Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Drotrecogin alfa · 6 trials · 4 indications
Expressed as percentage of participants who died from any cause at Day 28 endpoint.
Mean change in protein C from Study Day 1 to Study Day 7 was tested using an unadjusted two-sample t-test with a two-sided alpha of 0.05. To be included in the primary analysis, Intention-to-Treat (ITT) patients must have at least 1 protein C value available at 24 hours or earlier and at least 1 protein C value at a post-24-hour timepoint.
Number of patients with major bleeding events, defined as: Reduction in hemoglobin of 2 to 5 grams per deciliter (g/dL) within 24 hours; Transfusion of 2 to 4 units of packed red blood cells within 24 hours; Hematoma requiring prolonged hospitalization or surgical intervention; Intracranial or retroperitoneal hemorrhage.
| Arm | Type | Description |
|---|---|---|
| Drotrecogin alfa (activated) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | 24 microgram/kg/hr for 96 hours (+ or - 1 hour) |
| 2 | PLACEBO_COMPARATOR | 0.9% sodium chloride |
| Standard therapy | EXPERIMENTAL | 24 microgram/kilogram/hour (mcg/kg/hr) for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours |
| Alternative therapy:moderate protein C deficiency | EXPERIMENTAL | 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 48 to 144 hours (original protocol) or an additional 72 to 144 hours (amended protocol) |
| Alternative therapy:severe protein C deficiency | EXPERIMENTAL | 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for 48 to 144 hours (original protocol) or an additional 72 to 144 hours (amended protocol) |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| 5 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Drotrecogin alfa (activated) | DRUG | 24 microgram/kilogram/hour, intravenous, 96 hours (hr) |
| Placebo | DRUG | 0.9% sodium chloride, intravenous, 96 hours |
| Enoxaparin | DRUG | 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days |
Inclusion Criteria: * Must be 18 years or older * Must have evidence of infection * Must have systemic inflammatory response syndrome (SIRS) * Must have vasopressor-dependent septic shock Exclusion Criteria: * Have received vasopressor therapy (at any dose) for greater than 24 hours prior to the ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| ImmunityBio Inc | IBRX | 1 | PHASE2 | Nogapendekin alfa inbakicept |
| Bluejay Diagnostics, Inc. | BJDX | 2 | - | Undisclosed |
| CytoSorbents Corporation | CTSO | 1 | - | Undisclosed |
| Danaher Corporation | DHR | 3 | - | Undisclosed |
| Spectral AI, Inc. Class A | MDAI | 1 | N/A | Undisclosed |
Drotrecogin Alfa is an investigational small molecule being developed for sepsis, submassive pulmonary embolism, and severe sepsis. It is a recombinant activated protein C that has been studied in clinical trials for these serious conditions.
Drotrecogin Alfa is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY.
Drotrecogin Alfa is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. All four completed trials were Phase 3 studies, but the drug remains in earlier-stage development.
Drotrecogin Alfa has been studied in four completed clinical trials. These include NCT00049764 in pediatric severe sepsis, NCT00190788 comparing 4 vs 7 day infusion, NCT00568737 in adults with severe sepsis at low risk of death, and NCT00604214 in adults with septic shock.
Drotrecogin Alfa is also known by the brand name Xigris. It is a recombinant form of activated protein C that has been investigated for the treatment of severe sepsis and related conditions.
Drotrecogin Alfa is a recombinant activated protein C that exerts anti-inflammatory, antithrombotic, and profibrinolytic effects. It targets the coagulation and inflammatory pathways that are dysregulated in sepsis, potentially reducing organ damage and improving outcomes.