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Infigratinib · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1: Rollover subjects | EXPERIMENTAL | Children who have completed QED-sponsored interventional study with infigratinib |
| Phase 2 Cohort 1 | EXPERIMENTAL | infigratinib (0.128 mg/kg/day) |
| Phase 2 Cohort 2 | EXPERIMENTAL | infigratinib (0.25 mg/kg/day) |
| Name | Type | Description |
|---|---|---|
| Infigratinib | DRUG | Infigratinib to be administered by mouth and initiated at the last dose level received in the ACCEL 2/3 study or at the dose selected to be further evaluated after proof-of-concept is established for Phase 2 portion of ACCEL 2/3. |
| infigratinib 0.128 mg/kg/day | DRUG | Oral infigratinib 0.128 mg/kg/day |
| infigratinib 0.25 mg/kg/day | DRUG | Oral infigratinib 0.25 mg/kg/day |
Inclusion Criteria: * Inclusion Criteria for Participants Rolling Over from ACCEL 2/3 1. Pediatric participants with HCH who have completed ACCEL 2/3 2. Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche Exclusion Criteria: * Exclusion Criteri...
Infigratinib is an investigational small molecule being studied for the treatment of hypochondroplasia and achondroplasia, two rare skeletal disorders. It is in clinical development for children aged 3 years and older with these conditions. The drug is not yet approved and remains under investigation in clinical trials.
Infigratinib is a kinase inhibitor that targets fibroblast growth factor receptors FGFR1, FGFR2, FGFR3, and FGFR4. By inhibiting these receptors, particularly FGFR3, the drug aims to address the underlying signaling abnormalities associated with achondroplasia and hypochondroplasia.
Infigratinib is being developed by BridgeBio Pharma, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol BBIO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in children with achondroplasia and hypochondroplasia.
Infigratinib is in Phase 2 clinical development for hypochondroplasia and has completed Phase 2 and Phase 3 trials for achondroplasia. It is an investigational drug and has not received FDA approval. The drug has been granted breakthrough therapy, orphan drug, fast track, and rare pediatric disease designations.
Infigratinib has been studied in several clinical trials. NCT04265651 and NCT06164951 evaluated the drug in children with achondroplasia, while NCT06873035 is an interventional study in children with hypochondroplasia. NCT07393373 is a long-term extension study in hypochondroplasia. These trials are conducted across multiple countries including the United States, Canada, and European nations.
Yes, infigratinib 0.128 mg/kg/day refers to a specific dosing regimen of infigratinib. The drug is also known by the alternative name infigratinib /kg/day. These names describe the same investigational compound being developed by BridgeBio Pharma for achondroplasia and hypochondroplasia.