Daewoong wins Australian approval to conduct clinical trial of hair-loss treatment

By Lim Chang-won Posted : September 27, 2021, 10:06 Updated : September 27, 2021, 11:11

[Courtesy of Daewoong Pharmaceutical]

SEOUL -- Daewoong Pharmaceutical, a bioengineering company in South Korea, has secured approval from Australia's medicine and therapeutic regulatory agency to go ahead with the first-stage clinical trial of a long-acting male baldness therapy codenamed "IVL3001" that can be administered once every month or three months by subcutaneous injection.

The green light from the Therapeutic Goods Administration (TGA) will help Daewoong prove the efficacy of long-acting injections for hair loss treatment, based on in vivo dynamics and biochemical indicators. Daewoong aims to release products in 2023.

In previous tests, Daewoong said IVL3001 showed better effects even at a lower dose than oral drugs. "We will develop a long-acting hair loss treatment injection so that hair loss people who take medicine every day can enjoy convenience and stable effects," Daewoong CEO Jeon Seung-ho said in a statement on September 27.

IVL3001 is an injection formulation of finasteride-loaded polymer microspheres to deliver finasteride, a verified materias approved by the U.S. Food and Drug Administration. The formulation can reduce the inconvenience of daily oral drug taken while still maintaining therapeutic effects. Other benefits include sustained drug levels in the blood, fewer adverse effects, and improved patient compliance.

Under a deal in June 2021, Daewoong agreed with Inventage Lab, a domestic startup specializing in drug delivery system platforms, to develop long-acting hair-loss drugs. Daewoong is in charge of phase 3 clinical trials, licensing and sales. Inventory Lab will carry out pre-clinical and phase 1 clinical trials, while Withus Pharmaceutical is responsible for production.
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