10 completed, 4 unknown, 2 recruiting, 1 active not recruiting. 9 Phase 2, 5 Phase 1, 4 Phase 3, 1 Not applicable, 1 Phase 4.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Muco-active Agent Use and Clinical Outcomes After Lung Cancer Diagnosis in Chronic Obstructive Pulmonary Disease Muco-active agents, No muco-active agent use - Lung Cancer (Diagnosis), Chronic Obstructive Pulmonary Disease (COPD) | Active not recruiting | Seoul National University | 27000 | 2026-06-01 | 2026-07-21 | |
| High-Dose Ambroxol in Pediatric Type III Gaucher Disease (GD3) Ambroxol - Gaucher Disease, Type 3 | Not applicable | Completed | Agyany Pharma LTD | 12 | 2025-03-01 | 2026-08-24 |
| Ambroxol to Slow Progression in Parkinson Disease Ambroxol Hydrochloride (420mg), Placebo - Parkinson Disease | Phase 3 | Recruiting | University College, London | 330 | 2025-02-25 | 2025-05-01 |
| Ambroxol as a Novel Disease Modifying Treatment for Lewy Body Dementia Ambroxol Hydrochloride, Placebo - Lewy Body Disease | Phase 1 / Phase 2 | Not yet recruiting | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | 15 | 2025-01-01 | 2023-12-13 |
| 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 Ambroxol Hydrochloride 30 mg tablet - 9 mg/kg/day, Ambroxol Hydrochloride 30 mg tablet - 18 mg/kg/day, Ambroxol Hydrochloride 30 mg tablet - 27 mg/kg/day - Sanfilippo Syndrome, MPS3 | Phase 2 / Phase 3 | Unknown | Ozlem Goker-Alpan | 10 | 2024-12-01 | 2025-08-20 |
| A Double-blind Randomised, Placebo-controlled Clinical Trial to Test Ambroxol Treatment in ALS Ambroxol, Placebo - Amyotrophic Lateral Sclerosis | Phase 2 | Unknown | The Florey Institute of Neuroscience and Mental Health | 50 | 2023-06-13 | 2023-09-07 |
| Efficacy of Intravenous Amboxol Hydrochloride as an Adjunct Therapy for Severe Pneumonia in Critically Ill Patients Ambroxol Hydrochloride, Standard Therapy - Severe Pneumonia, Community-acquired Pneumonia | Phase 4 | Completed | National University of Malaysia | 32 | 2023-01-07 | 2023-12-27 |
| Ambroxol as a Disease-modifying Treatment in GBA-PD Ambroxol Hydrochloride, Placebo - Parkinson Disease, GBA Gene Mutation | Phase 2 | Completed | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | 65 | 2022-03-09 | 2025-08-14 |
| Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial Ambroxol, Placebo - Dementia With Lewy Bodies | Phase 2 | Recruiting | Helse Fonna | 180 | 2021-05-04 | 2026-05-05 |
| A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia Eucalyptol, Limonene and Pinene Enteric Soft Capsule, Ambroxol injection, Other oral mucolytic drugs - Community-acquired Pneumonia | Unknown | Beijing Grand Johamu Pharmaceutical Company, Ltd. | 10000 | 2020-09-01 | 2021-11-26 | |
| 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 N-acetylcysteine (NAC) 600 mg, Ambroxol hydrochloride 30 mg, placebo - Respiratory Tract Diseases, Abnormal Mucus Secretions | Phase 3 | Completed | Zambon SpA | 333 | 2019-06-25 | 2025-09-05 |
| Ambroxol Therapy for Patients With Type 1 Gaucher Disease and Suboptimal Response to Enzyme Replacement Therapy Ambroxol - Gaucher Disease, Type 1 | Phase 2 | Completed | Shaare Zedek Medical Center | 40 | 2019-03-01 | 2023-02-14 |
| Ambroxol in Disease Modification in Parkinson Disease Ambroxol - Parkinson Disease | Phase 2 | Completed | University College, London | 23 | 2016-12-01 | 2020-04-15 |
| Ambroxol as a Treatment for Parkinson's Disease Dementia Ambroxol, Placebo - Parkinson's Disease Dementia | Phase 2 | Unknown | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | 55 | 2015-11-01 | 2024-02-28 |
| Pharmacokinetics and Bioavailability Study of Lasolvan Hard Capsules and Effervescent Tablets in Healthy Volunteers Lasolvan tablet, Lasolvan effervescent tablet, Lasolvan prolonged-release hard capsule - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 24 | 2014-03-01 | 2015-05-13 |
| Clinical Trial of Ambroxol in Patients With Type I Gaucher Disease Ambroxol - Type I Gaucher Disease | Phase 1 / Phase 2 | Suspended | Exsar Corporation | 20 | 2012-12-01 | 2013-02-15 |
| A Drug-Drug Interaction Study of Ambroxol and Levodropropizine Ambroxol and Levodropropizine, Ambroxol, Levodropropizine - Healthy | Phase 1 | Completed | Hanmi Pharmaceutical Company Limited | 21 | 2012-02-01 | 2012-07-19 |
| Study to Evaluate Safety, Tolerability and Pharmacokinetics of Increasing Repeated Oral Doses of Ambroxol Lozenges in Healthy Male Volunteers Ambroxol - in single rising doses, Placebo - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 34 | 2009-10-01 | 2014-07-23 |
| Double-blind Trial to Investigate Efficacy and Tolerance of Ambroxol Lozenges 20 mg in Sore Throat Ambroxol, Placebo - Pharyngitis | Phase 3 | Completed | Boehringer Ingelheim | 249 | 2007-08-01 | 2019-07-11 |
Parkinson Disease (4) · Gaucher Disease (3) · Community-Acquired Pneumonia (2) · Dementia (2) · Lewy Body Disease (2) · Pulmonary Disease, Chronic Obstructive (2) · Amyotrophic Lateral Sclerosis (1) · Ataxia (1) · Basal Ganglia Diseases (1) · Brain Diseases (1) · Bronchitis (1) · Central Nervous System Diseases (1) · Cough (1) · Critical Illness (1) · Cystic Fibrosis (1)
Boehringer Ingelheim (3) · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (2) · University College, London (2) · Agyany Pharma LTD (1) · Beijing Grand Johamu Pharmaceutical Company, Ltd. (1) · Exsar Corporation (1) · Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta (1) · Hanmi Pharmaceutical Company Limited (1) · Helse Fonna (1) · National University of Malaysia (1) · Ozlem Goker-Alpan (1) · Seoul National University (1) · Shaare Zedek Medical Center (1) · The Florey Institute of Neuroscience and Mental Health (1) · Zambon SpA (1)
China (3) · Canada (2) · South Korea (2) · United Kingdom (2) · United States (2) · Australia (1) · Israel (1) · Italy (1) · Malaysia (1) · Norway (1) · Pakistan (1) · Russia (1)
Anthony Schapira (1) · Ari Zimran (1) · Arvid Rongve, Phd (1) · Bradley Turner (1) · David Schultz (1) · Huma Arshad Cheema, Prof. (1) · Hyun Woo Lee, MD, PhD (1) · Jiyu Sun (1) · Lauren Giles (1) · Matthew Kiernan (1) · Ozlem Goker-Alpan, MD (1) · Robert Johnston (1)
PMID 27866808, PMID 30738426, PMID 31930374, PMID 32372294, PMID 38027469, PMID 40587145