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rotigotine

Trade name: neupro

Small moleculeapproved

Approved

May 9, 2007

Rotigotine is an agonist at all 5 dopamine receptor subtypes (D1-D5) but binds to the D3 receptor with the highest affinity. It is also an antagonist at α-2-adrenergic receptors and an agonist at the 5HT1A receptors. Rotigotine also inhibits dopamine uptake and prolactin secretion. It is FDA approved for the treatment of Parkinson's disease, restless legs syndrome. Dopamine antagonists, such as antipsychotics or metoclopramide, may diminish the effectiveness of Rotigotine. Common adverse reactions include nausea, vomiting, somnolence, application site reactions, dizziness, anorexia, hyperhidrosis, insomnia and dyskinesia. — NCATS

Clinical trial activity

96 trials · 37 clinical orgs · 2 marketing orgs

Phase 1
26
Phase 2
54
Phase 3
35
Phase 4
13

Earliest trial started May 1, 1999 (NCT00001931)

Timeline

1990s

  1. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2002

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2002

    Earliest Phase 3 Sponsor(trial)

  3. May 9, 2007

    Schwarz Pharma — Earliest FDA Approval

  4. May 9, 2007

    Schwarz Pharma — NDA Organization

  5. May 9, 2007

    UCB — Marketing Organization

  6. May 9, 2007

    UCB — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedMay 9, 2007

Chemistry & pharmacology

Loading structure…

SMILES

CCCN(CCC1=CC=CS1)[C@H]2CCC3=C(O)C=CC=C3C2
Mol. weight
315.473 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 1-naphthalenol, 5,6,7,8-tetrahydro-6-(propyl(2-(2-thienyl)ethyl)amino)-
  • 2-(n-n-propyl-n-2-thienylethylamino)-5-hydroxytetralin
  • (+--)-5,6,7,8-tetrahydro-6-(propyl(2-(2-thienyl)ethyl)amino)-1-naphthol
  • (6s)-6-(propyl(2-(2-thienyl)ethyl)amino)-5,6,7,8-tetrahydro-1-naphthalenol
  • (6s)-6-(propyl(2-(2-thienyl)ethyl)amino)-5,6,7,8-tetrahydro-1-naphthalenol
  • ent-rotigotine
  • leganto
  • ly03003
  • n 0437
  • n-0437
  • n 0437, hydrochloride, (r)-isomer
  • n 0437, hydrochloride, (s)-isomer
  • n 0437, (-)-isomer
  • n 0437, (+-)-isomer
  • n 0437, (r)-isomer
  • n 0923
  • n-0923
  • n-0923
  • n-0923
  • n 0924
  • n-0924
  • neupro
  • neupro
  • neupro
  • neupro
  • neupro
  • rotigotine
  • rotigotine
  • rotigotine
  • rotigotine
  • rotigotine
  • rotigotine
  • rotigotine
  • rotigotine
  • rotigotine
  • rotigotine
  • rotigotine
  • rotigotine
  • rotigotine
  • rotigotine, (+--)-
  • rotigotine cds
  • ser-214
  • spm 962
  • spm 962
  • spm-962
  • spm-962
  • (s)-(-)-rotigotine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07015346N/ASep 1, 2025EVA pharma, Egypt
NCT06291116Phase 2Jan 1, 2025Rouen Normandy University
NCT06702124Phase 3Dec 1, 2023I.R.C.C.S. Fondazione Santa Lucia
NCT05886582Phase 2Sep 11, 2023National Institute on Drug Abuse (NIDA), Virginia Commonwealth University
NCT06247410Phase 2Aug 23, 2021Luye Pharma, SocraMetrics GmbH, SocraTec R&D GmbH
NCT04937452Phase 2Jun 3, 2021Alzheimer’s Drug Discovery Foundation, I.R.C.C.S. Fondazione Santa Lucia, University of Rome Tor Vergata
NCT04593511Phase 1Oct 31, 2020Luye Pharma
NCT04630860Phase 1Jul 7, 2020Luye Pharma
NCT04384666Phase 1May 15, 2020Luye Pharma, Pharmaceutical Research Associates, Inc. (PRA)
NCT04571164Phase 3May 11, 2020Luye Pharma, Parexel
NCT04183634Phase 1Dec 2, 2019Sandoz
NCT03992196Phase 3Jun 30, 2019UCB
NCT03728933Phase 3Dec 20, 2018UCB
NCT03733561Phase 1Nov 9, 2018Luye Pharma, Sponsor GmbH
NCT04629404Phase 1Nov 5, 2018Luye Pharma
NCT04455555Phase 3Aug 1, 2018Peking University
NCT03589066Phase 1May 15, 2018Luye Pharma
NCT04045678Phase 1Oct 10, 2017Beijing Bozhiyin T&S Co., Ltd., Luye Pharma
NCT03103919Phase 4Mar 16, 2017UCB
NCT03098368Phase 4Sep 1, 2016Abbott, Chulalongkorn University
Showing 20 of 96 trials
Page 1 / 5

Organizations

Research & Development (37)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Hoosier Cancer Research NetworkAcademic/Hospital515042002
Luye PharmaFor profit131232013
OtsukaFor profit131042005
UCBFor profit4422012
I.R.C.C.S. Fondazione Santa LuciaAcademic/Hospital3322016
Beijing Bozhiyin T&S Co., Ltd.For profit2012013
Schwarz PharmaFor profit2022002
University of Rome Tor VergataAcademic/Hospital2012016
AbbottFor profit1012016
Alzheimer’s Drug Discovery FoundationAcademic/Hospital1012021
A.O. Ospedale Card G. Panico di TricaseAcademic/Hospital1012013
Azienda Ospedaliera Cardinale G. PanicoAcademic/Hospital1112013
Bracket GlobalFor profit1012014
Chulalongkorn UniversityAcademic/Hospital1112016
East Carolina UniversityAcademic/Hospital1112015
EVA pharma, EgyptFor profit1112025
Harvard UniversityAcademic/Hospital1112014
InflamaxFor profit1112013
Johns Hopkins UniversityAcademic/Hospital1112016
Medical Research CouncilGovernment1012010
37 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
Schwarz PharmaFor profitNDAMay 9, 2007
UCBFor profitMKTGMay 9, 2007
UCBFor profitNDA2May 9, 2007