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Drug

Mosunetuzumab

Approved · FDA / EMA
Late-stage development

Also known as Lunsumio.

RxNorm2625122UNIILDJ89SS0YG
42
Active clinical trials
5
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma

Clinical trial2026-07-10Results expected Q1 2032 · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Mosunetuzumab
Aliases & brands
Lunsumio
RxNorm CUI
2625122
UNII
LDJ89SS0YG
Regulatory jurisdictions
emafda

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2022-06-032022-12-22)
Earliest approval
2022-06-03
Latest approval
2025-12-19
Authorities
FDA · EMA
Total events
5
fdaU.S. Food and Drug Administration· 4 events
2026-06-18Label change
Label change: MOSUNETUZUMAB (BLA761263)
Evidence ↗
2025-12-19Indication expansion
Indication expansion: MOSUNETUZUMAB (BLA761263)
Evidence ↗
2024-11-22Indication expansion
Indication expansion: MOSUNETUZUMAB (BLA761263)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2022-06-03ApprovalMulti-authority
Approval: Lunsumio (EMA)
Indication: Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemicShow full indication

Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

49 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
49
registered trials across all phases
LATEST COMPLETION 2025
42
Active studies
32
Recruiting
5
Late-stage (III+)
5
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 49
Phase 18Phase 1 / 29Phase 227Phase 35

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.