Drug approvals and pharmaceutical affairs in Japan

September 2023
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Eril mystique
Filed under: Medicinal products
Posted by: Kanri @ 11:55 am

Since 2001 we have received dozens of inquires about Eril. Surprising is also the span of the inquirers – from US testing laboratories to product developers in EU to university researchers. Why Eril?

Eril (fasudil hydrochloride hydrate) was discovered by Asahi Kasei KK in 1980s. It is absolutely impossible to decipher the name of Eril, even knowing the typical for those years penchant for cryptic and “meaningful” abbreviations. The name of the pharmaceutical form Eril Inj. S stands for: Epoch-making relaxant for ischemic locality Injections Sun. Obviously afraid that somebody else might come with the same pearl, the maker registered Eril as a trademark Eril trademarkin 1988 – more than ten years before the approval and much earlier before the clinical trials ever began. The picture on the left is the actual image deposited to the Japan Patent Office.

Eril was licensed out in 2001 to Schering AG for development of antiangina oral formulation - it was then when the interest started to flow together with requests for samples of the compound and information. Both are scarce, particularly the latter. Unlike the medicinal products approved in Japan after the enforcement in 2001 of the Public Access to Information Law (PAIL), neither the Approval Review, nor the Summary Basis of Approval (SBA) are publicly available. Yes, the Package Insert – in its 7th revision from April 2005 made to conform to the amended Pharmaceuticals Affairs Law (PAL) is obtainable, however all other known documents – Drug Profile, Interview Form (a predecessor in Japan of the SBA), Pharmacopoeial Information are only accessible through a members-only commercial third party.

Eril is rarely advertized and for an epoch-making product sells somewhat weakly in Japan – chalking at average 10-12 millions US$ annually. But the inquiries keep coming…

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