Overview
Dexmethylphenidate is the dextrorotary form of methylphenidate introduced in 2002. It is a norepinephrine-dopamine reuptake inhibitor (NDRI) and thus a psychostimulant. It is used for treatment of Attention Deficit Hyperactivity Disorder (ADHD). The d-isomer is thought to have greater effect with fewer side effects than the l-isomer or the racemic mixture.
Indication
Dexmethylphenidate is used as a treatment for ADHD, ideally in conjunction with psychological, educational, behavioral or other forms of treatment.
Associated Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/12 | Not Applicable | Completed | |||
2024/04/11 | Phase 3 | Not yet recruiting | |||
2023/06/29 | Phase 3 | Suspended | |||
2022/11/30 | Phase 3 | Completed | |||
2020/06/26 | Phase 1 | Completed | |||
2019/10/24 | Phase 1 | Completed | |||
2009/01/27 | Phase 1 | Completed | |||
2009/01/27 | Phase 1 | Completed | |||
2006/10/26 | Phase 3 | Completed | |||
2006/03/10 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novartis Pharmaceuticals Corporation | 0078-0433 | ORAL | 30 mg in 1 1 | 10/13/2023 | |
| Novartis Pharmaceuticals Corporation | 0078-0434 | ORAL | 40 mg in 1 1 | 10/13/2023 | |
| Camber Pharmaceuticals, Inc. | 31722-233 | ORAL | 25 mg in 1 1 | 12/17/2021 | |
| Lannett Company, Inc. | 0527-1901 | ORAL | 10 mg in 1 1 | 7/27/2023 | |
| Ascent Pharmaceuticals, Inc. | 43602-332 | ORAL | 30 mg in 1 1 | 12/10/2021 | |
| Camber Pharmaceuticals, Inc. | 31722-232 | ORAL | 20 mg in 1 1 | 12/17/2021 | |
| Sun Pharmaceutical Industries, Inc. | 57664-621 | ORAL | 5 mg in 1 1 | 1/16/2024 | |
| Ascent Pharmaceuticals, Inc. | 43602-329 | ORAL | 15 mg in 1 1 | 12/10/2021 | |
| Sun Pharmaceutical Industries, Inc. | 57664-623 | ORAL | 15 mg in 1 1 | 1/16/2024 | |
| Bryant Ranch Prepack | 63629-2305 | ORAL | 2.5 mg in 1 1 | 8/16/2021 |
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 |
|---|---|---|---|---|---|
| ATTENADE | biovail pharmaceuticals canada division of biovail corporation | 02247791 | Tablet - Oral | 2.5 MG | N/A |
| ATTENADE | biovail pharmaceuticals canada division of biovail corporation | 02247792 | Tablet - Oral | 5 MG | N/A |
| ATTENADE | biovail pharmaceuticals canada division of biovail corporation | 02247793 | Tablet - Oral | 10 MG | N/A |
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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