This page shows what was measured, who it was measured in, and what that does not settle.
What Hyaluronidase (HUMAN RECOMBINANT) does in the body
1.
From the FDA-approved label: Hyaluronidase is a dispersion agent, which modifies the permeability of connective tissue through the hydrolysis of hyaluronic acid, a polysaccharide found in the intercellular ground substance of connective tissue, and of certain specialized tissues, such as the umbilical cord and vitreous humor. Hyaluronic acid is also present in the capsules of type A and C hemolytic streptococci. Hyaluronidase hydrolyzes hyaluronic acid by splitting the glucosaminidic bond between C 1 of an N-acetylglucosamine moiety and C 4 of a glucuronic acid moiety.
Why people take it. Indications and Usage HYLENEX recombinant is an endoglycosidase indicated as an adjuvant in subcutaneous fluid administration for achieving hydration ( 1.1 ) to increase the dispersion and absorption of other injected drugs ( 1.2 ) in subcutaneous urography for improving resorption of radiopaque agents ( 1.3 ) 1.1.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The supplement label database classes it as enzyme, under the name Hyaluronidase.
The use the label states, quoted from it. No plain-language version of this sentence has been written.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 143 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Recurrence-free survival (RFS)
✗ The study did not show it
Who was studied
NCT06876714
How many people
1524
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
NIH Dietary Supplement Label Database · a recorded source, not a stored snapshot
Consolidation overall survival
✗ The study did not show it
Who was studied
NCT04566328
How many people
1450
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
NIH Dietary Supplement Label Database · a recorded source, not a stored snapshot
Ongoing pregnancy resulting in live birth after the first embryo transfer of the started treatment cycle.
✗ The study did not show it
Who was studied
NCT03428919
How many people
1064
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
NIH Dietary Supplement Label Database · a recorded source, not a stored snapshot
Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1
✗ The study did not show it
Who was studied
NCT05296798
How many people
922
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
NIH Dietary Supplement Label Database · a recorded source, not a stored snapshot
Time to sustained disability progression
✗ The study did not show it
Who was studied
NCT03500328
How many people
900
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
NIH Dietary Supplement Label Database · a recorded source, not a stored snapshot
Part 1 Safety Lead-In: Incidence of dose limiting toxicities
✗ The study did not show it
Who was studied
NCT05020236
How many people
893
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
NIH Dietary Supplement Label Database · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Amphadase ® is an endoglycosidase indicated as an adjuvant: • in subcutaneous fluid administration for achieving hydration ( 1.1 ) • to increase absorption and dispersion of other injected drugs ( 1.2 ) • in subcutaneous urography for improving resorption of radiopaque agents ( 1.3 ) 1.1 Subcutaneous Fluid Administration Amphadase ® is indicated as an adjuvant in subcutaneous fluid administration for achieving…
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “Pediatric Use Clinical hydration requirements for children can be achieved through administration of subcutaneous fluids facilitated with HYLENEX recombinant.”
US prescribing information · 3023cc56-ed4b-4e87-b3a1-81b20943f658 · read 2026-08-30
On older people, the label states: “Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.”
US prescribing information · 3023cc56-ed4b-4e87-b3a1-81b20943f658 · read 2026-08-30
On people who are pregnant, the label states: “Pregnancy Risk Summary There are no adequate and well-controlled studies of HYLENEX recombinant administration in pregnant women to inform a drug-associated risk.”
US prescribing information · 3023cc56-ed4b-4e87-b3a1-81b20943f658 · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Injection
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Sold as injectable, solution, injection, solution, liquid, given by the injection, subcutaneous, oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Injection
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
27 products list this as an active ingredient in the United States drug directory. 5 of them contain it and nothing else.
FDA National Drug Code directory · 18657-117 · read 2026-08-29
They are sold as injection, injection, solution, liquid, powder and solution/ drops, taken oral and subcutaneous.
FDA National Drug Code directory · 18657-117 · read 2026-08-29
The regulator's established pharmacologic class for it is endoglycosidase [epc] and glycoside hydrolases [cs].
FDA National Drug Code directory · 18657-117 · read 2026-08-29
18 published labels name it as an active ingredient. 3 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 27dd5e6b-72cd-458d-a015-cf4dab5800da · read 2026-08-29
Those labels are classed as human otc drug and human prescription drug.
US prescribing information · 27dd5e6b-72cd-458d-a015-cf4dab5800da · read 2026-08-29
1 marketed supplement label lists this ingredient, classed as other combinations and enzyme.
Those labels carry all other and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.
This order is fixed in code and does not count clicks or time on the page.
What is not here
9 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (8)
Q1
On the Hyaluronidase (HUMAN RECOMBINANT) label: indicated for what?
"1. Indications and Usage HYLENEX recombinant is an endoglycosidase indicated as an adjuvant in subcutaneous fluid administration for achieving hydration ( 1.1 ) to increase the dispersion and absorption of other injected drugs ( 1.2 ) in subcutaneous urography for improving resorption of radiopaque agents ( 1.3 ) 1.1.": indications and usage on Hyaluronidase (HUMAN RECOMBINANT)'s label. DailyMed label · 3023cc56-ed4b-4e87-b3a1-81b20943f658 · 2024-11-11
Q2
35 registered trials of Hyaluronidase (HUMAN RECOMBINANT) — at which phases?
"Study closed prior to opening to enrollment, due to funding availability for study"; 2 of 35 registered studies
Show the evidence
Trial
NCT04373603
withdrawn; "Study closed prior to opening to enrollment, due to funding availability for study"
NCT05498220
terminated; "Funding"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Hyaluronidase (HUMAN RECOMBINANT) used Hyaluronidase and Lidocaine 1% mixture — over how long?
Human studies of Hyaluronidase (HUMAN RECOMBINANT) used "Hyaluronidase and Lidocaine 1% mixture". ClinicalTrials.gov · 2026-09-01
Show the evidence
humanNCT07000058
Hyaluronidase and Lidocaine 1% mixture
recorded 2026-09-01 · last checked 2026-09-04
Q5
Which 19 trials of Hyaluronidase (HUMAN RECOMBINANT) posted no result?
Posted no result
19 of 19 completed trials
Registrations
NCT00000493, NCT00198510, NCT00198497, NCT00198419, NCT00198458 and NCT00198484, and 13 more
Completion dates
oldest 1985-12; newest 2024-08-10
Show the evidence
Trial
NCT00000493
1985-12
NCT00198510
2003-03
NCT00198497
2003-06
NCT00198419
2004-03
NCT00198458
2004-09
NCT00198484
2005-02
13 further recorded trials
NCT00198471
2006-11
NCT01719978
2011-12
NCT02654522
2016-02
NCT01945099
2016-07
NCT02265575
2016-12
NCT03411330
2018-04-24
NCT03675295
2018-07-01
NCT04347733
2019-07-16
NCT01722916
2022-02-22
NCT05280223
2023-08-25
NCT05671172
2024-02-10
NCT06501352
2024-03-30
NCT06604546
2024-08-10
Q6
At the median, Hyaluronidase (HUMAN RECOMBINANT)'s trials enrolled 53.5 people — anything larger?
Median enrolment
53.5
Largest enrolment
750
Registered trials counted
34
Q7
What do 134 spontaneous reports say about Hyaluronidase (HUMAN RECOMBINANT) — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Hyaluronidase (HUMAN RECOMBINANT) appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 134 reaction mentions were counted: lagophthalmos 19; parophthalmia 17; conjunctival oedema 15; visual acuity reduced 15. FAERS via Open Targets · CHEMBL1201636 · 2026-06-24
Show the evidence
lagophthalmos
19
parophthalmia
17
conjunctival oedema
15
visual acuity reduced
15
drug hypersensitivity
13
exophthalmos
13
4 more recorded rows
strabismus
12
diplopia
10
muscular weakness
10
myopathy toxic
10
recorded 2026-06-24 · last checked 2026-09-04
Q8
Which 10 reactions does Hyaluronidase (HUMAN RECOMBINANT)'s label not list?
ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.