CLINICAL TRIALS PROFILE FOR HYLENEX RECOMBINANT

All Clinical Trials for HYLENEX RECOMBINANT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00311519 ↗	A Phase IIIB Dose Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer Subjects	Completed	Halozyme Therapeutics	Phase 4	2005-11-01	The purpose of this research study to test the effectiveness of a study medication to increase how fast a solution called lactated Ringer's is absorbed when put under the skin subcutaneously. The medication to be studied is an enzyme called hyaluronidase, and is a human recombinant form of the enzyme. The drug company name for this medication is Hylenex. Hylenex was currently an investigational medication at the initiation of the study, but received FDA approval during the study. An investigational medication is a medication or formulation of a medication that is not approved by the United States Food and Drug Administration for use in this country but may be used in studies such as this one.
NCT00435604 ↗	A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase	Completed	Halozyme Therapeutics	Phase 1	2007-02-01	This Phase I, randomized, double-blinded, within-subject controlled, two-way crossover study comparing the time to inject (flow rate), safety, and tolerability of a subcutaneously (SC) administered, viscous antibody solution of with and without human recombinant hyaluronidase (rHuPH20) in volunteer subjects. The study hypothesizes that the time required to complete a 20-mL SC injection of a viscous antibody with rHuPH20 will be comparable or shorter than the time required for the injection without rHuPH20.
NCT00477152 ↗	Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children	Completed	Halozyme Therapeutics	Phase 4	2007-08-01	The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.
NCT00477152 ↗	Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children	Completed	PPD	Phase 4	2007-08-01	The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.
NCT00477152 ↗	Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children	Completed	Baxter Healthcare Corporation	Phase 4	2007-08-01	The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.
NCT00493220 ↗	Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration	Completed	Halozyme Therapeutics	Phase 1	2007-06-01	The objectives of this study are: - to establish the safety of subcutaneous administration of ceftriaxone at different concentrations, with and without HYLENEX recombinant, and to determine the maximum tolerated concentration; - and to establish the pharmacokinetic comparability of subcutaneous administration of ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX recombinant and to IV administration.
NCT00493220 ↗	Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration	Completed	Baxter Healthcare Corporation	Phase 1	2007-06-01	The objectives of this study are: - to establish the safety of subcutaneous administration of ceftriaxone at different concentrations, with and without HYLENEX recombinant, and to determine the maximum tolerated concentration; - and to establish the pharmacokinetic comparability of subcutaneous administration of ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX recombinant and to IV administration.

Clinical Trial Conditions for HYLENEX RECOMBINANT

Condition Name

Condition Name for HYLENEX RECOMBINANT
Intervention	Trials
Dehydration	8
Type 1 Diabetes Mellitus	6
Healthy	6
Diabetes Mellitus	2

Condition MeSH

Condition MeSH for HYLENEX RECOMBINANT
Intervention	Trials
Diabetes Mellitus	12
Diabetes Mellitus, Type 1	8
Dehydration	8
Diabetes Mellitus, Type 2	2

Clinical Trial Locations for HYLENEX RECOMBINANT

Trials by Country

Trials by Country for HYLENEX RECOMBINANT
Location	Trials
United States	93
China	1
Kenya	1

Trials by US State

Trials by US State for HYLENEX RECOMBINANT
Location	Trials
California	14
Texas	7
Michigan	6
Florida	6
Maryland	4

Clinical Trial Progress for HYLENEX RECOMBINANT

Clinical Trial Phase

Clinical Trial Phase for HYLENEX RECOMBINANT
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	1
Phase 2	8

Clinical Trial Status

Clinical Trial Status for HYLENEX RECOMBINANT
Clinical Trial Phase	Trials
Completed	29
Recruiting	1
Terminated	1

Clinical Trial Sponsors for HYLENEX RECOMBINANT

Sponsor Name

Sponsor Name for HYLENEX RECOMBINANT
Sponsor	Trials
Halozyme Therapeutics	23
Baxter Healthcare Corporation	10
Massachusetts General Hospital	2

Sponsor Type

Sponsor Type for HYLENEX RECOMBINANT
Sponsor	Trials
Industry	37
Other	14
NIH	1

HYLENEX (Hyaluronidase recombinant) — Clinical Trials Update, Market Analysis, and Projection

Last updated: April 27, 2026

What is HYLENEX RECOMBINANT and what is its market position?

HYLENEX is a branded hyaluronidase product. Clinical and commercial use for hyaluronidase centers on improving dispersion and absorption of co-administered injectable drugs and reducing local resistance to spread in tissue. HYLENEX RECOMBINANT is positioned as a recombinant hyaluronidase option within the hyaluronidase category, competing against both branded and generic hyaluronidase offerings depending on jurisdiction and payer formularies.

Where the category sits (functional class):

• Enzyme biologic: hyaluronidase
• Primary commercial role: dispersion/adjunct to injectable administration rather than primary disease-modifying therapy

What do the latest clinical trials indicate about HYLENEX RECOMBINANT?

No complete, trial-level, publicly verifiable update (study titles, NCT numbers, phase, design, endpoints, and readouts) can be produced from the information available in this workspace. A compliant clinical-trials update requires exact trial identifiers and outcomes; otherwise it risks reporting incorrect study status or endpoints.

Which regulatory and label mechanics drive utilization in practice?

For HYLENEX-type hyaluronidase products, prescribing and reimbursement patterns tend to track:

• Indications where hyaluronidase is used as an adjunct
• Administration workflows that integrate hyaluronidase with the co-administered injectable (timing, volume, site)
• Hospital and oncology infusion protocol adoption (where applicable)

Commercial uptake in this drug class is typically constrained by:

• Formularies and substitution rules for recombinant versus non-recombinant hyaluronidase
• Procurement cycles and tendering at hospital group level
• Evidence of comparable clinical outcomes in adjunct use (dispersion efficacy and tolerability)

What is the market structure for hyaluronidase products?

Hyaluronidase remains a niche adjunct category within hospital injectable ecosystems. The competitive set generally includes:

• Branded hyaluronidase (historically older, well-established brands)
• Generic hyaluronidase solutions (cost-driven substitution)
• Recombinant hyaluronidase where available (positioned on manufacturing consistency and supply reliability)

Key demand drivers:

• Use frequency tied to the volume of co-administered injectable regimens
• Institutional protocols and supply contracts
• Safety and tolerability outcomes impacting repeat use

Key value drivers:

• Acquisition cost per administered session (not annual treatment course)
• Dosing convenience and co-administration compatibility
• Evidence package supporting equivalence within adjunct contexts

How should investors and R&D teams project HYLENEX RECOMBINANT revenue growth?

HYLENEX RECOMBINANT projection should be modeled as a procedure-linked adjunct product with revenue driven by: 1) Patient or session volume in settings using hyaluronidase as adjunct 2) Share of recombinant vs non-recombinant hyaluronidase in the same protocols 3) Net pricing after rebates, tender discounts, and payer contracting 4) Geographic uptake where label permissions and procurement practices align

Because no complete trial readouts are available here, projection must use market mechanics rather than assume efficacy expansion. The most defensible scenario approach is share and contracting-based:

Revenue projection framework (scenario method)

Set baseline as current institutional uptake in target markets and then model incremental share under three levers:

• Share gain scenarios (recombinant adoption)

  • Base case: marginal share improvement from procurement preference shifts
  • Upside: protocol-level adoption from evidence consolidation or supply advantages
  • Downside: payer and tender substitution toward lower-cost alternatives

• Pricing scenarios (net price)

  • Base case: contracting reduces list price and increases rebates over time
  • Upside: recombinant premium holds in tenders
  • Downside: price compression under generic substitution pressure

• Volume scenarios

  • Base case: stable session volume with modest growth aligned to infusion activity
  • Upside: additional protocol inclusion increases session counts
  • Downside: utilization shifts away from hyaluronidase adjunct workflows

What are the key commercial risks and leading indicators?

Commercial risks

• Generic substitution: hyaluronidase is exposed to cost-driven switching in hospital tendering
• Protocol lock-in risk: once institutions standardize an adjunct regimen, switching costs slow adoption
• Evidence sufficiency risk: without current, strong comparative data in relevant co-administration contexts, uptake relies on contracting rather than clinical differentiation
• Supply and manufacturing risk: biologic supply stability can determine ability to win multi-site tenders

Leading indicators to track

• Formulary decisions at hospital group level
• Tender outcomes by geography and purchasing organization
• Share of spend within adjunct hyaluronidase contracts
• Changes in utilization rates of co-administered injectable regimens where hyaluronidase is used

What is the projection range for HYLENEX RECOMBINANT?

No credible numeric market sizing, share estimates, or forecast range can be produced here without verifiable source data (e.g., category sales by geography, recombinant penetration, tender pricing, or unit volumes). Generating a numeric forecast without sourced inputs would be non-actionable for high-stakes investment or R&D decisions.

Key Takeaways

• HYLENEX RECOMBINANT is a recombinant hyaluronidase adjunct product; its commercial model is driven by protocol-based co-administration rather than independent disease treatment.
• A complete clinical-trials update requires trial identifiers and readouts; none are provided in the available input set, so no trial status claims are made.
• Market growth should be projected using contracting, recombinant share penetration, and session-linked utilization mechanics.
• The highest-impact variables are generic substitution pressure, hospital tender dynamics, and whether evidence supports incremental protocol inclusion.

FAQs

1. What determines HYLENEX RECOMBINANT utilization in hospitals?
   Hospital protocols that specify hyaluronidase as an adjunct for co-administered injectable administration, plus procurement and formulary contracting.

2. Does HYLENEX RECOMBINANT compete primarily on clinical outcomes or cost?
   In practice, it competes on both, but hospital purchasing is frequently cost- and tender-driven given generic substitution pressure in hyaluronidase.

3. How should projections be structured for an adjunct hyaluronidase product?
   Use a procedure-linked model: session volume times recombinant penetration times net price, with scenario splits for share, price compression, and utilization shifts.

4. What are the biggest barriers to recombinant hyaluronidase adoption?
   Tender switching friction, existing standard-of-care selection, payer formularies, and the ability to demonstrate consistent adjunct performance in the relevant co-administration context.

5. What clinical data would most influence market uptake?
   Comparative evidence tied to the specific adjunct use context (co-administered injectable dispersion/absorption outcomes, tolerability, and workflow feasibility) and results that support protocol inclusion.

---

References

[1] APA: No sources were provided in the prompt that can be cited with trial-level identifiers or market data for HYLENEX RECOMBINANT.