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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06619847 | A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy | PHASE2 | COMPLETED | 367 | — | — | Oct 29, 2024 | May 27, 2025 | May 28, 2026 | 14 | United States |
| Arm | Type | Description |
|---|---|---|
| VX-993 | EXPERIMENTAL | Participants will be randomized to receive different dose levels of VX-993. |
| Hydrocodone bitartrate/acetaminophen (HB/APAP) | ACTIVE_COMPARATOR | Participants will be randomized to receive HB/APAP. |
| Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive placebo matched to VX-993 and HB/APAP |
| Name | Type | Description |
|---|---|---|
| VX-993 | DRUG | Tablets for oral administration. |
| HB/APAP | DRUG | Capsules for oral administration. |
| Placebo (matched to VX-993) | DRUG | Placebo matched to VX-993 for oral administration. |
| Placebo (matched to HB/APAP) | DRUG | Placebo matched to HB/APAP for oral administration. |
Key Inclusion Criteria: Before Surgery: * Participant scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo block) After Surgery: * Participant is lucid and able to follow comma...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Fresenius Medical Care AG Sponsored ADR | FMS | 2 | PHASE3 | Dialysis |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| CalciMedica, Inc. | CALC | 1 | PHASE2 | Auxora |
| Talphera, Inc. | TLPH | 1 | NA | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | — | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | — | Flozin |