Drug · Other
Lutetium (177lu) Vipivotide Tetraxetan
CI-DRUG-00000753Explore in graph →CHEMBL4594406 Approved
Regulatory
Approvals (2)
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 PLUVICTO (DIN 02530198) under ATC V10XX05 LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Nov 7, 2022 | health-canada-dpd |
| EU EMA | — | Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy. | approved | Dec 9, 2022 | ema |
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 14 days 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 | 30 | 19 | 4 | 41 | 2 | CA, EU | Nov 7, 2022 | 2016-12 |
| Malignant Prostate Neoplasm | Phase3 | Phase 3 | 20 | 14 | 2 | 29 | 0 | — | — | 2016-12 |
| Malignant Kidney Neoplasm | Phase2 | Phase 2 | 2 | 1 | 0 | 2 | 0 | — | — | Jul 31, 2025 |
| Malignant Salivary Gland Neoplasm | Phase2 | Phase 2 | 0 | 0 | 0 | 1 | 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 (43)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT06095089 | A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer | recruiting | Phase 1 | 355 | Janssen Research & Development, LLCINDUSTRY | 5 | Sep 28, 2026 | clinicaltrials |
| NCT05818683 | A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer | recruiting | Phase 1 |