Overview
Developed by Schering-Plough after its merger with Organon International, asenapine is a sublingually administered, atypical antipsychotic for treatment of schizophrenia and acute mania associated with bipolar disorder. Asenapine also belongs to the dibenzo-oxepino pyrrole class. It is also for severe post-traumatic stress disorder nightmares in soldiers as an off-label use. FDA approved on August 13, 2009.
Indication
适用于成人精神分裂症和双相情感障碍患者的治疗。
Associated Conditions
- Bipolar 1 Disorder
- Mixed manic depressive episode
- Schizophrenia
- Acute Manic episode
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2016/09/08 | N/A | Terminated | |||
2015/11/09 | N/A | Completed | |||
2014/02/27 | Phase 2 | Completed | |||
2013/10/23 | Phase 4 | UNKNOWN | Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec | ||
2013/09/23 | Phase 1 | Completed | |||
2013/03/08 | Phase 2 | Terminated | |||
2012/09/13 | Phase 3 | Suspended | |||
2012/08/21 | Phase 4 | Completed | |||
2012/06/12 | Phase 3 | Completed | |||
2012/06/12 | Phase 3 | Completed | Forest Laboratories |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Alembic Pharmaceuticals Inc. | 62332-544 | SUBLINGUAL | 2.5 mg in 1 1 | 9/2/2021 | |
| Noven Therapeutics, LLC | 68968-0173 | TRANSDERMAL | 5.7 mg in 1 d | 5/22/2023 | |
| Noven Therapeutics, LLC | 68968-0174 | TRANSDERMAL | 7.6 mg in 1 d | 5/22/2023 | |
| Noven Therapeutics, LLC | 68968-0172 | TRANSDERMAL | 3.8 mg in 1 d | 5/22/2023 | |
| Sigmapharm Laboratories, LLC | 42794-017 | SUBLINGUAL | 10 mg in 1 1 | 1/10/2023 | |
| Sigmapharm Laboratories, LLC | 42794-016 | SUBLINGUAL | 5 mg in 1 1 | 1/10/2023 | |
| Alembic Pharmaceuticals Limited | 46708-198 | SUBLINGUAL | 5 mg in 1 1 | 1/20/2023 | |
| Alembic Pharmaceuticals Limited | 46708-199 | SUBLINGUAL | 10 mg in 1 1 | 1/20/2023 | |
| Alembic Pharmaceuticals Limited | 46708-544 | SUBLINGUAL | 2.5 mg in 1 1 | 1/20/2023 | |
| Alembic Pharmaceuticals Inc. | 62332-198 | SUBLINGUAL | 5 mg in 1 1 | 9/2/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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