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.
Background
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 |
|---|---|---|---|---|---|
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 | |||
2005/09/01 | 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. | |||||