13 completed, 2 unknown, 1 recruiting, 1 withdrawn. 7 Phase 1, 6 Phase 2, 4 Phase 3, 1 Early Phase 1.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
Follow Protalix: new trials by email
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
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 2 | Recruiting | 150 | 2025-12-22 | 2026-09-29 |
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 1 | Completed | 64 | 2023-03-23 | 2025-02-11 |
Fabry Patient's Experience Of PegunigaLsidasE Alfa Monthly Infusion Interview - Fabry Disease | | Completed | 23 | 2022-01-26 | 2023-03-21 |
Safety, Efficacy, & PK of PRX-102 in Patients With Fabry Disease Administered Intravenously Every 4 Weeks Pegunigalsidase alfa - Fabry Disease | Phase 3 | Completed | 30 | 2017-07-10 | 2023-09-13 |
Study to Evaluate the Safety and EffIcacy of PRX-102 on Gastrointestinal Symptoms in Naïve Fabry Disease PRX-102, Placebo - Fabry Disease | Phase 3 | Withdrawn | | 2017-07-01 | 2018-01-08 |
Safety and Efficacy of PRX-102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa) PRX-102 (pegunigalsidase alfa) - Fabry Disease | Phase 3 | Completed | 22 | 2017-05-17 | 2023-09-13 |
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 2 | Unknown | 20 | 2016-09-01 | 2016-09-28 |
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 3 | Completed | 78 | 2016-06-01 | 2023-09-13 |
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 2 | Unknown | 15 | 2016-05-01 | 2016-09-28 |
Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult Volunteers AIR DNase, Placebo - Cystic Fibrosis (CF) | Phase 1 | Completed | 18 | 2015-12-01 | 2016-05-17 |
Study to Evaluate the Safety and Pharmacokinetics of Oral OPRX-106 (TNFR-Fc Fusion Protein) in Healthy Volunteers OPRX-106 - Human Volunteer | Phase 1 | Completed | 18 | 2014-07-01 | 2015-08-05 |
An Open-Label, Dose Escalation Study to Evaluate the Safety and the Pharmacokinetics of Oral PRX-112 PRX-112 - Gaucher Disease | Phase 2 | Completed | 10 | 2014-04-01 | 2016-09-28 |
Extension Study of PRX-102 for up to 60 Months PRX-102 (pegunigalsidase alfa) - Fabry Disease | Phase 1 / Phase 2 | Completed | 15 | 2014-01-16 | 2023-09-13 |
Safety and Pharmacokinetics of Oral PRX-112 in Gaucher Disease Patients PRX-112 - Gaucher Disease | Phase 1 | Completed | 16 | 2013-03-01 | 2014-04-07 |
Dose-ranging Study of PRX-102 in Adult Fabry Disease Patients PRX-102 - Fabry Disease | Phase 1 / Phase 2 | Completed | 18 | 2012-10-01 | 2023-09-13 |
An Exploratory Phase 1 Microdose Study of PRX-105 PRX-105 - Organophosphate Exposure | Early Phase 1 | Completed | 10 | 2010-03-01 | 2012-09-05 |
Phase I Single Dose-Escalation Safety Study of Human Glucocerebrosidase (prGCD) Human Glucocerebrosidase (prGCD) - Gaucher Disease | Phase 1 | Completed | 6 | 2005-11-01 | 2006-12-05 |
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