Drugs in R & D

, Volume 3, Issue 1, pp 58–60 | Cite as


Itavastatin, Nisvastatin, Nk 104, Nks 104, P 872441
Adis R&D Profile

Adis Comments

Pitavastatin [nisvastatin, itavastatin, NK 104, NKS 104, P 872441] inhibits HMG-CoA reductase, a rate-limiting key enzyme of cholesterol synthesis pathway. It originated with Nissan Chemical Industries and is now in joint development with Kowa in Japan. Phase III clinical trials have been completed in Japan for the treatment of hyperlipidaemia and an application for regulatory approval as a 2mg dose has been filed in this country. Phase III trials are underway in Europe (with Negma, now a subsidiary of Novartis) and phase II trials are scheduled to begin in the US (with Sankyo) in 2001. Novartis expects to file for regulatory approval in Europe in 2005. Sankyo has licensed pitavastatin for co-marketing in Japan and has also obtained exclusive development and marketing rights in the USA. In the USA, Novartis and Nissan hold certain patent rights relating to pitavastatin. Negma licensed partial European rights to pitavastatin. In April 2001, Novartis secured semi-exclusive...


Simvastatin Pravastatin Pitavastatin Familial Hypercholesterolaemia Rabbit Carotid Artery 
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