Ambroxol
Ambroxol is a small molecule pharmaceutical. It is currently being investigated in clinical studies. It is known to target lysosomal acid glucosylceramidase.
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Commercial
Therapeutic Areas
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Trade Name
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Drug Products
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tabcin | C200263 | 2025-12-05 |
| tabcin active | C200263 | 2025-08-29 |
| tabcin night | C200263 | 2025-07-17 |
Indications
FDA
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Agency Specific
FDA
EMA
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Patent Expiration
No data
ATC Codes
R: Respiratory system drugs
— R02: Throat preparations
— R02A: Throat preparations
— R02AD: Local anesthetic throat preparations
— R02AD05: Ambroxol
— R03: Drugs for obstructive airway diseases
— R03C: Adrenergics for systemic use
— R03CC: Selective beta-2-adrenoreceptor agonists, systemic
— R03CC63: Clenbuterol and ambroxol
— R05: Cough and cold preparations
— R05C: Expectorants, excl. combinations with cough suppressants
— R05CB: Mucolytics
— R05CB06: Ambroxol
HCPCS
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Clinical
Clinical Trials
39 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory tract diseases | D012140 | — | — | — | — | 1 | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | 1 | — | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | 1 | — | — | 1 |
| Bronchitis | D001991 | — | J40 | — | — | 1 | — | — | 1 |
| Cough | D003371 | — | R05 | — | — | 1 | — | — | 1 |
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ambroxol |
| INN | ambroxol |
| Description | Ambroxol is an aromatic amine. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Nc1c(Br)cc(Br)cc1CN[C@H]1CC[C@H](O)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 18683-91-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL153479 |
| ChEBI ID | — |
| PubChem CID | 2132 |
| DrugBank | — |
| UNII ID | 200168S0CL (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
GBA1
GBA1
Organism
Homo sapiens
Gene name
GBA1
Gene synonyms
GBA, GC, GLUC
NCBI Gene ID
Protein name
lysosomal acid glucosylceramidase
Protein synonyms
Acid beta-glucosidase, Alglucerase, Beta-GC, Beta-glucocerebrosidase, Beta-glucosylceramidase 1, Cholesterol glucosyltransferase, Cholesteryl-beta-glucosidase, D-glucosyl-N-acylsphingosine glucohydrolase, glucocerebrosidase, glucosidase, beta, acid, Glucosylceramidase beta 1, glucosylceramidase-like protein, Imiglucerase, lysosomal acid GCase, Lysosomal cholesterol glycosyltransferase, Lysosomal galactosylceramidase, lysosomal glucocerebrosidase, Lysosomal glycosylceramidase, SGTase
Uniprot ID
Mouse ortholog
Gba1 (14466)
lysosomal acid glucosylceramidase (Q78NR7)
Variants
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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1,437 adverse events reported
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