Drug · Monoclonal Antibody
Mosunetuzumab
CI-DRUG-00000773Explore in graph →CHEMBL4297788 Approved
Regulatory
Approvals (7)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- Health Canada — Drug Product Database (DPD)
- Dataset
- Health Canada DPD
- Version
- dpd-2026-09-11
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- Open Government Licence – Canada (https://open.canada.ca/en/open-government-licence-canada)
- Run
- ING-HEALTHCANADADPD-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| CA Health Canada | — | Marketed in Canada as LUNSUMIO SC (DIN 02567369) under ATC L01FX25 MOSUNETUZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jun 16, 2026 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as LUNSUMIO SC (DIN 02567377) under ATC L01FX25 MOSUNETUZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jun 16, 2026 | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as LUNSUMIO (DIN 02565226) under ATC L01FX25 MOSUNETUZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | May 5, 2026 | health-canada-dpd |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 18 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 3 | 41 | 25 | 5 | 49 | 7 | CA, EU, US | Jun 3, 2022 | Sep 15, 2015 |
| Non-Hodgkin Lymphoma | Approved | Phase 3 | 34 | 19 | 5 | 39 | 2 | EU, US | Jun 3, 2022 | Sep 15, 2015 |
| Leukemia | Phase2 | Phase 2 | 3 | 3 | 0 | 5 | 0 | — | — | Sep 15, 2015 |
| Hodgkin Lymphoma | Phase2 | Phase 2 | 2 | 2 | 0 | 2 | 0 | — |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
Clinical trials
Trials with this intervention (50)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT06284122 | Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5(MorningLyte) | active not recruiting | Phase 3 | 790 | The Lymphoma Academic Research OrganisationOTHER | 7 | Sep 25, 2026 | clinicaltrials |
| NCT06337318 | Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma |