Parkinson’s Disease : New Drugs in Development – Drug and Device Digest

The loss of dopamine-producing cells in the brain is an underlying issue in Parkinson’s disease.

Currently approved or in R&D medicines for Parkinson’s disease treat the symptoms of the disease, such as mobility problems and tremors, but do not replace lost nerve cells or halt the progression of the disease itself.

Several drugs in development are disease-modifying therapies focused on protecting brain cells in an attempt to halt disease progression, or treatments aimed at generating new cells or repairing damaged nerve cells.

Product Name Sponsor Indication Development Phase*
AAV-hAADC

gene therapy

Genzyme

Cambridge, MA

University of California San Francisco

San Francisco, CA

Voyager Therapeutics

Cambridge, MA

Parkinson’s disease Phase I

http://www.voyagertherapeutics.com

Duodopa®

levodopa/carbidopa intestinal gel

ORPHAN DRUG

AbbVie

North Chicago, IL

advanced Parkinson’s disease

(Fast Track)

application submitted

http://www.abbvie.com

AAV2 GDNF

gene therapy

UniQure

Amsterdam, Netherlands

University of California San Francisco

San Francisco, CA

Parkinson’s disease Phase I

http://www.uniqure.com

Ampyra®

dalfampridine

Acorda Therapeutics

Ardsley, NY

University of Miami

Miami, FL

Parkinson’s disease

(improve gait)

Phase I/II

http://www.acorda.com

AVE8112

(PDE4 inhibitor

The Michael J. Fox Foundation for

Parkinson’s Research

New York, NY

Sano_ US

Bridgewater, NJ

Parkinson’s disease Phase I

http://www.michaeljfox.org

AZD3241

(myeloper-oxidase [MPO]

inhibitor)

AstraZeneca

Wilmington, DE

Parkinson’s disease Phase II

http://www.astrazeneca.com

BIA 9-1067

(opicapone)

Bial

Coronado, Portugal

Parkinson’s disease Phase I completed

http://www.bial.com

DopaFuse

levodopa continuous infusion

therapy

SynAgile

Piedmont, CA

Parkinson’s disease Phase I

http://www.synagile.com

GM608 Genervon Biopharmaceuticals

Pasadena, CA

Parkinson’s disease Phase II

http://www.genervon.com

HT-1067

(MOA-B inhibitor

Dart NeuroScience

San Diego, CA

Parkinson’s disease Phase I

http://www.dartneuroscience.com

IPX203 Impax Pharmaceuticals Hayward, CA Parkinson’s disease Phase II http://www.impaxpharma.com
istradefylline (KW-6002) Kyowa Hakko Kirin Pharma Princeton, NJ severe Parkinson’s disease Phase III http://www.kyowa-kirin-pharma.com
levodopa inhalation (CVT-301) Civitas Therapeutics Chelsea, MA Parkinson’s disease (adjunctive therapy) Phase II http://www.civitastherapeutics.com
LY03003 (rotigotine extended-release microsphere formulation) Luye America Pharmaceuticals Princeton, NJ Parkinson’s disease (early-stage disease) Phase I http://www.luye.cn/en/
OS-320 (levodopa/carbidopa) Osmotica Pharmaceutical Wilmington, NC Parkinson’s disease Phase III http://www.osmotica.com
P2B001 (pramipexole/rasagiline ­ xed-dose combination) Pharma Two B Rehovot, Israel Parkinson’s disease (early-stage disease) Phase II http://www.pharma2b.com
Phosphen® R-phenserine QR Pharma Berwyn, PA Parkinson’s disease Phase II http://www.qrpharma.com
Rytary™ levodopa/carbidopa extended release Impax Pharmaceuticals Hayward, CA idiopathic Parkinson’s disease application submitted http://www.impaxpharma.com
safinamide Newron Pharmaceuticals Bresso, Italy early-stage Parkinson’s disease (adjunctive therapy)

——————————— late-stage and mid-stage Parkinson’s disease (adjunctive therapy)

Phase III http://www.newron.com

———————————— Phase III http://www.newron.com

tozadenant (SYN-115) Biotie Therapies South San Francisco, CA UCB Brussels, Belgium Parkinson’s disease (adjunctive therapy) Phase II/III http://www.biotie.com http://www.ucb.com
V81444 Vernalis Winnersh, United Kingdom Parkinson’s disease Phase I/II http://www.vernalis.com
vatiquinone Edison Pharmaceuticals Mountain View, CA Parkinson’s disease Phase II http://www.edisonpharma.com
XP21279 XenoPort Santa Clara, CA Parkinson’s disease Phase II http://www.xenoport.com
Florbenazine (18F-AV-133) Eli Lilly Indianapolis, IN Parkinson’s disease (diagnosis) Phase II

http://www.lilly.com

NAV5001

(123-I labeled imaging agent)

Navidea Biopharmaceuticals Dublin, OH Parkinsonian disorders (diagnosis) Phase III http://www.navidea.com
NuroPro® neurotrophic factor companion diagnostic Amarantus BioScience San Francisco, CA Parkinson’s disease (diagnosis) Phase I http://www.amarantus.com
Parkinson’s Disease—Related Conditions
ADS-5102 (amantadine controlled release) Adamas Pharmaceuticals Emeryville, CA levodopa-induced dyskinesia Phase II/III http://www.adamaspharma.com
AQW051 (alpha7 nicotinic receptor) Novartis Pharmaceuticals East Hanover, NJ Levodopa-induced dyskinesia Phase II completed http://www.novartis.com
AVP-923 (dextromethorphan/quinidine) Avanir Pharmaceuticals Aliso Viejo, CA Levodopa-induced dyskinesia Phase II

http://www.avanir.com

camicinal (motilin receptor agonist) GlaxoSmithKline , PA gastroparesis in Parkinson’s disease Phase II http://www.gsk.com
dipraglurant-IR (ADX48621) Addex Therapeutics Geneva, Switzerland Levodopa-induced dyskinesia Phase II http://www.addextherapeutics.com
eltoprazine Amarantus BioScience San Francisco, CA Levodopa-induced dyskinesia Phase II

http://www.amarantus.com


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