Nabota, Phase III clinical trial will be conducted

Expanded indications for treatment

Currently 4 indications have been obtained in Korea

Growth potential is high in botulinum market, not only in beauty but also in therapeutics

Daewoong's botulinum toxin preparation 'Nabota' is speeding up the indication of treatment as well as improving the wrinkles of the glans.

 

Nabota, which has four indications, is in the final phase of clinical trials to prove the effectiveness of improving the square jaw.

 

The Ministry of Food and Drug Safety approved the Phase III clinical trial plan to demonstrate the efficacy of improving Nabota's bilateral hypertrophy (square jaw).

 

The clinical trial will be conducted at Chung-Ang University Hospital, which has undergone Phase II.

 

When Nabota acquires the indication, there will have five effectiveness.

 

Currently, Nabota is can be used to treat ▲a temporary improvement in moderate to severe severe glabellar wrinkles associated with corrugator muscle and/or proerus muscle activity in adults aged 20 to 65 years, ▲treatment of upper limb muscle stiffness associated with stroke in adults 18 years and older, ▲temporary improvement of moderate to severe external angular wrinkles (eye wrinkles) associated with orbicularis oculi activity in adults 18 years and over 65 years ▲ treatment of benign essential eyelid spasms in adults 18 years and older.

 

Of these, eyelid spasm indications were obtained last June, the most recent.

 

For 230 adults, Nabota demonstrated non-inferiority by comparison with Botox.

 

After 4 weeks of administration, 96.15% of the Nabota group and 96.12% of the Botox group showed improvement of eyelid spasms.

 

Daewoong expects that botulinum toxin has great potential not only in the beauty market but also in the therapeutic market, and thus, the acquisition of indications will increase competitiveness on the global stage.

 

For reference, Botox (Allergan), which Nabota used as a reference, has eight indications.

 

It has been recognized for its effects in various areas including strabismus and eyelid spasms, spinal malformations, treatment of cirrhosis, primary hyperatrophic hypertension, muscle stiffness, temporal improvement of worry lines, headache relief in migraines, and bladder dysfunction.

 

Meditoxin of Medytox, which is fighting a legal battle on Daewoong about technology infringement, has five indications.

 

Meditoxin targets domestic and international markets with the effects of benign essential eyelid spasms, treatment of acute malformations, temporal improvement of glacial wrinkles, local muscle stiffness associated with stroke, and temporary improvement of eye wrinkles.

 

Botulinum preparations are expanding into treatment areas as well as basic wrinkle improvement.

 

Daedal Research, a global market analyst firm, predicts that the global botulinum toxin market will reach $5.9 billion (about ₩7 trillion) in 2021, and the therapeutic market will account for about $3.2 billion (about ₩3.8 trillion).

 

In Korea, more than 90% is used for cosmetic purposes, but in the US and overseas markets, it is known that botulinum toxin is used more for therapeutic purposes.

 

Nabota is also investigating its potential as a treatment for male hair loss, triangular hypertrophy and tearing symptoms.

 

Nabota was introduced to the US market last year through Evolus.

 

Evolus reported that the first year of performance in the overseas market has raised about ₩40 billion.