Biologic · MK-2214

MK-2214

Phase 2Merck & Co., Inc. (MRK)
  • Fast Track

Half-life-extended monoclonal antibody that selectively binds pathological phosphorylated-Ser413 (pS413) tau, intended to reduce the extracellular spread of tau seeds in Alzheimer's disease. Originated at Teijin Pharma (Japan) and licensed to Merck & Co. in 2017; in clinical development by Merck for early Alzheimer's disease. The murine surrogate has been reported as the IgG2a antibody Ta1505; the clinical antibody is a half-life-extended humanized/human IgG (exact isotype and FcRn-extension mutation not publicly disclosed).

Also known as: MK-2214

Data current as of

Modality
Biologic
Chemical class
monoclonal antibody
Mechanism
Tau (pT217) inhibitor
Highest phase
Phase 2
Lead indication
Alzheimer's disease
Developer
Merck & Co., Inc. (MRK)
Designations
Fast Track
Trials
2 tracked · 1 recruiting · 90 sites
Next catalyst
2029 — Topline data (Alzheimer's disease)

Mechanism of action

Passive tau immunotherapy. MK-2214 is a half-life-extended monoclonal antibody that selectively binds phosphorylated-Ser413 (pS413) tau, a pathological phospho-epitope in the C-terminal region of tau (MAPT) found in Alzheimer's disease brain and CSF. By binding and clearing/neutralizing extracellular pS413 tau species, it is designed to reduce trans-cellular propagation ('seeding') of pathological tau and slow downstream neurodegeneration. Preclinical work (Sugam et al., 2025) reported subnanomolar binding potency for extracellular pS413 tau in human CSF and reductions in tau pathology in cell-based seeding and in vivo models; no exact human Kd/Ki has been published. Originated at Teijin Pharma and licensed to Merck in 2017.

TargetActionAffinity
Tau (pT217)primaryMAPTInhibitor—ⓘ

Formulations

FormulationRouteRegimenPharmacokinetics
MK-2214 intravenous infusion
Investigational anti-tau (pS413) IgG monoclonal antibody given by IV infusion. Phase 1 MAD: escalating IV doses on Days 1, 29, and 57 (NCT05466422). Phase 2: IV infusion every 4 weeks for ~2 years in early Alzheimer's disease (NCT07033494).
Intravenous——

Development timeline

Phase 2Jul 2025 – Apr 2029
  1. UpcomingAnticipated Phase 2 readout in early Alzheimer's disease: change in tau PET SUVr (primary), per estimated primary completion April 2029.
  2. metPhase 1 first-in-human MK-2214 data at CTAD 2025: favorable safety/PK and CSF pS413 tau reductions consistent with near-saturating target engagement; FDA Fast Track granted.↗
  3. Phase 2 efficacy/safety study in early Alzheimer's disease (NCT07033494 / MK-2214-004) started; actively recruiting (340 participants planned, tau PET SUVr primary endpoint).
Phase 1Sept 2022
  1. Phase 1 multiple-ascending-dose study (NCT05466422 / MK-2214-002) initiated in adults with MCI or mild-to-moderate Alzheimer's disease; completed 2025-07-03 (34 participants).

MK-2214 for Alzheimer's disease

Phase 2RecruitingAlzheimer's disease indication →

Phase 2 development of MK-2214 in participants with early Alzheimer's disease (NCT07033494 / MK-2214-004), evaluating efficacy (change in tau PET SUVr) and safety of IV infusions every 4 weeks vs placebo. FDA Fast Track designation for Alzheimer's disease was announced 2025-12-01 alongside first-in-human Phase 1 data at CTAD 2025. last_phase_change set to the Phase 2 start date (2025-07-16).

Readouts

  • 2029AnticipatedTopline dataNCT07033494

    Anticipated Phase 2 readout in early Alzheimer's disease: change in tau PET SUVr (primary), per estimated primary completion April 2029.

  • 2025-12-01ReportedFull resultsmetNCT05466422

    Phase 1 first-in-human MK-2214 data at CTAD 2025: favorable safety/PK and CSF pS413 tau reductions consistent with near-saturating target engagement; FDA Fast Track granted. ↗

Clinical trials

NCT07033494MK-2214-004Phase 2Recruitingn=340

A Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MK-2214 in Participants With Early Alzheimer's Disease

Started Jul 2025· Primary completion Apr 2029· 📍 78 sites across 11 countries (United States, Japan, United Kingdom, Australia)

NCT05466422MK-2214-002Phase 1Completedn=34

A Multiple Ascending Dose Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease

Started Sept 2022· Primary completion Jul 2025· 📍 12 sites across 1 country (United States)

metpharmacodynamicCSF free pS413 tau concentration (target engagement / pharmacodynamics)

Multiple ascending doses in MCI / mild-to-moderate AD produced reductions in CSF free pS413 tau consistent with high potency and near-saturating target engagement (reported at CTAD 2025). No specific numeric effect size or p-value published in accessible sources.

Related compounds

Other Tau (pT217) compounds

More from Merck & Co., Inc.

Identifiers

    Sources

    1. A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004) — ClinicalTrials.gov (NIH)
    2. A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (NCT07033494) — ClinicalTrials.gov
    3. A Study of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease (MK-2214-002) — ClinicalTrials.gov (NIH)
    4. Merck Showcases Data for Alzheimer's Disease Candidates MK-2214 and MK-1167 at CTAD 2025 — Merck & Co., Inc.
    5. Preclinical development of MK-2214, a novel antibody targeting pS413 tau for the treatment of Alzheimer's Disease (Sugam et al.) — Alzheimer's & Dementia (PMC)