PTC923 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
240フェニルケトン尿症8

240. フェニルケトン尿症


臨床試験数 : 143 薬物数 : 90 - (DrugBank : 10) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 5
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-000474-29-NL
(EUCTR)
12/08/202214/04/2022A study to see if PTC923 reliefs phenylketonuria symptomsA Phase 3 Study of PTC923 in Subjects with Phenylketonuria - PTC923-MD-003-PKU Metabolic Disorders - Phenylketonuria
MedDRA version: 20.0;Level: LLT;Classification code 10034873;Term: Phenylketonuria (PKU);System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Code: PTC923
INN or Proposed INN: not available
Other descriptive name: (S)-2-amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4(3H)-one
INN or Proposed INN: not available
Other descriptive name: (S)-2-amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4(3H)-one
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
178Phase 3United States;Portugal;Spain;Turkey;United Kingdom;Italy;France;Mexico;Canada;Brazil;Australia;Denmark;Georgia;Netherlands;Germany
2EUCTR2021-000474-29-DK
(EUCTR)
13/05/202210/03/2022A Phase 3 Study of PTC923 in Subjects with PhenylketonuriaA Phase 3 Study of PTC923 in Subjects with Phenylketonuria Metabolic Disorders - Phenylketonuria
MedDRA version: 20.0;Level: LLT;Classification code 10034873;Term: Phenylketonuria (PKU);System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Code: PTC923
INN or Proposed INN: not available
Other descriptive name: (S)-2-amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4(3H)-one
Product Code: PTC923
INN or Proposed INN: not available
Other descriptive name: (S)-2-amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4(3H)-one
PTC Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
178Phase 3Portugal;United States;France;Mexico;Canada;Spain;Brazil;Australia;Denmark;Netherlands;Germany;Italy
3EUCTR2021-000474-29-ES
(EUCTR)
21/04/202219/10/2021A Phase 3 Study of PTC923 in Subjects with PhenylketonuriaA Phase 3 Study of PTC923 in Subjects with Phenylketonuria Metabolic Disorders - Phenylketonuria
MedDRA version: 20.0;Level: LLT;Classification code 10034873;Term: Phenylketonuria (PKU);System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Code: PTC923
INN or Proposed INN: not available
Other descriptive name: (S)-2-amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4(3H)-one
Product Code: PTC923
INN or Proposed INN: not available
Other descriptive name: (S)-2-amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4(3H)-one
PTC Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
178Phase 3Portugal;United States;Spain;Turkey;United Kingdom;Italy;France;Mexico;Canada;Brazil;Australia;Denmark;Georgia;Germany;Netherlands
4NCT05166161
(ClinicalTrials.gov)
February 14, 20228/12/2021A Long-Term Safety Study of PTC923 in Participants With PhenylketonuriaA Phase 3 Open-Label Extension Study of PTC923 in PhenylketonuriaPhenylketonuriaDrug: PTC923PTC TherapeuticsNULLRecruitingN/AN/AAll200Phase 3United States;Australia;Brazil;Canada;Denmark;France;Georgia;Germany;Italy;Mexico;Netherlands;Portugal;Spain;Turkey;United Kingdom
5EUCTR2021-000474-29-PT
(EUCTR)
02/02/202229/11/2021A Phase 3 Study of PTC923 in Subjects with PhenylketonuriaA Phase 3 Study of PTC923 in Subjects with Phenylketonuria Metabolic Disorders - Phenylketonuria
MedDRA version: 20.0;Level: LLT;Classification code 10034873;Term: Phenylketonuria (PKU);System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Code: PTC923
INN or Proposed INN: not available
Other descriptive name: (S)-2-amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4(3H)-one
Product Code: PTC923
INN or Proposed INN: not available
Other descriptive name: (S)-2-amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4(3H)-one
PTC Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
178Phase 3United States;Portugal;Spain;Turkey;United Kingdom;Italy;France;Mexico;Canada;Brazil;Australia;Denmark;Georgia;Germany;Netherlands
6NCT05099640
(ClinicalTrials.gov)
September 30, 20216/10/2021A Study of PTC923 in Participants With PhenylketonuriaA Phase 3 Study of PTC923 in Subjects With PhenylketonuriaPhenylketonuriaDrug: PTC923;Drug: PlaceboPTC TherapeuticsNULLRecruitingN/AN/AAll178Phase 3United States;Australia;Brazil;Canada;Denmark;France;Georgia;Germany;Italy;Mexico;Netherlands;Portugal;Spain;Turkey;United Kingdom
7EUCTR2021-000497-28-DE
(EUCTR)
22/12/2021A Phase 3 Extension Study of PTC923 in Subjects with PhenylketonuriaPhase 3 Open-Label Extension Study of PTC923 in Phenylketonuria Metabolic Disorders - Phenylketonuria
MedDRA version: 20.0;Level: LLT;Classification code 10034873;Term: Phenylketonuria (PKU);System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Code: PTC923
INN or Proposed INN: not available
Other descriptive name: (S)-2-amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4(3H)-one
Product Code: PTC923
INN or Proposed INN: not available
Other descriptive name: (S)-2-amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4(3H)-one
PTC Therapeutics, Inc.NULLNAFemale: yes
Male: yes
200Phase 3United States;Portugal;Spain;Turkey;Italy;United Kingdom;France;Mexico;Canada;Brazil;Australia;Denmark;Georgia;Netherlands;Germany
8EUCTR2021-000474-29-DE
(EUCTR)
13/09/2021A Phase 3 Study of PTC923 in Subjects with PhenylketonuriaA Phase 3 Study of PTC923 in Subjects with Phenylketonuria Metabolic Disorders - Phenylketonuria
MedDRA version: 20.0;Level: LLT;Classification code 10034873;Term: Phenylketonuria (PKU);System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Code: PTC923
INN or Proposed INN: not available
Other descriptive name: (S)-2-amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4(3H)-one
Product Code: PTC923
INN or Proposed INN: not available
Other descriptive name: (S)-2-amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4(3H)-one
PTC Therapeutics, Inc.NULLNAFemale: yes
Male: yes
178Phase 3United States;Portugal;Spain;Turkey;United Kingdom;Italy;France;Mexico;Canada;Brazil;Australia;Denmark;Georgia;Germany;Netherlands