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Caring SunshineIngredients

Serrazimes

Table of contents

Other Names

Aspergillus melleus and Aspergillus oryzae protease blendfungal proteolytic enzyme blendfungal serrapeptidaseserrapeptase alternativeserrapeptidase alternativeserratiopeptidase alternative

Synopsis

Serrazimes® (Proprietary): A Comprehensive Reference

1. Identity and Nomenclature

Serrazimes® is a registered proprietary trademark and patented enzyme ingredient. Serrazimes® is a registered trademark of National Enzyme Company (NEC), a Missouri-based enzyme manufacturer that subsequently became Deerland Probiotics & Enzymes and is now part of ADM (Archer Daniels Midland). Serrazimes® is a registered trademark of Deerland Probiotics & Enzymes.

Serrazimes is a patented blend of proteolytic (protein-breaking) enzymes made by the National Enzyme Company. Serrazimes® is a proteolytic system that is designed to provide activity equivalent to that expressed by serratiopeptidase as an alternative for use in dietary supplements. It is classified within the broader category of systemic proteolytic enzyme dietary supplements and is positioned specifically as a vegetarian and non-animal-derived functional equivalent to the well-known enzyme serratiopeptidase (serrapeptase).

The ingredient exists in at least two documented sub-forms on the ingredient market: Serrazimes® (the standard form) and Serrazimes®-I, both of which are described as proteolytic systems designed to provide serratiopeptidase-equivalent activity. Serrazimes®-I is a proteolytic system that is designed to provide activity equivalent to that expressed by serratiopeptidase as an alternative for use in dietary supplements. It is an enzyme therapy for nutritional systemic support and has a proteolytic activity comparable to serratiopeptidase.

1.1 Botanical and Fungal Sources

Developed as a vegetarian and non-animal alternative, Serrazimes typically includes a combination of protease enzymes derived from fungal sources — most notably Aspergillus melleus and Aspergillus oryzae. These are edible, filamentous fungi in the genus Aspergillus, belonging to the family Trichocomaceae, and are distinct from pathogenic species in the same genus.

The filamentous fungus Aspergillus oryzae is classified as a generally recognized as safe (GRAS) organism and is widely used in traditional fermentation of sake, soy sauce, vinegar, and mirin in Japan and China. A. oryzae has been recognized as Generally Recognized as Safe (GRAS) in the United States, and its safety has been confirmed by the WHO. Critically, carbohydrase and protease from Aspergillus oryzae are listed by FDA as "substances derived from microorganisms recognized by FDA as Generally Recognized as Safe in Opinion Letters."

Research screening of Aspergillus micromycetes has confirmed that A. melleus (among other species) is capable of producing fibrinolytic enzymes when cultivated under certain nitrogen source conditions. A. melleus is known as a protease producer since the end of the last century, and its protease is already well-studied.

1.2 Relationship to Serratiopeptidase

To understand the functional context of Serrazimes, the parent enzyme serratiopeptidase must be briefly characterized. This patented ingredient mimics the properties of serrapeptase (also known as serratiopeptidase or serrapeptidase), a proteolytic enzyme generated by native Serratia bacteria in the digestive system of silkworms — an enzyme that dissolves the worm's cocoon. Serrapeptase has been used as a dietary supplement for over 30 years, particularly in Japan. However, serrapeptase is not manufactured in the United States due to some safety concerns over its bacterial origin. As a result, Serrazimes was created as an alternative to serrapeptase, and uses a different source — the edible fungi Aspergillus melleus and Aspergillus oryzae.

1.3 Common Forms and Preparations

Serrazimes® is produced commercially as a dry enzyme blend and is formulated into various dosage forms for the dietary supplement market. The most common presentation is the vegetarian capsule. Product labeling and commercial documentation describe the ingredient as available in 20,000 and 40,000 Serratiopeptidase Units (SPU) per capsule formulations.

Serrazimes supplements typically come in 33 mg capsules with a potency of 20,000 units of activity. A double-strength formulation is also commercially available: Swanson Double Strength Serrazimes features an innovative, vegetarian-friendly source of serrapeptidase cultured on Aspergillus through a process developed by the enzyme experts at Deerland Probiotics & Enzymes (formerly National Enzyme Company). Serrapeptidase activity is measured in "serratiopeptidase units" and this formula delivers a powerful 40,000 units per capsule, compared to just 20,000 in the original high potency supplement.

US patent 7067124 describes the use of Serrazimes for alleviating digestive disorders. In this context, it is used as a digestive enzyme meant to enhance the digestion of dietary proteins in the gastrointestinal tract, and is typically mixed together with lipase (a fat-breaking enzyme) and antacid. The patent was granted to National Enzyme Company. Patent number 7067124, type: Grant, filed March 28, 2003, date of patent: June 27, 2006; assignee: National Enzyme Company (Forsyth, MO).

Other excipients observed in commercial formulations include rice bran, microcrystalline cellulose, hypromellose (for capsule shells), and maltodextrin. Formulations are described as vegetarian- and vegan-compatible (relying on plant- or fungal-derived capsule materials), though some products carry allergen warnings. Allergen information for some formulations indicates they contain soy and wheat, reflecting the fermentation substrate used in production.

2. Traditional and Historical Use

Serrazimes itself is a modern, patented proprietary ingredient with no traditional use history of its own — it was developed in the late 20th and early 21st centuries as an industrially produced enzymatic alternative to serratiopeptidase. Therefore, any discussion of "traditional use" must be framed around (a) the broader traditional use of enzymatic and fermented foods from which the conceptual lineage of the ingredient derives, and (b) the historical use of the parent compound serratiopeptidase.

2.1 Antecedents in Traditional Fermentation

Aspergillus oryzae has a long tradition in East Asian food processing and is widely used in traditional fermentation of sake, soy sauce, vinegar, and mirin in Japan and China. This centuries-long human consumption record of A. oryzae-fermented foods forms the historical foundation for the safety and cultural familiarity of this fungal species.

Traditional cultures have long used naturally occurring enzyme sources — such as papaya (papain), pineapple (bromelain), and fermented foods — to reduce inflammation, soften tissues, aid digestion, and accelerate healing. In particular, Asian cultures that consumed natto (fermented soybeans) were unknowingly supplementing with nattokinase, another enzyme with fibrinolytic properties.

2.2 Origin of the Serrapeptase Tradition

The emergence of serratiopeptidase in 20th-century Japan set the stage for the development of plant-based enzyme alternatives like Serrazimes. As serrapeptase gained popularity in clinical settings for managing post-operative inflammation and ENT (ear, nose, throat) conditions, demand grew for vegan-compatible versions. This led to the development of fungal-derived proteolytic complexes capable of delivering similar systemic effects.

Clinical studies done in the 1960s began to show the effect of serratiopeptidase in reducing inflammation. It was subsequently used extensively in Japan and parts of Europe as a clinical anti-inflammatory agent, particularly in post-operative, ENT, and musculoskeletal contexts. The commercial development of Serrazimes by National Enzyme Company in the United States — formally patented in the early 2000s — represents the direct lineal response to this clinical tradition and to the domestic manufacturing challenges associated with the bacterial-derived parent compound.

3. Composition, Active Constituents, and Mechanisms of Action

3.1 Enzyme Composition

Serrazimes® is described by its manufacturer and product databases as a blend of proteolytic enzymes rather than a single purified enzyme. Serrazimes® provides a blend of proteases shown to break down protein substrates in a manner similar to serratiopeptidase. The primary contributing fungal proteases are derived from Aspergillus melleus and Aspergillus oryzae, both of which are documented protease-producing species.

Research into the biochemistry of A. oryzae proteases is relevant to understanding the enzymatic constituents. An enzyme from Aspergillus oryzae KSK-3, isolated from commercial rice-koji for miso brewing, showed fibrinolytic activity in liquefied rice culture. A culture filtrate was concentrated by ultrafiltration and subsequently purified to electrophoretic homogeneity; the molecular weight of the purified enzyme was estimated to be approximately 30 kDa by SDS-PAGE and HPLC–size exclusion chromatography.

The activity of the A. oryzae KSK-3 enzyme was considerably inhibited by phenylmethylsulfonyl fluoride and pefabloc SC, indicating that the enzyme is a serine protease. Serine proteases are a major class of hydrolytic enzymes that cleave peptide bonds in proteins via a nucleophilic serine residue in their active site. Importantly, sequence analyses indicate no sequence similarities with other fibrinolytic enzymes, suggesting it to be a novel enzyme.

The pH and temperature stability characteristics of the A. oryzae fibrinolytic enzyme are notable from a supplement bioavailability standpoint: its maximum fibrinolytic activity was observed at pH 6 and 50°C, and the purified protease was stable between pH 4 and 9, at temperatures of up to 50°C. This relative pH stability across a wide range is relevant to the question of whether the enzyme can survive the gastrointestinal environment prior to absorption.

3.2 Enzyme Activity Measurement

The activity of Serrazimes is standardized and measured in Serratiopeptidase Units (SPU), using the same unit of measurement as serrapeptase, reflecting its functional equivalence claim. Serratiopeptidase 10 mg is equal to 20,000 units of enzyme activity. This equivalence allows direct label comparison between fungal-derived Serrazimes products and traditional serrapeptase products.

3.3 Mechanisms of Action

Serrazimes is understood to operate via the same primary mechanisms attributed to serratiopeptidase, translated through the functional activity of its constituent fungal proteases. These mechanisms include:

  • Proteolysis: These enzymes exhibit fibrinolytic and proteolytic activity, meaning they help break down proteins, fibrin (a clotting factor), and metabolic debris that may contribute to inflammation and tissue congestion.
  • Fibrinolysis: Serrazimes have the same thrombolytic and fibrinolytic activities as the popular enzyme products nattokinase and serrapeptase; therefore, they can be used as functional alternatives for these applications. Fibrinolysis is the enzymatic dissolution of fibrin-based blood clots and tissue matrices.
  • Protein Metabolism Support: This exclusive proteolytic enzyme system is designed as an enzymatic alternative to serratiopeptidase and may be used for protein digestion or as a systemic protease to support immune, cardiovascular, or musculoskeletal health. Serrazimes® proteases support healthy protein metabolism, both digestively and systemically.
  • Anti-inflammatory Protein Degradation: The reference parent molecule, serratiopeptidase, is documented to work by breaking down pro-inflammatory proteins. Serratiopeptidase has been shown to decrease levels of IL-6 and TNF-α and promote fibrinolysis, aiding in edema reduction — mechanisms which the fungal proteases in Serrazimes are proposed to replicate.
  • Mucolytic Activity (by analogy): The parent enzyme serratiopeptidase is established as a mucolytic (mucus-thinning) agent. Because serrapeptase's main function is to break down proteins, it is useful for decreasing inflammation and clearing mucus in numerous ways. This mucolytic mechanism is one rationale for application in respiratory conditions.

A critical mechanistic question for any orally administered enzyme is intestinal absorption into the systemic circulation. Research confirms that orally administered serrapeptase is absorbed into the circulation in its enzymatically active form. By functional analogy, the fungal proteases in Serrazimes are assumed to follow similar absorption kinetics, though this has not been independently validated for the Serrazimes formulation in published human pharmacokinetic studies.

4. Scientific Evidence by Area of Use

Critical framing note: Serrazimes as a whole has yet to be examined in human clinical trials. However, the protease enzymes from Aspergillus oryzae and related fungi that are used in Serrazimes have shown anti-inflammatory, cardiovascular, respiratory, and immune activity in various research contexts. The clinical evidence base for Serrazimes thus rests on: (1) in vitro and biochemical characterization of its constituent enzymes; (2) clinical studies on the comparator and functional model, serratiopeptidase; and (3) general research on fungal protease classes. Each area is characterized below with explicit attention to evidence strength.

4.1 Inflammation and Post-Operative Edema

Evidence strength: Moderate (for serrapeptase comparator); Indirect/Preliminary (for Serrazimes specifically).

Various published studies have reflected the use of serratiopeptidase for its anti-inflammatory, anti-edemic, and analgesic effects. A systematic review published in the International Journal of Surgery (2013) by Bhagat et al. examined the broader evidence base. A PubMed search using keywords "Serratiopeptidase" or "Serrapeptase" revealed 74 results, which showed 16 clinical trials, out of which 9 were RCTs related to efficacy of serratiopeptidase. A total of 14 RCTs were included in the review.

However, the review assessed evidence quality critically: The evidence supporting the use of serratiopeptidase as anti-inflammatory and analgesic agent is based on clinical studies which are of poor methodology. Only few RCTs, which are usually placebo-controlled, with a small sample size are there. The dose and duration of treatment was not specified in some studies, and the outcome of the study was not uniformly defined. An independent evidence assessment published in the online journal Bandolier stated that after searching PubMed and the Cochrane Library "to see if there are any randomised, controlled trials", evidence on serratiopeptidase being effective for anything is "not based on a firm foundation of clinical trials."

Within the trials that do exist, positive signals for post-operative swelling have been reported. One randomized controlled trial in 133 patients (mean age 23 years) examined serratiopeptidase plus paracetamol versus placebo plus paracetamol following impacted third molar surgery. This randomized clinical trial investigated the efficacy of serratiopeptidase and paracetamol after surgical removal of impacted third molar for 5 days (n=67) as compared with an equivalent dose of placebo and paracetamol (n=66). Outcome measures were reported pain, trismus, and swelling using the Laskin method. All outcome measures were recorded on days 0, 1, 2, 4, and 5 post-surgery. 133 patients completed the study.

A 2024 prospective comparative study examined ankle sprain management. Both groups (serrapeptase and comparator) exhibited reduced edema and pain over time. Serrapeptase demonstrated a superior reduction in ankle joint edema on the third and tenth day compared to paracetamol, while pain management did not differ significantly. The study's conclusion noted that serrapeptase's demonstrated superiority in reducing ankle joint edema compared to paracetamol suggests its viability as an alternative or complementary treatment.

A multi-centre double-blind, placebo-controlled trial is documented in the comparator literature: A multi-centre, double-blind, placebo-controlled trial was carried out to investigate the clinical efficacy of serratiopeptidase in 174 patients who underwent Caldwell-Luc antrotomy for chronic empyema. Changes in swelling at the puncture sites after the procedure were observed. The degree of swelling in the serratiopeptidase-treated patients was significantly less than that in the placebo-treated patients at every point of observation. No side-effects were reported.

Regarding the direct fibrinolytic activity comparison, Serrazimes has been demonstrated to have the same proteolytic activity (potency) as serrapeptase, but also has the advantage of stronger anti-inflammatory effects — though this claim is made by the manufacturer and has not been confirmed in independently published head-to-head human clinical trials.

4.2 Digestive Support and Protein Digestion

Evidence strength: Patent-supported; No published independent human clinical trials identified.

US patent 7067124 describes the use of Serrazimes for alleviating digestive disorders. In this context, it is used as a digestive enzyme meant to enhance the digestion of dietary proteins in the gastrointestinal tract, and is typically mixed together with lipase (a fat-breaking enzyme) and antacid. The resulting preparation can alleviate heartburn, indigestion, and disorders characterized by poor protein digestion.

It works in the digestive system to support protein digestion, and works systemically to support healthy joints, muscles, circulation, heart, and immunity. No independent peer-reviewed human clinical trials specifically on Serrazimes for digestive endpoints were identified in the available literature.

4.3 Cardiovascular and Fibrinolytic Support

Evidence strength: In vitro / biochemical (for Serrazimes-specific enzymes); Weak-to-moderate human evidence for comparator enzymes.

An enzyme from Aspergillus oryzae KSK-3 showed fibrinolytic activity in liquefied rice culture. Research published in peer-reviewed mycology and biochemistry journals has characterized the fibrinolytic serine protease from A. oryzae, and these results suggest the enzyme is capable of degrading fibrin substrates in vitro. This fibrinolytic enzyme may be developed as a safe potential candidate for oral administration as a functional food additive or as a drug for prevention and/or treatment of thrombolytic diseases. This conclusion reflects in vitro and preclinical data, not confirmed human trial outcomes.

The manufacturer positions Serrazimes for cardiovascular use: Serrazimes® is recommended for joint health, and Nattozimes® for cardiovascular health, suggesting a somewhat specialized cardiovascular role relative to other enzyme products in the same portfolio. The system is designed as an enzymatic alternative to serratiopeptidase and may be used for protein digestion or as a systemic protease to support immune, cardiovascular, or musculoskeletal health.

Some anecdotal studies on the parent compound also suggest possible anti-atherosclerotic effects: some anecdotal studies suggest serratiopeptidase to possess anti-atherosclerotic effects also.

4.4 Musculoskeletal and Joint Health

Evidence strength: Preliminary / Indirect (for Serrazimes); Weak human evidence for comparator serrapeptase.

Serrazimes is specifically highlighted for musculoskeletal applications by its manufacturer. From sports nutrition to muscle support and joint health, ADM offers support with Serrazimes®. The mechanistic rationale is that proteolytic degradation of inflammatory mediators and fibrin deposits in joint tissue may reduce pain and improve mobility.

Serrazimes is mostly used as a standalone anti-inflammatory ingredient that can be utilized in joint problems such as arthritis, which are characterized by persistent inflammation that not only leads to pain but also reduced joint function. As such, Serrazimes' anti-inflammatory activity can help improve joint health. These statements reflect manufacturer claims and indirect extrapolation, not Serrazimes-specific clinical trial data.

4.5 Respiratory / Mucolytic Applications

Evidence strength: Weak human evidence for comparator serrapeptase; No Serrazimes-specific respiratory trials identified.

The comparator compound serratiopeptidase has been examined in respiratory conditions. After 4 weeks of serrapeptase treatment in a Japanese research trial involving patients with chronic airway diseases, sputum output, viscosity, and sputum neutrophil count decreased significantly. No studies were found to have been conducted on the efficacy of serratiopeptidase as treatment for asthma specifically, however. By analogy, Serrazimes is sometimes promoted for respiratory mucolytic support, but no independent clinical data on this application for Serrazimes itself are available in the published literature.

4.6 Immune Function

Evidence strength: Preliminary / Mechanistic.

Serrazimes® is stated by the manufacturer to provide nutritional systemic support for a healthy immune system. The mechanistic basis would rest on the ability of systemic proteolytic enzymes to degrade immune complexes, modulate cytokine levels, and reduce chronic low-grade inflammation. The protease enzymes from Aspergillus oryzae and related fungi used in Serrazimes have shown anti-inflammatory, cardiovascular, respiratory, and immune benefits in research studies. The nature and quality of these "research studies" varies, and specific peer-reviewed clinical trials on Serrazimes for immune endpoints were not identified in the available literature.

5. Body Systems and Health Areas Associated with Serrazimes

Based on manufacturer documentation, product database listings, and the comparator enzyme literature, Serrazimes is associated with the following body systems and health domains:

  • Musculoskeletal System: Joints, muscles, connective tissue; inflammation, post-exercise recovery, arthritis-related conditions.
  • Cardiovascular System: Circulatory support, fibrin clearance, cardiovascular protein metabolism.
  • Digestive System: Protein digestion enhancement, relief of indigestion and protein maldigestion disorders.
  • Respiratory System: Mucolytic activity; potential support in chronic airway secretion disorders.
  • Immune System: Modulation of immune protein complexes and inflammatory mediators.

It works in the digestive system to support protein digestion, and works systemically to support healthy joints, muscles, circulation, heart, and immunity.

6. Dosage Forms and Reported Dosages

Serrazimes is commercially available primarily as an oral dietary supplement ingredient, encapsulated in vegetarian or hypromellose capsules. The following dosage information derives from commercial product labeling and ingredient database documentation:

  • Serrazimes supplements typically come in 33 mg capsules with a potency of 20,000 units of activity.
  • A double-strength formulation delivers 40,000 serratiopeptidase units per capsule.
  • One product label recommends taking 1 capsule 1 to 2 times daily between meals, and specifically states to take it on an empty stomach.
  • Another product's suggested use: take one veggie capsule per day with water on an empty stomach at least two hours before or after a meal.
  • There is no established recommended dosage due to a lack of clinical research on Serrazimes specifically.

For the comparator compound serrapeptase, established clinical dosing from published trials provides context: serratiopeptidase (SRP) is given at a dose of 5–10 mg three times a day in enteric-coated tablet formulations, corresponding to the equivalence of approximately 10,000–20,000 SPU per dose. Serratiopeptidase 10 mg is equal to 20,000 units of enzyme activity.

The rationale for taking Serrazimes on an empty stomach is consistent with the broader enzyme supplement literature: if enzymes are taken alongside food, the body will simply use them as digestive aids to break down the dietary protein in the meal. However, when taken on an empty stomach, the enzymes bypass the digestive process and are absorbed directly into the bloodstream through the intestinal wall.

7. Safety Considerations and Drug Interactions

7.1 Safety Profile of the Fungal Sources

The long history of safe use of A. oryzae by the food fermentation industry and the lack of aflatoxin production has earned it GRAS status from the FDA. However, some nuance is warranted: although no strains of A. oryzae have been found to produce aflatoxins, some strains of A. oryzae can produce mycotoxins such as CPA (cyclopiazonic acid), a neurotoxin, and 3-nitropropionic acid. To address this, the Joint FAO/WHO Expert Committee on Food Additives requires that food enzymes derived from fungal sources do not contain detectable amounts of aflatoxin B1, ochratoxin, sterigmatocystin, T-2 toxin, or zearalenone.

7.2 Known Adverse Effects (Derived from Comparator Serrapeptase Literature)

Because no independent safety database exists for Serrazimes specifically, the adverse event profile of the functional comparator, serratiopeptidase, is highly relevant. Serrapeptase was well tolerated in short-term clinical trials enrolling more than 1,400 patients, with an incidence of adverse effects similar to that with placebo.

However, rare but serious adverse events have been documented in case report literature, primarily from Japan where serrapeptase has been used clinically for decades:

  • Eosinophilic Pneumonitis (Lung Inflammation): Rare, serious adverse effects reported with serrapeptase include eosinophilic pneumonitis. This represents a very rare case of serrapeptase-induced eosinophilic pneumonia documented in the peer-reviewed literature. Eosinophilic pneumonitis is a rare but serious adverse effect that has been documented in a number of case reports, primarily in Japan. It is a type of allergic or hypersensitivity reaction in the lungs, where a specific type of white blood cell (eosinophil) accumulates in the lung tissue.
  • Serious Skin Reactions: Rare, serious adverse effects reported with serrapeptase also include bullous pemphigoid and possibly Stevens-Johnson syndrome.
  • Common Mild Side Effects: A systematic review on serrapeptase noted that there are limited adverse drug reactions reported, but they tend to be related to skin conditions (such as erythema or dermatosis) and both muscle and joint pain; there appear to be some reported coagulation problems.
  • Gastrointestinal Effects: There may also be certain gastric-related issues like nausea, anorexia, and stomach upset.
  • Long-Term Safety: While serrapeptase has been used for up to four weeks in clinical research, little is known about its long-term safety. Serrapeptase was well tolerated in short-term clinical trials, but long-term safety has not been evaluated.

7.3 Drug Interactions

There are no clinical studies reporting any drug interactions; the only available information is from drug company monographs. If administered along with warfarin, clopidogrel, or aspirin, as well as with other natural remedies such as garlic, fish oil, and turmeric, there may be an increased risk of bleeding or bruising.

The primary pharmacological concern with fibrinolytic and proteolytic enzymes of this class is additive anticoagulant or antiplatelet effect: serrapeptase may increase the risk of bleeding if coadministered with anticoagulants or antiplatelet drugs. This interaction risk is extrapolated to Serrazimes by functional analogy given its documented fibrinolytic activity.

An interaction with antibiotics has also been hypothesized: serratiopeptidase is also administered in conjunction with other antimicrobials, such as cephalexin, cefotiam, and sulbenicillin, to enhance their tissue penetration through its proteolytic properties. This may represent a beneficial pharmacokinetic interaction in clinical contexts but should be noted when considering polymedication.

7.4 Populations Requiring Special Consideration

Serrazimes-containing products are labeled "for adults only," are not recommended for pregnant or nursing women, and label guidance advises consultation with a physician when taking medications (especially blood-thinning medications) or when a medical condition is present.

The GRAS status of A. oryzae as a production organism provides a baseline safety context. A. oryzae has consistently been concluded safe as a production organism in food manufacturing, with no evidence of pathogenic or toxigenic concerns at commercially regulated purity standards. However, this GRAS status applies to the organism as a production source and does not automatically extend to isolated, concentrated enzyme preparations taken as systemic supplements.

8. Regulatory and Intellectual Property Status

Serrazimes is patented for alleviating inflammatory conditions and protein digestion disorders. The core US patent (7,067,124) was granted to National Enzyme Company in 2006. This patent describes the use of Serrazimes for alleviating digestive disorders.

As a dietary supplement ingredient sold in the United States, Serrazimes is regulated under the Dietary Supplement Health and Education Act (DSHEA) framework administered by the FDA. It has not received FDA approval as a drug and is not recognized as a pharmaceutical agent in the United States. The ingredient is not listed in the European Pharmacopoeia, WHO monographs, Commission E, or ESCOP monographs as an established therapeutic agent in its own right.

The comparator enzyme serrapeptase is available as a prescription or over-the-counter pharmaceutical in some countries (notably India and Japan) under trade names such as Danzen, but is sold only as a dietary supplement in the United States and other jurisdictions.

9. Summary of Evidence Strength

  • Proteolytic and fibrinolytic activity in vitro: Well-documented for the constituent Aspergillus enzymes in biochemical and cell-culture models.
  • Human clinical trial evidence for Serrazimes specifically: Serrazimes as a whole has yet to be examined in human clinical trials.
  • Human clinical evidence for serrapeptase (the functional comparator): Of the 10 medical conditions with randomized-evidence studies on file in connection with serratiopeptidase, the quality or construction of the trial studies was described as "generally poor." Some alternative medicine proponents claim that serrapeptase is beneficial for pain and inflammation but "existing trials have been small and generally of poor methodological quality."
  • Safety (short-term): Generally favorable safety profile in trials of the comparator; rare but documented serious adverse events (eosinophilic pneumonitis, severe skin reactions) documented in case reports.
  • Safety (long-term): Insufficiently studied for either Serrazimes or its comparator.

References

Health Conditions

Health conditions that Serrazimes may help support.

  • No conditions available.

Body Systems

Body systems that Serrazimes may help support.

  • No body systems available.
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Serrazimes | Caring Sunshine