Last reviewed 2026-05-31 · How we verify

Ambroxol Hydrochloride

Ambroxol Hydrochloride is a Mucolytic agent Small molecule drug developed by National University of Malaysia. It is currently FDA-approved for Acute and chronic bronchitis, Bronchiectasis, Asthma with mucus hypersecretion. Also known as: Mucosolvan®, Lasolvan®, Mucosolvan, Ambroxol.

Ambroxol hydrochloride is a mucolytic agent that breaks down and reduces the viscosity of respiratory mucus, facilitating clearance and improving airway patency.

Ambroxol Hydrochloride is a small molecule intervention used in clinical trials to study its potential effects on various conditions, including Parkinson Disease and Gaucher Disease. It is being investigated as a disease-modifying treatment, specifically in the context of GBA-PD, a subtype of Parkinson Disease associated with a GBA gene mutation.

At a glance

Mechanism of action

Ambroxol works by stimulating serous cells in the respiratory tract to increase mucus secretion while simultaneously reducing mucus viscosity through its mucolytic properties. This dual action helps thin secretions and promote their clearance via the mucociliary escalator, improving ventilation and reducing airway obstruction in conditions characterized by excessive or thick mucus production.

Approved indications

• Acute and chronic bronchitis
• Bronchiectasis
• Asthma with mucus hypersecretion
• Cystic fibrosis
• Chronic obstructive pulmonary disease (COPD)

Common side effects

• Gastrointestinal disturbances (nausea, vomiting, diarrhea)
• Headache
• Rash or allergic reactions
• Dizziness

Key clinical trials

• A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions (PHASE3)
• Fiberoptic Bronchoscopy in Severe Ventilator-associated Pneumonia (NA)
• 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 (PHASE2, PHASE3)
• Ambroxol as a Disease-modifying Treatment in GBA-PD (PHASE2)
• Ambroxol to Slow Progression in Parkinson Disease (PHASE3)
• A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Uterine Blood Mesenchymal Stem Cells Injection for the Treatment of Severe Pneumonia Caused by Viruses (PHASE1)
• High-Dose Ambroxol in GBA1-Related Parkinson (PHASE1, PHASE2)
• Efficacy of Intravenous Amboxol Hydrochloride as an Adjunct Therapy for Severe Pneumonia in Critically Ill Patients (PHASE4)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Ambroxol Hydrochloride CI brief — competitive landscape report
• Ambroxol Hydrochloride updates RSS · CI watch RSS
• National University of Malaysia portfolio CI

Frequently asked questions about Ambroxol Hydrochloride

Related

• Drug class: All Mucolytic agent drugs
• Manufacturer: National University of Malaysia — full pipeline
• Therapeutic area: All drugs in Respiratory
• Indication: Drugs for Acute and chronic bronchitis
• Indication: Drugs for Bronchiectasis
• Indication: Drugs for Asthma with mucus hypersecretion
• Also known as: Mucosolvan®, Lasolvan®, Mucosolvan, Ambroxol, Lysopain Ambr Mint™

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing