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# FDA Fast Track for AC Immune Alzheimer’s Drug
- URL: https://www.fdaweb.com/fda-fast-track-for-ac-immune-alzheimers-drug/
- Published: 2024-07-25T12:00:00.000Z
- Updated: 2026-09-14T14:36:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157436

FDA has granted fast-track designation for AC Immune’s ACI-35.030 (now in development with Janssen as JNJ-2056) for Alzheimer’s disease. A company [statement](https://ir.acimmune.com/news-releases/news-release-details/ac-immunes-aci-35030-now-jnj-2056-granted-fda-fast-track?ref=fdaweb.com) says the drug targets the pathologic form of the Tau protein, phosphorylated Tau. The Phase 2b ReTain clinical trial is recruiting participants with preclinical Alzheimer’s disease, where individuals have yet to show clinical symptoms, the company says.

JNJ-2056 is described as derived from AC Immune’s SupraAntigen platform and has been shown in clinical studies to induce a strong polyclonal antibody response that matures and is maintained against key pathological forms of Tau believed to drive Tau aggregation and disease progression. AC Immune says JNJ-2056 is designed to enhance the formation of broad-spectrum protective antibodies against phosphorylated Tau. It says the investigational candidate has the potential to reduce pathological Tau spreading in the early stages of Alzheimer’s disease and thus may reduce or prevent disease progression.