armodafinil

Trade name: nuvigil

Small moleculeapproved

Approved

Jun 15, 2007

Modafinil is a stimulant drug marketed as a 'wakefulness promoting agent' and is one of the stimulants used in the treatment of narcolepsy. Narcolepsy is caused by dysfunction of a family of wakefulness-promoting and sleep-suppressing peptides, the orexins, whose neurons are activated by modafinil. The prexin neuron activation is associated with psychoactivation and euphoria. Modafinil is not indicated for complaints of lack of energy or fatigue; but it appears to be very helpful for some patients. Also, it has been used in the treatment of hypersomnia, a disorder in which patients lack the capacity for meaningful sleep and may require ten or more hours per day. Recent studies have have found that modafinil may help recovering cocaine addicts fight their addiction. The exact mechanism of action is unclear, although in vitro studies have shown it to inhibit the reuptake of dopamine by binding to the dopamine reuptake pump, and lead to an increase in extracellular dopamine. Modafinil activates glutamatergic circuits while inhibiting GABA. Modafinil is thought to have less potential for abuse than other stimulants due to the absence of any significant euphoric or pleasurable effects. It is possible that modafinil acts by a synergistic combination of mechanisms including direct inhibition of dopamine reuptake, indirect inhibition of noradrenalin reuptake in the VLPO and orexin activation. Modafinil has partial alpha 1B-adrenergic agonist effects by directly stimulating the receptors. Modafinil is indicated for the improvement of wakefulness in patients with excessive daytime sleepiness (EDS) associated with narcolepsy. — NCATS

Clinical trial activity

56 trials · 36 clinical orgs · 11 marketing orgs

Phase 1
6
Phase 2
35
Phase 3
23
Phase 4
9

Earliest trial started Jan 1, 2004 (NCT00078312)

Timeline

2000s

  1. Jan 1, 2004

    Cephalon — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2007

    Cephalon — Earliest Phase 2 Sponsor(trial)

  4. Jun 15, 2007

    Cephalon — Earliest FDA Approval

  5. Jun 15, 2007

    Cephalon — NDA Organization

2010s

  1. Jun 1, 2012

    Mylan — Marketing Organization

  2. Aug 29, 2012

    Watson Pharmaceuticals — Marketing Organization

  3. Aug 29, 2012

    Actavis — Marketing Organization

  4. Sep 24, 2014

    Teva — Marketing Organization

  5. Nov 28, 2016

    Lupin — Marketing Organization

  6. Nov 28, 2016

    Natco Pharma — Marketing Organization

  7. Mar 6, 2018

    Aurobindo Pharma — Marketing Organization

  8. Mar 25, 2019

    Apotex — Marketing Organization

  9. Mar 25, 2019

    Corepharma — Marketing Organization

  10. Mar 25, 2019

    Amneal Pharmaceuticals — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedJun 15, 2007

Chemistry & pharmacology

Loading structure…

SMILES

NC(=O)C[S@@+]([O-])C(C1=CC=CC=C1)C2=CC=CC=C2
Mol. weight
273.35 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • (–)-2-[(r)-(diphenylmethyl)sulfinyl]acetamide
  • (–)-2-[(r)-(diphenylmethyl)sulfinyl]acetamide
  • 2-((r)-(diphenylmethyl)sulfinyl)acetamide
  • armodafinil
  • armodafinil
  • armodafinil
  • armodafinil
  • armodafinil
  • armodafinil
  • armodafinil
  • armodafinil
  • armodafinil
  • armodafinil
  • armodanifil
  • cep-10953
  • cep-10953
  • cep-10953
  • nuvigil
  • nuvigil
  • nuvigil
  • nuvigil
  • nuvigil
  • nuvigil
  • nuvigil
  • nuvigil
  • r-modafinil
  • r-modafinil
  • r-modafinil

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT02468856Phase 1May 21, 2017University of Florida
NCT02552303N/AApr 1, 2014Teva, University of Pennsylvania
NCT01781468Phase 3Jun 1, 2013Mayo Clinic, National Cancer Institute (NCI)
NCT01219673Phase 1/Phase 2 (Phase 2)Mar 1, 2013National Cancer Institute (NCI), University of Texas at Houston
NCT01746043Phase 2Feb 1, 2013National Cancer Institute (NCI), University of Texas at Houston
NCT01624480Phase 1Jul 1, 2012Teva
NCT01470651Phase 4Oct 1, 2011Cornell University, Icahn School of Medicine at Mount Sinai, Research Foundation for Mental Hygiene, Inc.
NCT01460628Phase 4Oct 1, 2011Harvard University, Teva
NCT02478580Phase 3Aug 1, 2011The University of Texas, Dallas
NCT01317550N/AJul 1, 2011National Cancer Institute (NCI), University of Texas at Houston
NCT01431573N/AJul 1, 2011Columbia University
NCT01330446Phase 1/Phase 2 (Phase 2)May 1, 2011National Cancer Institute (NCI), University of Texas at Houston
NCT02151253Phase 2/Phase 3 (Phase 3)May 1, 2011Duke University
NCT01169753N/AMay 1, 2011Cephalon, University of Texas at Houston
NCT01305408Phase 3Mar 1, 2011Cephalon
NCT01011218Phase 2/Phase 3 (Phase 3)Jan 1, 2011National Cancer Institute (NCI), Stanford University
NCT01256905N/ADec 1, 2010Cephalon, New York University
NCT01400958Phase 2Dec 1, 2010Cephalon, University of South Florida
NCT01032200Phase 2Aug 1, 2010National Cancer Institute (NCI), Wake Forest University
NCT01160380Phase 3Jun 1, 2010Cephalon, James R. Berenson MD, Inc., Oncotherapeutics
Showing 20 of 56 trials
Page 1 / 3

Organizations

Research & Development (36)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
CephalonFor profit312242004
National Cancer Institute (NCI)Government9132008
University of Texas at HoustonAcademic/Hospital6622010
TevaFor profit4142008
Harvard UniversityAcademic/Hospital3322007
Columbia UniversityAcademic/Hospital2222008
Mayo ClinicAcademic/Hospital2122009
University of CincinnatiAcademic/Hospital2212007
University of PennsylvaniaAcademic/Hospital2222009
Brain & Behavior Research FoundationAcademic/Hospital1012006
Burke Rehabilitation HospitalAcademic/Hospital1112008
ClinilabsFor profit1012010
Cornell UniversityAcademic/Hospital1012011
Dartmouth UniversityAcademic/Hospital1012008
Duke UniversityAcademic/Hospital1112011
Icahn School of Medicine at Mount SinaiAcademic/Hospital1012011
James R. Berenson MD, Inc.Academic/Hospital1012010
National Institute of Mental Health (NIMH)Government1012008
National Institute on Aging (NIA)Government1012009
New York UniversityAcademic/Hospital1112010
36 organizations
Page 1 / 2

Marketing (12)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGAug 29, 2012
Amneal PharmaceuticalsFor profitMKTGMar 25, 2019
ApotexFor profitMKTGMar 25, 2019
ApotexFor profitSYNMar 25, 2019
Aurobindo PharmaFor profitMKTGMar 6, 2018
CephalonFor profitNDAJun 15, 2007
CorepharmaFor profitMKTGMar 25, 2019
LupinFor profitMKTGNov 28, 2016
MylanFor profitMKTGJun 1, 2012
Natco PharmaFor profitMKTGNov 28, 2016
TevaFor profitMKTGSep 24, 2014
Watson PharmaceuticalsFor profitMKTGAug 29, 2012