Erdotin (erdosteine) / Recipharm, Alitair Pharma, Daewoong Pharma - LARVOL DELTA

Erdosteine in the Treatment of Nonalcoholic Fatty Liver Disease (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Tanta University | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease

Glycation-mediated binding defect in human serum albumin transport of erdosteine: implications in diabetes. (PubMed, Cell Mol Biol (Noisy-le-grand)) - "Elevated glucose levels in diabetic patients can induce structural and functional changes in proteins, potentially impacting the effective management of coexisting clinical conditions. Such changes may affect drug binding to transport proteins, thereby altering drug efficacy, clearance, and therapeutic outcomes."

Journal • Diabetes • Metabolic Disorders • Respiratory Diseases

Erdosteine in the Treatment of Nonalcoholic Fatty Liver Disease (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: Tanta University

New P1/2 trial • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease

Cost-Utility Analysis Of Erdosteine for the Prevention of Exacerbations in Patients With COPD in the Czech Republic (ISPOR-EU 2025) - "Adding erdosteine to conventional therapy in COPD patients at risk of exacerbations is a cost‑effective option from the Czech healthcare payer's perspective, primarily due to reducing the exacerbation rate. To our knowledge, this is the first cost-effectiveness analysis of erdosteine for preventing exacerbations in COPD patients."

Clinical • HEOR • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Clinical Benefit Analysis of Erdosteine plus azithromycin in comparsion to standard care in preventing exacerbation in recovered cases of acute exacerbation of Bronchiectasis: A long-term Comparative Efficacy Study (WBC 2025) - "Long-term combination therapy with azithromycin and the mucolytic erdosteine has shown significant clinical and microbiological benefits in bronchiectasis patients with recurrent exacerbations. The combination works synergistically to reduce exacerbation frequency, shorten recovery time, and prolong exacerbation-free intervals. Improvements in sputum rheological properties such as viscosity, clearance, volume, and color are maintained longer with this regimen, regardless of microbial cause."

Clinical • Bronchiectasis • Infectious Disease • Pneumococcal Infections • Pneumonia • Pulmonary Disease • Respiratory Diseases

Scalp Involvement in Sarcoidosis and Trichoscopic Features (EADV 2025) - "Treatment included methylprednisolone 24 mg daily, erdosteine 300 mg daily, and sildenafil 50 mg twice weekly. Sarcoidosis is a multisystem disease necessitating comprehensive evaluation and management of all patient symptoms. Dermoscopy aids in diagnosing lymphoproliferative and histiocytic disorders, facilitating prompt recognition and treatment of associated skin manifestations."

Chronic Cough • Cough • Dermatology • Fibrosis • Immunology • Infectious Disease • Respiratory Diseases • Sarcoidosis

Erdosteine's active metabolite MET-1 enhances antibiotic activity against S.aureus and P.aeruginosa in vitro (ERS 2025) - "Background Erdosteine is a mucolytic prodrug which has clinically demonstrated the ability to enhance antibiotic activity during respiratory infections. It also significantly lowered Vancomycin and Tobramycin LogIC50s against mature biofilms, reducing biomass and viability ( Table 1 ). Resazurin CV 6h 24h 48h 6h 24h 48h USA300 (Vancomycin) ns ns P<0.05 ns P<0.05 P<0.01 RP73 (Tobramycin) ns P<0.05 P<0.01 ns ns P<0.0001 Table 1: Reduction in antibiotic LogIC50 when combined with 10mg/L MET-1 Conclusion Combination of 10 mg/L MET-1 with appropriate SoC antibiotics significantly potentiated antimicrobial activity against biofilm of S.aureus and P.aeruginosa and against planktonic S.aureus cultures."

Preclinical • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Respiratory Diseases

Effectiveness of Erdosteine plus SITT (single inhaler triple therapy) in preventing exacerbation in comparsion to SITT in Non-smoker COPD: A muticenter study (ERS 2025) - "Erdosteine plus SITT should be considered as "Natural Trend changing regimen" in COPD cases with GOLD stage 2 to satge 4 with exacerbation history, and with or without eosinophilia in blood. This combination decreases the exacerbation risk, exacerbation free days, time to first exacerbation, duration to recovery & cost of care related to AECOPD."

Chronic Obstructive Pulmonary Disease • Eosinophilia • Immunology • Respiratory Diseases

Efficacy and safety of HL-301 compared with erdosteine in acute bronchitis: a randomized, double-blind, non-inferiority trial. (PubMed, Korean J Intern Med) - "The incidence of adverse events was higher in the HL-301 group compared to the erdosteine group, including gastrointestinal disorder, periodontitis, and increased blood cholesterol, although this difference was not statistically significant. HL-301 was non-inferior to erdosteine, confirming its positive effect on symptom relief in acute bronchitis patients managed with conservative care."

Clinical • Head-to-Head • Journal • Dental Disorders • Gastroenterology • Gastrointestinal Disorder • Oncology • Periodontitis • Pulmonary Disease • Respiratory Diseases • CRP • IL6 • TNFA

Exploring the effects of resveratrol and β-hydroxy-β-methylbutyric acid under different protein levels on the ileal health of tibetan sheep. (PubMed, Front Microbiol) - "Metabolomics analysis revealed a total of 229 significantly different metabolites, of which Irinotecan, Erdosteine thioacid, 4,4'-diaminodiphenylmethane, and Morphine N-oxide emerged as the key up-regulated metabolites. When the 14% protein diet was supplemented with RES and HMB, the concentration of butyric acid was increased. This increase was due to the regulation of the ileum microbiota (Firmicutes and Clostridium_sensu_stricto_1) and metabolites (xanthine and uric acid), which promoted the activities of digestive enzymes and immune responses and improved mucosal morphology in the ileum."

Journal

Interaction of Erdosteine with TrkA Signaling Pathways: Implications for Analgesia. (PubMed, Int J Mol Sci) - "This effect was inhibited by low millimolar concentrations of the two compounds, reaching a maximal inhibition (around 40%) after 24 h of exposure to 1 mM erdosteine, and then plateauing. These findings suggest that erdosteine can act as a TrkA antagonist, thus indicating that this drug may have potential as an analgesic via a novel non-opioid mechanism of action operating through NGF signaling inhibition at the level of TrkA."

Journal • Neuroblastoma • Oncology • Pain • Solid Tumor

An Unusual Cause of Hypoglycemia: Insulin Autoimmune Syndrome (ESPE-ESE 2025) - "We saw prescriptions for dexketoprofen, paracetamol, and erdosteine.​​ We adjusted the patient’s diet regimen and performed close blood sugar monitoring...The primary treatment for IAS is a diet consisting of low glycemic index foods. Additionally, steroids may be utilized as an adjunctive therapy."

Hypoglycemia • Immunology • Oncology • Solid Tumor

Antiviral Effect of Erdosteine in Cells Infected with Human Respiratory Viruses. (PubMed, Pathogens) - "The transcriptome analysis showed that erdosteine activated innate immune responses by stimulating overexpression of type I interferon and inflammasome pathways and modulated oxidative stress by inducing the modulation of oxidative stress and GSH pathways. These findings suggest that erdosteine may be a useful treatment for respiratory viral infections."

Journal • Colon Cancer • Colorectal Cancer • Infectious Disease • Influenza • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Respiratory Syncytial Virus Infections • Solid Tumor

Effect of Treatment with Mucoactive Drugs on COPD Exacerbations During 5 years of Follow-up in the Czech Republic: A Real-World Study. (PubMed, Lung) - "Mucoactive treatment for two years reduced the number of COPD exacerbations (all, moderate) over five years of follow-up. The reduction in exacerbations was more pronounced in patients with cough or with stage 3‒4 COPD but was independent of the use of ICS."

Journal • Observational data • Real-world evidence • Chronic Obstructive Pulmonary Disease • Cough • Immunology • Pulmonary Disease • Respiratory Diseases

Mucolytics for children with chronic suppurative lung disease. (PubMed, Cochrane Database Syst Rev) - "This systematic review is limited to a single small study, which we judged to be at high risk of bias. It remains uncertain whether regular nebulised hypertonic saline during a stable state reduces exacerbations or improves lung function. Further multi-centre, well-designed RCTs of longer duration that investigate various mucolytics are required to answer this important clinical question."

Clinical • Journal • Review • Bronchiectasis • Cough • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases

Development of a rat airway organoids model for studying chronic obstructive pulmonary disease. (PubMed, Tissue Cell) - "Inflammatory markers responded differently, with ensifentrine and erdosteine significantly reducing cytokine levels. These results demonstrate that rat airway organoids replicate important aspects of human COPD pathology, thus providing an accessible, ethical, and clinically relevant alternative to human tissues and traditional animal models to enhance our understanding of COPD pathogenesis and evaluate potential treatments."

Journal • Preclinical • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Pharmacological profile of erdosteine - known molecule - new effects. (PubMed, Ceska Slov Farm) - "Its antioxidant and anti-inflammatory properties come to the fore, or antiviral properties associated with them, as well as the ability to reduce bacterial adhesion and increase the effects of some antibiotics. Erdostein represents a comprehensive therapeutic option both in the field of self-treatment of respiratory infections and in other respiratory diseases."

Journal • Review • Infectious Disease • Respiratory Diseases

Erdosteine: Reigniting a Thiol Mucolytic for Management of Chronic Obstructive Pulmonary Disease. (PubMed, J Assoc Physicians India) - "One of these agents which has reignited interest lately is erdosteine, with recent evidence demonstrating advantages over traditionally used N-acetylcysteine. In this review, we have summarized the key available evidence for the role of erdosteine in COPD, with takeaways on its place in therapy."

Journal • Review • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Efficacy and safety of mucolytics in patients with stable chronic obstructive pulmonary disease: A systematic review and meta-analysis. (PubMed, Respir Investig) - "Mucolytics reduce exacerbations and hospitalizations in patients with stable COPD and have a safety profile comparable to that of placebo."

Journal • Retrospective data • Review • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

BRONCHIECTASIS AND POTENTIAL BENEFIT OF MUCOSAL VACCINE (CHEST 2024) - "The last infectious exacerbation was on January 2023 treated with ciprofloxacin 500 mgs bid for 2 weeks...We starting management based on dual bronchodilation (Tiotropium + Olodaterol), mucolytic (erdosteine) and immunotherapy with MV130, 2 sublingual shots OD for three months...By November 2023 she visited emergency department due to a new recurrence treated with amoxicillin/clavulanate... Clinical trials are needed to clear expectations of the mucosal vaccines in the bronchiectasis field."

Bronchiectasis • Chronic Cough • Chronic Obstructive Pulmonary Disease • Cough • Immunology • Infectious Disease • Otorhinolaryngology • Pneumonia • Pulmonary Disease • Respiratory Diseases

Improvement of Severe Scleroderma Cases with Lung and Heart Involvement Treated Using Methotrexat (EADV 2024) - "The therapy given is methotrexate 15 mg/week, folic acid 10 mg/week, mometasone furoate cream on the face, and clobetasol propionate ointment on other skin areas. Other treatments are salbutamol nebules, methylprednisolone 125 mg/day with tapering down, lansoprazole, erdosteine, furosemide, spironolactone and bisoprolol... T he patient is diagnosed with diffuse type scleroderma where there is involvement of major organs so that the patient has a poor prognosis. However, in the observations on patients for 1 month after therapy showed improvement of the condition of skin stiffness and reduced shortness of breath. MTX accompanied by systemic corticosteroids can be an inexpensive treatment option even in severe scleroderma conditions."

Clinical • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Fibrosis • Heart Failure • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Rheumatology • Scleroderma • Systemic Sclerosis • DHFR • TYMS

Erdosteine inhibits viral infection and modulates innate immunity and stress oxidative state in RSV-infected A549 cell (ERS 2024) - "Conclusions ERD modulates several molecular pathways involved in induction of anti-viral state. The upregulation of some ISGs and reduction of pro-inflammatory cytokines suggest ERD as adjuvant in respiratory viral infections."

Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • CASP4 • CCL2 • CXCL8 • DDX58 • GPX2 • ICAM1 • IFITM3 • IFNAR1 • IL1B • IL6 • ISG20 • SOD2

Effect of 5 years of treatment with mucoactive drugs on COPD exacerbations in the Czech Republic: a real-life study (ERS 2024) - "All patients had COPD with FEV1 ≤60% of predicted value, 81 of them were on treatment with thiol-based mucoactive drugs for 24 months (77 erdosteine, 4 N-acetylcysteine) and 371 patients were off mucoactive treatment for 24 months. The use of mucoactive treatment for two years showed a statistically significant reduction in the number of COPD exacerbations over the five years, for both all exacerbations and moderate exacerbations. The reduction in exacerbations was more pronounced in patients with cough and in patients with stage 3 to 4 COPD and was independent of the use of ICS."

Clinical • Chronic Obstructive Pulmonary Disease • Cough • Immunology • Pulmonary Disease • Respiratory Diseases

The effectiveness of erdosteine in patients with COPD in combination with secondary bronchiectasis (ERS 2024) - "Conclusion. Added erdosteine to the basic therapy leads to a reduction in the duration of AE of COPD plus BE and also leads to a decrease in the levels of CRP, both at the onset of the remission phase and on the 30th day of therapy compared to patients who as basic therapy received LAMA/LABA/ICS"

Clinical • Combination therapy • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

REPEAT: Reducing Exacerbations in people with primary ciliary dyskinesia (PCD) using Erdosteine and Azithromycin Therapy (ANZCTR) - P3/4 | N=120 | Completed | Sponsor: Menzies School of Health Research | Recruiting ➔ Completed

Trial completion • Otorhinolaryngology • Respiratory Diseases