Efficacy Study
Our product’s efficacy is evaluated by measuring its impact on Compound Muscle Action Potential (CMAP). When administered to a single muscle, it effectively suppresses contraction and induces muscle palsy in a dose-dependent manner. Notably, its muscle contraction inhibition at doses of 5 units/kg is comparable to that of Botox, maintaining strong, lasting effects.

Clinical Sample Production
We produce clinical samples under strict quality control to guarantee safety and efficacy. These samples undergo thorough testing before progressing to further clinical stages.

Clinical CRO Selection
We collaborate with reputable Clinical Contract Research Organizations (CROs) to conduct our trials, ensuring reliable and accurate study results.

IND Submission & Approval
Investigational New Drug (IND) documents detailing safety data, preclinical results, and clinical protocols are compiled and submitted for regulatory approval.

Export Permission
Our product meets international regulatory standards and has received approval for export, allowing access to global markets.

Clinical Trials (Phase I & II)
Comprehensive Phase I and II trials are conducted to assess safety, tolerability, dosage, and side effects in human participants.

KGMP License
Holding the Korean Good Manufacturing Practice (KGMP) license, our manufacturing adheres to rigorous quality standards for safe, consistent production.

Manufacturing Process & Patents
Our production process incorporates domestic patents and Patent Cooperation Treaty (PCT) protection, safeguarding proprietary technology and exclusivity.

• We hold a domestic patent for our innovative drying process, enhancing product quality and stability.

Composition
Each vial contains:

• 100 units of Clostridium botulinum toxin type A (IHS)

• 0.5 mg Human Serum Albumin (EP)

• 0.9 mg Sodium Chloride (EP)
  We use strains identified as Clostridium botulinum ATCC 3502 to ensure consistent performance.

Stable Production Technology
We have secured stable production technology by simplifying the manufacturing of the undiluted solution, ensuring product consistency.

High Purity Undiluted Solution
Our undiluted solution has a purity exceeding 99%, enhancing efficacy and minimizing adverse reactions.

Low Incidence of Resistance
The formulation allows small injection volumes per vial, resulting in a significantly low rate of resistance within the product group, promoting long-lasting effectiveness.

Uses

• Neurology: Treatment of muscle spasticity and related disorders.

• Cosmetic Procedures: Reduction of wrinkles and fine lines by relaxing targeted muscles.

Effectiveness may vary based on patient factors such as age, health status, and concurrent medications.

Dosage

Dosage should be determined by a qualified healthcare professional based on individual patient needs and response. Typical dosages are measured in units (e.g., 100 units) and administered by injection. Strict adherence to prescribed dosages is crucial to avoid over- or underdosing risks.

Administration

Novatox 100U is administered via intramuscular injection by trained healthcare providers using proper techniques to maximize efficacy and reduce discomfort or complications.

Side Effects

Common side effects include:

• Localized pain at injection site

• Headaches

• Nausea

• Temporary muscle weakness

Serious adverse reactions are rare but require close patient monitoring after administration.