Written By: Pharmacally Medical News Desk
Merck known as MSD outside the United States and Canada is advancing its pipeline in Alzheimer’s disease with the presentation of first-in-human data for two novel drug candidates, MK-2214 and MK-1167, at the Clinical Trials on Alzheimer’s disease (CTAD) conference held from December 1 to 4, 2025, in San Diego, California. Out of two, MK-2214, innovative antibody targeting tau protein abnormalities in the brain, has earned Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of Alzheimer’s disease.
MK-2214 is a new antibody drug being studied by Merck for the treatment of early Alzheimer’s disease. Early Phase 1 studies have shown it to be safe and well-tolerated in both healthy volunteers and people with mild cognitive impairment or mild-to-moderate Alzheimer’s. Favorable early data from these studies have supported the advancement of MK-2214 into a Phase 2 trial aimed at evaluating safety and efficacy, including brain changes in early Alzheimer’s patients (NCT07033494).
Simultaneously, MK-1167 is an oral drug being developed by Merck to potentially improve cognitive function in Alzheimer’s disease. Early Phase 1 studies showed promising results in healthy volunteers, supporting its advancement to a Phase 2 trial evaluating safety and efficacy in patients with mild-to-moderate Alzheimer’s who are on stable donepezil treatment (NCT06721156). This investigational approach aims to enhance cholinergic signaling and cognitive function.
Merck’s neuroscience vice president, Dr. Mike Egan, highlighted that Alzheimer’s is one of the greatest neurological challenges today, and innovative approaches such as MK-2214 and MK-1167 offer promising new therapeutic pathways. The FDA’s Fast Track status for MK-2214 facilitates an expedited development and review process, emphasizing the urgent need for treatments that address the neurodegenerative drivers underlying Alzheimer’s disease progression.
These presentations at CTAD 2025 mark significant progress in Merck’s Alzheimer’s disease pipeline. MK-2214 is being co-developed with Teijin Pharma. Both candidates exemplify Merck’s commitment to leveraging novel mechanisms against Alzheimer’s pathology tau aggregation and cholinergic receptor modulation with the goal of slowing disease progression and improving cognitive outcomes.
This exciting development positions Merck at the forefront of Alzheimer’s disease research, providing hope for new therapeutic options in a space with tremendous unmet medical need.
References
Merck Showcases Data for Alzheimer’s disease Candidates MK-2214 and MK-1167 at CTAD 2025, 01 December 2025, Merck, https://www.merck.com/news/merck-showcases-data-for-alzheimers-disease-candidates-mk-2214-and-mk-1167-at-ctad-2025/