MedPath

Rotigotine

Generic Name
Rotigotine
Brand Names
Neupro
Drug Type
Small Molecule
Chemical Formula
C19H25NOS
CAS Number
99755-59-6
Unique Ingredient Identifier
87T4T8BO2E

Overview

Rotigotine (Neupro) is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and restless legs syndrome (RLS) in Europe and the United States. It is formulated as a once-daily transdermal patch which provides a slow and constant supply of the drug over the course of 24 hours. Like other dopamine agonists, rotigotine has been shown to possess antidepressant effects and may be useful in the treatment of depression as well. Rotigotine was developed by Aderis Pharmaceuticals. In 1998 Aderis licensed worldwide development and commercialization rights to Schwarz Pharma of Germany. It was approved by the European Medicines Agency in 2006 and by the FDA in 2007. However, all Neupro patches in the United States and some of Europe were recalled in 2008 due to delivery mechanism issues. Rotigotine has been authorized as a treatment for RLS since August 2008.

Indication

For use/treatment in neurologic disorders and parkinson's disease as well as moderate-to-severe primary Restless Legs Syndrome.

Associated Conditions

  • Moderate restless legs syndrome (RLS)
  • Parkinson's Disease (PD)
  • Severe restless legs syndrome (RLS)

Research Report

Published: Jul 22, 2025

A Comprehensive Monograph on Rotigotine (Neupro®): Pharmacology, Clinical Efficacy, and Therapeutic Profile

Introduction and Overview

Executive Summary

Rotigotine is a second-generation, non-ergoline dopamine agonist that occupies a distinct position in the therapeutic armamentarium for specific neurological disorders.[1] Marketed globally under the brand name Neupro®, its defining characteristic is its formulation as a once-daily transdermal therapeutic system (TTS), or "patch".[3] This delivery system is designed to provide continuous, non-fluctuating plasma concentrations of the drug over a 24-hour period.[1] The primary approved indications for Rotigotine are the treatment of the signs and symptoms of idiopathic Parkinson's Disease (PD) and the symptomatic management of moderate-to-severe primary Restless Legs Syndrome (RLS).[7] As a small molecule drug, Rotigotine acts by directly stimulating dopamine receptors in the brain, thereby substituting for the depleted endogenous neurotransmitter in pathological states.[9] Its unique delivery method and broad receptor binding profile differentiate it from other therapies, presenting both distinct advantages and a specific set of clinical and manufacturing challenges that have shaped its development and therapeutic application.

The Concept of Continuous Dopaminergic Stimulation (CDS)

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/11/22
Phase 3
Recruiting
I.R.C.C.S. Fondazione Santa Lucia
2024/02/07
Phase 2
Completed
SocraTec R&D GmbH
2023/06/02
Phase 2
Recruiting
2021/07/12
N/A
UNKNOWN
2021/06/24
Phase 2
Completed
I.R.C.C.S. Fondazione Santa Lucia
2020/11/16
Phase 1
Completed
2020/11/16
Phase 1
Completed
2020/11/13
Phase 1
Completed
2019/12/03
Phase 1
Terminated
2019/06/20
Phase 3
Terminated

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
UCB, Inc.
50474-805
TRANSDERMAL
6 mg in 24 h
7/21/2021
UCB, Inc.
50474-804
TRANSDERMAL
4 mg in 24 h
7/21/2021
UCB, Inc.
50474-803
TRANSDERMAL
3 mg in 24 h
7/21/2021
UCB, Inc.
50474-802
TRANSDERMAL
2 mg in 24 h
7/21/2021
UCB, Inc.
50474-801
TRANSDERMAL
1 mg in 24 h
7/21/2021
UCB, Inc.
50474-806
TRANSDERMAL
8 mg in 24 h
7/21/2021

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
2/15/2006

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
NEUPRO
UCB Canada Inc
02403897
Patch - Transdermal
1 MG / 24 HOUR
12/19/2013
NEUPRO
UCB Canada Inc
02403900
Patch - Transdermal
2 MG / 24 HOUR
6/27/2013
NEUPRO
UCB Canada Inc
02403919
Patch - Transdermal
3 MG / 24 HOUR
12/19/2013
NEUPRO
UCB Canada Inc
02403935
Patch - Transdermal
6 MG / 24 HOUR
6/27/2013
NEUPRO
UCB Canada Inc
02403927
Patch - Transdermal
4 MG / 24 HOUR
6/27/2013

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
ROTIGOTINA LUYE 2 MG/24 H PARCHES TRANSDERMICOS EFG
89419
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
DARIANTE 4 MG/24 HORAS PARCHES TRANSDÉRMICOS EFG
Exeltis Healthcare S.L.
89092
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica
Commercialized
NEUPRO 8 MG/24 H PARCHE TRANSDERMICO
05331011
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica
Commercialized
ROTIGOTINA LUYE 4 MG/24 H PARCHES TRANSDERMICOS EFG
89421
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
NEUPRO 1 MG/24 H PARCHE TRANSDERMICO
05331040
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica
Commercialized
NEUPRO 2, 4, 6, 8 MG/24 H PARCHE TRANSDERMICO
05331013
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
DARIANTE 2 MG/24 HORAS PARCHES TRANSDÉRMICOS EFG
Exeltis Healthcare S.L.
89090
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica
Commercialized
DARIANTE 8 MG/24 HORAS PARCHES TRANSDÉRMICOS EFG
Exeltis Healthcare S.L.
89094
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica
Commercialized
NEUPRO 3 MG/24 H PARCHE TRANSDERMICO
05331049
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica
Commercialized
ROTIGOTINA LUYE 3 MG/24 H PARCHES TRANSDERMICOS EFG
89420
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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