIC BRONCHIECTASIS WITH AZITHROMYCIN AND NEBULIZED GENTAMICIN AFTER CIPROFLOXACIN RESISTANCE (MTS 2025) - "Case Report A 48-year-old male with Marfan's syndrome, post-tuberculosis bronchiectasis and post-lobectomy was initially treated with erythromycin and cyclical ciprofloxacin, which led to resistance after 3 years. Treatment was adjusted to azithromycin 250 mg thrice weekly and nebulized gentamicin 80 mg twice daily, with Ambroxol as mucolytic...Conclusion This case demonstrates that individualised treatment with azithromycin and nebulized gentamicin are effective in managing chronic respiratory infections in bronchiectasis. Multidisciplinary collaboration is crucial in ensuring efficacy and safety through proper medication use, adverse drug effects and drug interaction monitoring, education on nebulizer technique and adherence."

Bronchiectasis • Genetic Disorders • Immunology • Infectious Disease • Inflammation • Influenza • Non‐Cystic Fibrosis Bronchiectasis • Pneumococcal Infections • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Ambroxol mitigates renal ischemia/reperfusion-induced cardiac and renal injury via Nrf2/HO-1 activation and TLR4 pathway inhibition. (PubMed, J Pharm Pharmacol) - "Ambroxol's cardio-renal protecting potential was elicited by inhibiting oxidative stress, inflammation, and mitochondrial dysfunction through activating the Nrf2/HO-1 pathway and inhibiting multiple TLR4-interconnected signaling pathways, thus affording a theoretical base for ambroxol's clinical use in renal IR-induced injuries."

Journal • Acute Kidney Injury • Cardiovascular • Inflammation • Metabolic Disorders • Nephrology • Renal Disease • Reperfusion Injury • HIF1A • IL1B • TLR4 • TNFA

AMBITIOUS: Ambroxol as a Disease-modifying Treatment in GBA-PD (clinicaltrials.gov) - P2 | N=65 | Completed | Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | Active, not recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Movement Disorders • Parkinson's Disease • GBA • GBA1

An Open Label Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacologic Properties of High Dose Ambroxol Hydrochloride in Adult (≥ 18 Years of Age) Subjects With MPS III (clinicaltrials.gov) - P2/3 | N=10 | Recruiting | Sponsor: Ozlem Goker-Alpan | Not yet recruiting ➔ Recruiting | Trial completion date: Feb 2026 ➔ Jun 2026

Enrollment open • Trial completion date • Lysosomal Storage Diseases

Natural sunlight-driven phototransformation of the expectorant drug ambroxol in freshwaters. (PubMed, Environ Sci Process Impacts) - "Kinetic modeling predicted half-lives ranging from 2 to 4 days in well-mixed lake water columns (depth = 3 m, [DOC] = 5 mg C L-1). These findings highlight the significant role of direct photolysis in determining AMB's environmental fate in sunlit surface waters and provide insights into the photochemical behavior of pharmaceuticals in aquatic environments."

Journal

Efficacy and safety of inhaled ambroxol solution in improving sputum of lower respiratory tract infection in children: a multicenter, randomized, double-blind, placebo-controlled trial. (PubMed, BMC Pulm Med) - P3 | "Inhaled ambroxol solution could improve the sticky sputum symptoms in children with LRTIs and is safe in clinical application. Further research is needed to confirm these findings."

Clinical • Journal • Cough • Infectious Disease • Respiratory Diseases

Clinical Study on Xiao'er Huangjin Zhike Granules Combined with Ambroxol Hydrochloride in the Treatment of Infantile Acute Bronchitis (ChiCTR) - P=N/A | N=120 | Not yet recruiting | Sponsor: Shanghai Children's Hospital; Changchun Jinyian Pharmaceutical Co., Ltd.

New trial • Pulmonary Disease • Respiratory Diseases

Ambroxol confers neuroprotection against scopolamine-induced Alzheimer's-like pathology by modulating oxidative stress, neuroinflammation, and cognitive deficits via Nrf-2/JNK/GSK-3β signaling pathways. (PubMed, Front Aging Neurosci) - "Scopolamine also compromised synaptic integrity and induced deficits in memory formation and spatial learning. In contrast, ambroxol promoted synaptic integrity by upregulating the expression of SNAP-23 and PSD-95, thereby ameliorating scopolamine-induced impairments in spatial learning and memory."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Inflammation • FAP • GFAP • HMOX1 • IL1B • MAPK8 • TNFA

Combination therapy in pediatric bronchitis: Examining mucolytic, bronchodilator and anti-inflammatory drug effects on secretion management and recovery time. (PubMed, Pak J Pharm Sci) - "This study investigated the effectiveness of combining mucolytic agents (ambroxol hydrochloride), bronchodilators (terbutaline sulfate), and anti-inflammatory drugs (budesonide) in treating pediatric bronchitis. No significant difference in adverse reactions was observed between the groups (P>0.05). The findings suggest that the combined therapy of mucolytic agents, bronchodilators and anti-inflammatory drugs is highly effective in treating pediatric bronchitis, offering significant benefits in symptom improvement, pulmonary function enhancement, inflammatory reduction, sleep improvement, and airway clearance."

Journal • Cough • Pediatrics • Pulmonary Disease • Respiratory Diseases • IL6 • TNFA

Clinical study on modified Shenzhe Zhenqi Decoction combined with ambroxol hydrochloride in the treatment of severe pneumonia. (PubMed, Front Physiol) - "The incidence of adverse events was 4.35% in the combined group and 2.90% in the control group (P > 0.05). Modified Shenzhe Zhenqi Decoction combined with ambroxol hydrochloride demonstrated ideal clinical efficacy in treating severe pneumonia, alleviating symptoms and pulmonary inflammation and improving arterial blood gas indicators and lung function."

Journal • Cough • Infectious Disease • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • CRP • IL6 • TNFA

Recurrent Cough in a Pediatric Patient From China: A Case Report of Bordetella pertussis Infection With Genomic Insights. (PubMed, Cureus) - "Despite treatment with azithromycin, ambroxol, and nebulization, the cough symptoms did not improve, leading to multiple hospital admissions. Notably, genomic analysis during the first hospital stay discovered an A2047G mutation in the 23S rRNA gene of B. pertussis, indicating resistance to macrolide drugs; however, subsequent tests showed that this mutation had disappeared. This case highlights the complexity of diagnosing and treating persistent cough in pediatric patients and underscores the importance of targeted next-generation sequencing in identifying resistance and co-infections, ultimately enabling more precise and effective treatment strategies for challenging respiratory infections in children."

Journal • Chronic Cough • Cough • Infectious Disease • Influenza • Novel Coronavirus Disease • Pediatrics • Pertussis • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections • CRP

Ambroxol alleviates hippocampus injury after BRIR through suppression of the IRE1α/TRAF2 signaling pathway. (PubMed, Life Sci) - "Finally, BRIR induces both renal and hippocampal injury. Ambroxol mitigates this damage by reducing oxidative stress and inflammation, repairing BBB components, and regulating endoplasmic reticulum stress pathways (ERS)."

IO biomarker • Journal • Acute Kidney Injury • Cardiovascular • Inflammation • Nephrology • Renal Disease • Reperfusion Injury • BAX • BCL2 • CLDN5 • IL1B • KIM1 • OCLN • TNFA

LC-MS/MS-Based Determination of Ambroxol in Human Plasma and Cerebrospinal Fluid: Validation and Applicability in a Phase II Study on GBA-Associated Parkinson's Disease Patients. (PubMed, Int J Mol Sci) - "We evaluated and confirmed the stability of the analyte in plasma and CSF across various storage conditions. The method was successfully validated according to European Medicine Agency (EMA) guidelines and its applicability was confirmed in the context of a multicenter, randomized, double-blind, placebo-controlled, phase II study, designed to monitor the ambroxol levels in the plasma and CSF of GBA1-PD."

Clinical • Journal • P2 data • CNS Disorders • Movement Disorders • Parkinson's Disease • GBA1

Efficacy and safety of inhaled ambroxol hydrochloride solution in patients with lower respiratory tract infectious diseases: a randomized, double-blind, placebo-controlled, multicentre clinical trial. (PubMed, BMC Infect Dis) - "Inhaled ambroxol is better at ameliorating respiratory symptoms and has comparable safety to placebo in patients with LRTI diseases."

Clinical • Journal • Cough • Infectious Disease • Respiratory Diseases

Ambroxol as a Treatment for Parkinson Disease Dementia: A Randomized Clinical Trial. (PubMed, JAMA Neurol) - P2 | "However, the effect of ambroxol on cognition was not confirmed. ClinicalTrials.gov Identifier: NCT02914366."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Movement Disorders • Parkinson's Disease • Progressive Supranuclear Palsy

Ambroxol induces myeloma cell death by inhibiting autophagy. (PubMed, Blood Neoplasia) - "Existing anti-MM drugs demonstrate various effects on autophagy; panobinostat, a histone deacetylase inhibitor, induces autophagy, whereas bortezomib and lenalidomide do not. Gene set enrichment and pathway analyses also revealed that ambroxol increased the expression of genes related to autophagy inhibition and unfolded protein response. These results suggested that autophagy is a promising therapeutic target for MM."

Journal • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • MCL1

Modulation of NF-κB/NLRP3 inflammasome axis Nrf2/HO-1 signaling and attenuation of oxidative stress mediate the protective effect of ambroxol against cyclophosphamide cardiotoxicity. (PubMed, Biochem Biophys Res Commun) - "In conclusion, ABX confers significant protection against CP-induced cardiotoxicity through multifaceted mechanisms, including attenuation of oxidative stress, inhibition of NF-κB/NLRP3 inflamamsome axis, and upregulation of Nrf2/HO-1 signaling. These findings suggest that ABX could serve as an effective adjunct therapy to improve the safety profile of CP in clinical oncology."

Journal • Cardiovascular • Inflammation • Oncology • IL1B • NLRP3

Multisite Active Material for High-Performance Blue Perovskite Light-Emitting Diodes and Active-Matrix Displays. (PubMed, ACS Nano) - "Here, we investigate a biopharmaceutical agent, ambroxol hydrochloride (AMB), with multifunctional groups as a multifunctional perovskite crystallization regulator...High-quality active-matrix array displays are further demonstrated, achieving precise independent control of each pixel. These displays exhibit superior brightness and color consistency, making them highly promising for advanced optoelectronic applications."

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Cost-effectiveness analysis of ambroxol for the treatment of Chinese patients with Gaucher disease. (PubMed, Front Med (Lausanne)) - "Sensitivity analysis showed that the cost of imiglucerase had a significant effect on ICER as well as demonstrating the stability of the results. Ambroxol combination therapy is a cost-effective regimen compared with imiglucerase monotherapy."

HEOR • Journal • Gaucher Disease • Genetic Disorders • Metabolic Disorders

Safety and efficacy of inhalable ambroxol hydrochloride aerosol for adult patients with respiratory diseases: an open-label, single-arm, multicentre study. (PubMed, BMJ Open Respir Res) - P4 | "Inhalable ambroxol hydrochloride aerosol is well tolerated and effective in easing expectoration and alleviating cough, reducing sputum and improving the QoL of adult patients with acute and chronic respiratory diseases."

Journal • Chronic Obstructive Pulmonary Disease • Cough • Infectious Disease • Respiratory Diseases

The safety, tolerability, pharmacokinetics, and pharmacodynamics of nebulized pegylated interferon α-2b in healthy adults: a randomized phase 1 trial. (PubMed, BMC Pharmacol Toxicol) - P1 | "Nebulized PegIFNα-2b at doses of 90 µg and 180 µg showed acceptable safety and tolerability. Minimal systemic absorption was observed following inhalation. Further studies are needed to explore its potential, especially in patients with lower respiratory tract infections."

Clinical • Journal • P1 data • PK/PD data • Hematological Disorders • Infectious Disease • Leukopenia • Respiratory Diseases • IFNA1

An advanced inhalable dry powder, mucus-penetrating aerosol platform: Bridging Andrographolide delivery with clinical translation. (PubMed, Biomaterials) - "The platform encapsulates Andrographolide, a bioactive compound derived from traditional Chinese medicine, together with a chitosan-ambroxol coating to achieve mucus penetration, sequential drug release, and prolonged retention in the lungs...In murine models of acute lung injury (ALI), bacterial pneumonia (Klebsiella pneumoniae), and fungal pneumonia (Candida albicans), HCLplga-Ab demonstrated enhanced mucus penetration and biofilm destruction, uniform and prolonged drug retention in the lungs, and significant reduction in inflammation and pathogen burden. This versatile platform bridges traditional medicine with modern aerosol technology, offering a promising solution for respiratory disorders and clinical translation."

Journal • Acute Lung Injury • Infectious Disease • Inflammation • Pneumonia • Pulmonary Disease • Respiratory Diseases

ASPro-PD: Ambroxol to Slow Progression in Parkinson Disease (clinicaltrials.gov) - P3 | N=330 | Recruiting | Sponsor: University College, London | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2028 ➔ Sep 2029 | Trial primary completion date: Mar 2027 ➔ Feb 2029

Enrollment open • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease • GBA1

Evaluation of Additive Neuroprotective Effect of Combination Therapy for Parkinson's Disease Using In Vitro Models. (PubMed, Antioxidants (Basel)) - "We demonstrated that some of the medications, used in combination, can exert an additive neuroprotective effect in preclinical models of PD that is superior to that of each of the compounds individually. This project can lead to the development of the first treatment for PD that can slow or prevent its progression."

Journal • Preclinical • CNS Disorders • Movement Disorders • Parkinson's Disease • NEFH

Product Development of High-Dose Ambroxol HCl Capsules for an n-of-1 Clinical Trial Involving Dutch Patients with Gaucher Disease Type 3. (PubMed, Pharmaceutics) - "No degradation products or microbiological impurities were detected after production. The optimized formulation of 75 mg AMB capsules formulated within the hospital pharmacy setting resulted in qualitative and uniform capsules which can be used in clinical trials."

Journal • Gaucher Disease • Genetic Disorders • Metabolic Disorders • Rare Diseases