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AM

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

PubMedInfection and drug resistance2026-07-22

Association of Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution with Respiratory Symptom Improvement and Safety in Chinese Children with Pneumonia: A Real-World Propensity Score-Matched Study.

Liang Ying Y, Ling Yesheng Y, Hu Bing B, Zou Yingxue Y et al.

To evaluate the association of ambroxol hydrochloride and clenbuterol hydrochloride oral solution (AHCHOS) with respiratory symptom improvement and safety in Chinese children with pneumonia using real-world data. A propensity score-matched (PSM) cohort study was conducted. Children patients (≤14 years) with a diagnosis of pneumonia between May, 2018 and July, 2019 were considered as the study population. The main outcome of interest was the overall rate of improvement of respiratory symptoms in treatment groups with or without AHCHOS at day 7 using respiratory symptom scores (QS) and Visual Analog Scale (VAS) score of severity of respiratory signs. Secondary end points include medication adherence assessment and safety assessment. A total of 3103 children with a diagnosis of pneumonia were included. After propensity score matching, a sample of 1428 patients was analyzed. AHCHOS use was associated with greater improvement in cough score (p=0.01) and day 7 clinical sign improvement rate (p=0.03) compared with no AHCHOS use. Exploratory subgroup analyses suggested larger differences in children aged 3-6 years and in selected severity strata. Medication adherence assessmentdid not differ significantly between groups at days 4, 7, 14, and 28. Adverse events were similar between groups. In this real-world propensity score-matched analysis, AHCHOS use was associated with improved respiratory symptom outcomes in children with pneumonia and appeared to have an acceptable safety profile. These findings should be interpreted as observational and hypothesis-generating. The study was registered at Chinese Clinical Trial Registry (https://www.chictr.org.cn/, ChiCTR1800015818).

PMID 42483308
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PubMedTranslational pediatrics2026-07-11

Efficacy and safety of inhaled ambroxol hydrochloride solution in Chinese pediatric patients with acute lower respiratory tract infections: a real-world, multicenter, open-label, single-arm study.

Wang Hao H, Zou Yingxue Y, Shang Yunxiao Y, Chen Mingwu M et al.

Although randomized controlled trials (RCTs) have confirmed the mucolytic efficacy of ambroxol hydrochloride solution for inhalation (AHSI) in selected cohorts, their stringent exclusion criteria often omit children with comorbidities and complex presentations encountered in routine practice. Consequently, real-world evidence is needed to evaluate the effectiveness and safety of AHSI in a broader, clinically representative pediatric population with acute lower respiratory tract infections (ALRTIs). This study therefore aimed to assess the real-world effectiveness, safety, and nebulizer compatibility of a 7-day AHSI regimen added to standard care in a large, multicenter cohort of hospitalized pediatric patients with ALRTI. This real-world, multicenter, open-label, single-arm study enrolled hospitalized patients aged ≥6 months with ALRTI (acute bronchitis, bronchiolitis, or pneumonia) and symptom duration <7 days across 62 centers in China (April 2021-April 2022). Key inclusion criteria included a cough score ≥2 (0-4 scale), tenacious sputum, and difficulty expectorating. Major exclusions comprised severe pneumonia, bronchial asthma, interstitial lung disease, significant hepatic or renal dysfunction [alanine aminotransferase (ALT) >1.5× upper limit of normal (ULN), total bilirubin (TBil) or serum creatinine (Scr) > ULN], other severe comorbidities, known hypersensitivity to ambroxol, or recent trial participation. Participants received weight-based doses of nebulized AHSI twice daily for 7 days as add-on to standard care. Follow-up visits occurred at day 4 and day 7 (end of treatment). Primary endpoints were the cough improvement rate (defined by a reduction in cough score) and the overall clinical response rate (investigator-assessed improvement). Secondary endpoints included changes from baseline in cough, throat rales, and pulmonary auscultation scores. Safety assessments comprised monitoring of adverse events (AEs) (coded with MedDRA), vital signs, and laboratory tests (hematology, biochemistry, urinalysis) at baseline and day 7. A total of 2,599 children were enrolled [full analysis set (FAS)]. At baseline, mean age was 3.60±2.50 years, 57.6% were male, and symptom scores were: cough 2.10±0.30, throat sputum 1.65±0.59, lung auscultation 1.44±0.70. In the FAS, the cough improvement rate was 96.73% [95% confidence interval (CI): 96.05-97.41] and the clinical response rate was 94.73% (95% CI: 93.87-95.59). All symptom scores decreased significantly from baseline to day 7 (P<0.001). Drug-related AEs (DRAEs) occurred in 0.39% of patients, predominantly mild-to-moderate rash, transient liver enzyme elevations, and gastrointestinal events; no serious DRAEs were reported. Outcomes were consistent across pneumonia and bronchitis subgroups and across various nebulizer types. This large real-world study demonstrated that a 7-day course of AHSI, added to standard care, was associated with clinically meaningful improvements in respiratory symptoms and a favorable safety profile in children with ALRTI. The consistent effects across disease subtypes and nebulizer devices underscore the practical utility of AHSI in diverse pediatric settings. While the single-arm design limits causal inference, these findings provide robust real-world evidence supporting AHSI as an effective expectorant option. Prospective confirmation through RCTs will further define its role in first-line therapy.

PMID 42433940
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PubMedWater research2026-07-09

Photodegradation of expectorant drug ambroxol in seawater environment: Seasonal impact on a global scale.

Zhang Ying Y, Li Xiaoci X, Chovelon Jean-Marc JM, Ji Yuefei Y et al.

The ocean is a globally important zone for the photochemical transformation of various organic contaminants. Its unique chemical composition, especially the high concentration of halide ions, can significantly alter the photochemical reactivity and fate of these contaminants. Herein, we systematically investigated the effects of marine constituents on the sunlight-driven photolysis of ambroxol (AMB), an expectorant drug extensively used following COVID-19 pandemic, and assessed its spatiotemporal persistence on a global scale. The results revealed that marine matrix significantly promoted AMB photodegradation in a halide-specific manner, where chloride drove such acceleration via photonucleophilic substitution, while bromide exerted an inhibitory effect. Differing from the pathways in pure water, the marine photolysis of AMB was dominated by photonucleophilic substitution, generating the primary chlorinated product with a substantial formation yield of ∼50.5%. Toxicity evaluation suggested that the halogen exchange reaction reduced the toxicity of the photoproducts, whereas other transformation pathways heightened the environmental risks of AMB. Utilizing the global-scale photolysis model GCSOLAR, this study further indicated that near-surface environmental persistence of AMB was strictly governed by geographic latitude and seasonal dynamics, where environmental half-lives remained minimal (1.24-1.83 h) in equatorial zones while rising to 34.77 h in high-latitude regions during winter. These findings highlighted the critical role of the marine matrix and global spatiotemporal variations in collectively reshaping the transformation landscape and intensifying the ecological risks of typical emerging contaminants.

PMID 42419117
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PubMedEuropean respiratory review : an official journal of the European Respiratory Society2026-06-25

Mucoactive agents in bronchiectasis: a systematic review and meta-analysis.

McCullough Benjamin B, Busby John J, O'Neill Brenda B, Connolly Bronwen B et al.

Mucoactive agents aim to improve mucociliary clearance in bronchiectasis, disrupting the cycle of impaired clearance, infection and inflammation. Registry data show 28% of patients use these agents, but prescribing varies due to limited evidence. We aimed to update evidence on mucoactive agents' effects in adults with bronchiectasis. We conducted a systematic review and meta-analysis, searching Medline, Embase, CENTRAL and trial registries to 1 October 2025. Eligible studies included adults with bronchiectasis, evaluating any mucoactive agent versus placebo or control. Cystic fibrosis and paediatric studies were excluded. The primary outcome was exacerbation frequency; secondary outcomes included lung function, quality of life and adverse events. From 1512 records, 24 studies (20 randomised, four observational: n=7051) evaluated eight mucoactive agents (ambroxol, bromhexine, carbocisteine, erdosteine, hypertonic saline, mannitol, N-acetylcysteine, rhDNase). Most trials had high or some risk of bias. Seven randomised studies (n=1259) reported exacerbations; pooled analysis did not demonstrate a statistically significant difference in annualised exacerbation incidence (mean difference -0.40 per patient per year, 95% CI -1.04-0.24; p=0.22; I2=91%; very low certainty). Nine studies (n=767) reported percent predicted forced expiratory volume in 1 s (FEV1 % pred), showing a small mean increase of 3.23% (95% CI 0.31-6.15; p=0.03; I2=69.9%; very low certainty). Pooled analyses did not demonstrate significant differences for other spirometry measures, quality of life or adverse events. Pooled evidence did not show a reduction in exacerbations and FEV1 % pred improvements were small. Evidence certainty was low/very low, meaning overall clinical benefit remains uncertain, highlighting the need for targeted trials of specific agents and subgroups.

PMID 42342264
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PubMedInternational journal of pharmaceutics2026-06-21

Heated nebulization of ambroxol hydrochloride: engineering submicron aerosols for pulmonary drug delivery.

Tao Yushi Y, Chu Ming M, Deng Jingjing J, Zhao Jing J et al.

Chronic respiratory diseases (CRDs) remain challenging to treat, largely due to the difficulty in delivering therapeutic agents to the deep lung. Ambroxol hydrochloride (AH), a widely used mucolytic agent that promotes mucus clearance, is indicated for conditions such as asthma, emphysema, and chronic bronchitis. This study reports the in vitro characterization of a heated medical nebulizer (MD6-HA20-2) for the generation of AH inhalable aerosols. The device vaporizes a liquid AH formulation via a battery-operated heating element; upon inhalation, the vapor condenses into aerosols exhibiting a mass median aerodynamic diameter of 0.53 ± 0.06  µm (GSD = 1.26). Across 200 consecutive inhalation actuations, the nebulizer delivered 25.21 ± 0.06 µg of AH per actuation with an atomization efficiency of 99.66 ± 0.47%, confirming highly reproducible dosing. High-performance liquid chromatography verified the thermal stability of AH throughout the nebulization process, and analysis of carbonyl compounds and trace toxic metals in the aerosol indicated that exposures to potentially harmful by-products remained below established health-based benchmarks. Collectively, these in vitro findings demonstrate that the heated nebulization platform can reliably generate submicron AH aerosols with a favorable preliminary chemical safety profile, supporting its continued development for pulmonary drug delivery.

PMID 42323034
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PubMedJournal of medical case reports2026-06-19

Mycoplasma pneumoniae-induced rash and mucositis in a 5-year-old child: a case report.

Mania-Końsko Agnieszka A, Ślebioda Zuzanna Z, Cocuzza Clementina Elvezia CE, Wyganowska Marzena Liliana ML

Mycoplasma pneumoniae is a common cause of respiratory infections, which in some cases leads to extrapulmonary complications, including mucocutaneous eruptions. The authors describe a clinical case of a 5-year-old Polish boy presenting with symptoms consistent with the diagnostic criteria of Mycoplasma pneumoniae-induced rash and mucositis (MIRM), a relatively new clinical entity distinguished from the spectrum of erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). The patient was initially admitted to the acute admissions unit of the Children's Health Centre in Poznan, Poland, due to prolonged fever, erosive-ulcerative lesions of the oral mucosa and lips, and slightly elevated, pink, rash-like skin eruptions. After 2 months, he was followed up in the University outpatient department. The treatment included systemic and local steroids (hydrocortisone, prednisolone), antibiotics (gentamicin), mucolytics (ambroxol), analgesics (paracetamol), and local antifungal agents (nystatin). This report discusses the clinical presentation, diagnostic procedures, differential diagnosis, and treatment. We recommend that pneumonia accompanied by mucocutaneous eruptions, especially in young patients, should raise clinical suspicion of MIRM. Differential diagnosis should include EM, SJS, TEN, and Kawasaki disease.

PMID 42316381
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