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Tofersen · Qalsody, BIIB-067

Oligonucleotide (Antisense oligonucleotide) · Gene silencing: SOD1 · developed by Biogen Ma

Approved FDA, Apr 2023

BIIB Developer

1 Registered trials

What is Tofersen?

Tofersen (QALSODY) is an antisense oligonucleotide that binds SOD1 mRNA and causes its degradation, reducing SOD1 protein synthesis.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Qalsody, BIIB-067
Drug type: Oligonucleotide (Antisense oligonucleotide)
Targets: SOD1
Mechanism: Gene silencing: SOD1
Therapy area: Neurology
Developer: Biogen Ma (BIIB)
FDA status: Approved as Qalsody (April 25, 2023), NDA215887 · FDA label
UNII: 2NU6F9601K

✅ FDA-approved uses

Amyotrophic lateral sclerosis (ALS) in adults with SOD1 mutation

From the indications section of the FDA label (version of Nov 13, 2024). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT07223723	Phase 4	Amyotrophic Lateral Sclerosis	Active not recruiting	BIIB

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Amyotrophic Lateral Sclerosis

More from Biogen Ma

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Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the BIIB page.

Follow BIIB, the company behind Tofersen

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z