Aptiom, Exalief(eslicarbazepine)
Aptiom, Zebinix (eslicarbazepine) is a small molecule pharmaceutical. Eslicarbazepine was first approved as Exalief on 2009-04-21. It has been approved in Europe to treat epilepsy.
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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
Trade Name
FDA
EMA
Aptiom (generic drugs available since 2021-06-29)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Eslicarbazepine acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| APTIOM | Sunovion Pharmaceuticals | N-022416 RX | 2013-11-08 | 4 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| aptiom | New Drug Application | 2020-11-24 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Eslicarbazepine Acetate, Aptiom, Sunovion Pharms Inc | |||
| 9750747 | 2032-08-24 | U-2041, U-2121 | |
| 8372431 | 2030-04-17 | DP | |
| 9566244 | 2028-10-23 | DP | |
| 10912781 | 2028-10-23 | DP | |
| 9763954 | 2028-09-13 | U-2123 | |
| 9206135 | 2026-04-21 | DP | |
| 9643929 | 2026-04-21 | DP | |
| 10675287 | 2025-05-06 | U-2041, U-2831 | |
| 10695354 | 2025-05-06 | U-2501, U-2831 | |
| 10702536 | 2025-05-06 | U-2501 | |
| 11364247 | 2025-05-06 | U-2501, U-2831 | |
HCPCS
No data
Clinical
Clinical Trials
71 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 5 | 1 | 1 | 3 | 1 | 10 | ||
| Adenomatous polyposis coli | D011125 | — | — | — | 2 | — | 2 | ||
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | 1 | — | 1 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | — | — | 1 | — | 1 |
| Bronchiolitis obliterans | D001989 | EFO_0007183 | — | — | — | 1 | — | 1 | |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | — | 1 |
| Blepharitis | D001762 | EFO_0009536 | H01.0 | — | — | — | 1 | — | 1 |
| Pancreatitis | D010195 | EFO_0000278 | K85 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | 1 | — | 2 | 3 |
| Chlamydia infections | D002690 | EFO_0007205 | A74.9 | — | 1 | 1 | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | — | 1 | 2 | ||
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | 1 | — | — | 2 |
| Premature rupture fetal membranes | D005322 | HP_0001788 | O42 | — | — | 1 | — | — | 1 |
| Gastrointestinal hemorrhage | D006471 | K92.2 | — | — | 1 | — | — | 1 | |
| Hematemesis | D006396 | HP_0002248 | K92.0 | — | — | 1 | — | — | 1 |
| Epidermolysis bullosa | D004820 | Q81 | — | — | 1 | — | — | 1 | |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 1 | 1 | — | — | 1 |
| Ophthalmia neonatorum | D009878 | A54.31 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | — | 2 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | — | — | — | 2 |
| Feeding and eating disorders | D001068 | F50 | — | 1 | — | — | 1 | 2 | |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | 1 | 1 | — | — | — | 1 |
| Pulmonary fibrosis | D011658 | J84.10 | 1 | 1 | — | — | — | 1 | |
| Hermanski-pudlak syndrome | D022861 | E70.331 | 1 | 1 | — | — | — | 1 | |
| Oculocutaneous albinism | D016115 | E70.32 | 1 | 1 | — | — | — | 1 | |
| Platelet storage pool deficiency | D010981 | EFO_1001112 | 1 | 1 | — | — | — | 1 | |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | — | — | — | 1 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepacivirus | D016174 | 1 | — | — | — | — | 1 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | — | — | — | — | 1 | |
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | C80 | 1 | — | — | — | — | 1 | |
| Hepatocellular carcinoma | D006528 | C22.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 2 | 2 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Delirium | D003693 | R41.0 | — | — | — | — | 1 | 1 | |
| Inflammation | D007249 | — | — | — | — | 1 | 1 | ||
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | — | — | — | 1 | 1 |
| Sepsis | D018805 | A41.9 | — | — | — | — | 1 | 1 | |
| Septic shock | D012772 | A48.3 | — | — | — | — | 1 | 1 | |
| Skin diseases | D012871 | L00-L99 | — | — | — | — | 1 | 1 | |
| Whooping cough | D014917 | EFO_0000650 | A37 | — | — | — | — | 1 | 1 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ESLICARBAZEPINE |
| INN | eslicarbazepine |
| Description | Eslicarbazepine acetate is the acetate ester, with S configuration, of licarbazepine. An anticonvulsant, it is approved for use in Europe and the United States as an adjunctive therapy for epilepsy. It has a role as an anticonvulsant and a drug allergen. It is an acetate ester, a dibenzoazepine, a carboxamide and a member of ureas. It is functionally related to a licarbazepine. |
| Classification | Small molecule |
| Drug class | tricyclic compounds |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | NC(=O)N1c2ccccc2C[C@H](O)c2ccccc21 |
Identifiers
| PDB | — |
| CAS-ID | 104746-04-5 |
| RxCUI | 1482501 |
| ChEMBL ID | CHEMBL315985 |
| ChEBI ID | — |
| PubChem CID | 179344 |
| DrugBank | DB14575 |
| UNII ID | S5VXA428R4 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 815 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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155 adverse events reported
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