donepezil long-acting injectable (IVL3003) / Inventage Lab - LARVOL DELTA

A Clinical Trial to Access Pharmacokinetic Profiles and Safety of IVL3003. (clinicaltrials.gov) - P1/2 | N=62 | Active, not recruiting | Sponsor: Inventage Lab., Inc. | Recruiting ➔ Active, not recruiting | N=42 ➔ 62 | Trial completion date: Mar 2024 ➔ Nov 2025 | Trial primary completion date: Mar 2024 ➔ Nov 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Inventage Lab 'Various Drugs, Long-Term Formulation Development Possible' [KIW 2024] [Google translation] (Hankyung) - "Inventage Lab...participated in the 'Korea Investment Week (KIW) 2024' held at the Conrad Hotel in Yeouido-dong, Seoul on the 11th and had time to explain in detail about its candidate substances under development...Inventage Lab is developing long-acting injections using 'microfluidic technology'...Using this technology, Inventage Lab is developing...Alzheimer's treatment IVL3003...ILV3003 is in phase 1/2 clinical trials in Australia..."

Clinical • Alzheimer's Disease • CNS Disorders

SINGLE ASCENDING DOSE STUDY OF THE NOVEL DONEPEZIL LONG-ACTING INJECTION VERSUS ARICEPT® TABLETS IN HEALTHY ADULT PARTICIPANTS (ADPD 2024) - "A major difference in the observed PK over 672hours following SC IVL3001 was the more consistent donepezil plasma concentrations without initial burst and the absence of sharp fluctuations in peak and trough levels which are typical of daily oral dosing. The safety and pharmacokinetic/pharmacodynamic properties of IVL3003 confirmed through this trial showed that it achieved a fast effective concentration and maintained a stable effective concentration, unlike the conventional oral drug administered daily. IVL3003 was confirmed to be developed as a therapeutic agent for Alzheimer's disease (AD)."

Clinical • Alzheimer's Disease • CNS Disorders • Dementia • Pain

A Clinical Trial to Access Pharmacokinetic Profiles and Safety of IVL3003. (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Inventage Lab., Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders

Preparation of Novel Donepezil Long-Acting Injectable, IVL3003, and its Pharmacokinetic Study via Subcutaneous Injection in Dogs and Monkeys (AAIC 2023) - "As we postulated, narrow distribution of the particles was led to improvement of controlled-release characteristics. These results proved the excellence of IVL-DrugFluidics ® as an ideal microsphere fabrication method in manufacturing uniform and monodispersed microspheres. Long-acting injectable, IVL3003 is expected to increase the compliance and the safety in the treatment of Alzheimer’s patients."

PK/PD data • Alzheimer's Disease • CNS Disorders

A Clinical Trial to Access Pharmacokinetic Profiles and Safety of IVL3003. (clinicaltrials.gov) - P1/2 | N=42 | Not yet recruiting | Sponsor: Inventage Lab., Inc. | Trial completion date: Jul 2023 ➔ Mar 2024 | Initiation date: Aug 2022 ➔ Apr 2023 | Trial primary completion date: Jul 2023 ➔ Mar 2024

Trial completion date • Trial initiation date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

A Clinical Trial to Access Pharmacokinetic Profiles and Safety of IVL3003. (clinicaltrials.gov) - P1/2 | N=42 | Not yet recruiting | Sponsor: Inventage Lab., Inc.

New P1/2 trial • Alzheimer's Disease • CNS Disorders