gemfibrozil (FHL-301) / Forest Hills Lab - LARVOL DELTA

Unraveling the Function of PPARα in Neurodegenerative Disorders: A Potential Pathway to Novel Therapies. (PubMed, Biomedicines) - "Indicatively, gemfibrozil (PPARα agonist) markedly reduced the beta-amyloid burden, microgliosis, and astrogliosis in the hippocampus of 5xFAD mice and ameliorated their spatial learning and memory. Fenofibrate (PPARα agonist) reduced the depressive-like behavior and memory deficits in rotenone-lesioned rats developing Parkinsonism...Although current findings are promising, they underscore the necessity of further rigorous clinical validation of the efficacy of various PPARα agonists in the retardation or even prevention of AD and PD symptomatology in both genders and the development of reliable biomarkers for the early assessment of the impact of PPARα agonists on NDs. The safety of these drugs in the elderly and their longitudinal effectiveness should also be evaluated."

Journal • Review • Alzheimer's Disease • CNS Disorders • Inflammation • Metabolic Disorders • Movement Disorders • Parkinson's Disease • PPARA

Role of peroxisome proliferator-activated receptor alpha in neurodegenerative diseases and other neurological disorders: Clinical application prospects. (PubMed, Neural Regen Res) - "For instance, peroxisome proliferator-activated receptor alpha agonist gemfibrozil has been shown to reduce levels of soluble and insoluble amyloid-beta in the hippocampus of Alzheimer's disease mouse models through the autophagy-lysosomal pathway...Furthermore, peroxisome proliferator-activated receptor alpha has been found to reduce neuroinflammation and oxidative stress in various neurological diseases. In summary, peroxisome proliferator-activated receptor alpha plays a crucial role in the onset and progression of multiple nervous system diseases, and peroxisome proliferator-activated receptor alpha agonists hold promise as new therapeutic agents for the treatment of neurodegenerative diseases, providing new options for patient care."

Journal • Alzheimer's Disease • CNS Disorders • Inflammation • Movement Disorders • Multiple Sclerosis • Parkinson's Disease • PPARA

Study to Evaluate the Safety, Tolerability, Efficacy, and PK of FHL-301 in Parkinson's Disease Patients. (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Forest Hills Lab | Trial completion date: Dec 2024 ➔ Nov 2028 | Trial primary completion date: Dec 2024 ➔ Nov 2028

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

Erratum: Gottschalk et al., "Gemfibrozil Protects Dopaminergic Neurons in a Mouse Model of Parkinson's Disease via PPARα-Dependent Astrocytic GDNF Pathway". (PubMed, J Neurosci) - No abstract available

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

Study to Evaluate the Safety, Tolerability, Efficacy, and PK of FHL-301 in Parkinson's Disease Patients. (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Forest Hills Lab | Initiation date: Nov 2023 ➔ Nov 2024

Trial initiation date • CNS Disorders • Movement Disorders • Parkinson's Disease

Study to Evaluate the Safety, Tolerability, Efficacy, and PK of FHL-301 in Parkinson's Disease Patients. (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Forest Hills Lab

New P2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

FHL Announces Phase 2 Clinical Trial for Parkinson’s Drug, Korean Medical Device Company Acquisition and Saudi JV (EIN News) - "Forest Hills Partners Hong Kong...announced today an important FDA approval for a Phase 2 clinical trial to develop a drug for Parkinson’s and the signing of strategic initiatives in Korea and Saudi Arabia as management looks to accelerate global expansion in second half 2021....FHL-301 is a repurposed peroxisome proliferator-activated receptor (PPAR)-alpha agonist drug which has shown excellent animal proof of concept to slow down or reverse the progression of Parkinson’s disease. The upcoming Phase 2 clinical trial will enroll early stage patients diagnosed with Parkinson’s in a double-blind, placebo-controlled and randomized study for a period of 52 weeks."

New P2 trial • CNS Disorders • Parkinson's Disease

Forest Hills Lab is filing an IND to initiate a clinical phase 2 study on Parkinson's disease with the US FDA (Yahoo Finance) - "Forest Hills...is ready to file an Investigative New Drug (IND) application with the US FDA in April 2021 to assess tolerability and efficacy with one of its drug candidates, namely FHL-301 in a phase 2 clinical study for patients diagnosed with Parkinson's disease...It is very exciting to explore the efficacy of FH-301 with PD patients in upcoming phase 2 clinical study because FHL-301 has a unique mechanism of action which is not overlapped with other drugs, FHL-301 may be one of excellent alternative options for the treatment of Parkinson's disease."

IND • New P2 trial • CNS Disorders • Parkinson's Disease