Drugs / BIIB080
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT03186989 | Oct 2017 → May 2022 | Alzheimer disease | Ionis Pharmaceuticals, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-07-14 | Ionis Pharmaceuticals | Results Ionis Partner Biogen Presents Phase 2 CELIA Data at AAIC Demonstrating Meaningful Clinical Outcomes and Robust Tau Reduction with Diranersen in Early Alzheimer’s Disease ionis.com ↗
The data, presented at the Alzheimer’s Association International Conference (AAIC) 2026, expand upon previously reported topline results and demonstrate a combination of meaningful clinical efficacy and robust biomarker effects, providing Phase 2 proof of concept for diranersen’s tau-directed mechanism of action. |
| 2026-05-14 | Ionis Pharmaceuticals | Results Ionis partner Biogen announces 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 ionis.com ↗
The CELIA results provide the first evidence from a randomized Phase 2 study of a tau-directed therapy demonstrating both robust biomarker impact and cognitive benefit in early AD. |
| 2025-04-02 | Biogen | Regulatory Biogen’s Investigational Tau-Targeting Therapy BIIB080 Receives FDA Fast Track Designation for the Treatment of Alzheimer’s Disease biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, for the treatment of Alzheimer’s disease. |
| 2023-10-31 | Biogen | Results JAMA Neurology Publishes Data on Biogen’s Investigational Antisense Oligonucleotide Targeting Tau biogen.com ↗
JAMA Neurology published biomarker data from the placebo-controlled period (PCP) and long-term extension phase of the BIIB080 Phase 1b study of the antisense oligonucleotide (ASO) which targets tau pre-mRNA in early-stage Alzheimer's disease (AD). |
| 2023-10-25 | Biogen | Results New Data from Biogen’s Investigational Antisense Oligonucleotide (ASO) Targeting Tau Shows Promise for Potential New Generation of Treatments in Early Alzheimer’s Disease biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) reported new Phase 1b clinical data from the study of BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, in mild Alzheimer’s disease (AD). |
| 2023-04-28 | Biogen | Results Biogen Announces Publication of BIIB080 Phase 1b Data in Nature Medicine biogen.com ↗ |
| 2023-03-29 | Ionis Pharmaceuticals | Results New data presented at AD/PD™2023 show IONIS-MAPT Rx (BIIB080) substantially reduced tau protein in patients with early-stage Alzheimer's disease ionis.com ↗
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today reported that its partner Biogen presented new Phase 1b clinical data showing that IONIS-MAPTRx (BIIB080) reduced soluble tau protein in cerebrospinal fluid (CSF) in a dose-dependent and sustained manner in patients with early-stage Alzheimer's disease (AD). |
| 2023-03-29 | Biogen | Results New Data Presented at AD/PD™ 2023 Show Biogen’s BIIB080 (MAPT ASO) Substantially Reduced Tau Protein Levels in Patients with Early-stage Alzheimer’s Disease biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) reported new promising Phase 1b clinical data showing that the investigational antisense oligonucleotide (ASO) therapy, BIIB080, reduced soluble tau protein in cerebrospinal fluid (CSF) in a dose-dependent and sustained manner in patients with early-stage Alzheimer’s disease (AD). |
| 2021-07-26 | Ionis Pharmaceuticals | Results Biogen and Ionis report positive topline clinical data on investigational Alzheimer's disease treatment at AAIC ionis.com ↗
Biogen Inc. (Nasdaq: BIIB) and Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that topline data from a Phase 1b placebo-controlled, multiple ascending dose clinical study showed that BIIB080/IONIS-MAPTRx met its primary objective of safety and tolerability in patients with mild Alzheimer's disease. |
| 2021-07-26 | Biogen | Results Biogen and Ionis report positive topline clinical data on investigational Alzheimer’s disease treatment at AAIC biogen.com ↗
The study demonstrated robust time and dose-dependent lowering of tau protein in cerebrospinal fluid (CSF) over the three-month treatment period and sustained reductions during the six-month post-treatment period. |
All press releases naming this drug 11 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BIIB080 | “Intrathecal administration of BIIB080, a MAPT-targeting antisense oligonucleotide, or placebo.” PMID 37902726 ↗ Dec 2023 |
| Known as | IONIS MAPTRx | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03186989 ↗ |
| Known as | MAPTRx | “We sought to inhibit MAPT expression with a tau-targeting antisense oligonucleotide (MAPTRx) and reduce tau levels in patients with mild AD.” PMID 37095250 ↗ Apr 2023 |
| Action | Inhibit | “inhibit MAPT expression” PMID 37095250 ↗ Apr 2023 |
| Modality | Antisense oligonucleotide | “a MAPT-targeting antisense oligonucleotide” PMID 37902726 ↗ Dec 2023 |
| Route | Intrathecal | “Intrathecal administration of BIIB080” PMID 37902726 ↗ Dec 2023 |
| Target | MAPT | “inhibit MAPT expression” PMID 37095250 ↗ Apr 2023 |