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primary/secondary endpoints met in Phase III trial (5/09); enrollment in Phase III trials complete (7/09); positive phase III data announced for 2 trials 12/09; meets primary endpoint of complete clearance of AK lesions in non-head locations (2/10)
Brand N/A Generic ingenol mebutate (PEP005)
Company name Peplin Product type Non-speciality
Therapeutic category Dermatologic Key uses Actinic (solar) keratosis (AK)
Other Uses N/A Drug Class Miscellaneous dermatological agent
Dosage From topical gel Expected Approval 2012+
FDA Filing N/A Last Update date June 02,2010
Link to pipeline report
  • Peplin pipeline report
Link to news article
  • News article 2/10
  • News article 12/09
  • News article 7/09
  • News article 5/09
Link to clinicaltrials.gov
  • Trials registered with NIH
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