About CLINUVEL

Preclinical Testing

Preclinical tests assess the toxicity of a drug and examine its potential effects on the human body. The tests are conducted in-vitro (within the glass- test tubes, Petri dishes etc) and in-vivo (within the living - animal testing). These tests are required by pharmaceutical regulators to ensure that a drug is safe for human use prior to beginning human clinical trials.

Lab1
Preclinical testing in the lab

In-vivo trials may involve Pharmacokinetic (PK) and Pharmacodynamic (PD) studies, to begin to ascertain the drug's mechanism of action. PK and PD trials study what a body does to the drug and what a drug does to a body, respectively.  

Also investigated through pre-clinical trials is a drugs No Observable Effect Level (NOEL). This forms the starting point for subsequent trials and is the level at which the drug is dosed in amounts too small to have any measurable effect.

Latest Company Announcements

16 October 2017

CLINUVEL Newsletter - October 2017

I am addressing you during quite a turbulent period, when our teams are preparing various dossiers to meet regulatory obligations in Europe and the US

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10 October 2017

CLINUVEL CONFIRMS AGM DATE

CLINUVEL PHARMACEUTICALS LTD today announced it will hold its 2017 Annual General Meeting of shareholders on Tuesday 28 November 2017

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04 October 2017

ELIE ISHAG TO RETIRE FROM CLINUVEL BOARD

CLINUVEL today announced that Mr Elie Ishag has advised that he will not stand for re-election as Non-Executive Director of CLINUVEL at the Company’s 2017 Annual General Meeting

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19 September 2017

CLINUVEL PROVIDES UPDATE ON SCENESSE® FDA FILING

CLINUVEL PHARMACEUTICALS LTD today announced an update on its submission of the New Drug Application (NDA) for CLINUVEL’s drug SCENESSE® (afamelanotide 16 mg) to the US Food and Drug Administration (FDA).

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06 September 2017

Appendix 3B

Appendix 3B - New issue announcement

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30 August 2017

Appendix 4E - Preliminary Final Report 2016/17

Appendix 4E - Preliminary Final Report 2016/17

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