Kazia Therapeutics Ltd’s (ASX:KZA) new investigational drug GDC-0084 has been selected by the World Health Organisation (WHO) with ‘paxalisib’ as the proposed international non-proprietary name (INN).
The company is developing GDC-0084 for the treatment of various forms of brain cancer and the selection of paxalisib as an INN represents an important regulatory milestone.
It provides a more identifiable name for clinicians and researchers to use in relation to the drug and follows standard naming conventions laid down by WHO.
The lead is glioblastoma, the most common and most aggressive form of primary brain cancer with four clinical studies currently underway and expected data due in the second half of 2019.
The name has been published by WHO in the 121st list of proposed international non-proprietary names on August 21.
The proposed name is subject to a four-month period before paxalisib can be confirmed as the INN.
Once the selection procedure is complete the name will be formalised by the end of 2019 and Kazia will begin including the name in documentation and communications relating to GDC-0084.
New drugs typically receive at least three names during their development with the first being a company code number used for internal administration purposes during the early stages of development.
The INN is chosen around the time of phase II clinical trials and is used to refer to any product that contains that active drug.
An example of an INN is paracetamol, which is used in the description of any product containing that drug as an active ingredient.