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

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