Pegzilarginase

Overview

Pegzilarginase is under investigation in clinical trial NCT02488044 (A Phase 1/2 Study of AEB1102 in Patients With Arginase I Deficiency).

Background

Pegzilarginase is under investigation in clinical trial NCT02488044 (A Phase 1/2 Study of AEB1102 in Patients With Arginase I Deficiency).

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Pegzilarginase in Subjects <24 Months Old with Arginase 1 Deficiency	2024/09/03	NCT06582524	Phase 3	Recruiting	Immedica Pharma AB
A Study of Safety of Weekly Subcutaneous Pegzilarginase in Subjects With Arginase 1 Deficiency	2023/01/09	NCT05676853	Phase 3	Terminated	Aeglea Biotherapeutics
Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency	2019/04/19	NCT03921541	Phase 3	Completed	Aeglea Biotherapeutics
A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency	2017/12/20	NCT03378531	Phase 2	Completed	Aeglea Biotherapeutics
Pegzilarginase and Pembrolizumab for Extensive Disease Small Cell Lung Cancer	2017/12/13	NCT03371979	Phase 1	Completed	Aeglea Biotherapeutics
A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS	2016/04/08	NCT02732184	Phase 2	Completed	Aeglea Biotherapeutics
A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors	2015/09/28	NCT02561234	Phase 1	Completed	Aeglea Biotherapeutics
A Phase 1/2 Study of AEB1102 in Patients With Arginase I Deficiency	2015/07/02	NCT02488044	Phase 1	Completed	Aeglea Biotherapeutics

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Loargys	Immedica Pharma AB,Solnavagen 3H,113 63 Stockholm,Sweden	Authorised	12/15/2023
Loargys	Immedica Pharma AB,Solnavagen 3H,113 63 Stockholm,Sweden	Authorised	12/15/2023

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

Aeglea BioTherapeutics Submits BLA for Pegzilarginase as First Potential Treatment for Arginase 1 Deficiency

3 years ago

Aeglea BioTherapeutics has submitted a Biologics License Application to the FDA for pegzilarginase with Priority Review request, potentially becoming the first approved treatment for Arginase 1 Deficiency.

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