Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Infigratinib
Infigratinib/kg · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Infigratinib 0.25 mg/kg/day | EXPERIMENTAL | Infigratinib at 2, 3.5, 5, 7, 10 mg |
| Placebo 0.25 mg/kg/day | PLACEBO_COMPARATOR | Placebo Comparator at 2, 3.5, 5, 7, 10 mg |
| Arm 1: Rollover subjects | EXPERIMENTAL | Children who have completed QED-sponsored interventional study with infigratinib (Phase 2 or Phase 3) |
| Arm 2: Treatment naïve subjects | EXPERIMENTAL | Children naïve to infigratinib |
| Infigratinib 0.016 mg/kg | EXPERIMENTAL | Dose Escalation: Infigratinib is provided as minitablets in 2 strengths: 0.1 mg and 1 mg for daily oral administration. The dose and number of minitablets/day will be calculated based on individual participant weight. Doses will be adjusted based on weight changes approximately every 3 months. |
| Infigratinib 0.032 mg/kg | EXPERIMENTAL | Dose Escalation and PK substudy: Infigratinib is provided as minitablets in 2 strengths: 0.1 mg and 1 mg for daily oral administration. The dose and number of minitablets/day will be calculated based on individual participant weight. Doses will be adjusted based on weight changes approximately every 3 months. |
| Infigratinib 0.064 mg/kg | EXPERIMENTAL | Dose Escalation and PK substudy: Infigratinib is provided as minitablets in 2 strengths: 0.1 mg and 1 mg for daily oral administration. The dose and number of minitablets/day will be calculated based on individual participant weight. Doses will be adjusted based on weight changes approximately every 3 months. |
| Infigratinib 0.128 mg/kg | EXPERIMENTAL | Dose Escalation and PK substudy: Infigratinib is provided as minitablets in 2 strengths: 0.1 mg and 1 mg for daily oral administration. The dose and number of minitablets/day will be calculated based on individual participant weight. Doses will be adjusted based on weight changes approximately every 3 months. |
| Infigratinib 0.25 mg/kg | EXPERIMENTAL | Dose Escalation and PK substudy: Infigratinib is provided as minitablets in 2 strengths: 0.1 mg and 1 mg for daily oral administration. The dose and number of minitablets/day will be calculated based on individual participant weight. Doses will be adjusted based on weight changes approximately every 3 months. Dose Expansion: Upon identification of the recommended dose from all cohorts analyzed, an expansion cohort of 20 subjects may begin enrollment to further determine safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of the selected dose. |
| Name | Type | Description |
|---|---|---|
| Infigratinib 0.25 mg/kg/day | DRUG | Daily doses of oral Infigratinib (sprinkle capsules) at 2, 3.5, 5, 7, 10 mg |
| Placebo Comparator 0.25 mg/kg/day | DRUG | Daily doses of oral Placebo Comparator (sprinkle capsules) at 2, 3.5, 5, 7, 10 mg |
| Infigratinib | DRUG | Infigratinib minitablets or sprinkle capsules to be administered by mouth. In subjects that completed a prior study with infigratinib, the starting dose will be the same as the last dose received in the prior interventional study with infigratinib. Infigratinib dose may be adjusted to 0.25 mg/kg/day (the dose selected to be explored further in the dose escalation portion of Phase 2 study QBGJ398-201 (PROPEL 2)). |
| Infigratinib 0.016 mg/kg | DRUG | Initial cohort dose of infigratinib at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria. Infigratinib tablets to be administered by mouth. |
| Infigratinib 0.032 mg/kg | DRUG | Subsequent cohort dose escalation based on protocol-specific criteria. Infigratinib tablets to be administered by mouth. |
| Infigratinib 0.064 mg/kg | DRUG | Subsequent cohort dose escalation based on protocol-specific criteria. Infigratinib tablets to be administered by mouth. |
| Infigratinib 0.128 mg/kg | DRUG | Subsequent cohort dose escalation based on protocol-specific criteria. Infigratinib tablets to be administered by mouth. |
| Infigratinib 0.25 mg/kg | DRUG | Subsequent cohort dose escalation based on protocol-specific criteria. Infigratinib tablets to be administered by mouth. |
Inclusion Criteria: 1. Subject must be 3 to \<18 years of age at screening with growth potential defined as annualized height velocity of \>1.5 cm/year over a period of at least 6 months of participation in the PROPEL observational study (QBGJ398-001), pubertal Tanner stage ≤4, and bone age ≤13 yea...
Infigratinib is an investigational small molecule being developed for the rare skeletal disorders achondroplasia and hypochondroplasia. It is studied in children and adolescents, with clinical trials enrolling participants as young as 3 years old. The drug is not approved and remains in clinical development.
Infigratinib is a kinase inhibitor, belonging to the -tinib class of drugs that target tyrosine kinases. It is being studied for its effects on bone growth in achondroplasia and hypochondroplasia. The specific molecular target is not disclosed in the available information.
Infigratinib is being developed by BridgeBio Pharma, Inc., a biopharmaceutical company traded on NASDAQ under the ticker BBIO. BridgeBio is conducting clinical trials of the drug in multiple countries for achondroplasia and hypochondroplasia.
Infigratinib is in Phase 2 and Phase 3 clinical trials. It has received FDA designations including Breakthrough Therapy, Orphan Drug, Fast Track, and Rare Pediatric Disease. The drug is investigational and has not been approved by the FDA.
Infigratinib has been studied in several trials, including NCT04265651, a completed Phase 2 study in achondroplasia with 84 participants, and NCT06164951, a completed Phase 3 study with 114 participants. An extension study, NCT05145010, is enrolling by invitation with a target of 300 participants.
Yes, infigratinib 0.128 mg/kg/day and infigratinib/kg/day refer to the same drug, Infigratinib, at specific dosing levels used in clinical studies. These alternative names describe the dose administered per kilogram of body weight per day in pediatric trials.