Parkinson's Disease Drug Therapies in the Clinical Trial Pipeline: 2023 Update.

Publisher: IOS Press Country of Publication: Netherlands NLM ID: 101567362 Publication Model: Print Cited Medium: Internet ISSN: 1877-718X (Electronic) Linking ISSN: 18777171 NLM ISO Abbreviation: J Parkinsons Dis Subsets: MEDLINE

Original Publication: Amsterdam : IOS Press

Parkinson Disease*/drug therapy ; Neurodegenerative Diseases*; Humans

Background: Since 2020, annual reports on the clinical development of new drug-based therapies for the neurodegenerative condition of Parkinson's disease (PD) have been generated. These reviews have followed the progress of both "symptomatic treatments" (ST - improves/reduces symptoms of the condition) and "disease modifying treatments" (DMT - attempts to delay/slow progression by addressing the underlying biology of PD). Additional efforts have been made to further categorize these experimental treatments based on their mechanisms of action and class of drug.
Methods: A dataset of clinical trials for drug therapies in PD was obtained using trial data downloaded from the ClinicalTrials.gov online registry. A breakdown analysis of all the studies that were active as of January 31st, 2023, was conducted.
Results: There was a total of 139 clinical trials registered on the ClinicalTrials.gov website as active (with 35 trials newly registered since our last report). Of these trials, 76 (55%) were considered ST and 63 (45%) were designated DMT. Similar to previous years, approximately a third of the studies were in Phase 1 (n = 47; 34%), half (n = 72, 52%) were in Phase 2 and there were 20 (14%) studies in Phase 3. Novel therapies again represented the most dominant group of experimental treatments in this year's report with 58 (42%) trials testing new agents. Repurposed drugs are present in a third (n = 49, 35%) of trials, with reformulations and new claims representing 19% and 4% of studies, respectively.
Conclusions: Our fourth annual review of active clinical trials evaluating ST and DMT therapeutics for PD demonstrates that the drug development pipeline is dynamic and evolving. The slow progress and lack of agents transitioning from Phase 2 to Phase 3 is concerning, but collective efforts by various stakeholders are being made to accelerate the clinical trial process, with the aim of bringing new therapies to the PD community sooner.

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Keywords: Clinical trials; Parkinson’s; disease modification; gene therapy; immunotherapy; inflammation; neuroprotection; studies

Date Created: 20230611 Date Completed: 20230620 Latest Revision: 20230722

20231215

PMC10357160

10.3233/JPD-239901

37302040