INFIGRATINIB ( DrugBank: Infigratinib )


1 disease
IDDisease name (Link within this page)Number of trials
276Achondroplasia5

276. Achondroplasia


Clinical trials : 46 Drugs : 29 - (DrugBank : 6) / Drug target genes : 5 - Drug target pathways : 30
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-001855-15-ES
(EUCTR)
02/02/202215/09/2021A study to evaluate long-term Infigratinib in children with AchondroplasiaPhase 2, Open-Label, Long-Term, Extension (OLE) Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children with Achondroplasia: PROPEL OLE - PROPEL OLE Achondroplasia in Children
MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Infigratinib
Product Code: BGJ398 (also known as BBP-831)
INN or Proposed INN: INFIGRATINIB
QED Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 2France;United States;Canada;Spain;Australia;United Kingdom
2NCT05145010
(ClinicalTrials.gov)
December 6, 202122/11/2021Extension Study of Infigratinib in Children With Achondroplasia (ACH)Phase 2, Open-Label, Long-Term, Extension (OLE) Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children With Achondroplasia: PROPEL OLEAchondroplasiaDrug: InfigratinibQED Therapeutics, Inc.NULLRecruiting3 Years18 YearsAll280Phase 2Australia;United Kingdom
3EUCTR2019-002954-21-FR
(EUCTR)
06/05/202020/01/2020A study to evaluate Infigratinib in children with AchondroplasiaPhase 2, Open-Label, Dose-Escalation and Dose-Expansion Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children with Achondroplasia: PROPEL 2 - PROPEL 2 Achondroplasia in Children
MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Infigratinib phosphate
Product Code: BGJ398 (also known as BBP-831)
INN or Proposed INN: INFIGRATINIB
QED Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;France;Canada;Spain;Australia;United Kingdom
4EUCTR2019-002954-21-GB
(EUCTR)
31/03/202013/05/2020A study to evaluate Infigratinib in children with AchondroplasiaPhase 2, Open-Label, Dose-Escalation and Dose-Expansion Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children with Achondroplasia: PROPEL 2 - PROPEL 2 Achondroplasia in Children
MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Infigratinib phosphate
Product Code: BGJ398 (also known as BBP-831)
INN or Proposed INN: INFIGRATINIB
QED Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
78Phase 2United States;France;Canada;Spain;Australia;United Kingdom
5NCT04265651
(ClinicalTrials.gov)
March 10, 202029/1/2020Study of Infigratinib in Children With AchondroplasiaPhase 2, Open-Label, Dose-Escalation and Dose-Expansion Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children With Achondroplasia: PROPEL 2AchondroplasiaDrug: Infigratinib 0.016 mg/kg;Drug: Infigratinib 0.032 mg/kg;Drug: Infigratinib 0.064 mg/kg;Drug: Infigratinib 0.128 mg/kgQED Therapeutics, Inc.NULLRecruiting3 Years11 YearsAll78Phase 2United States;Australia;Canada;France;Spain;United Kingdom