There are many examples of the use of large-scale chiral chromatography to produce chiral APIs. Widely used in early development programs to rapidly prepare pure enantiomers for clinical programs, this technique is also well established for full development and commercial production of APIs. Some examples of APIs produced using chiral chromatography are shown in the table below.
Drug Name |
Indication |
Company |
Phase |
2008 World. Sales |
Comments |
Armodafinil Nuvigil® |
Narcolepsy, Jet lag disorder, obstructive sleep apnea and shift work sleep disorder |
Cephalon |
Marketed |
- |
Large-scale chiral chromatography has been used to significantly reduce the time to market and produce launch quantities |
Escitalopram Lexapro® |
Depression, generalized anxiety disorder |
Lundbeck |
Marketed |
$1.24 |
Currently produced by industrial chiral chromatography |
Levitiracetam Keppra® |
Epilepsy |
UCB |
Marketed |
$1.75 |
Currently produced by large-scale chiral chromatography |
Radafaxine - |
Restless leg syndrome, depression |
GlaxoSmithKline |
Discontinued |
- |
Thanks to the use of chiral chromatography for Radafaxine production, GSK was awarded twice for green chemistry |
AMG221 - |
Type 2 diabetes |
Amgen |
Phase I |
- |
The shorter reaction |
Pagoclone - |
Persistent developmental stuttering |
Indevus Pharmaceuticals |
Phase III |
- |
Chiral chromatography appeared to be the most time-efficient and cost-effective method in development |
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