CLINICAL TRIALS PROFILE FOR HYALURONIDASE RECOMBINANT HUMAN

505(b)(2) Clinical Trials for Hyaluronidase Recombinant Human

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01839487 ↗	PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer	Completed	Halozyme Therapeutics	Phase 2	2013-05-14	This study is designed to compare the treatment effect of PEGPH20 combined with nab-paclitaxel (NAB) and gemcitabine (GEM) [PAG] to NAB and GEM [AG] in participants with Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). The study will have 2 run-in phases, one for each formulation of PEGPH20 (original and new formulations), and a Phase 2 portion. The 2 run-in phases will evaluate the safety and tolerability of the PAG treatment using the original and new succinic acid PEGPH20 formulation, respectively, compared with AG treatment. Phase 2 will have 2 stages due to a partial clinical hold that occurred from April through July 2014. The participants will be randomized in 3:1 for the run-in phases. The first stage will randomize participants in a 1:1 ratio. The second stage will randomize participants in a 2:1 ratio (PAG:AG). This is an open-label study. To minimize bias to the progression-free survival endpoint, disease progression will be based on the assessment of the Central Imaging Reader (CIR). Determination of clinical progression by the Investigator without corresponding CIR confirmation will be documented with the relevant signs and symptoms.
New Formulation	NCT05388669 ↗	A Study of Lazertinib and Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer	Not yet recruiting	Janssen Research & Development, LLC	Phase 3	2022-08-05	The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.

All Clinical Trials for Hyaluronidase Recombinant Human

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000493 ↗	Multicenter Investigation of Limitation of Infarct Size (MILIS)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1977-09-01	To assess the ability of two separate therapeutic interventions, propranolol and hyaluronidase, to limit the ultimate size of an acute myocardial infarction. A secondary objective was to assess the influence of these therapies upon ventricular function and morbidity following myocardial infarction.
NCT00198419 ↗	Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)	Completed	Bausch & Lomb Incorporated	Phase 1	2004-03-01	The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to 10% hypersensitivity response was considered acceptable.
NCT00198458 ↗	Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)	Completed	Bausch & Lomb Incorporated	Phase 1	2004-07-01	The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to a 10% hypersensitivity response was considered acceptable.
NCT00198471 ↗	Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment	Completed	Bausch & Lomb Incorporated	Phase 2	2005-07-01	The purpose of this study is to assess the efficacy of intravitreous injections of Vitrase to induce posterior vitreous detachment(PVD) in subjects with moderate to severe non-proliferative diabetic retinopathy.

Clinical Trial Conditions for Hyaluronidase Recombinant Human

Condition Name

Condition Name for Hyaluronidase Recombinant Human
Intervention	Trials
Healthy	6
Type 1 Diabetes Mellitus	6
Multiple Myeloma	5
Dehydration	5

Condition MeSH

Condition MeSH for Hyaluronidase Recombinant Human
Intervention	Trials
Diabetes Mellitus	12
Multiple Myeloma	10
Neoplasms, Plasma Cell	10
Diabetes Mellitus, Type 1	9

Clinical Trial Locations for Hyaluronidase Recombinant Human

Trials by Country

Trials by Country for Hyaluronidase Recombinant Human
Location	Trials
United States	436
United Kingdom	17
Spain	15
France	15
Canada	14

Trials by US State

Trials by US State for Hyaluronidase Recombinant Human
Location	Trials
California	36
New York	22
Texas	20
Washington	19
North Carolina	18

Clinical Trial Progress for Hyaluronidase Recombinant Human

Clinical Trial Phase

Clinical Trial Phase for Hyaluronidase Recombinant Human
Clinical Trial Phase	Trials
Phase 4	16
Phase 3	20
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Hyaluronidase Recombinant Human
Clinical Trial Phase	Trials
Completed	60
Recruiting	26
Not yet recruiting	17

Clinical Trial Sponsors for Hyaluronidase Recombinant Human

Sponsor Name

Sponsor Name for Hyaluronidase Recombinant Human
Sponsor	Trials
Halozyme Therapeutics	36
National Cancer Institute (NCI)	10
Baxter Healthcare Corporation	7

Sponsor Type

Sponsor Type for Hyaluronidase Recombinant Human
Sponsor	Trials
Other	90
Industry	82
NIH	12

Hyaluronidase Recombinant Human: Clinical Trials, Market Analysis, and Projections

Introduction to Hyaluronidase Recombinant Human

Hyaluronidase, particularly the recombinant human form (rHuPH20), has been a subject of significant interest in medical and cosmetic fields due to its unique properties. This enzyme temporarily breaks down hyaluronan, a key component of the extracellular matrix, facilitating the rapid absorption of large volumes or high doses of co-administered therapies.

Clinical Trials Overview

Tolerability and Safety of rHuPH20 in PIDD

One notable clinical trial focused on the tolerability and safety of rHuPH20 when used with Immune Globulin Infusion (Human), 10% (IGI, 10%) in patients with Primary Immunodeficiency Diseases (PIDD). Conducted from December 2011 to January 2013, this study enrolled 54 participants. The trial aimed to assess the safety and tolerability of subcutaneous treatment facilitated by rHuPH20. However, due to safety concerns, participants were transitioned to the licensed product Gammagard Liquid during the safety follow-up period[1].

Dose Determination for Subcutaneous IGIV Infusion

Another clinical trial, conducted from December 2006 to November 2007, aimed to determine the feasibility of infusing a full 4-week dose of Immune Globulin Intravenous (Human), 10% in a single subcutaneous site using rHuPH20. This study involved 11 participants and focused on finding the optimal dose of rHuPH20 that could facilitate this infusion with minimal adverse reactions[4].

Key Findings from Clinical Trials

• Safety and Tolerability: The trials highlighted the importance of monitoring safety and tolerability, especially when introducing new administration routes and enzyme facilitation. The transition to licensed products during safety follow-ups underscores the cautious approach taken to ensure patient safety[1][4].
• Dose Optimization: The study on dose determination showed that rHuPH20 can enable the subcutaneous infusion of large doses of IGIV, but careful dosing is crucial to avoid adverse reactions[4].

Market Analysis

Current Market Size and Growth

The global hyaluronidase market was valued at USD 909.5 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 8.4% from 2023 to 2030. This growth is driven by increasing applications in cosmetic treatments, cancer therapy, and ophthalmic solutions[2].

Regional Dominance

North America, particularly the United States, dominates the hyaluronidase market due to advanced healthcare infrastructure and high demand for aesthetic and medical treatments. The region is expected to maintain its leading position in the global market[2][3].

Segment Analysis

• Recombinant vs. Animal-Derived: The recombinant human hyaluronidase segment is expected to grow significantly, with a CAGR of 9.4% over the forecast period, due to its high consistency and purity. However, the animal-derived segment, primarily from bovine and porcine sources, still holds a substantial market share[2][5].
• Application Areas: Hyaluronidase finds applications in dermatology, chemotherapy, ophthalmology, plastic surgery, and cosmetology. Its role in cancer metastasis and therapy, particularly in noninvasive tumor imaging, is a key growth driver[2][5].

Market Projections

Future Growth

The hyaluronidase market is anticipated to reach USD 1,896.8 million by 2032, growing at a CAGR of 9.3%. Technological advancements, continuous research, and innovations in drug delivery systems are expected to fuel this growth[3].

Power Injection Market

The hyaluronidase power injection market is projected to reach USD 2 billion by 2036, growing at a CAGR of over 9%. This growth is driven by increasing applications and the degradation kinetics of products like TEOSYAL RHA accumulation[5].

Emerging Trends and Innovations

Technological Advancements

Advancements in drug delivery systems and the development of recombinant hyaluronidase are enhancing treatment effectiveness and reducing allergic reactions. Innovations such as maintained network technology (PNT) are being implemented to improve product performance[5].

Clinical Applications

Hyaluronidase is increasingly being used in various clinical applications, including:

• Cosmetic Treatments: Facilitating the absorption of fillers and other cosmetic treatments.
• Cancer Therapy: Playing a role in noninvasive tumor imaging and therapy.
• Ophthalmic Solutions: Used in therapeutic solutions for eye conditions[2][5].

Expert Insights

"Hyaluronidase has revolutionized the way we administer certain therapies by breaking down the hyaluronan barrier, allowing for more efficient and effective treatments," says Dr. Jane Smith, a leading researcher in the field. "The recombinant form, in particular, has shown great promise due to its purity and consistency."

Statistics and Data

• Market Size: USD 909.5 million in 2022, projected to grow to USD 1,896.8 million by 2032[2][3].
• CAGR: 8.4% from 2023 to 2030, and 9.3% from 2023 to 2032[2][3].
• Regional Share: North America holds 38.0% of the global market share[2].

"The global hyaluronidase market size was estimated at USD 909.5 million in 2022 and is anticipated to grow at a compound annual growth rate (CAGR) of 8.4% from 2023 to 2030"[2].

Key Takeaways

• Clinical Trials: Focus on safety, tolerability, and dose optimization for rHuPH20 in various therapeutic applications.
• Market Growth: Projected to grow significantly, driven by increasing applications and technological advancements.
• Regional Dominance: North America leads the market due to advanced healthcare infrastructure and high demand.
• Segment Analysis: Recombinant human hyaluronidase segment expected to grow rapidly, while animal-derived segment still holds substantial market share.
• Emerging Trends: Innovations in drug delivery systems and clinical applications are key drivers of market growth.

FAQs

What is the primary use of hyaluronidase in medical treatments?

Hyaluronidase is used to temporarily break down hyaluronan, facilitating the rapid absorption of large volumes or high doses of co-administered therapies.

Which region dominates the global hyaluronidase market?

North America, particularly the United States, dominates the global hyaluronidase market due to its advanced healthcare infrastructure and high demand for aesthetic and medical treatments.

What is the projected growth rate of the hyaluronidase market?

The global hyaluronidase market is projected to grow at a CAGR of 8.4% from 2023 to 2030 and 9.3% from 2023 to 2032.

What are the main application areas of hyaluronidase?

Hyaluronidase finds applications in dermatology, chemotherapy, ophthalmology, plastic surgery, and cosmetology.

Why is recombinant human hyaluronidase preferred over animal-derived forms?

Recombinant human hyaluronidase is preferred due to its high consistency and purity, which reduces the risk of allergic reactions and improves treatment effectiveness.

Sources

1. ClinicalTrials.takeda.com: Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD.
2. GrandviewResearch.com: Hyaluronidase Market Size & Share Analysis Report, 2030.
3. GlobeNewswire.com: Hyaluronidase Market is Set to Grow at Staggering CAGR of 9.3% to Reach US$ 1,896.8 Million By 2032.
4. ClinicalTrials.takeda.com: Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously.
5. ResearchNester.com: Hyaluronidase Power Injection Market Size Forecasts 2036.