Drugs / posdinemab
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05407818 | Jun → Aug 2022 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03689153 | Sep 2018 → Jul 2019 | — | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT03375697 | Dec 2017 → Dec 2019 | Alzheimer disease | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 21 trial · 1 missed | ||||||
| Phase 2 | NCT04619420 | Jan 2021 → Oct 2025 | Alzheimer disease | Janssen Research & Development, LLC | Terminated | Missed primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-11-21 | Janssen Research & Development, LLC | Results Johnson & Johnson Statement on the Auτonomy Study jnj.com ↗
Following a scheduled review that determined posdinemab did not achieve statistical significance in slowing clinical decline, the Auτonomy study will be discontinued. |
| 2025-07-24 | Janssen Research & Development, LLC | Results Johnson & Johnson showcases latest advancements in Alzheimer's research at AAIC 2025 jnj.com ↗
Early data from robust Autonomy Phase 2b posdinemab trial demonstrate Company's leadership in multimodal biomarkers and early detection |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-11-21 | Janssen Research & Development, LLC | Johnson & Johnson Statement on the Auτonomy Study jnj.com ↗ |
| 2025-07-24 | Janssen Research & Development, LLC | Johnson & Johnson showcases latest advancements in Alzheimer's research at AAIC 2025 jnj.com ↗ |
| 2025-01-08 | Janssen Research & Development, LLC | Johnson & Johnson’s Posdinemab and Tau Active Immunotherapy Receive U.S. FDA Fast Track Designations for the Treatment of Alzheimer’s Disease jnj.com ↗ |
| 2025-01-08 | Janssen Research & Development, LLC | Johnson & Johnson's Posdinemab and Tau Active Immunotherapy Receive U.S. FDA Fast Track Designations for the Treatment of Alzheimer's Disease jnj.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | posdinemab | “Posdinemab (JNJ-63733657), a humanized IgG1/kappa monoclonal antibody that targets phosphorylated Tau protein at amino acid 217 (p217+tau), is currently in clinical development...” PMID 41431125 ↗ Dec 2025 |
| Known as | JNJ-63733657 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03375697 ↗ |
| Action | Inhibit | “induced dose-dependent reductions in p217+tau levels in cerebrospinal fluid (CSF)” PMID 41431125 ↗ Dec 20251“Microtubule-associated protein tau inhibitor” CHEMBL4650402 ↗ |
| Modality | Monoclonal antibody | “a humanized IgG1/kappa monoclonal antibody” PMID 41431125 ↗ Dec 2025 |
| Route | Intravenous | “Subjects will receive single (Part 1) or multiple (Part 2) ascending dose levels of JNJ-63733657 intravenously.” NCT03375697 ↗ |
| Target | MAPT | “Microtubule-associated protein tau inhibitor” CHEMBL4650402 ↗ |