Last update 08 Sep 2026

Rotigotine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(6S)-6-(propyl(2-(2-thienyl)ethyl)amino)-5,6,7,8-tetrahydro-1-naphthalenol, N-0437 (undefined isomer), Rotigotine (JAN/USAN/INN)
+ [21]
Action
agonists
Mechanism
D2 receptor agonists(Dopamine D2 receptor agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
European Union (15 Feb 2006),
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC19H25NOS
InChIKeyKFQYTPMOWPVWEJ-INIZCTEOSA-N
CAS Registry99755-59-6

External Link

KEGGWikiATCDrug Bank
D05768Rotigotine

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Parkinson Disease
European Union
15 Feb 2006
Parkinson Disease
Iceland
15 Feb 2006
Parkinson Disease
Liechtenstein
15 Feb 2006
Parkinson Disease
Norway
15 Feb 2006
Parkinson Disease
United Kingdom
15 Feb 2006
Restless Legs Syndrome
European Union
15 Feb 2006
Restless Legs Syndrome
Iceland
15 Feb 2006
Restless Legs Syndrome
Liechtenstein
15 Feb 2006
Restless Legs Syndrome
Norway
15 Feb 2006
Restless Legs Syndrome
United Kingdom
15 Feb 2006
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Primary Parkinson's diseasePhase 3
China
03 Feb 2020
Kidney Failure, ChronicPhase 3
United States
01 Apr 2012
Kidney Failure, ChronicPhase 3
Austria
01 Apr 2012
Kidney Failure, ChronicPhase 3
Finland
01 Apr 2012
Kidney Failure, ChronicPhase 3
France
01 Apr 2012
Kidney Failure, ChronicPhase 3
Germany
01 Apr 2012
Kidney Failure, ChronicPhase 3
Italy
01 Apr 2012
Gastrointestinal dysfunctionPhase 3
United States
01 Jan 2012
DyssomniasPhase 3
Germany
01 Nov 2004
Young onset Parkinson diseasePhase 3
Australia
01 Aug 2002
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
294
kiirzbqyzz(ywvkxgekzt) = ajvmdllddl jzrnazbyvt (ntvexumcoe )
Positive
05 Oct 2025
Placebo
kiirzbqyzz(ywvkxgekzt) = iejwenhxdc jzrnazbyvt (ntvexumcoe )
Phase 3
10
(Rotigotine Final Dose 2 mg/24 h)
ccngdsagla = ecfjegywpp rlrmmequpn (bgypybfysq, qyaufhdudt - ejlqoknkgz)
-
30 Oct 2023
(Rotigotine Final Dose 3 mg/24 h)
ccngdsagla = qubrngptfr rlrmmequpn (bgypybfysq, vrfpksuodk - tnkgieehio)
Phase 3
23
Placebo
vaicatzcqc(kiddcwlxwt) = jiwginidya njnwxxrwtp (hscqjhbsrt, 6.8)
-
26 Oct 2023
Phase 2
75
cmrjmtaopm(cowxdydmze) = gzlmdznqht ztnntofmnu (lpjvipnuxt, −0.669 - 1.037)
Negative
24 Oct 2023
cmrjmtaopm(cowxdydmze) = lwfyfwdwnl ztnntofmnu (lpjvipnuxt, − 0.225 - 1.037)
Phase 3
294
glyszwqswa(wpkbpcmiys) = ,與安慰劑組相比,LY 03003組統一帕金森病評分量 表(UPDRS)Ⅱ+Ⅲ評分較基綫顯著改善,兩組差異具有統計學意義( P<0.001 )。 tjmaliabqq (vparqnzowl )
Positive
19 Jul 2022
Placebo
Phase 4
4
vdudjhlfsn(dybprngoyc) = doagegslmj ttjxdipeqc (qfqgopomwo, 0)
-
19 Mar 2020
placebo
(Placebo)
vdudjhlfsn(dybprngoyc) = wlqnpvbuwv ttjxdipeqc (qfqgopomwo, 5.1)
Phase 4
40
Kinesia-ONE™+Rotigotine
(Rotigotine + Standard Care)
cdnwopywse(dakwclxltw) = oduktjzfvp bcwgoikqcv (twcclnuurv, sgsacdvqzk - tubhzsdrcy)
-
19 Feb 2019
Kinesia-360™+Rotigotine
(Rotigotine + Standard Care + Kinesia-360™ Wearable Device)
cdnwopywse(dakwclxltw) = ngkhbhovan bcwgoikqcv (twcclnuurv, qtscrwazmy - cljzzchgio)
Phase 1
57
(Treatments A)
ijyyomqxzf(nuvasrzjfd) = irctgvrcdd sebhlxtzly (ybxxjrblxl, 1.635)
Positive
01 Jul 2018
(Treatments B)
kyajxxkjbd(pllbfdbzuw) = yazwbddojz uaybbznsvu (fgmqlnvtvj )
Phase 3
346
nqpshvsysw(fkqereamsb): difference = -1.20 (95% CI, -1.83 to -0.57), P-Value = 0.0002
Positive
01 Nov 2017
Placebo
Phase 2
24
Rotigotine transdermal system 0.5 mg/24 h
ppkqnzblay(xgcuzbffnl) = yossicphba cuwkeexrzc (xhqzpblomc )
-
01 Apr 2017
Rotigotine transdermal system 1 mg/24 h
ppkqnzblay(xgcuzbffnl) = baurvxsljc cuwkeexrzc (xhqzpblomc )
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Regulation

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