Overview & Pipeline |
Raptor is building a balanced, robust pipeline of drug candidates which may expand the reach and benefit of existing therapeutics. Raptor’s commercial, clinical, and preclinical pipeline includes both candidates from Raptor's proprietary molecules and in-licensed and acquired product candidates.
Raptor's lead product, PROCYSBI™ (cysteamine bitartrate) delayed-release capsules, received FDA approval on April 30, 2013. The Company anticipates receiving a determination from the EMA regarding its PROCYSBI™ marketing application in the European Union in the second half of 2013.
Raptor's clinical-stage product pipeline includes two active development programs based on the Company's proprietary delayed-release formulation of cysteamine bitartrate (RP103 capsules), as well as the Company's Convivia™ (oral 4-methylpyrazole) program which the Company licensed to Uni Pharma Ltd., Taiwan. Raptor's preclinical pipeline includes two development programs based upon the Company's proprietary molecules.
Product Pipeline (Potential Clinical Indications)
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Clinical Development Pipeline
Raptor has two active clinical development programs based on its proprietary extended and delayed-release formulation of cysteamine bitartrate.
- RP103 capsules for the potential treatment of:
- Huntington's disease, an inherited neurodegenerative disease (Phase 2/3)
- Nonalcoholic Fatty Liver Disease (NAFLD) in Children, a metabolic disorder of the liver (Phase 2b)
Raptor's other clinical development program:
- Convivia™(oral 4-methylpyrazole) for the potential management of acetaldehyde toxicity due to ALDH2 deficiency, an inherited metabolic disorder (Phase 2, licensed to Uni Pharma Ltd., Taiwan)
Convivia™ is a Phase 2 product candidate that addresses ALDH2 deficiency. The ALDH2 enzyme is a component of the primary metabolic pathway for ethanol and other alcohols. Consumption of alcohol by individuals with ALDH2 deficiency leads to an accumulation of acetaldehyde, a known carcinogen, in blood, saliva, liver and other tissues. This condition is commonly known as alcohol intolerance or Asian Flush.
Preclinical Programs
Raptor's preclinical programs consist of: