Drug

Tofersen clinical trials

Also written QALSODY and BIIB067.

studies test it: 6
open now: 1
in phase 3: 3
first study started: 2016

How each study uses tofersen is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study

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Approvals

The first approval found in each region, with its record

United States: 25 Apr 2023 · QALSODY · NDA 215887 (FDA, Drugs@FDA)
European Union: 29 May 2024 · Qalsody · EMEA/H/C/005493 (EMA)

From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out

How studies write it

Studies that test it under each name

Name

Tofersen: 6

Brand

QALSODY: 4

Development codes

BIIB067: 4

Studies by the year they started

6 studies that test it; most in 2025 (2)

Studies that test tofersen, by start year
Year	Studies
2016	1
2017	1
2018	1
2021	1
2025	2

By phase

A phase 1/2 study counts in both.

Phase 1: 1
Phase 2: 1
Phase 3: 3
Phase 4: 1

What it is tested for

Each study’s main condition, where its own words name it, so a study counts once.

Amyotrophic Lateral Sclerosis: 3

Who runs them

Industry 5 · Other 1

Biogen (5) · Washington University School of Medicine (1)

Coming up

From the study records. Dates are the sponsors’ own estimates and often move.

Reaching primary completion within a year · 3, 1 in phase 3

Studies that test tofersen, phase 3 first.

Aug 2027Study to Learn If Tofersen (BIIB067) Can Delay ALS Symptoms and About Its Safety in Adults With a SOD1 Gene Mutation Who Have Not Yet Developed ALS SymptomsPhase 3 · Biogen
Jan 2027Tofersen in Non-SOD1 ALSPhase 2 · Washington University School of Medicine
May 2027A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Chinese Participants With SOD-1 Amyotrophic Lateral Sclerosis (ALS)Phase 4 · Biogen

Studies

Open first, then newest update. How each study uses tofersen is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.

Testing it · 6

Codes

What other systems call tofersen · ClinicalTrials.gg INT001373

MeSH (NLM) C000709090tofersenConfirmed ClinicalTrials.gov, NLM
UNII (FDA) 2NU6F9601KTOFERSENConfirmed FDA, NLM
NCI Thesaurus C166584TofersenOne source FDA

System	Code	Name there	Checked by
MeSH (NLM)	C000709090	tofersen	Confirmed ClinicalTrials.gov, NLM
UNII (FDA)	2NU6F9601K	TOFERSEN	Confirmed FDA, NLM
NCI Thesaurus	C166584	Tofersen	One source FDA

Also registered as tofersen sodium (UNII 5YL205692C).

“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.