Korea’s 40th new drug, Nuviju Injection (ingredient: cholic acid), has been approved for launch, marking the nation’s first locally developed fat-dissolving injectable based on cholic acid.

On September 19, Medytox announced it had received marketing authorization from the Ministry of Food and Drug Safety (MFDS). Nuviju is indicated for improving moderate to severe submental fat (double chin) in adults, with commercial rollout scheduled for February next year.

Conventional treatments using deoxycholic acid (DCA) have faced limitations, including bruising, swelling, and pain. To address these unmet needs, Medytox began a seven-year R&D program in 2018.

In its Phase 3 trial, 216 adults with moderate to severe submental fat received either Nuviju 1.5% (150 mg) or placebo every four weeks for up to six sessions. The formulation was designed at physiologic pH 7.4 to improve fat cell destruction compared with DCA.

Patient recruitment was challenging, as submental fat stems from factors beyond obesity, including genetics, body type, and skin elasticity. To ensure robust evaluation, researchers applied the Submental Fat Rating Scale (SMFRS) and subgroup analyses.

At 12 weeks, 88.6% of patients achieved at least a one-grade reduction in submental fat, and 46.7% achieved a two-grade reduction—both statistically significant versus placebo (p<0.0001). The most common adverse events were mild injection-site reactions such as bruising, pain, and warmth.

Medytox expects that lower adverse events will strengthen competitiveness in Korea’s double-chin market, estimated at $22 million annually. The company also plans to expand exports to all markets where its botulinum toxin and HA fillers are already available.

Globally, the fat-dissolving injection market is valued at $440 million, with a projected CAGR of 9.4% through 2036. While FDA-approved Belkyra and CE-marked Aqualyx exist, neither has reached blockbuster status, leaving significant room for new entrants.

A Medytox official said, “We have invested about 20% of revenue into R&D over the past five years. Nuviju is the outcome of those efforts. By leveraging synergies with our botulinum toxin and filler businesses, we aim to accelerate global market entry with tailored marketing strategies.”

Other notable Korean-developed new drugs include Pelubi (osteoarthritis), Kanarb (antihypertensive), K-CAB (anti-ulcer), Leclaza (lung cancer), and Ja Q Bo (GERD). Of these, ten—including K-CAB, Kanarb, Zemiglo, Leclaza, and Pelubi—have each surpassed $7 million in annual sales.