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Drugs / Hyaluronidase
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Hyaluronidase

also known as Hylenex · rHuPH20 · H-LASE · Hyalase · Hynidase · Sine

Protein / enzyme biologic

Developed for
type 1 diabetes mellitus · chronic pain syndrome · cutaneous sclerosis · impacted teeth, multiple · infectious disease · myocardial infarction · myocardial ischemia · myofascial pain syndrome
+8 more · radiculopathy · scleroderma · stroke disorder · systemic sclerosis · voice disorders · frozen shoulder · neuropathy, painful · vertebral column disorder
Investigated by
Benha University · Johns Hopkins University · Amphastar Pharmaceuticals, Inc. · Assiut University · Baxter Healthcare Corporation · Brigham and Women's Hospital
+24 more · Duke University · EPC Education s.r.o. · East Slovak Institute for Cardiovascular Diseases · Fayoum University · Hacettepe University · Halozyme Therapeutics · Mansoura University · Mariam Hesham Mahmoud Abdelfattah Eissa · Massachusetts General Hospital · Medical University of South Carolina · Misr University for Science and Technology · National Center for Complementary and Integrative Health (NCCIH) · National Heart, Lung, and Blood Institute (NHLBI) · Northwestern University · PPD Development, LP · Postgraduate Institute of Dental Sciences Rohtak · Samsung Medical Center · Sheikh Khalifa Stroke Institute · Slovak Academy of Sciences · Sohag University · Stanford University · University of Colorado, Denver · University of Nebraska · Yale University

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) VITRASE — 2004-05-05 fda.gov ↗

Trials 25

today
US approved 2004
NCT07697274 · Ph 0 NCT06854380 · Ph 0 NCT07101016 · not/applicable NCT07000058 · Ph 2/3 NCT06980363 · Ph 1 NCT06718413 · Ph 2 NCT07436546 · not/applicable NCT06839391 · Ph 0 NCT05995626 · Ph 0 NCT05671172 · not/applicable NCT03306615 · Ph 2 NCT05083663 · Ph 2/3 NCT07411950 · not/applicable NCT04656704 · Ph 0 NCT05466604 · Ph 4 NCT03266406 · not/applicable NCT02059694 · not/applicable NCT02265575 · Ph 2 NCT02199028 · Ph 1 NCT01945099 · Ph 0 NCT01722916 · Ph 0 NCT01689363 · Ph 2 NCT02293083 · not/applicable NCT00477152 · Ph 4 NCT00000493 · Ph 3
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 07 trials
Phase 0 NCT07697274 Sep 2026 → Sep 2027 expected cutaneous sclerosis, systemic sclerosis Medical University of South Carolina Not yet recruiting No outcome recorded
Phase 0 NCT06854380 Jan → Jul 2026 overdue voice disorders Mansoura University Recruiting No outcome recorded
Phase 0 NCT06839391 Mar 2025 → Mar 2026 overdue — Benha University Not yet recruiting No outcome recorded
Phase 0 NCT05995626 Mar → Sep 2024 scleroderma University of Nebraska Completed No outcome recorded
Phase 0 NCT04656704 Jan 2020 → Jan 2022 CREST syndrome, localized scleroderma, scleromyxedema Brigham and Women's Hospital Withdrawn No outcome recorded
Phase 0 NCT01945099 Sep 2013 → Dec 2015 type 1 diabetes mellitus Yale University Completed No outcome recorded
Phase 0 NCT01722916 Oct 2012 → Feb 2022 — Northwestern University Completed No outcome recorded
Phase 12 trials
Phase 1 NCT06980363 Jun → Aug 2025 overdue — Fayoum University Not yet recruiting No outcome recorded
Phase 1 NCT02199028 Jul 2014 → Mar 2015 type 1 diabetes mellitus Stanford University Completed No outcome recorded
Phase 24 trials
Phase 2 NCT06718413 Mar 2025 → Aug 2027 expected stroke disorder Johns Hopkins University Recruiting No outcome recorded
Phase 2 NCT03306615 Oct 2021 → Jun 2026 overdue — Johns Hopkins University Active not recruiting No outcome recorded
Phase 2 NCT02265575 Oct 2014 → Dec 2016 — Massachusetts General Hospital Completed No outcome recorded
Phase 2 NCT01689363 Sep → Nov 2012 hypersensitivity reaction disease Amphastar Pharmaceuticals, Inc. Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT07000058 Jun → Dec 2025 overdue — Misr University for Science and Technology Active not recruiting No outcome recorded
Phase 2/3 NCT05083663 Sep → Nov 2021 — Sohag University Unknown No outcome recorded
Phase 31 trial
Phase 3 NCT00000493 Sep 1977 → Dec 1985 coronary artery disorder, myocardial infarction, myocardial ischemia National Heart, Lung, and Blood Institute (NHLBI) Completed No outcome recorded
Phase 42 trials
Phase 4 NCT05466604 Dec 2019 → Jun 2022 infectious disease Hacettepe University Completed No outcome recorded
Phase 4 NCT00477152 Aug 2007 → Jun 2008 — Baxter Healthcare Corporation Completed No outcome recorded
Phase not applicable7 trials
— NCT07101016 Aug 2025 overdue periapical periodontitis Mariam Hesham Mahmoud Abdelfattah Eissa Not yet recruiting No outcome recorded
— NCT07436546 Mar → Dec 2025 impacted teeth, multiple Postgraduate Institute of Dental Sciences Rohtak Completed No outcome recorded
— NCT05671172 May 2023 → Jan 2024 — Benha University Completed No outcome recorded
— NCT07411950 Jan 2021 → May 2025 chronic pain syndrome, radiculopathy EPC Education s.r.o. Completed No outcome recorded
— NCT03266406 Sep 2017 → Sep 2018 ocular hypotension Assiut University Unknown No outcome recorded
— NCT02293083 Apr 2010 → Apr 2011 myofascial pain syndrome Samsung Medical Center Completed No outcome recorded
— NCT02059694 ? → Jul 2015 — Duke University Withdrawn No outcome recorded
Comparator or background therapy20 trials
Phase 0 NCT05344495 Comparator Jan → Jul 2022 neuropathy, painful Minia University Unknown No outcome recorded
Phase 0 NCT03411330 Comparator Jan 2017 → Apr 2018 — Cairo University Completed No outcome recorded
Phase 1 NCT05004259 Background Mar 2022 → Sep 2024 hemolytic anemia Dartmouth-Hitchcock Medical Center Completed No outcome recorded
Phase 2 NCT07527806 Background May 2026 → May 2029 expected breast cancer Peking University Cancer Hospital & Institute Not yet recruiting No outcome recorded
Phase 2 NCT07485647 Background May 2026 → May 2028 expected plasma cell myeloma Eden Biltibo Not yet recruiting No outcome recorded

Press releases naming this drug 99 releases

DateIssuerRelease
2026-09-23 Janssen Research & Development, LLC New model-based analysis further supports the potential of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) to redefine long-term survival expectations in early line relapsed/refractory multiple myeloma jnj.com ↗
2026-09-23 Janssen Research & Development, LLC New model-based analysis further supports the potential of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) to redefine long-term survival expectations in early line relapsed/refractory multiple myeloma jnj.com ↗
2026-09-15 Janssen Research & Development, LLC RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE® (lazertinib) with prophylactic strategies shows low rates of treatment-related events at WCLC 2026 jnj.com ↗
2026-09-14 Janssen Research & Development, LLC RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE® (lazertinib) with prophylactic strategies shows low rates of treatment-related events at WCLC 2026 jnj.com ↗
2026-07-30 Janssen Research & Development, LLC Johnson & Johnson’s RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Priority Review as potential first-in-class EGFR- and MET-targeted subcutaneous treatment for advanced head and neck cancer jnj.com ↗
2026-07-30 Janssen Research & Development, LLC Johnson & Johnson's RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Priority Review as potential first-in-class EGFR- and MET-targeted subcutaneous treatment for advanced head and neck cancer jnj.com ↗
2026-06-13 Janssen Research & Development, LLC New TALVEY® (talquetamab-tgvs) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) data demonstrate the strength of a bispecific combination in earlier-line relapsed or refractory multiple myeloma jnj.com ↗
2026-06-13 Janssen Research & Development, LLC New TALVEY® (talquetamab-tgvs) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) data demonstrate the strength of a bispecific combination in earlier-line relapsed or refractory multiple myeloma jnj.com ↗
2026-05-31 Janssen Research & Development, LLC RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) pivotal data show strong and durable responses in advanced head and neck cancer where options remain limited jnj.com ↗
2026-05-31 Janssen Research & Development, LLC RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) pivotal data show strong and durable responses in advanced head and neck cancer where options remain limited jnj.com ↗
2026-03-31 Shanghai Henlius Biotech Henlius' Next-Generation rHuPH20 Approved for Clinical Trials, Accelerating Subcutaneous Delivery Platform Development henlius.com ↗
2026-02-19 Janssen Research & Development, LLC RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) plus immunotherapy shows strong clinical benefit with 56 percent overall response rate in first-line recurrent or metastatic head and neck cancer jnj.com ↗

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 46 sources stand behind the page.

FieldValueCited text
Known as Hyaluronidase “Hyaluronidase: 1 mL of gel prepared by dissolving the contents of 1 ampoule (1500 IU) Hyalase powder in 2.5 mL of 0.9% sodium chloride, and then incorporating 1 mL of this...” NCT07101016 ↗
44

“Hyaluronidase, or Hylenex, is not an investigational drug; it is FDA-approved, regularly used in the U.S., and will be procured for this study through the pharmacy of the...” NCT02265575 ↗

“Subcutaneous injection vial with a fixed dose of trastuzumab (600mg) and recombinant human hyaluronidase (10.000U) identical to that provided by the device.” NCT01875367 ↗

“All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive” NCT03824665 ↗

“Advanced Touhy needle delivery of 80 mg triamcinolone and 1500 IU hyaluronidase into the epidural space to target inflammation and adhesions” NCT07370233 ↗

“600 mg Pertuzumab, 600 mg Trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days” NCT07527806 ↗

“bupivacaine 15 mg 0.5% plus 2 mL normal saline containing 300 international units (IU) hyaluronidase.” NCT05344495 ↗

“hyaluronidase (H-LASE®, 1500 iu” NCT02293083 ↗

“hyaluronidase (1,500 IU)” NCT07411950 ↗

NCT05995626 ↗

NCT06854380 ↗

Show 34 more sources
Known as H-LASE “hyaluronidase (H-LASE®, 1500 iu” NCT02293083 ↗
Known as Hyalase “Hyaluronidase: 1 mL of gel prepared by dissolving the contents of 1 ampoule (1500 IU) Hyalase powder in 2.5 mL of 0.9% sodium chloride, and then incorporating 1 mL of this...” NCT07101016 ↗
Known as Hylenex “Hyaluronidase, or Hylenex, is not an investigational drug; it is FDA-approved, regularly used in the U.S., and will be procured for this study through the pharmacy of the...” NCT02265575 ↗
1

“Hyaluronidase (Hylenex)” NCT07697274 ↗
Known as Hynidase “Intralesional injection of steroids (betamethasone), (Betafos®) and hyaluronidase (enzyme), (Hynidase®) into benign vocal fold lesions” NCT06854380 ↗
Known as rHuPH20 “recombinant human hyaluronidase (rHuPH20)-facilitated subcutaneous rehydration” PMID 19805455 ↗ Oct 2009
1

“recombinant hyaluronidase (rHuPH20) as an adjunctive for local anaesthesia” NCT02059694 ↗
Known as Sine “Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and...” NCT03101033 ↗
Modality Protein / enzyme biologic “recombinant human hyaluronidase” NCT00477152 ↗
Route Subcutaneous “Single 150 U subcutaneous (SC) HYLENEX dose” NCT00477152 ↗