Rubitecan

Rubitecan
Clinical data
Trade names Orathecin
Routes of
administration		 Oral (capsules)
ATC code
  • None
Legal status
Legal status
  • Application withdrawn
Pharmacokinetic data
Bioavailability 25–30% (rubitecan and 9-AC; in dogs)
Protein binding 97% (rubitecan), 65% (9-AC)
Metabolism Probably CYP-dependent
Metabolites 9-Aminocamptothecin (9-AC)
Biological half-life 15–18 hours (rubitecan), 18–22 hours (9-AC)
Excretion Bile and feces (major proportion), urine (the minor one)[1]
Identifiers
Synonyms 9-Nitrocamptothecin
Camptogen
(19S)-19-Ethyl-19-hydroxy-10-nitro-17-oxa-3,13-diazapentacyclo[11.8.0.02,11.04,9.015,20]henicosa-1(21),2,4,6,8,10,15(20)-heptaene-14,18-dione
CAS Number
PubChem CID
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
Chemical and physical data
Formula C20H15N3O6
Molar mass 393.349 g/mol
3D model (JSmol)
 NYesY (what is this?)  (verify)

Rubitecan (INN, marketing name Orathecin) is an oral topoisomerase inhibitor, developed by Supergen.

History

On January 27, 2004, Supergen announced that it has completed the submission of an NDA for rubitecan to the US FDA,[2] and was accepted for filing on March 2004.[3]

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,[4] and on January 2006, the Marketing Authorization Application (MAA) filed with the European Medicines Agency (EMA) was also withdrawn.[5]

References

  1. ↑ "Withdrawal Assessment Report for Orathecin (rubitecan). Applicant: EuroGen Pharmaceuticals, Ltd." (PDF). European Medicines Agency. 30 November 2007. pp. 4–8. Retrieved 15 July 2016.
  2. ↑ "Drugs.com, SuperGen completes submission of New Drug Application (NDA) for Orathecin as an oral treatment for pancreatic cancer". Retrieved 2008-03-25.
  3. ↑ "Drugs.com, SuperGen’s New Drug Application for Orathecin (rubitecan) capsules accepted by FDA for filing". Retrieved 2008-03-25.
  4. ↑ "Drugs.com, SuperGen Announces Withdrawal of Orathecin NDA". Retrieved 2008-03-25.
  5. ↑ "Press release from the EMEA website regarding withdrawal of Orathecin MAA" (PDF). Retrieved 2008-03-25.
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