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Systematic (IUPAC) name
Clinical data
Routes of
CAS Number 91421-42-0
ATC code none
PubChem CID 11954380
Synonyms (19S)-19-ethyl-19-hydroxy-10-nitro-17-oxa-3,13-diazapentacyclo[,11.04,9.015,20]henicosa-1(21),2,4,6,8,10,15(20)-heptaene-14,18-dione
Chemical data
Formula C20H15N3O6
Molar mass 393.349 g/mol[[Script error: No such module "String".]]
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Rubitecan (INN, marketing name Orathecin) is an oral topoisomerase inhibitor, developed by Supergen.


On January 27, 2004, Supergen announced that it has completed the submission of an NDA for rubitecan to the US FDA, [1] and was accepted for filing on March 2004.[2]

On January 2005, Supergen withdrew the NDA for rubitecan, based on feedback indicating that the current data package would not be sufficient to gain US approval,[3] and on January 2006, the Marketing Authorization Application (MAA) filed with the European Medicines Agency (EMA) was also withdrawn.[4]


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  1. ", SuperGen completes submission of New Drug Application (NDA) for Orathecin as an oral treatment for pancreatic cancer". Retrieved 2008-03-25. 
  2. ", SuperGen's New Drug Application for Orathecin (rubitecan) capsules accepted by FDA for filing". Retrieved 2008-03-25. 
  3. ", SuperGen Announces Withdrawal of Orathecin NDA". Retrieved 2008-03-25. 
  4. "Press release from the EMEA website regarding withdrawal of Orathecin MAA" (PDF). Retrieved 2008-03-25.