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Gepirone is an antidepressant and anxiolytic drug of the azapirone group that was synthesized by Bristol-Myers Squibb in 1986 and has been under development for the treatment of depression but has yet to be marketed. It has been under development in the U.S. in an extended release form (referred to as gepirone ER), but despite completing phase III clinical trials and demonstrating efficacy, it has been rejected multiple times by the Food and Drug Administration (FDA) during the drug approval process. However, in March 2016, the FDA reversed course and ruled favorably on the efficacy of gepirone.

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  • Gepirone (en)
  • ゲピロン (ja)
  • Gepirona (pt)
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  • ゲピロン(Gepirone)は、系の抗うつ薬、抗不安薬である。アザピロン系の他の薬剤と比べ、5-HT1A受容体の選択的パーシャルアゴニストとして作用する。アメリカ合衆国で開発されたが、第三相の臨床試験をクリアできず、承認されなかった。その結果、商標名まで決まっていたものの、ゲピロンは市場には出されなかった。 ゲピロンは、ブリストル・マイヤーズ スクイブが開発したが、1993年にFabre-Kramerにライセンスされた。アメリカ食品医薬品局(FDA)はゲピロンの承認を2004年に拒絶した。2007年5月には、FDAが2004年に要請した追加の書類を添えて、再び事前登録の申請がなされたが、再び拒絶された。 (ja)
  • Gepirone is an antidepressant and anxiolytic drug of the azapirone group that was synthesized by Bristol-Myers Squibb in 1986 and has been under development for the treatment of depression but has yet to be marketed. It has been under development in the U.S. in an extended release form (referred to as gepirone ER), but despite completing phase III clinical trials and demonstrating efficacy, it has been rejected multiple times by the Food and Drug Administration (FDA) during the drug approval process. However, in March 2016, the FDA reversed course and ruled favorably on the efficacy of gepirone. (en)
  • Gepirona é um antidepressivo e ansiolítico da classe das azapironas. Foi sintetizado por Bristol-Myers Squibb em 1986 e tem sido estudado para o tratamento da depressão, mas ainda não é comercializado. O fármaco está em desenvolvimento nos EUA em uma forma de liberação prolongada, mas apesar de completar os ensaios clínicos de fase III e demonstrar eficácia, foi rejeitado várias vezes pela Food and Drug Administration (FDA). No entanto, em março de 2016, o FDA posicionou-se favoravelmente sobre a eficácia da gepirona. (pt)
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  • gepirone hydrochloride (en)
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