Addpharma, entering phase 3 of low-dose Dutasteride

On the 29th of last month, IND was approved by the MFDS. The commercial value was high because of the preference for low doses

Avodart for prostatic hypertrophy and hair loss

Addpharma, a subsidiary of Yuhan's improved drug development, has entered phase 3 clinical trials of low-dose tablets of Dutasteride (Avodart, GSK), a hair loss treatment.

 

Currently, Dutasteride is already on the market, but the value of Addpharma's developed products is high as there is no low dose product.

 

The MFDS approved Addpharma's phase 3 clinical trial protocol for AD-208 on the 29th of last month.

 

This trial is a multicenter, randomized, double-blind, placebo-controlled, parallel, phase 3 clinical trial to evaluate the efficacy and safety of AD-208 in male androgen alopecia patients.

 

AD-208 is Yuhan's IMD.

 

However, it is not known in detail what type of drug it is.

 

As a result of the interviews, it was found to be Dutasteride 0.2mg, not conventional Dutasteride 0.5mg.

 

Avodart is released in 0.5mg capsule type.

 

Generics were released due to the expiration of the patent in 2016, and tablet types were also released.

 

JW Pharma was the first to develop Dutasteride in tablet form based on its underlying technology in 2018.

 

It relieves the discomfort of the capsule sticking to the mouth and esophagus.

 

It also became possible to split pills.

 

Due to the long half-life of Dutasteride, some patients with hair loss may take one pill every two days.

 

When taken in half, it is possible to maintain the drug agonism in the blood for a day.

 

Since the drug developed by Addpharma contains only half of the existing content, there is no need for splitting tablets.

 

It is easy to prescribe or dispense, and the patient's adherence to medication is increased.

 

Pharmaceutical companies can expect cost reduction because only half of the ingredients are included.

 

Phase 3 is conducted at 8 hospitals including Seoul National University Hospital.

 

It plans to recruit a total of 130 patients.

 

It is noted whether it will be validated and commercialized.