dexmethylphenidate

Trade name: focalin

Small moleculeapproved

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

Phase 1
6
Phase 2
11
Phase 3
8
Phase 4
8

Earliest trial started Jun 1, 2002 (NCT00047476)

Timeline

2000s

  1. Nov 13, 2001

    Novartis — Earliest FDA Approval

  2. Nov 13, 2001

    Novartis — NDA Organization

  3. Nov 13, 2001

    Sandoz — Marketing Organization

  4. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  5. Jan 1, 2004

    Teva — Earliest Phase 1 Sponsor(trial)

  6. Jan 1, 2005

    Novartis — Earliest Phase 3 Sponsor(trial)

2010s

  1. Aug 28, 2013

    Mylan — Marketing Organization

  2. Nov 18, 2013

    Intellipharmaceutics — Marketing Organization

  3. Nov 19, 2013

    Teva — Marketing Organization

  4. Nov 21, 2013

    Impax Laboratories — Marketing Organization

  5. Aug 25, 2015

    Aurobindo Pharma — Marketing Organization

  6. Sep 24, 2015

    Sun Pharmaceuticals — Marketing Organization

  7. Dec 4, 2015

    Abhai LLC — Marketing Organization

  8. Dec 4, 2015

    Novel Anti-Infective Technologies, LLC — Marketing Organization

  9. Aug 26, 2016

    Tris Pharma, Inc. — Marketing Organization

  10. Nov 30, 2016

    Par Pharmaceuticals — Marketing Organization

  11. Nov 30, 2016

    Bristol-Myers Squibb — Marketing Organization

  12. Nov 30, 2016

    Endo Pharmaceuticals — Marketing Organization

  13. Sep 25, 2017

    Lannett Company, Inc. — Marketing Organization

  14. Nov 20, 2017

    Rhodes Pharmaceuticals, L.P. — Marketing Organization

  15. Sep 19, 2018

    Cediprof Inc — Marketing Organization

  16. Oct 9, 2018

    Adare Pharmaceuticals — Marketing Organization

  17. Jul 19, 2019

    Alkem Labs Ltd — Marketing Organization

2020s

  1. Mar 24, 2020

    Bionpharma Inc — Marketing Organization

  2. Mar 24, 2020

    US Pharma — Marketing Organization

  3. Sep 9, 2020

    Granules India — Marketing Organization

  4. Mar 2, 2021

    Boston Pharmaceuticals — NDA Secondary Org

  5. Dec 8, 2021

    Ascent Pharmahealth — Marketing Organization

  6. Dec 8, 2021

    AbbVie — Marketing Organization

Indications

Mechanism of action

Combination products

Approval history

  • approvedNov 13, 2001

Chemistry & pharmacology

Loading structure…

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

Black box warning

Sources

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 IDPhaseStart dateSponsor(s)
NCT07119073Phase 1Oct 31, 2024Cingulate Therapeutics
NCT06359899Phase 3May 31, 2024Ark Biosciences Inc.
NCT06000501Phase 4Sep 14, 2023Corium International Inc., New York University
NCT05924594Phase 3Jul 31, 2023Cingulate Therapeutics
NCT05286762Phase 3Jun 1, 2023Center for Psychiatry And Behavioral Medicine Inc., Cingulate Therapeutics, Premier Research Group
NCT05721235Phase 4May 24, 2023Almac Clinical Services LLC, Center for Psychiatry And Behavioral Medicine Inc., Corium International Inc., Premier Research Group, Prometrika, LLC, Worldwide Clinical Trials
NCT05685732Phase 4Mar 22, 2023Almac Clinical Services LLC, Center for Psychiatry And Behavioral Medicine Inc., Corium International Inc., Premier Research Group, Prometrika, LLC
NCT05631626Phase 3Dec 31, 2022Cingulate Therapeutics, Rho, Inc.
NCT04449250Phase 1Feb 1, 2021Cingulate Therapeutics
NCT04138498Phase 1/Phase 2 (Phase 2)Nov 12, 2019Cingulate Therapeutics, Sponsor GmbH
NCT01985581Phase 4Oct 1, 2013JPM van Stralen Medicine Professional
NCT02142140N/ADec 1, 2012Canadian Institutes of Health Research (CIHR), McGill University
NCT02566824Phase 4Oct 1, 2010Canadian Institutes of Health Research (CIHR), McGill University
NCT00776009Phase 4Oct 1, 2008Novartis
NCT00564954Phase 4Oct 1, 2007Novartis
NCT00593138Phase 1/Phase 2 (Phase 2)Dec 1, 2006Harvard University
NCT00361387Phase 4Jun 1, 2006University of Cincinnati
NCT00301236Phase 3Feb 1, 2006Novartis
NCT00393042Phase 3Jan 1, 2006Novartis, University of Illinois at Chicago, University of Washington
NCT00141063Phase 3Jun 1, 2005Novartis
Showing 20 of 24 trials
Page 1 / 2

Organizations

Research & Development (23)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Cingulate TherapeuticsFor profit6632019
NovartisFor profit6522005
Center for Psychiatry And Behavioral Medicine Inc.Academic/Hospital3022023
Corium International Inc.For profit3212023
Premier Research GroupFor profit3022023
Almac Clinical Services LLCFor profit2012023
Canadian Institutes of Health Research (CIHR)Academic/Hospital2022010
McGill UniversityAcademic/Hospital2222010
PRACSFor profit2012004
Prometrika, LLCFor profit2012023
TevaFor profit2212004
Ark Biosciences Inc.For profit1112024
Bayou City ResearchAcademic/Hospital1012005
CelgeneFor profit1112002
Harvard UniversityAcademic/Hospital1112006
JPM van Stralen Medicine ProfessionalAcademic/Hospital1112013
New York UniversityAcademic/Hospital1112023
Rho, Inc.For profit1012022
Sponsor GmbHAcademic/Hospital1012019
University of CincinnatiAcademic/Hospital1112006
23 organizations
Page 1 / 2

Marketing (30)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGDec 8, 2021
Abhai LLCFor profitMKTGDec 4, 2015
Adare PharmaceuticalsFor profitMKTGOct 9, 2018
Alkem Labs LtdFor profitMKTGJul 19, 2019
Ascent PharmahealthFor profitMKTGDec 8, 2021
Aurobindo PharmaFor profitMKTGAug 25, 2015
Bionpharma IncFor profitMKTGMar 24, 2020
Bionpharma IncFor profitSYNMar 24, 2020
Boston PharmaceuticalsFor profitNDA2Mar 2, 2021
Bristol-Myers SquibbFor profitMKTGNov 30, 2016
Cediprof IncFor profitMKTGSep 19, 2018
Endo PharmaceuticalsFor profitMKTGNov 30, 2016
Granules IndiaFor profitMKTGSep 9, 2020
Granules IndiaFor profitMKTGSep 9, 2020
Impax LaboratoriesFor profitMKTGNov 21, 2013
IntellipharmaceuticsFor profitMKTGNov 18, 2013
Lannett Company, Inc.For profitMKTGSep 25, 2017
MylanFor profitSYNAug 28, 2013
MylanFor profitMKTGAug 28, 2013
NovartisFor profitNDANov 13, 2001
Novel Anti-Infective Technologies, LLCFor profitMKTGDec 4, 2015
Par PharmaceuticalsFor profitMKTGNov 30, 2016
Rhodes Pharmaceuticals, L.P.For profitMKTGNov 20, 2017
SandozFor profitMKTGNov 13, 2001
Sun PharmaceuticalsFor profitMKTGSep 24, 2015
Sun PharmaceuticalsFor profitSYNNov 5, 2021
TevaFor profitSYNJan 29, 2007
TevaFor profitMKTGNov 19, 2013
Tris Pharma, Inc.For profitMKTGAug 26, 2016
US PharmaFor profitMKTGMar 24, 2020