(Health Korea News / Lee Soon-ho) Dong-A ST has completed the clinical trial of ‘DA-5212’, which is being developed as a follow-up product to ‘Motilitone’. ‘DA-5212’ is known as a natural medicine, and as Dong-A ST is considered a strong player in the relevant market, it is expected to establish itself as a new strategic product when commercialized.
According to the Ministry of Food and Drug Safety on the 12th, Dong-A ST has completed the phase 3 clinical trial of ‘DA-5212’ targeting patients with functional dyspepsia. It has been a year and a half since the clinical trial plan was approved in March of last year.
The company recruited 384 subjects, slightly more than the original plan of 380, and completed the final subject observation and the trial early this month. Data and statistical analysis have not yet begun, but Dong-A ST expects to confirm the results by the end of this year.
‘DA-5212’ is a non-public business strategy drug of Dong-A ST. Other than the fact that it is known to be a natural medicine, specific information about the drug, such as its main ingredient and dosage, has not been disclosed. The company also claims that it is difficult to disclose information due to its development strategy.
However, considering that the target disease of ‘DA-5212’ is functional dyspepsia, it seems to be a follow-up product of ‘Motilitone’, one of the main natural medicines sold by Dong-A ST. ‘Motilitone’ is the 6th domestic natural new drug developed by Dong-A ST and is a prescription medicine with extracts of Hyeonhosak and Gyeonuja as its main ingredients. ‘Motilitone’ is the only product among Dong-A ST’s that has an indication for the treatment of functional dyspepsia.
Although information on ‘DA-5212’ is limited, looking at the company’s patent and clinical status, ‘DA-5212’ is likely to be a sustained-release formulation of ‘Motilitone’.
Looking at the patent applications published by the Korean Intellectual Property Office, it appears that Dong-A ST has not registered or applied for any new functional indigestion natural ingredients. However, the patent for the ‘Method for Manufacturing Extended-release Tablets’ registered in 2019 includes the main ingredients of ‘Motilitone’, the mixed extracts of Hyeonhosak and Gyeonuja. This patent covers not only ‘Motilitone’ but also the main ingredient of Dong-A ST’s representative natural new drug ‘Styrene’, the mugwort extract.
Meanwhile, Dong-A ST received approval for phase 3 clinical trials for ‘DA-5219’, a sustained-release formulation of ‘Styrene’, in October of last year and is currently conducting the trials. It began recruiting the first subject for phase 3 trials early this year, and is aiming to complete phase 3 trials by December of this year.
‘DA-5219’ is a sustained-release formulation that reduces the dosage of ‘Styren’, which is taken three times a day, and the high-dose product ‘Styrentuex’, which is taken twice a day, to once a day. It has a similar project name to ‘DA-5212’, and there is not much difference in the timing of entering phase 3 clinical trials.
The dosage and method of taking ‘DA-5212’ are also noteworthy. ‘Motilitone’ should be taken 1 tablet 3 times a day, but ‘DA-5212’, like ‘Styrene’ sustained-release preparation ‘DA-5219’, only needs to be taken 1 tablet once a day. ‘Motilitone’ and ‘DA-5212’ also have one thing in common: they should be taken before meals, not after.
This is the reason why there is speculation that ‘DA-5212’ may be a western-release formulation of ‘Motilitone’.
Meanwhile, ‘Motilitone’, which was launched in December 2011, grew to a 30 billion won product, but its sales are currently stagnant. This product, which first broke the 30 billion won barrier with sales of 31.2 billion won in 2021, grew by about 10% to 34.1 billion won in 2022. However, sales fell to 31.8 billion won last year, returning to the level of two years ago.
Since ‘DA-5212’ is a product with a dosage reduced to one-third of that of ‘Motilitone’, it is expected to receive attention as an alternative that can overcome the stagnant sales of ‘Motilitone’ when commercialized.
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