Drugs / Diranersen
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06454721 | Jan 2025 → Mar 2026 | — | Biogen | Completed | No outcome recorded |
| Phase 21 trial · 1 missed | ||||||
| Phase 2 | NCT05399888 | Aug 2022 → Mar 2026 overdue | Alzheimer disease | Biogen | Active not recruiting | Missed primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-07-14 | Biogen | Results Biogen Presents Phase 2 CELIA Data at AAIC Demonstrating Meaningful Clinical Outcomes and Robust Tau Reduction with Diranersen in Early Alzheimer’s Disease biogen.com ↗
Diranersen is the first tau-directed therapy to demonstrate robust reductions in both CSF total tau, with mean reductions of 50–65%, and brain tau pathology, as measured by PET, across all studied doses in a Phase 2 study |
| 2026-06-29 | Biogen | Results Biogen to Highlight Breadth of Alzheimer’s Disease Portfolio at AAIC 2026, Including Phase 2 CELIA Data for Diranersen biogen.com ↗
Diranersen presentation will feature Phase 2 CELIA data in early Alzheimer’s disease, including clinical, biomarker and safety results for Biogen’s investigational tau-targeting ASO, following topline results announced in May 2026 |
| 2026-05-14 | Biogen | Results Topline Results from Phase 2 CELIA Study of Diranersen (BIIB080): First Study to Show Reduction in Tau Pathology and Cognitive Benefit in Patients with Early Alzheimer’s Disease biogen.com ↗
CELIA did not meet its primary endpoint assessing dose response; based on the strength of the biomarker and efficacy data, Biogen plans to advance diranersen to registrational development |
All press releases naming this drug 3 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Diranersen | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06454721 ↗ |
| Action | Inhibit | “prevent production of tau protein” NCT05399888 ↗ |
| Modality | Antisense oligonucleotide | “Diranersen is an investigational antisense therapy” NCT05399888 ↗ |
| Route | Intrathecal | “intrathecal (IT) injection” NCT05399888 ↗ |
| Target | MAPT | “target microtubule-associated protein tau (MAPT) messenger ribonucleic acid (mRNA)” NCT05399888 ↗ |