Pyridostigmine bromide
Mestinon, Regonol (pyridostigmine bromide) is a small molecule pharmaceutical. Pyridostigmine bromide was first approved as Mestinon on 1982-01-01. It is used to treat drug-induced abnormalities and myasthenia gravis in the USA. It is known to target cholinesterase and acetylcholinesterase.
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Commercial
Trade Name
FDA
EMA
Mestinon, Regonol (generic drugs available since 2003-04-24)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pyridostigmine bromide
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
MESTINON | Bausch Health Companies | N-009829 RX | 1982-01-01 | 1 products, RLD, RS |
MESTINON | Bausch Health Companies | N-009830 RX | 1982-01-01 | 1 products, RLD, RS |
MESTINON | Bausch Health Companies | N-011665 RX | 1982-01-01 | 1 products, RLD, RS |
MESTINON | Bausch Health Companies | N-015193 RX | 1982-01-01 | 1 products, RLD, RS |
REGONOL | Sandoz | N-017398 RX | 1982-01-01 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
mestinon | New Drug Application | 2020-12-02 |
pyridostigmine bromide | ANDA | 2023-05-09 |
regonol | New Drug Application | 2022-10-13 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
drug-induced abnormalities | — | D000014 | — |
myasthenia gravis | EFO_0004991 | D009157 | G70.0 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
30 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Covid-19 | D000086382 | U07.1 | — | 1 | 1 | — | — | 1 | |
Sars-cov-2 | D000086402 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Orthostatic hypotension | D007024 | I95.1 | 1 | 3 | — | — | — | 4 | |
Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 2 | 1 | — | — | 1 | 3 |
Spinal muscular atrophies of childhood | D014897 | Orphanet_83419 | G12.0 | — | 2 | — | — | — | 2 |
Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 2 | — | — | — | 2 |
Parkinson disease | D010300 | EFO_0002508 | G20 | — | 2 | — | — | — | 2 |
Hiv infections | D015658 | EFO_0000764 | B20 | — | 2 | — | — | — | 2 |
Constipation | D003248 | HP_0002019 | K59.0 | 1 | 2 | — | — | — | 2 |
Spinal muscular atrophy | D009134 | EFO_0008525 | G12.1 | — | 1 | — | — | — | 1 |
Chronic fatigue syndrome | D015673 | EFO_0004540 | G93.31 | — | 1 | — | — | — | 1 |
Primary dysautonomias | D054969 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pure autonomic failure | D054970 | 1 | — | — | — | — | 1 | ||
Orthostatic intolerance | D054971 | 1 | — | — | — | — | 1 | ||
Glycogen storage disease type ii | D006009 | Orphanet_365 | E74.02 | 1 | — | — | — | — | 1 |
Job syndrome | D007589 | EFO_0003775 | D82.4 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Diabetic neuropathies | D003929 | EFO_1000783 | — | — | — | — | 1 | 1 | |
Diabetes complications | D048909 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | PYRIDOSTIGMINE BROMIDE |
INN | pyridostigmine bromide |
Description | Pyridostigmine is a pyridinium ion. |
Classification | Small molecule |
Drug class | cholinesterase inhibitors (physostigmine type) |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CN(C)C(=O)Oc1ccc[n+](C)c1.[Br-] |
Identifiers
PDB | — |
CAS-ID | 101-26-8 |
RxCUI | 9000 |
ChEMBL ID | CHEMBL812 |
ChEBI ID | — |
PubChem CID | 4991 |
DrugBank | DB00545 |
UNII ID | KVI301NA53 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
BCHE
BCHE
ACHE
ACHE
Organism
Homo sapiens
Gene name
BCHE
Gene synonyms
CHE1
NCBI Gene ID
Protein name
cholinesterase
Protein synonyms
Acylcholine acylhydrolase, Butyrylcholine esterase, Choline esterase II, cholinesterase (serum) 2, cholinesterase 1, Pseudocholinesterase
Uniprot ID
Mouse ortholog
Bche (12038)
cholinesterase (Q543J3)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,334 adverse events reported
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