Neupro (rotigotine transdermal) / Otsuka, UCB - LARVOL DELTA

Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder (clinicaltrials.gov) - P2 | N=50 | Completed | Sponsor: Virginia Commonwealth University | Recruiting ➔ Completed | Trial completion date: Nov 2026 ➔ Aug 2026 | Trial primary completion date: Nov 2026 ➔ Aug 2026

Trial completion • Trial completion date • Trial primary completion date

No acronyms: Bioequivalence and Adhesion of a Rotigotine Patch in Healthy Subjects (clinicaltrials.gov) - P1 | N=35 | Completed | Sponsor: Amarin Technologies S.A.U.

New P1 trial

Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Virginia Commonwealth University | Trial completion date: Jun 2026 ➔ Nov 2026 | Trial primary completion date: Jun 2026 ➔ Nov 2026

Trial completion date • Trial primary completion date

Comparative Study of Rotigotine Release and Permeation from the Neupro® Transdermal Patch: An In Vitro-In Vivo Correlation. (PubMed, AAPS PharmSciTech) - "The developed methods effectively differentiated between modified and reference patches, confirming their applicability for quality control and post-registration changes. Additionally, the results highlight the role of in vitro models in predicting in vivo performance of the RTG transdermal system, contributing to formulations optimization/development and guiding regulatory decisions in bioequivalence studies."

Clinical • Journal • Preclinical • CNS Disorders • Movement Disorders • Parkinson's Disease • Restless Legs Syndrome • Sleep Disorder

2022/0345/HP: Safety of rotigotine in patients with autosomal dominant polycystic kidney disease - ETERNAL-PKD (clinicaltrialsregister.eu) - P1/2 | N=120 | Recruiting | Sponsor: Centre Hospitalier Universitaire Rouen | Not yet recruiting ➔ Recruiting

Enrollment open • Autosomal Dominant Polycystic Kidney Disease • Genetic Disorders • Nephrology • Polycystic Kidney Disease • Renal Disease

1462rot25ct: Clinical trial to investigate the adherence of a new Rotigotine patch to the skin of patients with Parkinsons disease (clinicaltrialsregister.eu) - P1/2 | N=24 | Active, not recruiting | Sponsor: Luye Pharma Switzerland AG | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

Patient-Reported Outcomes of Rotigotine in Parkinson's Disease: Real-World Evidence on Symptom Control and Quality of Life From China. (PubMed, Parkinsons Dis) - "Over half of the patients reported improvement in PD symptoms as per PGIC, and PDQ-8 scores indicated an overall improvement in quality of life, particularly in patients with advanced PD. This study reaffirms the safety and effectiveness of rotigotine in a real-world Chinese PD population, including both early and advanced stages, aligning with previous research findings."

HEOR • Journal • Real-world evidence • CNS Disorders • Dermatology • Movement Disorders • Parkinson's Disease • Pruritus

Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Virginia Commonwealth University | N=60 ➔ 40

Enrollment change

START: Adhesion and Safety of Rotigexole Compared to Neupro® (clinicaltrials.gov) - P=N/A | N=40 | Not yet recruiting | Sponsor: Eva Pharma

Head-to-Head • New trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Dopaminergic Therapy for Frontotemporal Dementia Patients (clinicaltrials.gov) - P2 | N=75 | Completed | Sponsor: I.R.C.C.S. Fondazione Santa Lucia | Active, not recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Developmental Disorders • Frontotemporal Lobar Degeneration • Mental Retardation • Metabolic Disorders • Proteinopathy • Psychiatry

Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Virginia Commonwealth University | Phase classification: P2a ➔ P2

Phase classification

Dissolving microarray patches loaded with a rotigotine nanosuspension: A potential alternative to Neupro® patch. (PubMed, J Control Release) - "The in vivo pharmacokinetic studies demonstrated that RTG-NS MAPs, though smaller (2 cm2 for dissolving MAPs and 6 cm2 for Neupro®), delivered drug levels comparable to Neupro®, indicating higher efficiency per unit area. This could potentially avoid unnecessarily high plasma levels after the next dose at 24 h, highlighting the benefits of dissolving MAPs over conventional transdermal patches in PD treatment."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Carboxymethyl cellulose-based rotigotine nanocrystals-loaded hydrogel for increased transdermal delivery with alleviated skin irritation. (PubMed, Carbohydr Polym) - "Transdermal rotigotine (RTG) therapy is prescribed to manage Parkinson's disease (Neupro® patch)...Further, NS-HG was chemically stable; >95 % of the drug was preserved up to 4 weeks under long term (25 °C/RH60%), accelerated (40 °C/RH75%), and stress (50 °C) storage conditions. Therefore, this novel cellulose derivative-based nanoformulation presents a promising approach for effective transdermal RTG delivery with improved tolerability."

Journal • CNS Disorders • Dermatology • Movement Disorders • Parkinson's Disease

A follow-up study of rotigotine patch in adolescent subjects with Restless Legs Syndrome (clinicaltrialsregister.eu) - P3 | N=138 | Sponsor: UCB Biopharma SRL

Monotherapy • New P3 trial • Movement Disorders • Restless Legs Syndrome • Sleep Disorder

A study of rotigotine patch in adolescent subjects with Restless Legs Syndrome of unknown cause (clinicaltrialsregister.eu) - P3 | N=138 | Sponsor: UCB Biopharma SRL

New P3 trial • Movement Disorders • Restless Legs Syndrome • Sleep Disorder

Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder (clinicaltrials.gov) - P2a | N=60 | Recruiting | Sponsor: Virginia Commonwealth University | Not yet recruiting ➔ Recruiting

Enrollment open

Financial impact of Parkinson’s disease on women and men (MDS Congress 2023) - "Symptom severity for the past 12 months, use of mobility devices, history of device-assisted therapy (deep brain stimulation, duopa or levodopa-carbidopa intestinal gels, apomorphine infusion, neupro patch), financial costs associated with Parkinson’s medications for the past 12 months were compared between women and men.; Majority of the cohort had medical insurance (98.9%) and identified as non-Hispanic (96%) and White (97.3%). Financial costs associated with Parkinson’s medications are similar for women and men, despite women having less income and being younger. Longer disease duration, more income, device assisted therapy use are associated with higher costs associated with Parkinson’s medication. Socioeconomic and demographic factors can contribute to the gender disparities in PD."

Clinical • CNS Disorders • Pain • Parkinson's Disease

Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder (clinicaltrials.gov) - P2a | N=60 | Not yet recruiting | Sponsor: Virginia Commonwealth University | Initiation date: Jun 2023 ➔ Sep 2023

Trial initiation date

Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder (clinicaltrials.gov) - P2a | N=60 | Not yet recruiting | Sponsor: Virginia Commonwealth University

New P2a trial

A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome (clinicaltrials.gov) - P3 | N=10 | Terminated | Sponsor: UCB Biopharma SRL | N=138 ➔ 10 | Trial completion date: Oct 2024 ➔ Sep 2022 | Enrolling by invitation ➔ Terminated | Trial primary completion date: Oct 2024 ➔ Sep 2022; Sponsor decision; Not a safety decision

Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Movement Disorders • Restless Legs Syndrome • Sleep Disorder

A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause (clinicaltrials.gov) - P3 | N=23 | Terminated | Sponsor: UCB Biopharma SRL | N=138 ➔ 23 | Trial completion date: Oct 2023 ➔ Jul 2022 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2023 ➔ Jul 2022; Sponsor decision; Not a safety decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Movement Disorders • Restless Legs Syndrome • Sleep Disorder

Teva, Viatris win U.S. appeal in patent fight over Parkinson's drug (The Economic Times) - "Belgian biopharmaceutical company UCB on Wednesday lost its U.S. court appeal seeking to revive a patent covering its Parkinson's disease drug Neupro, clearin an obstacle for Teva's Actavis Laboratories UT Inc and Viatris' Mylan Technologies Inc to sell generic versions of the drug. The U.S. Court of Appeals for the Federal Circuit agreed with a Delaware federal court that UCB's patent on Neupro patches was invalid. A ruling for UCB could have delayed U.S. Food and Drug Administration approval of a Neupro generic until it expired in December 2030, the court said."

Corporate lawsuit • Patent • CNS Disorders • Parkinson's Disease

"$CEVA CEVA NeuPro-M Edge AI Processor Architecture Recognized at EE Awards Asia 2022 https://t.co/Mz8RbVj7Mk" (,@stock_titan)

BioCareSD Adds Six New Products to Existing Portfolio in Partnership with UCB (BioSpace) - "BioCareSD...announced a contract with UCB to add six new product offerings to its already diverse portfolio. This partnership, which will enable BioCareSD to service a wider patient population, demonstrates the organization’s continued commitment to being the industry’s most trusted healthcare partner....BRIVIACT® - partial-onset seizures in patients one month of age and older CIMZIA® - Crohn’s Disease and Rheumatoid Arthritis NAYZILAM® - intermittent, stereotypic episodes of frequent seizure activity, distinct from patient’s usual seizure pattern in patients with epilepsy 12 years of age and older NEUPRO® - Parkinson’s Disease and Restless Leg Syndrome KEPPRA® - partial-onset seizures in adults with epilepsy VIMPAT® - partial-onset seizures in patients with epilepsy 17 years of age and older."

Licensing / partnership • CNS Disorders • Crohn's disease • Epilepsy • Parkinson's Disease • Restless Legs Syndrome • Rheumatoid Arthritis

Strong first six months – UCB with continued delivery and strong resilience (UCB Press Release) - "NEUPRO® (rotigotine), the patch for Parkinson’s disease and restless legs syndrome, recorded declining net sales in the U.S. and international markets, namely Japan, and stable net sales in Europe – in a competitive market environment."

Commercial • CNS Disorders • Parkinson's Disease • Restless Legs Syndrome