Taliglucerase alfa
- Generic Name
- Taliglucerase alfa
- Brand Names
- Elelyso
- Drug Type
- Biotech
- CAS Number
- 37228-64-1
- Unique Ingredient Identifier
- N69L6LM4QU
- Background
Taliglucerase alfa is the recombinant active form of the human lysosomal enzyme, β-glucocerebrosidase. It was approved in 2012 and is marketed under the name Elelyso for use in patients with type 1 Gaucher's disease.
- Indication
For the treatment of adult Type 1 Gaucher disease.
- Associated Conditions
- Gaucher Disease, Type 1, Gaucher Disease, Type III
Assessing the Impact of Elelyso on Bone Involvement Currently Treated With Other ERTs
- Conditions
- Gaucher Disease, Type 1
- Interventions
- Procedure: quantitative chemical shift imaging (QCSI)
- First Posted Date
- 2020-04-20
- Last Posted Date
- 2022-10-28
- Lead Sponsor
- Shaare Zedek Medical Center
- Target Recruit Count
- 30
- Registration Number
- NCT04353466
A Multicenter, Safety and Efficacy Study of Taliglucerase Alfa in Subjects With Type 3 Gaucher Disease
- First Posted Date
- 2019-07-01
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- Ari Zimran
- Target Recruit Count
- 14
- Registration Number
- NCT04002830
- Locations
- 🇮🇱
Shaare Zedek Medical Center, Jerusalem, Israel
🇮🇳All India Institute of Medical Sciences, New Delhi, India
🇹🇷Gazi University, Ankara, Turkey
Pharmacokinetics, Pharmacodynamics And Safety Study Of Elelyso(tm) In Pediatric Subjects With Type 1 Gaucher Disease
- First Posted Date
- 2017-01-16
- Last Posted Date
- 2019-09-24
- Lead Sponsor
- Pfizer
- Registration Number
- NCT03021941
- Locations
- 🇺🇸
O&O Alpan LLC, Fairfax, Virginia, United States
An Open-Label, Dose Escalation Study to Evaluate the Safety and the Pharmacokinetics of Oral PRX-112
- First Posted Date
- 2014-04-08
- Last Posted Date
- 2016-09-28
- Lead Sponsor
- Protalix
- Target Recruit Count
- 10
- Registration Number
- NCT02107846
- Locations
- 🇮🇱
Shaare Zedek Medical Center, Jerusalem, Israel
Safety and Pharmacokinetics of Oral PRX-112 in Gaucher Disease Patients
- First Posted Date
- 2012-12-12
- Last Posted Date
- 2014-04-07
- Lead Sponsor
- Protalix
- Target Recruit Count
- 16
- Registration Number
- NCT01747980
- Locations
- 🇮🇱
Shaare Zedek Medical Center, Jerusalem, Israel
🇮🇱Rambam Medical Center, Haifa, Israel
A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease
- First Posted Date
- 2011-08-23
- Last Posted Date
- 2023-04-19
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 19
- Registration Number
- NCT01422187
A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
- First Posted Date
- 2011-08-08
- Last Posted Date
- 2018-09-07
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 15
- Registration Number
- NCT01411228
- Locations
- 🇮🇱
Shaare Zedek Medical Center, Jerusalem, Israel
🇿🇦Morningside Medi-Clinic, Morningside, South Africa
🇵🇾Instituto Privado de Hematologia E Investigacion Clinica (I.P.H.I.C), Barrio Asuncion, Paraguay
A Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
- First Posted Date
- 2010-05-28
- Last Posted Date
- 2018-10-05
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 11
- Registration Number
- NCT01132690
- Locations
- 🇵🇾
Instituto Privado de Hematologia E Investigacion Clinica (I.P.H.I.C), Barrio Sajonia Asunción, Paraguay
🇮🇱Shaare Zedek Medical Center, Jerusalem, Israel
🇿🇦Morningside Medi-Clinic, Morningside, South Africa
Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease
- Conditions
- Gaucher Disease
- First Posted Date
- 2009-08-19
- Last Posted Date
- 2018-09-07
- Lead Sponsor
- Pfizer
- Registration Number
- NCT00962260
- Locations
- 🇮🇱
Sha'are Zedek Medical Center, Jerusalem, Israel
🇺🇸University Research Foundation for Lysosomal Storage Diseases, Inc., Coral Springs, Florida, United States
🇺🇸University of Colorado Denver, Aurora, Colorado, United States
Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase
- First Posted Date
- 2008-07-10
- Last Posted Date
- 2018-10-04
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 31
- Registration Number
- NCT00712348
- Locations
- 🇮🇱
Shaare Zedek Medical Center, Jerusalem, Israel
🇬🇧Royal Free Hospital, London, United Kingdom
🇬🇧Lysosomal Disorders Service, Addenbrookes Hospital NHS Trust, Cambridge, United Kingdom
Drug Development Updates
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