Drugs / Salanersen
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05575011 | Oct 2022 → Nov 2031 expected | spinal muscular atrophy | Biogen | Active not recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07444476 | Sep 2026 → Jun 2028 expected | spinal muscular atrophy | Biogen | Recruiting | No outcome recorded |
| Phase 3 | NCT07444450 | Sep 2026 → Jul 2029 expected | spinal muscular atrophy | Biogen | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07221669 | Apr 2026 → Nov 2028 expected | spinal muscular atrophy | Biogen | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-06-04 | Biogen | Regulatory Biogen’s Salanersen Receives FDA Breakthrough Therapy Designation for Spinal Muscular Atrophy biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has granted salanersen Breakthrough Therapy Designation for the treatment of spinal muscular atrophy (SMA). |
| 2026-03-11 | Biogen | Results Biogen Presents Additional Salanersen Data Showing New Motor Milestones Achieved in Children with SMA Previously Treated with Gene Therapy biogen.com ↗
Participants experienced a slowing of neurodegeneration and functional improvement, including achievement of new World Health Organization (WHO) motor milestones, following initiation of salanersen. |
| 2026-03-05 | Biogen | Results Biogen to Share New SMA Data at Muscular Dystrophy Association and SMA Europe Conferences biogen.com ↗
New Phase 1b data further illustrate potential of salanersen in SMA, as Phase 3 studies begin to evaluate this investigational drug that has the potential for high potency with once-yearly dosing |
| 2025-06-25 | Ionis Pharmaceuticals | Results Ionis announces Biogen to advance salanersen into SMA registrational studies based on positive interim Phase 1 results ionis.com ↗
Both dose levels tested, 40 mg and 80 mg, given once a year, were generally well-tolerated and led to substantial slowing of neurodegeneration, as shown by reductions in neurofilament. |
| 2025-06-25 | Biogen | Results Biogen to Advance Investigational Spinal Muscular Atrophy Asset to Registrational Studies Based on Positive Interim Phase 1 Results biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) announced topline results from the Phase 1 study of salanersen (BIIB115/ION306), an antisense oligonucleotide (ASO) being developed for the treatment of spinal muscular atrophy (SMA). |
All press releases naming this drug 5 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Salanersen | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07444450 ↗ |
| Known as | BIIB115 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05575011 ↗ |
| Action | Activate | “Salanersen works by helping the SMN2 gene to make more SMN protein.” NCT07221669 ↗ |
| Route | Intrathecal | “BIIB115 administered via intrathecal (IT) bolus injection” NCT05575011 ↗ |
| Target | SMN2 | “Salanersen works by helping the SMN2 gene to make more SMN protein.” NCT07221669 ↗ |