Drug · Small Molecule
Tivozanib
CI-DRUG-00000800Explore in graph →CHEMBL1289494 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.
emaProvenance
- Source
- EMA — European public assessment reports (centrally authorised medicines)
- Dataset
- EMA medicines data (xlsx)
- Version
- ema-medicines-2026-09-11T06:00
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- EMA copyright — reproduction and distribution permitted for non-commercial and commercial purposes provided EMA is acknowledged as the source (https://www.ema.europa.eu/en/about-us/legal-notice)
- Run
- ING-EMA-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| EU EMA | Renal Cell Carcinoma | Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC. Treatment of advanced renal cell carcinoma. | approved | Aug 24, 2017 | ema |
| US FDA | Renal Cell Carcinoma | FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. ( 1 ) | approved | Mar 10, 2021 | openfda |
Data updated 3 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 | 5 | 4 | 5 | 31 | 2 | EU, US | Aug 24, 2017 | 2007-10 |
| Malignant Kidney Neoplasm | Approved | Phase 3 | 3 | 2 | 5 | 13 | 2 | EU, US | Aug 24, 2017 | 2007-10 |
| Malignant Breast Neoplasm | Phase2 | Phase 2 | 1 | 1 | 0 | 2 | 0 | — | — | 2012-11 |
| Malignant Ovarian Neoplasm | Phase2 | Phase 2 | 1 | 1 | 0 | 3 | 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
No curated evidence item mentions this therapy yet.
Clinical trials
Trials with this intervention (31)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- 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 |
|---|---|---|---|---|---|---|---|---|
| NCT04645160 | Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers | recruiting | Phase 1 / Phase 2 | 31 | National Cancer Institute (NCI)NIH | 1 | Sep 28, 2026 | clinicaltrials |
| NCT06661720 | Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer(STRIKE) |