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ambroxol (ambroxol, Diffucaps)

✓ Approved

Adare Pharma Solutions · Small Molecule · Small Molecule

What is ambroxol?

ambroxol is a small molecule developed by Adare Pharma Solutions. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand Namesambroxol, Diffucaps
CompanyAdare Pharma Solutions
Drug ClassSmall Molecule
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Adare Pharma Solutions

Therapeutic Indications

ambroxol is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Respiratory, thoracic and mediastinal disordersBronchitis chronic✓ Approved

Related Research Articles

PubMedEuropean journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V2026-11-10

Antibacterial, antibiofilm, mucus penetration properties and pulmonary biocompatibility of inhalable spray-dried levofloxacin-ambroxol composite microparticles.

Suraweera Ruwani K RK, Panthi Vijay Kumar VK, Hickson Sarah M SM, Yarlagadda Tejasri T et al.

This study evaluated the antibacterial and biofilm-disruption activities of spray-dried levofloxacin (LVX) and ambroxol (AMB) composite dry powder inhaler (DPI) formulations against laboratory and clinical strains of P. aeruginosa and a clinical S. aureus strain. Cytotoxicity and pro-inflammatory activity of the formulations were investigated in THP-1 derived macrophages, healthy and COPD bronchial epithelial cells (HBE), and mucus penetration using an artificial mucus model. Spray dried LVX retained antibacterial activity against PA14 (MIC50 0.075-0.099 µg/mL versus 0.076 µg/mL for free LVX), whereas free AMB showed no antibacterial activity. Formulations containing higher AMB proportions, exhibited greater antibacterial activity than free LVX against AUST-02 and 2.1. The developed formulations also enhanced biofilm disruption against PA14 and AUST-02. AMB improved penetration of spray-dried LVX, particularly with F4 (LVX:AMB 1:1 with 5 % leucine) showing statistically significant (p < 0.05) penetration enhancement compared to free LVX (60.8 % and 82.8 % in 2 h) at 16 µg/mL. All formulations maintained high cell viability (>83 %) in THP-1 macrophages, while no significant cytotoxicity or increase in IL-8 production was observed. Overall, the prepared composite antibiotic microparticles demonstrated superior antibacterial activity against the tested clinical strains, enhanced biofilm disruption and LVX mucus penetration, while preserving pulmonary biocompatibility in the tested cell models.

PMID 43008901
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PubMedBrazilian journal of otorhinolaryngology2026-10-31

Exploring the role and mechanism of methionine metabolism in chronic rhinosinusitis with nasal polyps based on bioinformatics analysis.

Lin Dan D

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) affects 1%-4% of the global population with high recurrence rates. While methionine metabolism abnormalities contribute to various inflammatory diseases, their role in CRSwNP pathogenesis remains unclear. This study aimed to systematically investigate the role of methionine metabolism in CRSwNP and identify potential biomarkers and therapeutic targets through integrating multi-omics data and interpretable machine learning approaches. CRSwNP transcriptomic datasets (GSE136825, GSE179265) and single-cell data (GSE276503) were obtained from GEO database. Single-cell RNA sequencing analysis, differential expression analysis using limma, and Weighted Gene co-expression Network Analysis (WGCNA) were performed to identify methionine metabolism-related candidate genes. Three machine learning algorithms (LASSO, SVM-RFE, XGBoost) with SHAP interpretation screened core genes. Functions and mechanisms were explored through single-gene GSEA, ceRNA network construction, transcription factor prediction, immune infiltration analysis, and pseudotime trajectory analysis. Potential therapeutic drugs were identified via molecular docking. Among 14 candidate genes, CSTB, IGFBP3, and TCN1 were identified as core genes with excellent diagnostic performance (AUC > 0.85). SHAP analysis revealed CSTB and IGFBP3 as disease risk-promoting factors, while TCN1 showed protective effects. Single-cell analysis demonstrated all three genes were predominantly expressed in epithelial cells with significant differential expression patterns. They were enriched in primary immunodeficiency pathways and significantly correlated with immune cell infiltration, particularly M2 macrophages and activated dendritic cells. Molecular docking identified five potential therapeutic drugs including ambroxol, carbamazepine, and curcumin with favorable binding energies. Methionine metabolism participates in CRSwNP pathogenesis by regulating CSTB, IGFBP3, and TCN1, affecting epithelial cell function and immune microenvironment. These genes represent promising biomarkers for diagnosis and potential therapeutic targets, providing theoretical basis for developing metabolic-immune intervention strategies in CRSwNP management.

PMID 42965986
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PubMedPerspectives in clinical research2026-10-28

Patterns of irrational drug use in pediatric acute respiratory infections: A hospital- based cross- sectional study in South India.

Abimannane Anitha A, Kommu Peter Prasanth Kumar PPK, Dhodapkar Rahul R, Krishnakumar Gowshika G

Irrational drug use is a growing public health concern, with the World Health Organization estimating that 50% of prescriptions worldwide are irrational. Data on rational drug prescriptions for acute respiratory infections (ARIs) in children are limited. Children under 14 years of age with ARIs visiting a tertiary care hospital in South India were enrolled. Data on prescriptions, demographics, and clinical information were collected and analyzed. A total of 156 children (median age: 2 years, 53.8% male) were enrolled. The most common ARI was upper respiratory tract infection (65.3%), followed by viral bronchiolitis/pneumonia (22.3%). Of 262 prescriptions, 86.2% were written by physicians, and 13.7% were self-prescribed. The median number of drugs per child was 3 (range: 2-5). Antibiotics were included in 58.8% of physician prescriptions (97.7% irrational), and 61.9% included cough medications (65.7% irrational). A viral pathogen was detected in 35% of children who received antibiotics. Commonly prescribed antibiotics were cephalosporins and amoxicillin-clavulanate, while cough syrups included chlorpheniramine-phenylephrine, levosalbutamol, ambroxol, and guaifenesin. Only 12.3% of prescriptions used generic drug names, and polypharmacy (≥2 medications) was found in 81.4% of prescriptions. Presence of sore throat and respiratory distress were associated with antibiotic prescription by physicians. This study highlights a high prevalence of irrational drug use in children with ARIs, with inappropriate antibiotic and cough medication prescriptions. There is a need for better prescribing practices, diagnostic accuracy, and adherence to evidence-based guidelines.

PMID 42948800
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PubMedEnvironmental science & technology2026-10-23

Functional Groups in Pharmaceutical Contaminants Reshape Sludge Fermentation Pathways: Substrate Selectivity and Microbial Stress Responses.

Zheng Xiong X, Niu Qiuqi Q, Cui Zihan Z, Sun Chuanzhi C et al.

The post-COVID-19 era has led to a dramatic increase in the consumption of respiratory pharmaceuticals, leading to their inevitable accumulation in waste-activated sludge. Although the impact of these contaminants on anaerobic resource recovery has been recognized, the specific contribution of their functional groups, which are fundamental determinants of chemical reactivity, remains largely overlooked. This study challenges traditional generalized assessments by using two structural analogues, hydroxyl-functionalized ambroxol hydrochloride (AMB) and tertiary amine-functionalized bromhexine hydrochloride (BRO), to reveal the role of functional groups in altering volatile fatty acid (VFA) production. AMB demonstrated a biphasic dose response, whereas BRO showed a relatively stable enhancement pattern, reflecting distinct fermentation profiles driven by functional group variation. The hydroxyl group of AMB exhibited a low promotion and high inhibition dose response, wherein this moiety interacted with proteins via hydrogen bonds, enriching proteolytic bacteria. However, excessive accumulation induced severe oxidative stress, forcing microorganisms to shift their energy from acidogenesis to multidrug efflux pumps for survival. Conversely, the tertiary amine group of BRO drove a continuous and monotonic enhancement of the VFA yields. This group targeted polysaccharides through hydrophobic interactions, enriching the glycolytic bacteria. Consequently, upregulated carbohydrate metabolism provided key precursors for membrane repair, thereby sustaining metabolic activity, even under high stress.

PMID 42915391
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PubMedFrontiers in pharmacology2026-10-09

Incidence, burden, and associated factors of severe potential drug-drug interactions in intensive care unit patients: a real-world retrospective study.

Jiang Huaqiao H, Shen Tingting T, Yang Yun Y, Zhang Lin L et al.

Severe potential drug-drug interactions (pDDIs) in intensive care unit (ICU) patients remain insufficiently characterized. This study investigated the incidence, patterns, burden, and associated factors of severe pDDIs. This single-center retrospective cohort included ICU admissions from January 2023 through December 2024 for adults aged ≥18 years who received ≥2 eligible systemic medications administered orally or intravenously. Category D and X pDDIs were identified with Lexi-Interact (Lexidrug, UpToDate) using confirmed administration records. Logistic and ordinal logistic regression were performed to evaluate severe-pDDI occurrence (≥1) and admission-level burden (0, 1-2, or ≥3). A total of 1,170 ICU admissions were included, involving 26,627 medication administrations. 64.44% were male and 55.38% received mechanical ventilation support. The most common implicated pharmacological group was alimentary-tract and metabolism agents, while ambroxol and glutathione emerged as the top two individual drugs. Among 1,170 ICU admissions, 1,092 (93.33%) exhibited pDDIs, and 769 (65.73%) experienced at least one category D or X pDDI. The 2,704 severe pDDIs comprised 1,681 (62.17%) category D and 1,023 (37.83%) category X events, yielding 231.1 pDDIs per 100 admissions and 101.6 pDDIs per 1,000 medication administrations. Nervous-system agents predominated; butorphanol [948/5,408 ingredient involvements (17.53%)] and dexmedetomidine [824/5,408 (15.24%)] were most frequently implicated. Butorphanol-dexmedetomidine [335/2,704 events (12.39%)] and noscapine-chlorphenamine [176/2,704 (6.51%)] were the leading category D and X pairs, respectively. Additive pharmacodynamic central nervous system depression predominated. Mechanical ventilation and medication count were the strongest adjusted correlates of severe-pDDI occurrence and burden, while baseline variables (sex, APACHE II score) lost significance after adjusting for ICU process variables. These associations remained materially unchanged after excluding 29 readmission encounters. In an exploratory review of 50 severe-pDDI episodes, 32 (64.0%) had temporally associated clinical signs or events documented and 29 (58.0%) had a documented management action. Category D or X pDDI alerts were frequent, primarily driven by pharmacodynamic additive central nervous system depression from sedative-analgesic combinations. Treatment intensity rather than baseline characteristics was associated with severe-pDDI exposure. Regional ICU-tailored surveillance and pharmacist-integrated medication management may facilitate identification of high-risk combinations, although specific drug pairs require validation across different healthcare settings.

PMID 42851402
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PubMedActa neurologica Belgica2026-09-27

Ambroxol in Gaucher disease and GBA1-related Parkinson disease: an updated systematic review.

Lipiński Patryk P, Jezela-Stanek Aleksandra A, Tylki-Szymańska Anna A

Ambroxol (ABX) is a central nervous system (CNS)-penetrant compound that can increase glucocerebrosidase activity and has been investigated in Gaucher disease (GD) and GBA1-related Parkinson disease (GBA1-PD). This PRISMA 2020 systematic review and narrative synthesis searched PubMed/MEDLINE, Europe PMC, SSRN and ClinicalTrials.gov through 19 August 2026, with an additional Web of Science Core Collection search performed during revision on 14 September 2026, without restrictions on date, language or publication status. Two reviewers independently selected studies, extracted data and assessed risk of bias using design-specific tools. Substantial clinical and methodological heterogeneity precluded meta-analysis RESULTS: Of 149 records in the original searches, 137 were screened, 41 full texts were assessed and 20 clinical outcome reports were included. The additional Web of Science search retrieved 50 records and did not identify further clinical outcome reports. Evidence in GD consisted mainly of small, uncontrolled and sometimes overlapping reports. Biochemical and neurological improvements were described in selected patients, but outcome definitions and functional responses varied. In GBA1-PD, conclusions remain provisional because the AMBITIOUS results are available only as a non-peer-reviewed preprint and did not show disease modification. Evidence on the safety of chronic high-dose treatment is limited. Biomarker changes alone do not establish clinical efficacy. ABX remains an off-label, investigational treatment in GD and GBA1-PD, and no GBA1 genotype or functional assay currently defines a validated indication.

PMID 42801449
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