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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Events Timeline
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tabcin | C200263 | 2024-12-12 |
| tabcin active | C200263 | 2025-08-29 |
| tabcin night | C200263 | 2025-07-17 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
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
No data
Clinical
Clinical Trials
38 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | — | — | 1 | 2 | 4 |
| Community-acquired pneumonia | D000098968 | — | — | — | — | — | 1 | 1 | 2 |
| Critical illness | D016638 | — | — | — | — | — | 1 | 1 | 2 |
| Healthcare-associated pneumonia | D000077299 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | 5 | 2 | — | 1 | 7 |
| Pharyngitis | D010612 | — | R07.0 | — | 1 | 4 | — | — | 5 |
| Cough | D003371 | — | R05 | — | 1 | 1 | — | — | 2 |
| Bronchitis | D001991 | — | J40 | — | — | 2 | — | — | 2 |
| 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 |
| Mucopolysaccharidosis iii | D009084 | — | E76.22 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dementia | D003704 | EFO_0003862 | F03 | 1 | 3 | — | — | 1 | 4 |
| Lewy body disease | D020961 | EFO_0006792 | G31.83 | 1 | 2 | — | — | 1 | 3 |
| Gaucher disease | D005776 | Orphanet_355 | E75.22 | 1 | 2 | — | — | 1 | 3 |
| Pain | D010146 | EFO_0003843 | R52 | — | 1 | — | — | — | 1 |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | — | 1 | — | — | — | 1 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 8 | — | — | — | — | 8 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Bronchiectasis | D001987 | — | J47 | — | — | — | — | 1 | 1 |
| Chinese traditional medicine | D008516 | — | — | — | — | — | — | 1 | 1 |
| Peripheral nervous system diseases | D010523 | — | G64 | — | — | — | — | 1 | 1 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | — | — | — | 1 | 1 |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | — | — | — | 1 | 1 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | — | — | 1 | 1 |
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
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,681 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,375 adverse events reported
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