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'''Ampligen''', also known as '''polyI:polyC12U''', is an experimental [[RNA#Double-stranded RNA|double stranded RNA]] [[drug]] developed by HEMISPHERx Biopharma, Inc. Ampligen completed a pivotal clinical trial phase III for [[Chronic Fatigue Syndrome]] (CFS), a severely debilitating [[disease]] in 2004 [http://www.hemispherx.net/content/investor/default.asp?goto=298]. A [[new drug application]], or NDA, is in preparatory stages, and Hemispherx management has targeted late 2006 for its filing with the U.S. [[Food and Drug Administration]], although the company has missed several target deadlines for an NDA filing in the past, including the end of 2005 and the third quarter of 2006 [http://sec.edgar-online.com/2006/01/03/0000946644-06-000001/Section4.asp]. |
'''Ampligen''', also known as '''polyI:polyC12U''', is an experimental [[RNA#Double-stranded RNA|double stranded RNA]] [[drug]] developed by HEMISPHERx Biopharma, Inc. Ampligen completed a pivotal clinical trial phase III for [[Chronic Fatigue Syndrome]] (CFS), a severely debilitating [[disease]] in 2004 [http://www.hemispherx.net/content/investor/default.asp?goto=298]. A [[new drug application]], or NDA, is in preparatory stages, and Hemispherx management has targeted late 2006 for its filing with the U.S. [[Food and Drug Administration]], although the company has missed several target deadlines for an NDA filing in the past, including the end of 2005 and the third quarter of 2006 [http://sec.edgar-online.com/2006/01/03/0000946644-06-000001/Section4.asp]. |
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It will we up to the FDA to approve its use. |
It will we up to the FDA to approve its commercial use. |
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Revision as of 22:13, 9 February 2007
| File:Ampligen.jpg | |
| Clinical data | |
|---|---|
| Routes of administration | IV |
| Identifiers | |
| PubChem CID | |
| CompTox Dashboard (EPA) | |
| Chemical and physical data | |
| Formula | C28H40N9O25P3 |
| Molar mass | 995.584 g·mol−1 |
Ampligen, also known as polyI:polyC12U, is an experimental double stranded RNA drug developed by HEMISPHERx Biopharma, Inc. Ampligen completed a pivotal clinical trial phase III for Chronic Fatigue Syndrome (CFS), a severely debilitating disease in 2004 [1]. A new drug application, or NDA, is in preparatory stages, and Hemispherx management has targeted late 2006 for its filing with the U.S. Food and Drug Administration, although the company has missed several target deadlines for an NDA filing in the past, including the end of 2005 and the third quarter of 2006 [2].
It will we up to the FDA to approve its commercial use.