Drug

Vinflunine

Approved · EMA

ClassTubulin inhibitorEmerging researchLate-stage development

Also known as 4'-deoxy-20',20'-difluoro-5'-norvincaleukoblastine, 4'-deoxy-20',20'-difluoro-8'-norvincaleukoblastine, Vinflunina, 20',20'-difluoro-3',4'-dihydrovinorelbine+1 more

4'-deoxy-20',20'-difluoro-5'-norvincaleukoblastine, 4'-deoxy-20',20'-difluoro-8'-norvincaleukoblastine, Vinflunina, 20',20'-difluoro-3',4'-dihydrovinorelbine, Vinfluninum.

RxNorm194315 ChEMBLCHEMBL2110725 ATCL01CA05UNII5BF646324K

Research papers

Active clinical trials

Protein targets

Regulatory events

Latest activity

beta

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

A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator's Choice of Non-platinum Chemotherapy in Participants With Pretreated Locally Advanced/Metastatic Urothelial Carcinoma

Clinical trial2026-07-10Results expected Q3 2029 · ClinicalTrials.gov

A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

Clinical trial2026-07-06Results posted · ClinicalTrials.gov

A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects With Metastatic or Locally Advanced Unresectable Urothelial Cancer

Clinical trial2026-06-02Results posted · ClinicalTrials.gov

An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

Clinical trial2026-01-09Results posted · ClinicalTrials.gov

A Phase II Trial of Vinflunine as Salvage Chemotherapy in Hormone Refractory Prostate Cancer (HRPC)

Clinical trial2021-12-16Results posted · ClinicalTrials.gov

A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel or Vinflunine in Subjects With Recurrent or Progressive Metastatic Urothelial Cancer

Clinical trial2021-09-20Results posted · ClinicalTrials.gov

Phase III Trial of IV Vinflunine Versus an Alkylating Agent in Patients With Metastatic Breast Cancer Previously Treated With or Resistant to an Anthracycline, a Taxane, an Antimetabolite, and a Vinca-alkaloid (Study L00070 IN 308 B0)

Clinical trial2019-09-16Results posted · ClinicalTrials.gov

Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma.

Research2017-02-17The New England journal of medicine

A phase II trial of vinflunine as monotherapy or in combination with trastuzumab as first-line treatment of metastatic breast cancer.

Research2010-11-01Cancer investigation

Phase II trial of vinflunine in relapsed small cell lung cancer.

Research2010-06-01Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer

Single agent vinflunine in the salvage treatment of patients with castration-resistant prostate cancer: a phase II trial of the Sarah Cannon research consortium.

Research2010-03-01Cancer investigation

Approval: Javlor (EMA)

Regulatory2009-09-21EMA

Profile

Identifiers & mechanism

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

Canonical name

Vinflunine

Aliases & brands

4'-deoxy-20',20'-difluoro-5'-norvincaleukoblastine4'-deoxy-20',20'-difluoro-8'-norvincaleukoblastineVinflunina20',20'-difluoro-3',4'-dihydrovinorelbineVinfluninum

RxNorm CUI

194315

ChEMBL ID

CHEMBL2110725

ATC codes

L01CA05

UNII

5BF646324K

Primary mechanism

Tubulin inhibitor

Regulatory jurisdictions

ema

Pharmacology & targets

15 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Tubulin beta-4B chain

TUBB4B · P68371

INHIBITORTubulin inhibitor

Tubulin beta-1 chain

TUBB1 · Q9H4B7

INHIBITORTubulin inhibitor

Tubulin alpha-3C chain

TUBA3C · P0DPH7

INHIBITORTubulin inhibitor

Tubulin alpha-4A chain

TUBA4A · P68366

INHIBITORTubulin inhibitor

Tubulin beta-3 chain

TUBB3 · Q13509

INHIBITORTubulin inhibitor

Tubulin alpha-1A chain

TUBA1A · Q71U36

INHIBITORTubulin inhibitor

Tubulin beta-4A chain

TUBB4A · P04350

INHIBITORTubulin inhibitor

Tubulin beta-8 chain

TUBB8 · Q3ZCM7

INHIBITORTubulin inhibitor

Tubulin beta chain

TUBB · P07437

INHIBITORTubulin inhibitor

Tubulin alpha-1B chain

TUBA1B · P68363

INHIBITORTubulin inhibitor

Tubulin alpha-1C chain

TUBA1C · Q9BQE3

INHIBITORTubulin inhibitor

Tubulin alpha-3E chain

TUBA3E · Q6PEY2

INHIBITORTubulin inhibitor

Tubulin beta-2A chain

TUBB2A · Q13885

INHIBITORTubulin inhibitor

Tubulin beta-2B chain

TUBB2B · Q9BVA1

INHIBITORTubulin inhibitor

Tubulin beta-6 chain

TUBB6 · Q9BUF5

INHIBITORTubulin inhibitor

Regulatory timeline

1 event

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.

Earliest approval

2009-09-21

Latest approval

2009-09-21

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2009-09-21Approval

Approval: Javlor (EMA)

Indication: Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional-cell carcinoma of the urothelial tract after failure of a prior… Show full indication

Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional-cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen. Efficacy and safety of vinflunine have not been studied in patients with performance status ? 2.

Evidence ↗

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

Clinical trials

26 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

registered trials across all phases

LATEST COMPLETION 2025

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 26

Phase 13Phase 1 / 21Phase 210Phase 2 / 33Phase 39

Late-stage studies

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

RecruitingPH IIIMerck Sharp & Dohme LLCn=5902030

A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

Active, not recruitingPH IIIJanssen Research & Development, LLCn=6292026

An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

CompletedPH IIIAstellas Pharma Global Development, Inc.n=6082025

A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects With Metastatic or Locally Advanced Unresectable Urothelial Cancer

CompletedPH IIIGilead Sciencesn=7112025

A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel or Vinflunine in Subjects With Recurrent or Progressive Metastatic Urothelial Cancer

CompletedPH IIIMerck Sharp & Dohme LLCn=5422020

Recent completions

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

An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

CompletedPH IIIAstellas Pharma Global Development, Inc.n=6082025

A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects With Metastatic or Locally Advanced Unresectable Urothelial Cancer

CompletedPH IIIGilead Sciencesn=7112025

A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel or Vinflunine in Subjects With Recurrent or Progressive Metastatic Urothelial Cancer

CompletedPH IIIMerck Sharp & Dohme LLCn=5422020

Phase III Study of IV Vinflunine in Combination With Methotrexate Versus Methotrexate Alone in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With Platinum-based Chemotherapy

CompletedPH IIIPierre Fabre Medicamentn=4592018

A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy

CompletedPH IIIHoffmann-La Rochen=9312018

A Phase II Trial of Vinflunine Chemotherapy in Locally-advanced and Metastatic Carcinoma of the Penis

CompletedPH IIInstitute of Cancer Research, United Kingdomn=222018

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20102017

Most influential

Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma.

The New England journal of medicine · 2017 · 2,620 cites

A phase II trial of vinflunine as monotherapy or in combination with trastuzumab as first-line treatment of metastatic breast cancer.

Cancer investigation · 2010 · 19 cites

Phase II trial of vinflunine in relapsed small cell lung cancer.

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2010 · 9 cites

Single agent vinflunine in the salvage treatment of patients with castration-resistant prostate cancer: a phase II trial of the Sarah Cannon research consortium.

Cancer investigation · 2010 · 5 cites

Related drugs

4 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Docetaxel

Acts on the same molecular target as Vinflunine, with 2 overlapping disease areas.

15 shared targets2 shared diseases1 shared paper

Paclitaxel

Acts on the same molecular target as Vinflunine, with 2 overlapping disease areas.

15 shared targets2 shared diseases1 shared paper

Pembrolizumab

Studied across 2 of the same disease areas as Vinflunine in the shared literature.

2 shared diseases1 shared paper

Vinblastine

Studied across 2 of the same disease areas as Vinflunine in the shared literature.

2 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.