Tikosyn(dofetilide)
Dofetilde, Dofetilide, Tikosyn (dofetilide) is a small molecule pharmaceutical. Dofetilide was first approved as Tikosyn on 1999-10-01. It is used to treat atrial fibrillation, atrial flutter, and cardiac arrhythmias in the USA. It has been approved in Europe to treat atrial fibrillation and atrial flutter. The pharmaceutical is active against voltage-gated inwardly rectifying potassium channel KCNH2; potassium voltage-gated channel subfamily H member 2. In addition, it is known to target voltage-gated delayed rectifier potassium channel KCNH1; potassium voltage-gated channel subfamily H member 1.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Dofetilde, Dofetilide, Tikosyn (discontinued: Dofetilide)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dofetilide | ANDA | 2025-09-10 |
| dofetilide 0.125mg dofetilide 0.25mg dofetilide 0.5mg | ANDA | 2024-11-14 |
| tikosyn | New Drug Application | 2025-02-09 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| atrial fibrillation | EFO_0000275 | D001281 | I48.0 |
| atrial flutter | EFO_0003911 | D001282 | — |
| cardiac arrhythmias | EFO_0004269 | D001145 | I49.9 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
22 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 | — | — | 3 | 3 | 8 | 14 |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | — | 1 | 3 | 4 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | 3 | 1 | — | — | 1 | 4 |
| Syndrome | D013577 | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
| Pharmacological phenomena | D000069437 | — | — | 2 | — | — | — | — | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 1 | 1 |
| Atrial flutter | D001282 | EFO_0003911 | — | — | — | — | — | 1 | 1 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 1 | 1 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dofetilide |
| INN | dofetilide |
| Description | Dofetilide is a tertiary amino compound that is N-ethyl-N-methylethanamine substituted by a 4-[(methylsulfonyl)amino]phenoxy and a 4-[(methylsulfonyl)amino]phenyl group at the terminal carbon atoms respectively. It is used as an anti-arrhythmia drug. It has a role as an anti-arrhythmia drug and a potassium channel blocker. It is a sulfonamide, an aromatic ether and a tertiary amino compound. |
| Classification | Small molecule |
| Drug class | class III antiarrhythmic agents |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN(CCOc1ccc(NS(C)(=O)=O)cc1)CCc1ccc(NS(C)(=O)=O)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 115256-11-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL473 |
| ChEBI ID | 4681 |
| PubChem CID | 71329 |
| DrugBank | DB00204 |
| UNII ID | R4Z9X1N2ND (ChemIDplus, GSRS) |
Target
Agency Approved
KCNH2
KCNH2
Organism
Homo sapiens
Gene name
KCNH2
Gene synonyms
ERG, ERG1, HERG
NCBI Gene ID
Protein name
potassium voltage-gated channel subfamily H member 2
Protein synonyms
Eag homolog, Eag-related protein 1, ERG-1, Ether-a-go-go-related gene potassium channel 1, ether-a-go-go-related potassium channel protein, Ether-a-go-go-related protein 1, H-ERG, hERG-1, hERG1, human ether-a-go-go-related, long QT syndrome type 2, potassium channel, voltage gated eag related subfamily H, member 2, potassium voltage-gated channel, subfamily H (eag-related), member 2, Voltage-gated potassium channel subunit Kv11.1
Uniprot ID
Mouse ortholog
Kcnh2 (16511)
potassium voltage-gated channel subfamily H member 2 (O35989)
Alternate
KCNH1
KCNH1
Organism
Homo sapiens
Gene name
KCNH1
Gene synonyms
EAG, EAG1
NCBI Gene ID
Protein name
potassium voltage-gated channel subfamily H member 1
Protein synonyms
EAG channel 1, ether-a-go-go 1, Ether-a-go-go potassium channel 1, ether-a-go-go, Drosophila, homolog of, h-eag, hEAG1, potassium channel, voltage gated eag related subfamily H, member 1, potassium voltage-gated channel, subfamily H (eag-related), member 1, Voltage-gated potassium channel subunit Kv10.1
Uniprot ID
Mouse ortholog
Kcnh1 (16510)
potassium voltage-gated channel subfamily H member 1 (Q60603)
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Tikosyn – Pfizer
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,164 documents
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Safety
Black-box Warning
Black-box warning for: Dofetilide 0.125mg dofetilide 0.25mg dofetilide 0.5mg, Tikosyn
Adverse Events
Top Adverse Reactions
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8,846 adverse events reported
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