Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06842355 | A Study of TYRA-300 in Children With Achondroplasia: BEACH301 | PHASE2 | RECRUITING | 92 | — | — | Mar 4, 2025 | Jun 1, 2030 | Jun 5, 2026 | 17 | United States, Australia +2 |
| Arm | Type | Description |
|---|---|---|
| TYRA-300 0.125 mg/kg | EXPERIMENTAL | TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months. |
| TYRA-300 0.25 mg/kg | EXPERIMENTAL | TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months. |
| TYRA-300 0.375 mg/kg | EXPERIMENTAL | TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months. |
| TYRA-300 0.50 mg/kg | EXPERIMENTAL | TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months. |
| Name | Type | Description |
|---|---|---|
| TYRA-300 0.125 mg/kg | DRUG | Initial dose level of TYRA-300 per protocol, subsequent dose level escalations will occur based on criteria outlined in the protocol. |
| TYRA-300 0.25 mg/kg | DRUG | Subsequent dose level escalations will occur based on criteria outlined in the protocol. |
| TYRA-300 0.375 mg/kg | DRUG | Subsequent dose level escalations will occur based on criteria outlined in the protocol. |
| TYRA-300 0.50 mg/kg | DRUG | Subsequent dose level escalations will occur based on criteria outlined in the protocol. |
Inclusion Criteria: * Aged 3 to 10 years old (inclusive) at the time of consent. * Informed consent provided by parent(s) or legal guardian(s). As study participants are less than 18 years old, participants are willing and able to provide written assent (where applicable and required). * Molecular ...