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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04691154 | A Phase 3 Study to Evaluate the Safety and Tolerability of L606 in Subjects With PAH or PH-ILD | PHASE3 | ACTIVE NOT_RECRUITING | 28 | — | — | Aug 1, 2021 | Mar 31, 2031 | Apr 1, 2026 | 8 | United States |
(MSP for Cohort A): Proportion of patients with PAH or PH-ILD on a stable Tyvaso dose who would develop treatment-emergent AEs/SAEs after switching to L606 dosing for up to 2 weeks during MSP.
(OEP for Cohorts A and B): Proportion of subjects with PAH or PH-ILD, choosing to continue twice daily L606 dosing for up to 48 weeks, who would develop treatment emergent AEs/SAEs up to 48 hours after the last dose.
| Arm | Type | Description |
|---|---|---|
| L606 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| L606 inhalation suspension | COMBINATION_PRODUCT | L606 inhalation suspension |
Key Inclusion Criteria: 1. Males and females ≥18 and ≤80 years of age. 2. Diagnosed with 1. PAH belonging to at least 1 of the following subgroups of Group 1 pulmonary hypertension (PH) per European Society of Cardiology/European Respiratory Society Guidelines for the diagnosis and treatment of...