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  • Daewoong starts developing XR formulation of tofacitinib
  • by Lee, Tak-Sun | translator Kim, Jung-Ju | Nov 8, 2023 05:37am
starts clinical trial
Different dose to its comparator Xeljanz SR
Expected to be released after patent expiry in November 2025
 ¡ã Pfizer
Daewoong Pharmaceutical has begun developing a product that can rival Pfizer's oral JAK inhibitor 'Xeljanz XR 11mg'.

Xeljanz XR (tofacitinib citrate) is Prizer's latest tofacitinib product approved in December 2020. Daewoong Pharmaceutical, like the original company Pfizer, is building a lineup of immediate-release and extended-release tablets before entering the tofacitinib generic drug market.

On the 3rd, the Ministry of Food and Drug Safety approved the Phase 1 clinical trial plan for DWJ1431, for intake with and without food. DWJ1431 is known to contain 10mg of tofacitinib.

The trial will focus on confirming DWJ1431¡¯s pharmacokinetic properties and safety compared with tofacitinib 11mg. The reference dr
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