Korea’s minoxidil market is undergoing a complete reset as drugmakers respond to shifting oversight of the hair loss and hypertension drug. Oral tablets are clawing back after a regulatory crackdown. At the same time, new foam sprays hit the market, and noncompliant topicals continue to disappear.

Last Friday, the Ministry of Food and Drug Safety approved Damonoxil, an oral minoxidil tablet developed by Nova M Healthcare and manufactured by local CDMO Binex. 

The approval brings the number of authorized products in the class to four, marking the first addition since six generics were pulled last year for failing bioequivalence standards.

Two days earlier, Youngil Pharm secured clearance to launch a crossover trial on two tablet candidates, including the Hyundai Minoxidil Tab, the original reference product caught in the 2024 crackdown. The open-label, two-period design under fasting conditions is now standard under Korea’s tightened rules for proving therapeutic equivalence.

The six withdrawn products -- branded versions from Daehan Nupharm, Medica Korea, and Korea Union Pharm -- had all been manufactured by Union, whose own Uni-Minoxidil tablet failed two trials before the company exited the category entirely.

The shakeout isn’t over. On May 29, two forms of Mobarin, a minoxidil gel, and solution marketed by HTB and manufactured by Taiguk Pharm, were voluntarily withdrawn from the market. In March, TDS Pharm allowed two of its minoxidil products, also made by Taiguk, to lapse after their shelf life expired.

Oral minoxidil in Korea is used for resistant hypertension in patients with organ damage or poor response to triple-drug regimens. 

The market is small and highly regulated. However, the latest approval places Damonoxil alongside Hyundai Minoxidil Tab, Binex’s Bimo 5mg, and Dongkwang’s Minoxidil Tab 5mg as the only surviving options.

Korean drugmakers also expanded into topical minoxidil, where cosmetic demand is stronger. Hyundai Pharm launched Minoxyl Foam 5-percent Aerosol on May 28, rounding out its topical lineup. The company said the new foam avoids propylene glycol and uses minoxidil, which the U.S. FDA approved.

JW Shinyak followed with Mydil 5-percent Foam Aerosol, approved for male and female pattern baldness. A spokesperson said hair loss impacts the quality of life and that JW will expand its complete hair care portfolio, which includes oral finasteride, dutasteride, and cosmeceuticals from France’s Pierre Fabre.

Raon Pharma moved first, launching Minoxyfoam on May 26 -- the first Korean-made foam-based generic to challenge Johnson & Johnson’s eight-year monopoly with Rogaine Foam. Developed by Sinsin Pharmaceutical and marketed by Raon, the product uses domestic manufacturing and proprietary aerosol tech to compete on price and supply.