IRLAB’s IRL790 is proposed a unique INN by WHO

September 26, 2019

IRLAB announced today that the World Health Organization (WHO) has proposed the name mesdopetam as the International Nonproprietary Name (INN) for the company’s drug candidate IRL790. WHO concluded that IRL790 is wholly unique in its mode of action and, therefore, its new proposed INN does not need to be incorporated into any existing INN stem in the classification system. The INN will serve to identify the active pharmaceutical substance of IRL790 during its lifetime worldwide among healthcare professionals, scientists as well as patients.

The INN system is a WHO governed classification system that has been established to facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients in a unique and globally recognized manner. Through the system, healthcare professionals are provided with a clear identification of a drug enabling a safe prescription and dispense of medicine to patients. The proposal and recommendation of an INN, also known as a generic name, therefore, marks an important preparatory step for a drug candidate’s marketing authorization and subsequent launch.

Nicholas Waters, CEO at IRLAB, commented “In the INN system, the relationship between pharmacologically-related substances is identified through the use of a common stem. Only when substances show a novel mode of action, which is rather rare, a new INN stem is established. Therefore, we are very pleased to have been proposed the unique “-dopetam” ending for IRL790, which may become a stem in the future. This would underline the candidate’s position as a potential first-in-class treatment of Parkinson’s disease.”

According to the WHO’s regulations, following the publication of a proposed INN there is a period of four months where potential objections supported by strong rationale can be submitted to the WHO. If no party objects to the INN, the proposed INN becomes a recommended INN.

For further information

Nicholas Waters, CEO                
Phone: +46 730 75 77 01                
E-mail: nicholas.waters@irlab.se

About IRLAB

IRLAB is a Swedish biotech company focused on Parkinson's disease. The company's clinical Phase II candidates, IRL752 and IRL790, intend to treat some of the most difficult symptoms related to Parkinson's disease: involuntary movements (LIDs), psychosis and dementia. Through the proprietary ISP (Integrative Screening Process) research platform, IRLAB discovers and develops drug candidates for central nervous system (CNS) related diseases where big growing medical needs exist. In addition to the clinical candidates, the ISP platform has also generated several CNS programs that are now in preclinical phase. IRLAB's Certified Adviser on Nasdaq First North is FNCA Sweden AB, info@fnca.se, +46 (0)8‑528 00 399. More information on www.irlab.se.

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Quotes

"In the INN system, the relationship between pharmacologically-related substances is identified through the use of a common stem. Only when substances show a novel mode of action, which is rather rare, a new INN stem is established. Therefore, we are very pleased to have been proposed the unique “-dopetam” ending for IRL790, which may become a stem in the future. This would underline the candidate’s position as a potential first-in-class treatment of Parkinson’s disease." Nicholas Waters, CEO