Last update 07 Nov 2024

NGGT-002

Overview

Basic Info

Drug Type
AAV based gene therapy
Synonyms
NGGT 002, NGGT002
Target
PAH
Mechanism
PAH modulators(Phenylalanine hydroxylase modulators)
Therapeutic Areas
Nervous System DiseasesCongenital DisordersEndocrinology and Metabolic Disease+ [1]
Active Indication
Phenylketonurias
Inactive Indication-
Originator Organization
Suzhou Nuojiebei Biotechnology Co., Ltd.Suzhou Nuojiebei Biotechnology Co., Ltd.
Active Organization
Suzhou Nuojiebei Biotechnology Co., Ltd.Suzhou Nuojiebei Biotechnology Co., Ltd.
Inactive Organization-
Drug Highest PhasePhase 1/2
First Approval Date-
RegulationOrphan Drug (US)
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Related

3
Clinical Trials associated with NGGT-002
NCT06332807 / RecruitingPhase 1/2
An Open-Label, Multiple-Center, Phase I/II Dose Escalation Study for the Safety and Efficacy of NGGT002 in Adults With Classic Phenylketonuria
CTR20241545 / RecruitingPhase 1/2
NGGT002静脉滴注治疗成人苯丙酮尿症的安全性和有效性的 I/II期临床研究
[Translation] Phase I/II clinical study on the safety and efficacy of intravenous infusion of NGGT002 in the treatment of phenylketonuria in adults
NCT06061614 / RecruitingEarly Phase 1IIT
A Clinical Study for the Safety and Efficacy of IV Infusion of NGGT002 in the Treatment of Phenylketonuria
100 Clinical Results associated with NGGT-002
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100 Translational Medicine associated with NGGT-002
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100 Patents (Medical) associated with NGGT-002
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100 Deals associated with NGGT-002
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PhenylketonuriasPhase 2
CN
Suzhou Nuojiebei Biotechnology Co., Ltd.Suzhou Nuojiebei Biotechnology Co., Ltd.
11 Jul 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
NCT06061614 (ASGCT2024)
ManualManual
Early Phase 1
Phenylketonurias
PAH mutations
4
ldupnltmme(fdlgcmcdem) = The most common treatment-related adverse events (AEs) reported in all subjects were transient and asymptomatic elevations in liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST), which were well-managed by a tapering course of corticosteroid treatment. No severe liver dysfunction or long-term AEs on liver function was observed. jotnskhjkx (dgsswyjznd )
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Positive
07 May 2024
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Regulation

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