MK-2214 / Merck (MSD), Teijin - LARVOL DELTA

A phase 2 randomized, controlled trial of MK-2214, a novel antibody targeting pS413 tau, in early Alzheimer's disease: Study rationale and design (CTAD 2026) - No abstract available

Clinical • P2 data • Alzheimer's Disease • CNS Disorders

Novel Anti-Tau Seeding Antibody MK-2214 Achieves Near-Complete CSF Target Engagement in Phase 1 (NeurologyLive) - "Across all 3 studies, MK-2214 was generally well-tolerated, with no dose-limiting tolerability issues and no drug-related adverse event pattern. The half-life was approximately 80 days, consistent with the extended half-life engineering and supporting a monthly or less frequent dosing interval. Exposures and Cmax were approximately dose-proportional in each study. Subcutaneous bioavailability relative to IV was 0.63 across the 50-mg and 200-mg subcutaneous doses tested in Study 1...Pharmacokinetics in Japanese participants in Study 2 and in cognitively impaired older adults in Study 3 were both comparable to those in healthy younger adults in Study 1, supporting consistent drug behavior across populations."

Retrospective data • Alzheimer's Disease

A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004) (clinicaltrials.gov) - P2 | N=340 | Recruiting | Sponsor: Merck Sharp & Dohme LLC

Trial initiation date • Alzheimer's Disease • CNS Disorders

A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004) (clinicaltrials.gov) - P2 | N=340 | Recruiting | Sponsor: Merck Sharp & Dohme LLC

Trial initiation date • Alzheimer's Disease • CNS Disorders

A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004) (clinicaltrials.gov) - P2 | N=340 | Recruiting | Sponsor: Merck Sharp & Dohme LLC

Trial initiation date • Alzheimer's Disease • CNS Disorders

Drug Development. (PubMed, Alzheimers Dement) - "The preclinical profile presented here supports the clinical development of MK-2214 as an optimal tau antibody to slow the progression of AD."

Journal • Alzheimer's Disease • CNS Disorders

Phase 1 studies of MK-2214, a novel antibody targeting pS413 tau, for the treatment of Alzheimer's disease (CTAD 2025) - No abstract available

P1 data • Alzheimer's Disease • CNS Disorders

…the company announced that MK-2214, a novel candidate targeting the abnormal accumulation and aggregation of tau in the brain, has been granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of Alzheimer’s disease. (Merck (MSD) Press Release)

Fast track • Alzheimer's Disease

Merck Showcases Data for Alzheimer’s Disease Candidates MK-2214 and MK-1167 at CTAD 2025 (Merck (MSD) Press Release) - "Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced plans to present first-in-human data for MK-2214 and MK-1167 at Clinical Trials on Alzheimer’s Disease (CTAD) 2025 in San Diego, California from Dec. 1-4."

P1 data • P2 data • Alzheimer's Disease

A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004) (clinicaltrials.gov) - P2 | N=340 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2029 ➔ Apr 2029 | Trial primary completion date: Sep 2029 ➔ Apr 2029

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

A Study of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease (MK-2214-002) (clinicaltrials.gov) - P1 | N=34 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004) (clinicaltrials.gov) - P2 | N=340 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P2 trial • Alzheimer's Disease • CNS Disorders

A Study of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease (MK-2214-002) (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • CSF P-tau

A Study of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease (MK-2214-002) (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Nov 2024 ➔ May 2025 | Trial primary completion date: Nov 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • CSF P-tau

A Study of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease (MK-2214-002) (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • CSF P-tau

A Study of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease (MK-2214-002) (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • CSF P-tau