Daewoong starts developing XR formulation of tofacitinib

starts clinical trial

Different dose to its comparator Xeljanz SR

Expected to be released after patent expiry in November 2025

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 drug, tofacitinib 11mg appears to be Pfizer's Xeljanz XR Tab 11mg.

 

Pfizer received approval for the once-daily Xeljanz XR Tab 11mg on December 1, 2020.

 

With its approval, the company secured various prescription options, in addition to the twice-daily Xeljanz 5mg Tab (approved in April 2014) and Xeljanz 10mg Tab (approved in December 2018).

 

Xeljanz XR Tab is used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

 

In particular, its extended-release tablet is expected to play a major role in protecting the market from its generics, which are scheduled to be released in November 2025.

 

As of now, 56 generic versions of Xeljanz have been approved by the Ministry of Food and Drug Safety, most of which are tofacitinib 5 mg salt-modified drugs that have overcome the Xeljanz composition patent, and are immediate-acting tablets that are taken twice a day.

 

Daewoong Pharmaceutical also received approval for its Zeltopa Tab 5mg, which contains tofacitinib aspartate, in September 2020 and is waiting to release the product.

 

If it receives approval for its XR formulation as well, the company’s competitiveness is expected to double when the market for generics opens.

 

Meanwhile, Pfizer's Xeljanz recorded outpatient prescriptions worth KRW 12.3 billion in Korea in 2022 based on UBIST.