Is Liporase FDA Approved?

The U.S. Food and Drug Administration (FDA) plays a pivotal role in safeguarding the health of the public by ensuring the safety and effectiveness of medications and medical devices, including those used in aesthetic medicine. Over the years, the FDA has granted approval to several forms of hyaluronidase, a key enzyme in both clinical and aesthetic treatments, after rigorous testing for efficacy, safety, and manufacturing standards.

One of the most popular brands of hyaluronidase is Liporase, a product originally developed in South Korea. Widely utilized in off-label aesthetic procedures, Liporase has become a go-to solution for many practitioners looking to enhance their treatments. However, despite its widespread use, there remains some uncertainty around its FDA approval status in the United States.

In this article, we’ll explore whether Liporase is FDA-approved, what that means for both patients and professionals, and how it compares to other FDA-cleared hyaluronidase alternatives in the market.

Key Takeaways

• Liporase is approved in South Korea by the MFDS but is not FDA-approved in the U.S., making its use off-label and potentially non-compliant with U.S. law.
• FDA-approved hyaluronidases, such as Hylenex, Vitrase, and Amphadase, have undergone extensive clinical trials and inspections, ensuring their safety and efficacy for use in the U.S.
• Using Liporase in the U.S. without FDA approval is illegal and could expose healthcare providers to liability, malpractice risks, and legal consequences. Unregulated imports may also lack consistency and quality.
• While Liporase is widely used internationally, it has not been submitted for FDA review, and its use in the U.S. remains restricted.
• Despite its widespread use in other markets, Liporase’s absence from FDA approval raises concerns about its safety documentation and potential complications.
• Healthcare providers should prioritize FDA-approved alternatives to ensure patient safety, regulatory compliance, and legal protection.

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Liporase Regulatory Status: KFDA vs FDA‑listed Hyaluronidases

Liporase is approved by the Ministry of Food and Drug Safety (MFDS), formerly known as the KFDA, in South Korea. This approval confirms that Liporase meets stringent national standards for safety, efficacy, and manufacturing quality. The product contains hyaluronidase derived from bovine or ovine sources, and it is commonly used to dissolve hyaluronic acid (HA) fillers and reduce localized swelling or fibrosis in both aesthetic and therapeutic procedures.

Despite its established use in Korean clinics and several international markets, Liporase is not approved by the U.S. Food and Drug Administration (FDA) as a biologic. A search through the FDA’s biologics database reveals no listing for Liporase, indicating that it has not gone through the agency’s preclinical review, clinical trials, or Biologics License Application (BLA) process. This absence from the FDA registries means Liporase is not legally cleared for use in the United States.

Due to this lack of FDA approval, medical professionals in the U.S. typically rely on FDA-approved alternatives, such as Hylenex, Vitrase, and Amphadase, which have undergone necessary trials and quality control measures to ensure patient safety. Until Liporase undergoes similar FDA processes, its use in FDA-regulated jurisdictions remains off-label and may not comply with U.S. federal law.

Differences vs FDA‑Approved Hylenex, Vitrase, & Amphadase

To better understand why Liporase is not FDA-approved, it’s helpful to compare it with FDA-licensed hyaluronidase formulations that have successfully passed the complete FDA vetting process, including clinical trials, manufacturing inspections, and safety audits. Although all of these products serve the same purpose—enhancing tissue permeability and aiding the breakdown of hyaluronic acid—they differ in formulation sources and the regulatory pathways they have undergone.

Product	Source	Approved Use
Hylenex	Recombinant human	FDA-approved to increase absorption of subcutaneous fluids, local anesthetics, and radiopaque agents. Often used in medical emergencies and aesthetic corrections.
Vitrase	Ovine (sheep-derived)	Used to facilitate the dispersion and absorption of injected drugs or fluids, also approved for enhancing contrast agent uptake in diagnostic imaging.
Amphadase	Bovine-derived	Approved for subcutaneous administration of fluids and drugs, with added documentation for enzyme stability and safety.
Hydase	Bovine-derived	Shares similar approved indications with Amphadase, commonly used in ophthalmology and dermatology.

These FDA-approved products have passed stringent protocols, including Investigational New Drug (IND) applications, Biologics License Applications (BLA), and comprehensive quality control audits. Their consistent performance in clinical and hospital settings ensures the safe use of HA dissolution and supports drug absorption.

Liporase, however, has not undergone these regulatory steps. While it is widely popular in South Korea and parts of Asia, its absence from the U.S. regulatory framework raises concerns about product documentation, manufacturing consistency, and liability in case of adverse effects. This is a critical consideration for practitioners deciding whether to use Liporase or its FDA-approved counterparts.

Legal Implications of U.S. Use & Gray‑Market Sourcing

Using non-approved products like Liporase in the United States comes with several legal and ethical risks that healthcare providers must carefully consider:

• Import Legality: Importing Liporase without FDA clearance is a violation of the Federal Food, Drug, and Cosmetic Act. Even for personal use, unauthorized importation is considered illegal and may result in product seizure, fines, or professional sanctions.
• Liability and Malpractice Risk: Should complications arise from the use of non-FDA-approved products, clinicians could face legal claims, licensing issues, and insurance denials in cases of off-label or unregulated treatments.
• Product Quality & Authenticity: Liporase sourced from unverified suppliers may be counterfeit, expired, or improperly stored, which can compromise batch consistency, sterility, and labeling. This can put patient safety and practitioner credibility at significant risk.

Given these challenges, professionals should avoid the unauthorized use of Liporase in U.S. clinical practice. Instead, they should rely on FDA-approved hyaluronidase products to ensure compliance, traceability, and patient safety. For practitioners in regions where Liporase is permitted, it’s critical to follow strict handling protocols, including understanding how to dilute Liporase properly to preserve its enzymatic activity and avoid complications.

Global Approval Landscape & Ongoing Regulatory Efforts

Liporase has found widespread use across global markets, including Asia, Latin America, parts of Europe, and the Middle East. In South Korea, its approval by the Korean FDA (MFDS) confirms that it meets local safety and efficacy standards. However, Liporase has not been submitted for FDA review in the United States, and there is no evidence of ongoing trials or regulatory efforts to seek entry into the U.S. market.

Internationally, the classification of hyaluronidase varies based on each country’s regulatory framework. In some regions, it qualifies under existing biologic regulations due to its established use in tissue dispersion and the reversal of hyaluronic acid (HA) fillers. Other countries treat it as a new drug, necessitating extensive clinical trials, Good Manufacturing Practice (GMP) audits, and post-market surveillance before granting approval.

While no confirmed pathway exists for Liporase’s U.S. clearance, global regulatory trends and potential collaborations with FDA-recognized manufacturers could provide signals for its future submissions. Until then, Liporase remains widely available internationally. However, its use in the U.S. should be approached with full awareness of the legal and safety implications.

Conclusion

Liporase does not have FDA approval, so practitioners and aesthetic clinics in the United States cannot use it for their patients. While Liporase has regulatory approval in South Korea and several international markets, it remains outside the scope of U.S. regulatory clearance. 

U.S. clinicians must rely on FDA-approved alternatives, such as Hylenex, Vitrase, Amphadase, and Hydase, all of which meet the strict safety standards established by the FDA. Until Liporase undergoes the same rigorous review process, its use in FDA-regulated jurisdictions remains off-label, and professionals must approach it with caution.

FAQs

1. Is Liporase available in the United States?

No, practitioners in the United States cannot use Liporase because it does not have FDA approval. Liporase holds KFDA approval but lacks FDA clearance or official listing. 

2. How does Liporase differ from FDA-approved hyaluronidases?

Unlike FDA-approved Hylenex, Vitrase, Amphadase, and Hydase, Liporase hasn’t undergone U.S. clinical trials or regulatory review.

3. Are no-label products safe?

Quality and sterility vary greatly among imports. Only FDA-approved hyaluronidases guarantee consistent manufacturing and traceability in the U.S.

References

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Ponomareva T, Sliadovskii D, Timchenko M, Molchanov M, Timchenko A, Sogorin E. The effect of hepatopancreas homogenate of the Red king crab on HA-based filler. PeerJ. 2020;8:e8579. doi:10.7717/peerj.8579