ambroxol
Small moleculeexperimental
Ambroxol is a drug that breaks up phlegm, used in the treatment of respiratory diseases associated with viscid or excessive mucus. Ambroxol is often administered as an active ingredient in cough syrup. — Wikipedia
Clinical trial activity
34 trials · 33 clinical orgs · 0 marketing orgs
Phase 1
14
Phase 2
19
Phase 3
9
Phase 4
1
Earliest trial started Jun 1, 1999 (NCT02194296)
Timeline
Indications
Approved for
Studied for
- Amyotrophic Lateral Sclerosis · Phase 2
- Bronchitis · Phase 3
- Community-Acquired Infections · Phase 4
- Cough · Phase 2
- Critical Illness · Phase 4
- Gaucher Disease · Phase 2
- Healthcare-Associated Pneumonia · Phase 4
- Healthy Volunteers · Phase 1
- Lewy Body Disease · Phase 2
- Mucopolysaccharidosis III · Phase 2/Phase 3
- Mucus · Phase 3
- Mutation · Phase 2
- Pain · Phase 2
- Parkinson Disease · Phase 3
- Pharyngitis · Phase 3
- Pneumonia · Phase 4
- Respiratory Tract Diseases · Phase 3
- Vision, Ocular · Phase 1/Phase 2
Mechanism of action
Sodium channel alpha subunits; brain (Types I, II, III) inhibitor
Chemistry & pharmacology
Loading structure…
SMILES
Nc1c(Br)cc(Br)cc1CN[C@H]1CC[C@H](O)CC1- Mol. weight
- 378.11 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaAmbroxol ↗
- ChEMBLCHEMBL153479 ↗
Also known as
- acebrophylline
- acebrophylline
- acebrophylline
- acebrophylline
- ambromucil
- ambromucil
- ambroxils
- ambroxol
- ambroxol
- ambroxol
- ambroxol
- ambroxol
- ambroxol
- ambroxol
- ambroxol acefyllinate
- ambroxol acefyllinate
- ambroxol acefyllinate
- ambroxol hcl
- ambroxol hcl
- ambroxol hcl
- ambroxol hydrochloride
- ambroxol hydrochloride
- ambroxol hydrochloride
- ambroxol hydrochloride
- ambroxol hydrochloride
- ambroxol hydrochloride
- ambroxol hydrochloride
- ambroxol theophyllinacetate
- ambroxol theophyllinacetate
- ambroxol-theophylline-7-acetate
- ambroxolum
- ambroxolum
- benzyl ambroxol
- bisolvon metabolite viii
- bisolvon metabolite viii
- bromhexine metabolite viii
- bromhexine metabolite viii
- bromhexine-metabolite viii
- bromhexine-metabolite viii
- broncomnes
- broncomnes
- cyclohexanol, 4-((2-amino-3,5-dibromobenzyl)amino)- (e)-
- cyclohexanol, 4-((2-amino-3,5-dibromobenzyl)amino)- (e)-
- ht-002-01
- lasolvan
- n-(2-amino-3,4-dibromociclohexil)-trans-4-aminociclohexanol
- n-(2-amino-3,4-dibromociclohexil)-trans-4-aminociclohexanol
- n-(2-amino-3,4-dibromocyclohexyl)-trans-4-aminocyclohexanol
- n-(2-amino-3,4-dibromocyclohexyl)-trans-4-aminocyclohexanol
- surfolase
- surfolase
- trans-4-((2-amino-3,5-dibromobencil)amino)ciclohexanol
- trans-4-((2-amino-3,5-dibromobencil)amino)ciclohexanol
- trans-4-((2-amino-3,5-dibromobenzyl)amine)cyclohexanol
- trans-4-((2-amino-3,5-dibromobenzyl)amine)cyclohexanol
- trans-4-((2-amino-3,5-dibromobenzyl)amino)cyclohexanol
- trans-4-((2-amino-3,5-dibromobenzyl)amino)cyclohexanol
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07285369 | N/A | Mar 1, 2025 | Agyany Pharma LTD |
| NCT06614894 | Phase 2/Phase 3 (Phase 3) | Dec 1, 2024 | Lysosomal and Rare Disorders Research and Treatment Center, Inc. |
| NCT06193421 | Phase 1/Phase 2 (Phase 2) | Oct 24, 2023 | Agyany Pharma LTD |
| NCT05778617 | Phase 3 | Sep 30, 2023 | University of London |
| NCT05959850 | Phase 2 | Jun 13, 2023 | Calvary Health Care Bethlehem, Concord Repatriation General Hospital, Flinders University, The Florey Institute of Neuroscience and Mental Health, University of Queensland |
| NCT05830396 | Phase 2/Phase 3 (Phase 3) | May 31, 2023 | University of Groningen |
| NCT05663905 | Phase 4 | Dec 31, 2022 | National University of Malaysia |
| NCT05558878 | N/A | Oct 1, 2022 | Ain Shams University |
| NCT05287503 | Phase 2 | Feb 15, 2022 | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, IRCCS National Neurological Institute C. Mondino Foundation, University of Campania Luigi Vanvitelli |
| NCT04588285 | Phase 2 | Dec 1, 2020 | Helse Bergen, Helse Fonna, University of Oslo |
| NCT04405596 | Phase 1/Phase 2 (Phase 2) | Sep 30, 2020 | University of Western Ontario |
| NCT03843541 | Phase 3 | Apr 17, 2019 | Zambon |
| NCT03950050 | Phase 2 | Mar 1, 2019 | Hebrew University |
| NCT03583658 | Phase 3 | Jun 30, 2018 | Sanofi |
| NCT03415269 | Phase 2 | Feb 28, 2018 | Sanofi, University of Hull |
| NCT02941822 | Phase 2 | Dec 1, 2016 | Cure Parkinson's Trust, PRO.MED.CS Praha a.s - Czech Republic, University of London |
| NCT02914366 | Phase 2 | Nov 1, 2015 | University of Western Ontario, Weston Foundation |
| NCT02792946 | Phase 3 | Nov 1, 2015 | Hyundai |
| NCT02373891 | Phase 1 | Apr 1, 2014 | Hyundai, Yonsei University |
| NCT02036775 | Phase 1 | Mar 1, 2014 | Boehringer Ingelheim |
Showing 20 of 34 trials
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Organizations
Research & Development (33)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Boehringer Ingelheim | For profit | 10 | 10 | 3 | 1999 |
| Hyundai | For profit | 4 | 4 | 2 | 2012 |
| Agyany Pharma LTD | For profit | 2 | 2 | 2 | 2023 |
| Sanofi | For profit | 2 | 1 | 2 | 2018 |
| University of London | Academic/Hospital | 2 | 2 | 2 | 2016 |
| University of Western Ontario | Academic/Hospital | 2 | 2 | 1 | 2015 |
| Yonsei University | Academic/Hospital | 2 | 0 | 1 | 2013 |
| Ain Shams University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| B.I. South Africa (Pty.) Ltd. | For profit | 1 | 0 | 1 | 2005 |
| Calvary Health Care Bethlehem | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Concord Repatriation General Hospital | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Cure Parkinson's Trust | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Flinders University | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Hallym University | Academic/Hospital | 1 | 1 | 1 | 2011 |
| Hanmi Pharmaceutical | For profit | 1 | 1 | 1 | 2012 |
| Hebrew University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Helse Bergen | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Helse Fonna | Academic/Hospital | 1 | 1 | 1 | 2020 |
| IRCCS National Neurological Institute C. Mondino Foundation | Academic/Hospital | 1 | 0 | 1 | 2022 |
33 organizations
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