AMPHADASE

(Hyaluronidase)

ApprovedProtein / enzyme

AAmphastar Pharmaceuticals, Inc.

AMPHADASE is one of 464 small molecule programs targeting Spasticity. It is currently in Approved.

Indications

Total Trials

Active Trials

463

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

SpasticityActive, not recruiting

Hemolytic AnemiaActive, not recruiting

T-Cell Acute Lymphoblastic LeukemiaActive, not recruiting

LymphomaActive, not recruiting

Vitreous HemorrhageActive, not recruiting

Graves OphthalmopathyActive, not recruiting

Frozen ShoulderActive, not recruiting

CataractActive, not recruiting

Allergic DiseaseActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

SpasticityPhase 2

Active, not recruiting

Hemolytic AnemiaPhase 1

Active, not recruiting

T-Cell Acute Lymphoblastic LeukemiaPhase 2

Active, not recruiting

LymphomaPhase 3

Active, not recruiting

Vitreous HemorrhagePreclinical

Active, not recruiting

Graves OphthalmopathyPhase 2

Active, not recruiting

Frozen ShoulderPhase 3

Active, not recruiting

CataractApproved

Active, not recruiting

Allergic DiseasePhase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 2

Active, not recruiting

Showing 10 of 20 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

AMPHADASE

AAmphastar Pharmaceuticals, Inc.

Approved

20 2

Velban

EEastern Cooperative Oncology Group

Preclinical

15 3

Zofran

Novartis

Preclinical

2 4

Norvir

AbbVie

Preclinical

1 5

Wellcovorin

GGlaxo Dba Glaxosmithkline

Preclinical

4 6

Nuvigil

NNuvo Research GmbH

Preclinical

1 7

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—8

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—9

Rhg-CSF

CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Preclinical

3 10

Stem Cells

KKang Stem Biotech Co., Ltd.

Preclinical

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

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

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

Intraocular Pressure1 trial

Effect of Hyaluronidase on Intraocular Pressure

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

14 more indications

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

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

Surgery1 trial

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

Withdrawn·—·N/A·NCT02059694

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

Scleroderma1 trial

Hyaluronidase Via LADD Scleroderma-induced Microstomia

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

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

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

Acute Lymphoblastic Leukemia1 trial

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

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

Closed-Loop1 trial

Acceleration of Insulin Action by Hyaluronidase During Closed-Loop Therapy

Completed·YYale University·Phase 1·NCT01945099·13 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 — Amphastar Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Protein / enzyme[2]
Highest Phase: Approved[1]
Company: AAmphastar Pharmaceuticals, Inc.

AMPHADASE

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2027

Trials by Indication[1]

Infusion2 trials

Adhesive Capsulitis1 trial

Erector Spinae Plane Block1 trial

Hemodynamic1 trial

Intraocular Pressure1 trial

Diffuse Large B-Cell Lymphoma1 trial

Supraclavicular Brachial Plexus Block1 trial

Surgery1 trial

Cataract1 trial

Scleroderma1 trial

Safety and Efficacy1 trial

RCT1 trial

Cesarean Section1 trial

Bupivacaine1 trial

Acute Lymphoblastic Leukemia1 trial

Closed-Loop1 trial

Systemic Sclerosis1 trial

Drug Safety1 trial

Muscle Spasticity1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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