Trastuzumab Deruxtecan | Anti-HER2 | Therapeutic Antibody-drug conjugate (ADC)

Aliquoted from the original drug | Now available for research use

Aliquots of the reference drug Trastuzumab Deruxtecan are now available as research consumables.

Trastuzumab Deruxtecan 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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Enhertu® / Trastuzumab Deruxtecan Reference Product

Drug nameEnhertu®
INNTrastuzumab Deruxtecan
API typeAntibody-drug conjugate (ADC)
Pharmacotherapeutic group
Antineoplastic agents, HER2 (Human Epidermal Growth Factor
Receptor 2) inhibitors
ATC code
L01FD04
Target of antibody
HER2
General function
Short descriptionTrastuzumab Deruxtecan is an antibody-drug conjugate (ADC) that contains a humanised anti-HER2 IgG1 monoclonal antibody (mAb) with the same amino acid sequence as trastuzumab, produced by mammalian (Chinese Hamster Ovary) cells, covalently linked to DXd, an exatecan derivative and a topoisomerase I inhibitor, via a tetrapeptide-based cleavable linker. Approximately 8 molecules of deruxtecan are attached to each antibody molecule.
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Trastuzumab Deruxtecan, is a HER2-targeted antibody-drug conjugate. The antibody is a humanised anti-HER2 IgG1 attached to Deruxtecan, a topoisomerase I inhibitor (DXd) bound by a tetrapeptide-based cleavable linker. The antibody-drug conjugate is stable in plasma. The function of the antibody portion is to bind to HER2 expressed on the surface of certain tumour cells. After binding, the trastuzumab deruxtecan complex then undergoes internalisation and intracellular linker cleavage by lysosomal enzymes that are upregulated in cancer cells. Upon release, the membrane-permeable DXd causes DNA damage and apoptotic cell death. DXd, an exatecan derivative, is approximately 10 times more potent than SN-38, the active metabolite of irinotecan.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)Trastuzumab Deruxtecan undergoes intracellular cleavage by lysosomal enzymes to release the DXd. The humanised HER2 IgG1 monoclonal antibody is expected to be degraded into small peptides and amino-acids via catabolic pathways in the same manner as endogenous IgG.
In vitro metabolism studies in the human liver, microsomes indicate that DXd is metabolised mainly by CYP3A4 via oxidative pathways.
Original license holder
Daiichi Sankyo Europe GmbH
Zielstattstrasse 48
81379 Munich
Germany
Marketing authorisation numbers
EU/1/20/1508/001
Marketing authorisation holder
Daiichi Sankyo Europe GmbH
Zielstattstrasse 48
81379 Munich
Germany
Name of the manufacturer of the biological active substance
Daiichi Sankyo Chemical Pharma Co., Ltd.
Onahama Plant
389-4, Izumimachi Shimokawa Aza Otsurugi, Iwaki,
Fukushima 971-8183
Japan
Name and address of the manufacturer(s) responsible for batch releaseDaiichi Sankyo Europe GmbH
Luitpoldstrasse 1
85276 Pfaffenhofen
Germany
Max shelf life
3 years
Storage conditions
2°C – 8°C
List of excipients
L-histidine
L-histidine hydrochloride monohydrate
Sucrose
Polysorbate 80

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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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