Enfortumab Vedotin Drug Aliquot | Anti-Nectin-4 | Therapeutic ADC

Aliquoted from the original drug | Now available for research use

Aliquots of the reference drug Enfortumab Vedotin are now available as research consumables.

Enfortumab Vedotin drug aliquots can be used for in vitro or in vivo experiments. Several other reference drugs are also available.

The drug aliquots are generated by aliquoting (dividing and repackaging) the EU-licensed biosimilar drug.

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Padcev® / Enfortumab Vedotin Reference Product

Drug namePadcev®
INNEnfortumab Vedotin
API typeADC
Pharmacotherapeutic group
Antineoplastic agents, other antineoplastic agents
ATC code
L01FX13
Target of antibody
Nectin-4
General function
Short descriptionEnfortumab Vedotin is comprised of a fully human IgG1 kappa antibody, conjugated to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a protease-cleavable maleimidocaproyl valine-citrulline linker.
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Enfortumab Vedotin is an antibody drug conjugate (ADC) targeting Nectin-4, an adhesion protein located on the surface of the urothelial cancer cells. It is comprised of a fully human IgG1-kappa antibody conjugated to the microtubule-disrupting agent MMAE via a protease-cleavable maleimidocaproyl valine-citrulline linker. Nonclinical data suggest that the anticancer activity of Enfortumab Vedotin is due to the binding of the ADC to Nectin-4-expressing cells, followed by internalisation of the ADC-Nectin-4 complex, and the release of MMAE via proteolytic cleavage.
Release of MMAE disrupts the microtubule network within the cell, subsequently inducing cell cycle arrest and apoptotic cell death. MMAE released from Enfortumab Vedotin targeted cells can diffuse into nearby Nectin-4 low expressing cells resulting in cytotoxic cell death.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)Concomitant use of Enfortumab Vedotin with ketoconazole (a combined P-gp and strong CYP3A inhibitor) is predicted to increase unconjugated MMAE Cmax and AUC exposure to a minor extent, with no change in ADC exposure.
Concomitant use of Enfortumab Vedotin with rifampin (a combined P-gp and strong CYP3A inducer) is predicted to decrease unconjugated MMAE Cmax and AUC exposure with moderate effect, with no change in ADC exposure. The full impact of rifampin on the Cmax of MMAE may be underestimated in the PBPK model.
Concomitant use of Enfortumab Vedotin is predicted not to affect exposure to midazolam (a sensitive CYP3A substrate). In vitro studies using human liver, microsomes indicate that MMAE inhibits CYP3A4/5 but not other CYP450 isoforms. MMAE did not induce major CYP450 enzymes in human hepatocytes.
Original license holder
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
The Netherlands
Marketing authorisation numbers
EU/1/21/1615/002
Marketing authorisation holder
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
The Netherlands
Name of the manufacturer of the biological active substance
Lonza AG
Lonzastrasse
Visp, 3930
Switzerland
Name and address of the manufacturer(s) responsible for batch releaseAstellas Ireland Co. Limited,
Killorglin, Co. Kerry
V93 FC86
Ireland
Max shelf life
3 years
Storage conditions
2°C – 8°C
List of excipients
Histidine
Histidine hydrochloride monohydrate
Trehalose dihydrate
Polysorbate 20

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Evidentic offers multiple batches of original drug aliquots in low binding Eppendorf tubes for research use only. We provide licence-free drug aliquots with long, short or even “negative shelf life” by storing the products at recommended temperatures (either 2-8°C or -80°C) and ensuring fully functional molecules for research purposes.

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