Nattokinase

Single-ingredient nattokinase reference formula with 100 mg per serving, developed as a capsule, with a softgel option.

Nattokinase is a reference formula for brands building a single-ingredient enzyme product at a default amount of 100 mg of nattokinase per serving. Nattokinase is the only active, so the development work centers on the enzyme activity of the raw material, keeping an enzyme stable in a capsule or oil, and the label unit, which is mg on the reference labels while suppliers and studies often state fibrinolytic units.

Capsule is the lead format because the reference labels are mostly capsules, with the 100 mg serving given as two capsules of 50 mg, and a softgel version for brands that prefer an oil-based unit. The reference labels range from 36.7 mg to 800 mg per serving, so the amount is a brand decision set around the default.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
Nattokinase100 mg (default amount)Nattokinase enzyme powder; specification 100 mg per serving with enzyme activity in fibrinolytic units per gram stated by the supplierA higher-activity grade, which needs a smaller mass for the same activity

Amounts are stated as mg of nattokinase powder, the unit used on the reference labels. Enzyme activity is expressed in fibrinolytic units, which are not converted to mg on this page, because the activity per mg differs by grade and the conversion comes from the supplier’s certificate.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around circulatory wellness nutrition. Nattokinase is included as the single active so that the activity, the amount and the excipient system can be set without interaction with other actives.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Blood pressure nutritionNattokinaseA systematic review and meta-analysis of 6 randomized trials with 546 participants reported that nattokinase significantly reduced systolic blood pressure (mean difference −3.45), and that a relatively low total dose had no significant lipid-lowering effect [1]. Evidence: Referenced
Long-term vascular researchNattokinaseIn a double-blind trial of 265 adults followed for a median of 3 years, nattokinase at 2,000 fibrinolytic units per day did not significantly change the rate of subclinical atherosclerosis progression compared with placebo [2]. Evidence: Contested

The amounts in [1] and [2] were set by each study and [2] is expressed in fibrinolytic units, so amount, claims and target market for a finished product are brand decisions reviewed for each sales market.

Available Formats

The nattokinase reference formula is built for a capsule version and a softgel version; counts per serving are design choices that the brand can adjust.

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Capsule2 capsules100 mg (50 mg per capsule)60 or 120 capsulesCapsule shell (vegetable), cellulose filler, flow agentLead format; dry enzyme powder in a standard fill
Softgel2 softgels100 mg (50 mg per softgel)60 or 120 softgelsVegetable oil, suspending agent, gelatin or plant-based shell, glycerinOil suspension; the enzyme stays dry in an oil base

Raw Material Input & Fill (Design Estimate)

Design estimates. The input is the labeled nattokinase weight at an assumed 100% of the powder as purchased, so each unit uses the weight shown below; the real input follows the certificate of analysis and its activity.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Capsule50 mg nattokinase powder300 mg per capsule250 mgBlend uniformity, fill weight variation, enzyme activity
Softgel50 mg nattokinase powder450 mg fill per softgel400 mg oil and suspending agentSuspension stability, shell compatibility, enzyme activity

Tablet and powder versions are separate projects, because compression and moisture exposure reduce enzyme activity and need their own stability work.

Formulation Considerations

Activity, not weight. Two nattokinase powders of the same weight can differ in activity. The specification names the activity in fibrinolytic units, the assay method and the retained activity at the end of shelf life.
Moisture and heat. Enzymes lose activity with moisture, heat and some excipients. Low-moisture excipients, a moisture-barrier pack and limits on process temperature are set early, and activity is tested on the finished unit.
Small active in a larger fill. At 50 mg in a fill of about 300 mg, the powder is blended in steps and checked for uniformity so that every capsule carries the same activity.
Evidence and tier. The review in [1] covers different total doses, and the trial in [2] used a defined activity over three years. The dose limit, label wording and any interaction statement for each sales market are reviewed before a product is developed.

Customization Options

Brands adjust the nattokinase amount, the activity grade, the format and the add-ons.

ParameterRangeNote
Nattokinase per serving50, 100, 200 or 800 mgExamples for the brand; the capsule count changes with the amount
Activity gradeSupplier grades in fibrinolytic unitsChanges the input weight for the same activity
FormatCapsule or softgelTablet and powder are separate projects
Pack size60 to 120 unitsSet by the brand
Add-onsRed yeast rice, coenzyme Q10Each add-on raises the fill weight and may call for a larger capsule

The pilot run confirms blend uniformity of the enzyme powder, suspension stability in the softgel version, and the enzyme activity of the first units against the specification.

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (100 mg on the label of CF008690; example DSLD labels 66384, 66421, 216291). The label names the ingredient as nattokinase in mg; the enzyme activity unit is set with the supplier.
SpecificationSet in formulationNattokinase powder, 100 mg per serving; enzyme activity in fibrinolytic units, moisture, heavy-metal limits and method are fixed with the supplier. Unit size, fill weight and stability are set in formulation.
Data sourceNIH DSLDDSLD v9.4.0, downloaded 2026-01-10: 50,824 reference formulas merged from on-market labels with complete ingredient amounts. Counts show how labels are distributed.
Market reviewPer marketDose limits, labeling and claims are reviewed for each sales market before a finished product is developed.
ReferencesSources[1] Li X, Long J, Gao Q, Pan M, Wang J, Yang F, Zhang Y. Nattokinase supplementation and cardiovascular risk factors: a systematic review and meta-analysis of randomized controlled trials. Rev Cardiovasc Med. 2023;24(8):234. DOI · PubMed<br>[2] Hodis HN, Mack WJ, Meiselman HJ, et al. Nattokinase atherothrombotic prevention study: a randomized controlled trial. Clin Hemorheol Microcirc. 2021;78(4):339-353. DOI · PubMed

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