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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07436689 | Long-Term Open-Label Extension Study of Oral Levosimendan | PHASE3 | ENROLLING BY_INVITATION | 800 | — | — | Mar 13, 2026 | Mar 1, 2029 | Mar 19, 2026 | 5 | United States |
| NCT07288398 | LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2 | PHASE3 | RECRUITING | 540 | — | — | Mar 3, 2026 | Jun 30, 2029 | Mar 16, 2026 | 92 | United States, Argentina +13 |
The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs will be tabulated by system organ class and preferred term.
Change in 6-minute walk distance
| Arm | Type | Description |
|---|---|---|
| TNX-103 | EXPERIMENTAL | Open-label oral levosimendan 1-3mg |
| Placebo | PLACEBO_COMPARATOR | Matching placebo (oral) |
| Name | Type | Description |
|---|---|---|
| TNX-103 | DRUG | Open-label oral levosimendan 1-3mg |
| Placebo | DRUG | Matching placebo (oral) |
Inclusion Criteria: * Completed a TNX-103 parent study * Investigator confirmation that participant may derive clinical benefit from continued access to TNX-103 * Requirements related to childbearing potential, contraception, and egg/sperm donation Exclusion Criteria: * Investigator or Sponsor op...