donepezil/memantine (BPDO-1603) / Hyundai Pharm - LARVOL DELTA

Bioequivalence of a Donepezil/Memantine 10/20 mg Fixed-Dose Combination Versus Single-Component Tablets in Healthy Korean Males. (PubMed, Clin Pharmacol Drug Dev) - "Regarding the safety profile, all adverse events were mild, with no serious adverse events. These findings support the use of an FDC formulation as a viable alternative to SCs of donepezil and memantine, potentially improving treatment adherence in patients with moderate-to-severe AD."

Journal • Alzheimer's Disease • CNS Disorders

Hyundai Pharmaceutical fails to reach ’statistical significance’ in phase 3 clinical trial for Alzheimer’s disease [Google translation] (Pharm News) - P3 | N=712 | NCT04229927 | Sponsor: Hyundai Pharmaceutical Co., LTD. | "Phase 3 clinical trial (multicenter, randomized, double-blind, active- control) did not yield the expected results. This trial showed donepezil to improve cognitive function as assessed by the 'Severe Impairement Battery' (SIB) and overall outcome as assessed by the 'Clinician's Interview-based Impression of Change-plus' (CIBIC-plus) in patients with moderate to severe AD. To prove the superiority of 'BPDO-1603' to hydrochloride, 60 domestic institutions conducted it...in terms of clinical trial efficacy conducted on 712 patients (356 in the test group and 356 in the control group), statistical analysis through SIB's repeated measures mixed effects model (MMRM) showed a least square mean difference of 0.11. (95% CI -0.37, 0.58), P-value = 0.6621, did not reach statistical significance to verify superiority over onepezil hydrochloride."

P3 data • Alzheimer's Disease • CNS Disorders

Pharmacokinetics of BPDO-1603 or BPDO-16031 and BPDO-16033 Administration in Healthy Adults (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Hyundai Pharm

New P1 trial

BPDO-1603 Intervention Trial in Patients With Moderate-to-severe Alzheimer's Disease (clinicaltrials.gov) - P3; N=712; Recruiting; Sponsor: Hyundai Pharmaceutical Co., LTD.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Alzheimer's Disease • CNS Disorders • Tauopathies And Synucleinopathies