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LIQ865A bupivacaine formulation · 1 trial · 1 indication
Safety assessments will include the incidence and severity of AEs during treatment and the follow-up period of the study
| Arm | Type | Description |
|---|---|---|
| LIQ865A bupivacaine formulation | EXPERIMENTAL | Liquidia's PRINT bupivacaine free base/PLGA (poly D,L-lactic-co-glycolic acid) suspension for subcutaneous injection at doses ranging from 150mg to 600mg |
| LIQ865B bupivacaine formulation | EXPERIMENTAL | Liquidia's PRINT bupivacaine free base suspension for subcutaneous injection at doses ranging from 150mg to 600mg |
| Diluent for LIQ865 | PLACEBO_COMPARATOR | Negative control for subcutaneous injection. Each subject will act as his own control, receiving a LIQ865 formulation subcutaneous injection in one calf, and a diluent subcutaneous injection in his other calf |
| 0.5% bupivacaine hydrochoride | ACTIVE_COMPARATOR | Positive control arm to be used with one of the LIQ865 cohorts, with each subject acting as his own positive control (i.e., one leg will receive subcutaneous injection of LIQ865A or LIQ865B, and the other leg will receive subcutaneous injection of 0.5% bupivacaine hydrochloride). |
| Name | Type | Description |
|---|---|---|
| LIQ865A bupivacaine formulation | DRUG | single subcutaneous injection in medial calf |
| LIQ865B bupivacaine formulation | DRUG | single subcutaneous injection in medial calf |
| Diluent for LIQ865 | DRUG | Sterile diluent composed of 12.5mg/g sodium hyaluronate, 5.8mg/g sodium chloride, 1mg/g polysorbate 80, 6.1mg/g Tris base, in sterile water for injection - single subcutaneous injection |
| 0.5% bupivacaine hydrochoride | DRUG | single subcutaneous injection |
Inclusion Criteria: * provide written informed consent prior to enrollment * be a non-smoking male, American Society of Anesthesiologist (ASA) physical class 1 or 2 * have a BMI between 18.5 and 25 kg. inclusive, and a weight of at least 60 kg * be willing and able to participate for the duration o...
| 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 | N/A | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | - | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | - | Flozin |
LIQ865A bupivacaine formulation is an investigational small molecule being developed for acute pain. It is a bupivacaine formulation intended to manage acute pain, though it is still in early clinical development and not yet approved for any use.
LIQ865A bupivacaine formulation is being developed by Liquidia Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker LQDA. The company is conducting clinical research on this bupivacaine formulation for acute pain.
LIQ865A bupivacaine formulation is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and tolerability.
LIQ865A bupivacaine formulation has one completed Phase 1 clinical trial, identified as NCT02982889. This was a single ascending dose study of two Liquidia bupivacaine formulations, conducted in Denmark with 29 healthy male volunteers aged 18 years and older.
LIQ865A bupivacaine formulation is a specific formulation of bupivacaine, a local anesthetic. It is being developed by Liquidia Corporation for acute pain, and the clinical trial evaluated two Liquidia bupivacaine formulations, including LIQ865A.