dexmethylphenidate
Trade name: focalin
Approved
Nov 13, 2001
Dexmethylphenidate is the dextrorotary form of methylphenidate. Dexmethylphenidate is marketed under the trade name Focalin. Focalin (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threoenantiomers. Focalin is a central nervous system (CNS) stimulant, available in three tablet strengths. Each tablet contains dexmethylphenidate hydrochloride 2.5, 5, or 10 mg for oral administration. Dexmethylphenidate is used as a treatment for ADHD, ideally in conjunction with psychological, educational, behavioral or other forms of treatment. Methylphenidate blocks dopamine uptake in central adrenergic neurons by blocking dopamine transport or carrier proteins. Methylphenidate acts at the brain stem arousal system and the cerebral cortex and causes increased sympathomimetic activity in the central nervous system. Methylphenidate is a catecholamine reuptake inhibitor that indirectly increases catecholaminergic neurotransmission by inhibiting the dopamine transporter (DAT) and norepinephrine transporter (NET), which are responsible for clearing catecholamines from the synapse, particularly in the striatum and meso-limbic system. — NCATS
Clinical trial activity
24 trials · 23 clinical orgs · 25 marketing orgs
Earliest trial started Jun 1, 2002 (NCT00047476)
Timeline
2000s
2010s
- Aug 28, 2013
Mylan — Marketing Organization
- Nov 18, 2013
Intellipharmaceutics — Marketing Organization
- Nov 19, 2013
Teva — Marketing Organization
- Nov 21, 2013
Impax Laboratories — Marketing Organization
- Aug 25, 2015
Aurobindo Pharma — Marketing Organization
- Sep 24, 2015
Sun Pharmaceuticals — Marketing Organization
- Dec 4, 2015
Abhai LLC — Marketing Organization
- Dec 4, 2015
Novel Anti-Infective Technologies, LLC — Marketing Organization
- Aug 26, 2016
Tris Pharma, Inc. — Marketing Organization
- Nov 30, 2016
Par Pharmaceuticals — Marketing Organization
- Nov 30, 2016
Bristol-Myers Squibb — Marketing Organization
- Nov 30, 2016
Endo Pharmaceuticals — Marketing Organization
- Sep 25, 2017
Lannett Company, Inc. — Marketing Organization
- Nov 20, 2017
Rhodes Pharmaceuticals, L.P. — Marketing Organization
- Sep 19, 2018
Cediprof Inc — Marketing Organization
- Oct 9, 2018
Adare Pharmaceuticals — Marketing Organization
- Jul 19, 2019
Alkem Labs Ltd — Marketing Organization
2020s
- Mar 24, 2020
Bionpharma Inc — Marketing Organization
- Mar 24, 2020
US Pharma — Marketing Organization
- Sep 9, 2020
Granules India — Marketing Organization
- Mar 2, 2021
Boston Pharmaceuticals — NDA Secondary Org
- Dec 8, 2021
Ascent Pharmahealth — Marketing Organization
- Dec 8, 2021
AbbVie — Marketing Organization
Indications
Approved for
Mechanism of action
- Dopamine transporterINHIBITOR
SLC6A3 inhibitor
- Norepinephrine transporterINHIBITOR
SLC6A2 inhibitor
Combination products
azstarys
Also known as ak0901, serdexmethylphenidate and dexmethylphenidate
Approval history
- approvedNov 13, 2001
Chemistry & pharmacology
SMILES
COC(=O)[C@H](c1ccccc1)[C@H]1CCCCN1- Mol. weight
- 233.31 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- Yes
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL827 ↗
- WikipediaDexmethylphenidate ↗
- NCATSM32RH9MFGP ↗
- ChEMBLCHEMBL904 ↗
Also known as
- biphentin
- biphentin
- dexmethylphenidate
- dexmethylphenidate
- dexmethylphenidate
- dexmethylphenidate
- dexmethylphenidate
- dexmethylphenidate
- dexmethylphenidate
- dexmethylphenidate
- dex-methylphenidate
- dex-methylphenidate
- dexmethylphenidate hcl
- dexmethylphenidate hcl
- dexmethylphenidate hcl
- dexmethylphenidate hydrochloride
- dexmethylphenidate hydrochloride
- dexmethylphenidate hydrochloride
- dexmethylphenidate hydrochloride
- dexmethylphenidate hydrochloride
- d-methylphenidate
- d-methylphenidate
- d-threo-methylphenidate
- d-threo-methylphenidate
- d-threo-methylphenidate
- d-tmp
- d-tmp
- focalin
- focalin
- focalin
- focalin
- focalin
- focalin
- focalin
- focalin xr
- focalin xr
- methyl d-phenidate
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07119073 | Phase 1 | Oct 31, 2024 | Cingulate Therapeutics |
| NCT06359899 | Phase 3 | May 31, 2024 | Ark Biosciences Inc. |
| NCT06000501 | Phase 4 | Sep 14, 2023 | Corium International Inc., New York University |
| NCT05924594 | Phase 3 | Jul 31, 2023 | Cingulate Therapeutics |
| NCT05286762 | Phase 3 | Jun 1, 2023 | Center for Psychiatry And Behavioral Medicine Inc., Cingulate Therapeutics, Premier Research Group |
| NCT05721235 | Phase 4 | May 24, 2023 | Almac Clinical Services LLC, Center for Psychiatry And Behavioral Medicine Inc., Corium International Inc., Premier Research Group, Prometrika, LLC, Worldwide Clinical Trials |
| NCT05685732 | Phase 4 | Mar 22, 2023 | Almac Clinical Services LLC, Center for Psychiatry And Behavioral Medicine Inc., Corium International Inc., Premier Research Group, Prometrika, LLC |
| NCT05631626 | Phase 3 | Dec 31, 2022 | Cingulate Therapeutics, Rho, Inc. |
| NCT04449250 | Phase 1 | Feb 1, 2021 | Cingulate Therapeutics |
| NCT04138498 | Phase 1/Phase 2 (Phase 2) | Nov 12, 2019 | Cingulate Therapeutics, Sponsor GmbH |
| NCT01985581 | Phase 4 | Oct 1, 2013 | JPM van Stralen Medicine Professional |
| NCT02142140 | N/A | Dec 1, 2012 | Canadian Institutes of Health Research (CIHR), McGill University |
| NCT02566824 | Phase 4 | Oct 1, 2010 | Canadian Institutes of Health Research (CIHR), McGill University |
| NCT00776009 | Phase 4 | Oct 1, 2008 | Novartis |
| NCT00564954 | Phase 4 | Oct 1, 2007 | Novartis |
| NCT00593138 | Phase 1/Phase 2 (Phase 2) | Dec 1, 2006 | Harvard University |
| NCT00361387 | Phase 4 | Jun 1, 2006 | University of Cincinnati |
| NCT00301236 | Phase 3 | Feb 1, 2006 | Novartis |
| NCT00393042 | Phase 3 | Jan 1, 2006 | Novartis, University of Illinois at Chicago, University of Washington |
| NCT00141063 | Phase 3 | Jun 1, 2005 | Novartis |
Organizations
Research & Development (23)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Cingulate Therapeutics | For profit | 6 | 6 | 3 | 2019 |
| Novartis | For profit | 6 | 5 | 2 | 2005 |
| Center for Psychiatry And Behavioral Medicine Inc. | Academic/Hospital | 3 | 0 | 2 | 2023 |
| Corium International Inc. | For profit | 3 | 2 | 1 | 2023 |
| Premier Research Group | For profit | 3 | 0 | 2 | 2023 |
| Almac Clinical Services LLC | For profit | 2 | 0 | 1 | 2023 |
| Canadian Institutes of Health Research (CIHR) | Academic/Hospital | 2 | 0 | 2 | 2010 |
| McGill University | Academic/Hospital | 2 | 2 | 2 | 2010 |
| PRACS | For profit | 2 | 0 | 1 | 2004 |
| Prometrika, LLC | For profit | 2 | 0 | 1 | 2023 |
| Teva | For profit | 2 | 2 | 1 | 2004 |
| Ark Biosciences Inc. | For profit | 1 | 1 | 1 | 2024 |
| Bayou City Research | Academic/Hospital | 1 | 0 | 1 | 2005 |
| Celgene | For profit | 1 | 1 | 1 | 2002 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2006 |
| JPM van Stralen Medicine Professional | Academic/Hospital | 1 | 1 | 1 | 2013 |
| New York University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Rho, Inc. | For profit | 1 | 0 | 1 | 2022 |
| Sponsor GmbH | Academic/Hospital | 1 | 0 | 1 | 2019 |
| University of Cincinnati | Academic/Hospital | 1 | 1 | 1 | 2006 |
Marketing (30)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AbbVie | For profit | MKTG | Dec 8, 2021 |
| Abhai LLC | For profit | MKTG | Dec 4, 2015 |
| Adare Pharmaceuticals | For profit | MKTG | Oct 9, 2018 |
| Alkem Labs Ltd | For profit | MKTG | Jul 19, 2019 |
| Ascent Pharmahealth | For profit | MKTG | Dec 8, 2021 |
| Aurobindo Pharma | For profit | MKTG | Aug 25, 2015 |
| Bionpharma Inc | For profit | MKTG | Mar 24, 2020 |
| Bionpharma Inc | For profit | SYN | Mar 24, 2020 |
| Boston Pharmaceuticals | For profit | NDA2 | Mar 2, 2021 |
| Bristol-Myers Squibb | For profit | MKTG | Nov 30, 2016 |
| Cediprof Inc | For profit | MKTG | Sep 19, 2018 |
| Endo Pharmaceuticals | For profit | MKTG | Nov 30, 2016 |
| Granules India | For profit | MKTG | Sep 9, 2020 |
| Granules India | For profit | MKTG | Sep 9, 2020 |
| Impax Laboratories | For profit | MKTG | Nov 21, 2013 |
| Intellipharmaceutics | For profit | MKTG | Nov 18, 2013 |
| Lannett Company, Inc. | For profit | MKTG | Sep 25, 2017 |
| Mylan | For profit | SYN | Aug 28, 2013 |
| Mylan | For profit | MKTG | Aug 28, 2013 |
| Novartis | For profit | NDA | Nov 13, 2001 |
| Novel Anti-Infective Technologies, LLC | For profit | MKTG | Dec 4, 2015 |
| Par Pharmaceuticals | For profit | MKTG | Nov 30, 2016 |
| Rhodes Pharmaceuticals, L.P. | For profit | MKTG | Nov 20, 2017 |
| Sandoz | For profit | MKTG | Nov 13, 2001 |
| Sun Pharmaceuticals | For profit | MKTG | Sep 24, 2015 |
| Sun Pharmaceuticals | For profit | SYN | Nov 5, 2021 |
| Teva | For profit | SYN | Jan 29, 2007 |
| Teva | For profit | MKTG | Nov 19, 2013 |
| Tris Pharma, Inc. | For profit | MKTG | Aug 26, 2016 |
| US Pharma | For profit | MKTG | Mar 24, 2020 |