Amiodarone
Nexterone (amiodarone) is a small molecule pharmaceutical. Amiodarone was first approved as Cordarone on 1985-12-24. It is used to treat cardiac arrhythmias, supraventricular tachycardia, and ventricular fibrillation in the USA. It is known to target potassium voltage-gated channel subfamily A member 7, muscarinic acetylcholine receptor M5, sodium channel protein type 5 subunit alpha, and NAD-dependent protein deacetylase sirtuin-3, mitochondrial.
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Commercial
Trade Name
FDA
EMA
Nexterone (generic drugs available since 1998-04-30, discontinued: Cordarone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amiodarone hydrochloride
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
NEXTERONE | Baxter | N-022325 RX | 2010-11-16 | 2 products, RLD, RS |
Show 4 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
amiodarone hydrochloride | ANDA | 2023-04-18 |
nexterone | New Drug Application | 2016-11-22 |
pacerone | ANDA | 2020-09-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
cardiac arrhythmias | EFO_0004269 | D001145 | I49.9 |
supraventricular tachycardia | HP_0004755 | D013617 | I47.1 |
ventricular fibrillation | EFO_0004287 | D014693 | I49.01 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Amiodarone Hydrochloride, Nexterone, Baxter Hlthcare | |||
7635773 | 2029-03-13 | DP |
HCPCS
Code | Description |
---|---|
J0282 | Injection, amiodarone hydrochloride, 30 mg |
Clinical
Clinical Trials
102 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 5 | 19 | 21 | 16 | 60 |
Ventricular tachycardia | D017180 | I47.2 | — | 1 | 3 | 3 | 4 | 11 | |
Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | 1 | 4 | 1 | 3 | 9 |
Ventricular fibrillation | D014693 | EFO_0004287 | I49.01 | — | — | 3 | 1 | — | 4 |
Heart failure | D006333 | EFO_0003144 | I50 | — | — | 1 | 3 | — | 4 |
Sepsis | D018805 | A41.9 | — | — | 1 | 2 | — | 3 | |
Septic shock | D012772 | A48.3 | — | — | 1 | 2 | — | 3 | |
Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | 1 | 1 | — | 2 |
Ventricular premature complexes | D018879 | I49.3 | — | — | 1 | 1 | — | 2 | |
Tachycardia | D013610 | HP_0001649 | R00.0 | — | — | — | 1 | 1 | 2 |
Show 4 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 5 | — | 1 | 6 |
Heart arrest | D006323 | EFO_0009492 | I46 | — | 1 | 3 | — | 1 | 5 |
Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 4 | — | 1 | 5 |
Coronary artery disease | D003324 | I25.1 | 1 | — | 2 | — | — | 3 | |
Sudden death cardiac | D016757 | EFO_0004278 | — | — | 2 | — | 1 | 3 | |
Chagas cardiomyopathy | D002598 | EFO_0005529 | — | — | 1 | — | 1 | 2 | |
Atrial flutter | D001282 | EFO_0003911 | — | 1 | 1 | — | — | 2 | |
Ebola hemorrhagic fever | D019142 | EFO_0007243 | A98.4 | — | 1 | 1 | — | — | 1 |
Covid-19 | D000086382 | U07.1 | — | 1 | 1 | — | — | 1 | |
Implantable defibrillators | D017147 | EFO_0010674 | — | — | 1 | — | — | 1 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Supraventricular tachycardia | D013617 | HP_0004755 | I47.1 | — | 1 | — | — | 2 | 3 |
Immunoglobulin light-chain amyloidosis | D000075363 | — | 1 | — | — | — | 1 | ||
Blood pressure | D001794 | EFO_0004325 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 2 | — | — | — | — | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | — | — | 1 | 1 |
Death | D003643 | PATO_0001422 | — | — | — | — | 1 | 1 | |
Out-of-hospital cardiac arrest | D058687 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | AMIODARONE |
INN | amiodarone |
Description | Amiodarone is a member of the class of 1-benzofurans that is 1-benzofuran substituted by a butyl group at position 2 and a 4-[2-(diethylamino)ethoxy]-3,5-diiodobenzoyl group at position 3. It is a cardiovascular drug used for the treatment of cardiac dysrhythmias. It has a role as a cardiovascular drug. It is a member of 1-benzofurans, an organoiodine compound, an aromatic ketone and a tertiary amino compound. |
Classification | Small molecule |
Drug class | antiarrhythmics: indicates high iodine content |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1 |
Target
Agency Approved
No data
Alternate
KCNA7
KCNA7
CHRM5
CHRM5
SCN5A
SCN5A
SIRT3
SIRT3
Organism
Homo sapiens
Gene name
KCNA7
Gene synonyms
NCBI Gene ID
Protein name
potassium voltage-gated channel subfamily A member 7
Protein synonyms
potassium channel, voltage gated shaker related subfamily A, member 7, potassium voltage-gated channel, shaker-related subfamily, member 7, voltage-dependent potassium channel Kv1.7, voltage-gated potassium channel KCNA7, Voltage-gated potassium channel subunit Kv1.7
Uniprot ID
Mouse ortholog
Kcna7 (16495)
potassium voltage-gated channel subfamily A member 7 (Q17ST2)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 25,157 documents
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Safety
Black-box Warning
Black-box warning for: Pacerone
Adverse Events
Top Adverse Reactions
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362,114 adverse events reported
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