AMPHADASE

(Hyaluronidase)

ApprovedProtein / enzyme

AAntares Pharma Inc.

AMPHADASE is one of 218 small molecule programs targeting Vitreous Hemorrhage. It is currently in Approved.

Indications

Total Trials

Active Trials

217

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Vitreous HemorrhageActive, not recruiting

Muscle SpasticityActive, not recruiting

Cesarean SectionActive, not recruiting

Systemic SclerosisNot yet recruiting

CataractActive, not recruiting

Intraocular PressureUnknown status

BupivacaineNot yet recruiting

SurgeryWithdrawn

Diffuse Large B-Cell LymphomaActive, not recruiting

Vitreous HemorrhagePreclinical

Active, not recruiting

Muscle SpasticityPhase 2

Active, not recruiting

Cesarean SectionPreclinical

Active, not recruiting

Systemic SclerosisPhase 1

Not yet recruiting

CataractApproved

Active, not recruiting

Intraocular PressurePreclinical

Unknown status

BupivacainePhase 1

Not yet recruiting

SurgeryPreclinical

Withdrawn

Diffuse Large B-Cell LymphomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

109 competitors in Diffuse Large B-Cell Lymphoma

#DrugCompanyPhaseTrials

Adriamycin

Pfizer

Phase 3

38 2

Rituxan

Oncovin

33 4

Polivy

Roche

Phase 3

20 5

Gazyva

Roche

Phase 3

18 6

Gemzar

Johnson & Johnson

Phase 3

18 7

Adriamycin

Pfizer

Phase 3

18 8

Oncovin

Eli Lilly

Phase 3

18 9

Cytoxan

BBaxter Healthcare Corporation

Rayos

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Diffuse Large B-Cell Lymphoma

NCT05498220

Q2 2027

Phase 2Active, not recruiting

Muscle Spasticity

NCT03306615

Q4 2027

Phase 1Not yet recruiting

Systemic Sclerosis

NCT07697274

Clinical

Trials by Indication[1]

Infusion2 trials

Hyaluronidase Assisted Subcutaneous Infusion

Completed·SShanghai Bao Pharmaceuticals Co., Ltd.·Phase 3·NCT06604546·45 enrolled

Hyaluronidase Effect on Infusion Set Life

Completed·SStanford University·Phase 1·NCT02199028·30 enrolled

Acute Lymphoblastic Leukemia1 trial

Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)

Completed·AAmphastar Pharmaceuticals, Inc.·Phase 2·NCT01689363·253 enrolled

Supraclavicular Brachial Plexus Block1 trial

Effectiveness of Adding Hyaluronidase to Bupivacaine in Ultrasound Guided Supraclavicular Brachial Plexus Block

Unknown status·SSohag University·Phase 2/3·NCT05083663·40 enrolled

Closed-Loop1 trial

Acceleration of Insulin Action by Hyaluronidase During Closed-Loop Therapy

Completed·YYale University·Phase 1·NCT01945099·13 enrolled

Bupivacaine1 trial

Effect of Hyaluronidase in Different Doses Added to Bupivacaine on TAB Block Quality During CS

Not yet recruiting·—·Phase 1·NCT06839391·120 enrolled

14 more indications

Adhesive Capsulitis1 trial

Hyaluronidase in Intra-articular Steroid Injection Treating the Adhesive Capsulitis for Shoulder

Completed·VVeterans Health Service Medical Center, Seoul, Korea·Phase 3·NCT04347733·30 enrolled

Cataract1 trial

Efficacy and Safety of Adding Atracurium to Percaruncular Block for High Myopes Undergoing Cataract Surgery

Completed·KKasr El Aini Hospital·Phase 4·NCT03243500·91 enrolled

Intraocular Pressure1 trial

Effect of Hyaluronidase on Intraocular Pressure

Unknown status·—·N/A·NCT03266406·50 enrolled

Scleroderma1 trial

Hyaluronidase Via LADD Scleroderma-induced Microstomia

Completed·UUniversity of Nebraska·Phase 1·NCT05995626·3 enrolled

Surgery1 trial

Use of Recombinant Hyaluronidase Human is Effective for the Use of Local Blocks for Eyelid's Surgery

Withdrawn·—·N/A·NCT02059694

Safety and Efficacy1 trial

Safety and Efficacy of Addition of Hyaluronidase to Lidocaine and Bupivacaine in Scalp Nerves Block in Elective Craniotomy Operations, Comparative Study

Completed·—·Phase 1·NCT03411330·64 enrolled

RCT1 trial

Multicenter Investigation of Limitation of Infarct Size (MILIS)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000493

Cesarean Section1 trial

Effect of Adding Hyaluronidase to Bupivacaine in Transversus Abdominis Plane Block for Cesarean Section

Completed·—·N/A·NCT05671172·114 enrolled

Erector Spinae Plane Block1 trial

Ultrasound Guided Erector Spinae Plane Block in Breast Surgery

Unknown status·—·N/A·NCT03660020·60 enrolled

Hemodynamic1 trial

Hemodynamic and Electrocardiographic Effects of Hyaluronidase Associated With Local Anaesthetics

Completed·MMauricio Jose Tornelli·Phase 4·NCT01719978·20 enrolled

Diffuse Large B-Cell Lymphoma1 trial

Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma

Active, not recruiting·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT05498220·5 enrolled

Systemic Sclerosis1 trial

Digital Intradermal Hyaluronidase for Sclerodactyly in Systemic Sclerosis

Not yet recruiting·MMedical University of South Carolina·Phase 1·NCT07697274·10 enrolled

Drug Safety1 trial

Pilot Study of Appropriate Dosing for Reducing and Removing Hyaluronic Acid Filler With Hyaluronidase: A Randomized Control Clinical Trial

Completed·NNorthwestern University·Phase 1·NCT01722916·5 enrolled

Muscle Spasticity1 trial

Peripheral Modulation of Muscle Stiffness and Spasticity

Active, not recruiting·JJohns Hopkins University·Phase 2·NCT03306615·56 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 26, 2004

AMPHADASE

BLA BLA021665

Dec 2, 2005

HYLENEX RECOMBINANT

BLA BLA021859

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for Hyaluronidase. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Hyaluronidase compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Hyaluronidase. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA021859). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Antares Pharma Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Protein / enzyme[2]
Highest Phase: Approved[1]
Company: AAntares Pharma Inc.

AMPHADASE

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2027

Trials by Indication[1]

Infusion2 trials

Acute Lymphoblastic Leukemia1 trial

Supraclavicular Brachial Plexus Block1 trial

Closed-Loop1 trial

Bupivacaine1 trial

Adhesive Capsulitis1 trial

Cataract1 trial

Intraocular Pressure1 trial

Scleroderma1 trial

Surgery1 trial

Safety and Efficacy1 trial

RCT1 trial

Cesarean Section1 trial

Erector Spinae Plane Block1 trial

Hemodynamic1 trial

Diffuse Large B-Cell Lymphoma1 trial

Systemic Sclerosis1 trial

Drug Safety1 trial

Muscle Spasticity1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Related News