Protalix: Clinical Trials

17 trials sponsored by Protalix, newest first

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

13 completed, 2 unknown, 1 recruiting, 1 withdrawn. 7 Phase 1, 6 Phase 2, 4 Phase 3, 1 Early Phase 1.

By phase and status

PhaseTrialsStatus
Phase 17Completed 7
Phase 26Completed 3, Unknown 2, Recruiting 1
Phase 34Completed 3, Withdrawn 1
Early Phase 11Completed 1

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

TrialPhaseStatusSponsorEnrollmentStartUpdated
A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)
PRX-115, Methotrexate (MTX), PRX-115 placebo - Gout
Phase 2RecruitingProtalix1502025-12-222026-09-29
A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels
PRX-115, Placebo - Gout
Phase 1CompletedProtalix642023-03-232025-02-11
Fabry Patient's Experience Of PegunigaLsidasE Alfa Monthly Infusion
Interview - Fabry Disease
CompletedChiesi Farmaceutici S.p.A.232022-01-262023-03-21
Safety, Efficacy, & PK of PRX-102 in Patients With Fabry Disease Administered Intravenously Every 4 Weeks
Pegunigalsidase alfa - Fabry Disease
Phase 3CompletedProtalix302017-07-102023-09-13
Study to Evaluate the Safety and EffIcacy of PRX-102 on Gastrointestinal Symptoms in Naïve Fabry Disease
PRX-102, Placebo - Fabry Disease
Phase 3WithdrawnProtalix2017-07-012018-01-08
Safety and Efficacy of PRX-102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa)
PRX-102 (pegunigalsidase alfa) - Fabry Disease
Phase 3CompletedProtalix222017-05-172023-09-13
Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis
OPRX-106 - Ulcerative Colitis
Phase 2UnknownProtalix202016-09-012016-09-28
Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function
PRX-102 (pegunigalsidase alfa), agalsidase beta - Fabry Disease
Phase 3CompletedProtalix782016-06-012023-09-13
Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme®
AIR DNase™ - Cystic Fibrosis
Phase 2UnknownProtalix152016-05-012016-09-28
Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult Volunteers
AIR DNase, Placebo - Cystic Fibrosis (CF)
Phase 1CompletedProtalix182015-12-012016-05-17
Study to Evaluate the Safety and Pharmacokinetics of Oral OPRX-106 (TNFR-Fc Fusion Protein) in Healthy Volunteers
OPRX-106 - Human Volunteer
Phase 1CompletedProtalix182014-07-012015-08-05
An Open-Label, Dose Escalation Study to Evaluate the Safety and the Pharmacokinetics of Oral PRX-112
PRX-112 - Gaucher Disease
Phase 2CompletedProtalix102014-04-012016-09-28
Extension Study of PRX-102 for up to 60 Months
PRX-102 (pegunigalsidase alfa) - Fabry Disease
Phase 1 / Phase 2CompletedProtalix152014-01-162023-09-13
Safety and Pharmacokinetics of Oral PRX-112 in Gaucher Disease Patients
PRX-112 - Gaucher Disease
Phase 1CompletedProtalix162013-03-012014-04-07
Dose-ranging Study of PRX-102 in Adult Fabry Disease Patients
PRX-102 - Fabry Disease
Phase 1 / Phase 2CompletedProtalix182012-10-012023-09-13
An Exploratory Phase 1 Microdose Study of PRX-105
PRX-105 - Organophosphate Exposure
Early Phase 1CompletedProtalix102010-03-012012-09-05
Phase I Single Dose-Escalation Safety Study of Human Glucocerebrosidase (prGCD)
Human Glucocerebrosidase (prGCD) - Gaucher Disease
Phase 1CompletedProtalix62005-11-012006-12-05

Conditions studied

Fabry Disease (7)  ·  Gaucher Disease (3)  ·  Cystic Fibrosis (2)  ·  Gout (2)  ·  Hyperuricemia (2)  ·  Abdominal Pain (1)  ·  Colitis, Ulcerative (1)  ·  Diarrhea (1)  ·  Digestive System Diseases (1)  ·  Disease (1)  ·  Genetic Diseases, Inborn (1)  ·  Lung Diseases (1)  ·  Pain (1)  ·  Pancreatic Diseases (1)  ·  Proteinuria (1)

Interventions

Etanercept (1)  ·  Interviews as Topic (1)  ·  Methotrexate (1)  ·  PRX-105 (1)  ·  agalsidase beta (1)  ·  taliglucerase alfa (1)

Countries

Israel (8)  ·  United Kingdom (6)  ·  United States (6)  ·  Czechia (3)  ·  Italy (3)  ·  Norway (3)  ·  Spain (3)  ·  Australia (2)  ·  Belgium (2)  ·  Denmark (2)  ·  Netherlands (2)  ·  Paraguay (2)  ·  Slovenia (2)  ·  Canada (1)  ·  Finland (1)

Top investigators

Einat Almon, PhD (3)  ·  Einat Dekel, DVM (2)  ·  Einat Almon, PdH (1)  ·  Eithan Galun, MD (1)  ·  Mark Marshall, Dr. (1)  ·  Raul Chertkoff, MD (1)

Results publications

PMID 39847314, PMID 19277123, PMID 30834538, PMID 37865771, PMID 37940383