CDEK by Data4ThePeople
Sign in Sign up
← All drugs Report issue

apomorphine

Trade name: apokyn

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Apr 20, 2004

Apomorphine, sold under the brand name Apokyn among others, is a type of aporphine having activity as a non-selective dopamine agonist which activates both D2-like and, to a much lesser extent, D1-like receptors. It also acts as an antagonist of 5-HT2 and α-adrenergic receptors with high affinity. The compound is an alkaloid belonging to nymphaea caerulea, or blue lotus, but is also historically known as a morphine decomposition product made by boiling morphine with concentrated acid, hence the -morphine suffix. Contrary to its name, apomorphine does not actually contain morphine or its skeleton, nor does it bind to opioid receptors. The apo- prefix relates to it being a morphine derivative ("[comes] from morphine"). — Wikipedia

Clinical trial activity

53 trials · 42 clinical orgs · 9 marketing orgs

Phase 1
7
Phase 2
32
Phase 3
19
Phase 4
7

Earliest trial started Aug 1, 1998 (NCT00003822)

Timeline

1990s

  1. Apr 22, 1993

    Orphan Drug Designation

  2. Jan 1, 1998

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 1999

    Mylan — Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 1999

    Mylan — Earliest Phase 3 Sponsor(trial)

2000s

  1. Apr 20, 2004

    Mylan — Earliest FDA Approval

  2. Apr 20, 2004

    US WorldMeds — NDA Secondary Org

  3. Apr 20, 2004

    Mylan — NDA Organization

  4. Apr 20, 2004

    Supernus Pharmaceuticals — Marketing Organization

  5. Apr 20, 2004

    Supernus Pharmaceuticals — NDA Secondary Org

2020s

  1. May 21, 2020

    Sunovion — Marketing Organization

  2. May 21, 2020

    Sumitomo — Marketing Organization

  3. May 21, 2020

    Sumitomo Dainippon — NDA Secondary Org

  4. Feb 23, 2022

    Sage Products, Inc. — Marketing Organization

  5. Feb 23, 2022

    Stryker — Marketing Organization

  6. Feb 23, 2022

    TRUPHARMA — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackApr 20, 2004

Chemistry & pharmacology

Loading structure…

SMILES

CN1CCC2=C3[C@@H]1CC4=CC=C(O)C(O)=C4C3=CC=C2
Mol. weight
267.3224 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • (-)-10,11-dihydroxyaporphine
  • (-)-10,11-dihydroxyaporphine
  • (−)-10,11-dihydroxyaporphine
  • (−)-10,11-dihydroxyaporphine
  • (6ar)-6-methyl-5,6,6a,7-tetrahydro-4h-dibenzo[de,g]quinoline-10,11-diol
  • (6ar)-6-methyl-5,6,6a,7-tetrahydro-4h-dibenzo[de,g]quinoline-10,11-diol
  • acetomorphin
  • acetomorphine
  • apl-130277
  • apl-130277
  • apo-go
  • apo-go pen
  • apo-go pfs
  • apokyn
  • apokyn
  • apokyn
  • apokyn
  • apomorphin
  • apomorphin
  • apomorphin
  • apomorphine
  • apomorphine
  • apomorphine
  • apomorphine
  • apomorphine
  • apomorphine
  • apomorphine
  • apomorphine
  • apomorphine
  • apomorphine
  • apomorphine
  • (-)-apomorphine
  • apomorphine chloride
  • apomorphine hcl
  • apomorphine hcl
  • apomorphine hcl
  • apomorphine hydrochloride
  • apomorphine hydrochloride
  • apomorphine hydrochloride
  • apomorphine hydrochloride
  • apomorphine hydrochloride
  • apomorphine hydrochloride hemihydrate
  • apomorphine hydrochloride hydrate
  • britaject
  • britaject
  • bromophin
  • diagesil
  • diagesil
  • diamorph,cocaine,chlorpromazine
  • diamorph hcl
  • diamorphine hcl
  • diamorphine hydrochloride
  • diamorphine hydrochloride
  • diamorphine hydrochloride
  • diamorphine hydrochloride
  • diamorphine hydrochloride
  • diamorphine hydrochloride
  • diamorphine hydrochloride
  • diamorph roche
  • diaphine
  • euphorin
  • euphorin
  • in 10 003
  • kw-6500
  • l-apomorphine
  • (r)-5,6,6a,7-tetrahydro-6-methyl-4h-dibenzo[de,g]quinoline-10,11-diol
  • r-(-)-apomorphine
  • r-(-)-apomorphine
  • r-(−)-apomorphine
  • r-(−)-apomorphine
  • uprima
  • uprima
  • vr040

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06954428Phase 1Jun 20, 2025Beyond Drug Development, CMAX Clinical Research, Nano PharmaSolutions
NCT05979415Phase 2Sep 30, 2023Alexza Pharmaceuticals, Inc., Peachtree BioResearch Solutions Inc.
NCT05529095Phase 4Sep 1, 2022Sumitomo Dainippon, The University of Texas, Dallas
NCT04957095N/AFeb 18, 2022National Institute of Neurological Disorders and Stroke (NINDS), The University of Texas, Dallas, University of California, Los Angeles
NCT04879134Phase 2/Phase 3 (Phase 3)Sep 30, 2021Paladin Labs, University of Calgary
NCT04887467Phase 4Sep 16, 2021University of Rennes
NCT05213169Phase 2/Phase 3 (Phase 3)Jun 18, 2021University of Liege
NCT04157933Phase 1Oct 16, 2019Alexza Pharmaceuticals, Inc., Leiden University
NCT03693872N/AMay 15, 2019University of Rennes
NCT03822364Phase 1Nov 26, 2018Alexza Pharmaceuticals, Inc., Leiden University
NCT03391882Phase 3Sep 24, 2018Sunovion
NCT03623828Phase 2Sep 15, 2018Université catholique de Louvain, University of Liege
NCT03292016Phase 2Aug 22, 2017Sunovion
NCT03187301Phase 2Jun 28, 2017Sunovion
NCT02702076Phase 2May 1, 2017University of Groningen
NCT02864004Phase 3Mar 3, 2017University of Rennes
NCT02940912Phase 4Oct 1, 2016Clinique Beau Soleil, University of Paris
NCT02688465Phase 4Mar 1, 2016Adolphe Rothschild Ophtalmologic Foundation
NCT02549573Phase 4Jan 1, 2016US WorldMeds
NCT02542696Phase 3Aug 1, 2015Sunovion
Showing 20 of 53 trials
Page 1 / 3

Organizations

Research & Development (42)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
SunovionFor profit6622014
Kyowa Hakko KirinFor profit4422007
MylanFor profit4411999
National Institute of Neurological Disorders and Stroke (NINDS)Government4122002
University of RennesAcademic/Hospital4432009
Alexza Pharmaceuticals, Inc.For profit3322018
GenzymeFor profit3321998
US WorldMedsFor profit3322012
Britannia Pharmaceuticals Ltd.For profit2212006
Leiden UniversityAcademic/Hospital2012018
Oregon Health and Science UniversityAcademic/Hospital2212005
Technion UniversityAcademic/Hospital2222009
The University of Texas, DallasAcademic/Hospital2222022
University of GlasgowAcademic/Hospital2212006
University of GroningenAcademic/Hospital2212015
University of LiegeAcademic/Hospital2222018
University of ToulouseAcademic/Hospital2222007
VecturaFor profit2012006
Adolphe Rothschild Ophtalmologic FoundationAcademic/Hospital1112016
Beyond Drug DevelopmentFor profit1012025
42 organizations
Page 1 / 3

Marketing (10)

OrganizationOrg typeRelationshipDate
MylanFor profitNDAApr 20, 2004
Sage Products, Inc.For profitMKTGFeb 23, 2022
StrykerFor profitMKTGFeb 23, 2022
SumitomoFor profitMKTGMay 21, 2020
Sumitomo DainipponFor profitNDA2May 21, 2020
SunovionFor profitMKTGMay 21, 2020
Supernus PharmaceuticalsFor profitMKTGApr 20, 2004
Supernus PharmaceuticalsFor profitNDA2Apr 20, 2004
TRUPHARMAFor profitMKTGFeb 23, 2022
US WorldMedsFor profitNDA2Apr 20, 2004