Lacosamide
- Generic Name
- Lacosamide
- Brand Names
- Motpoly, Vimpat, Lacosamide Adroiq, Lacosamide Accord, Lacosamide UCB
- Drug Type
- Small Molecule
- Chemical Formula
- C13H18N2O3
- CAS Number
- 175481-36-4
- Unique Ingredient Identifier
- 563KS2PQY5
Overview
Lacosamide is a functionalized amino acid that has activity in the maximal electroshock seizure test, and is indicated for the adjunctive treatment of partial-onset seizures and diabetic neuropathic pain. Recent studies indicate that Lacosamide only affects those neurons which are depolarized or active for long periods of time, typical of neurons at the focus of an epileptic seizure, as opposed to other antiepileptic drugs such as carbamazepine or lamotrigine which slow the recovery from inactivation and reduce the ability of neurons to fire action potentials.
Background
Lacosamide is a functionalized amino acid that has activity in the maximal electroshock seizure test, and is indicated for the adjunctive treatment of partial-onset seizures and diabetic neuropathic pain. Recent studies indicate that Lacosamide only affects those neurons which are depolarized or active for long periods of time, typical of neurons at the focus of an epileptic seizure, as opposed to other antiepileptic drugs such as carbamazepine or lamotrigine which slow the recovery from inactivation and reduce the ability of neurons to fire action potentials.
Indication
Lacosamide is indicated for the treatment of partial-onset seizures in patients aged one month and older and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients aged four years and older.
Associated Conditions
- Epilepsy, Primary Generalized Tonic-Clonic Seizures
- Partial-Onset Seizures
- Status Epilepticus
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2016/11/23 | Phase 1 | Completed | UCB Biopharma S.P.R.L. | ||
2016/04/04 | Phase 3 | Withdrawn | |||
2016/03/17 | Phase 2 | Completed | |||
2015/10/21 | Phase 3 | Completed | UCB Biopharma S.P.R.L. | ||
2015/06/23 | Phase 3 | Completed | |||
2015/04/06 | Phase 4 | Terminated | |||
2015/04/03 | Phase 3 | Completed | |||
2015/04/03 | Phase 3 | Completed | |||
2015/03/02 | Phase 3 | Terminated | |||
2015/01/21 | Phase 2 | Withdrawn |
FDA Approved Products
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Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
ORAL | 150 mg in 1 1 | 2023/11/14 | 68462-680 | ||
ORAL | 50 mg in 1 1 | 2023/01/09 | 50228-192 | ||
ORAL | 100 mg in 1 1 | 2023/11/20 | 47335-922 | ||
ORAL | 100 mg in 1 1 | 2023/05/17 | 53746-924 | ||
ORAL | 150 mg in 1 1 | 2023/12/21 | 73289-0064 | ||
ORAL | 150 mg in 1 1 | 2023/05/17 | 53746-925 | ||
ORAL | 100 mg in 1 1 | 2022/03/19 | 14445-130 | ||
ORAL | 150 mg in 1 1 | 2024/02/08 | 51407-723 | ||
ORAL | 10 mg in 1 mL | 2024/01/25 | 59651-016 | ||
ORAL | 200 mg in 1 1 | 2023/06/01 | 69367-351 |
EMA Approved Products
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Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
HSA Approved Products
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Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. |
|---|
No HSA products found
No HSA products found for this drug
NMPA Approved Products
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Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|---|---|---|---|---|---|---|---|---|
国药准字HJ20180063 | 片剂 | 维派特 | 100mg | Chemical Drug | Approved | 2023/10/19 | Import | ||
国药准字H20234094 | 片剂 | N/A | 50mg | Chemical Drug | Approved | 2023/12/18 | Domestic | ||
国药准字HJ20191025 | 片剂 | 维派特 | 50mg | Chemical Drug | Approved | 2023/10/19 | Import | ||
H20180069 | 片剂 | 维派特 | 50mg | Chemical Drug | Expired | 2018/11/21 | Import | ||
H20180070 | 片剂 | 维派特 | 100mg | Chemical Drug | Expired | 2018/11/21 | Import | ||
国药准字HJ20180070 | 片剂 | 维派特 | 100mg | Chemical Drug | Approved | 2023/10/19 | Import | ||
H20180072 | 片剂 | 维派特 | 200mg | Chemical Drug | Expired | 2018/11/21 | Import | ||
国药准字H20213663 | 片剂 | N/A | 50mg | Chemical Drug | Approved | 2021/08/25 | Domestic | ||
国药准字H20223722 | 片剂 | N/A | 50mg | Chemical Drug | Approved | 2022/10/11 | Domestic | ||
国药准字H20213307 | 片剂 | N/A | 100mg | Chemical Drug | Approved | 2021/04/27 | Domestic |
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Reg. Date |
|---|---|---|---|---|---|
HK-68641 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2025/04/12 | ||
HK-68642 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2025/04/12 |
TGA Approved Products
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Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
|---|---|---|---|---|---|
296754 | Active | 2019/05/29 | lacosamide | ||
296762 | Active | 2019/05/29 | lacosamide | ||
337894 | Active | 2021/05/11 | lacosamide | ||
353583 | Active | 2022/02/08 | lacosamide | ||
353593 | Active | 2022/02/08 | lacosamide | ||
230190 | Active | 2015/09/30 | lacosamide | ||
230192 | Active | 2015/09/30 | lacosamide | ||
230191 | Active | 2015/09/30 | lacosamide | ||
151815 | Active | 2009/07/20 | lacosamide | ||
296757 | Active | 2019/05/29 | lacosamide |