Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]AZD4144 Oral Solution, [14C]AZD4144 Solution for Infusion
AZD4144 · 4 trials · 8 indications
The total area under the curve for 24-hour creatinine clearance measured throughout the treatment period.
area under the concentration-time curve from zero to infinity
area under the concentration-time curve from zero to the last measurable concentration
area under the curve from time zero to time 144hours post dose
maximum observed plasma concentration
The safety and the tolerability of AZD4144 compared with placebo will be evaluated.
The effect of AZD4144 on circulating inflammatory biomarker IL-6 compared with placebo will be evaluated.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To evaluate the safety and tolerability of AZD4144 single dose in participants with severe renal impairment, ESKD, and their healthy controls.
| Arm | Type | Description |
|---|---|---|
| Arm 1 (AZD4144) | EXPERIMENTAL | AZD4144 solution for IV infusion |
| Arm 2 (Placebo) | PLACEBO_COMPARATOR | Placebo concentrate for solution for infusion |
| Group 1 | EXPERIMENTAL | Participants with mild hepatic impairment (CP Class A, score of 5 or 6) |
| Group 2 | EXPERIMENTAL | Participants with moderate hepatic impairment (CP Class B, score of 7 to 9). |
| Group 3 | EXPERIMENTAL | Participants with severe hepatic impairment (CP Class C, score of 10 to 15). |
| Group 4 | EXPERIMENTAL | Participants with normal hepatic function matched on a group level regarding sex, age, and BMI to the impaired groups |
| AZD4144 | EXPERIMENTAL | Participants will receive oral dose of AZD4144 for 28 days. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive oral dose of Placebo for 28 days. |
| Cohort 1: AZD4144 | EXPERIMENTAL | Participants with severe renal impairment will receive a single oral dose of AZD4144 on Day 1. |
| Cohort 2: AZD4144 | EXPERIMENTAL | Healthy participants with normal renal function will receive a single oral dose of AZD4144 on Day 1. |
| Cohort 3: AZD4144 | EXPERIMENTAL | Participants with ESKD on intermittent haemodialysis will receive a single oral dose of AZD4144 on the first day of Treatment Period 1 and Treatment Period 2. |
| Cohort 4: AZD4144 | EXPERIMENTAL | Participants with moderate renal impairment will receive a single oral dose of AZD4144 on Day 1. |
| Cohort 5: AZD4144 | EXPERIMENTAL | Participants with mild renal impairment will receive a single oral dose of AZD4144 on Day 1. |
| Name | Type | Description |
|---|---|---|
| AZD4144 | DRUG | Intravenous solution of AZD4144 will be administered to randomised participants according to the treatment arm to which they have been assigned. |
| Placebo | DRUG | Intravenous solution of Placebo will be administered to randomised participants according to the treatment arm to which they have been assigned. |
Inclusion Criteria Age ≥ 18 to ≤ 80 years at the time of signing the informed consent. Participants who are admitted to an ICU or an equivalent critical-care unit. Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-...
Top 3 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Bayer | BAYRY | 2 | PHASE1 | BAY 3389934 |
AZD4144 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN). It is being studied in clinical trials for chronic kidney disease, end-stage kidney disease, hepatic impairment, and sepsis. It is a Phase 1 stage asset overall, with one Phase 2 study also underway in sepsis-associated acute kidney injury.
AZD4144 is being studied for chronic kidney disease, end-stage kidney disease, hepatic impairment, and sepsis, including sepsis-associated acute kidney injury. It is investigational and has not been approved for any indication. Clinical work spans pharmacokinetic studies in patients with organ impairment and a Phase 2 efficacy and safety study in sepsis-associated acute kidney injury.
AZD4144 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating the drug across kidney, liver, and sepsis-related conditions, including studies conducted in the United States, Europe, Canada, Argentina, and Turkey.
AZD4144 is in Phase 1 development, with completed Phase 1 studies in renal impairment and in chronic kidney disease with atherosclerotic cardiovascular disease. A Phase 2 study in sepsis-associated acute kidney injury is also recruiting. The drug is investigational and has not been approved by the FDA for any indication.
AZD4144 has been studied in NCT06693765, a completed Phase 1 trial in severe renal impairment, end-stage kidney disease, and healthy participants, and NCT06675175, a completed Phase 1b trial in chronic kidney disease with atherosclerotic cardiovascular disease. NCT07215702 is a recruiting Phase 2 trial in sepsis-associated acute kidney injury, and NCT07783308 is a Phase 1 hepatic impairment study not yet recruiting.
Yes. [14C]AZD4144 Oral Solution is an alternative name for AZD4144. The 14C label denotes a carbon-14 radiolabeled oral solution formulation used in clinical pharmacology work, while AZD4144 is the compound itself. Both names refer to the same AstraZeneca investigational small molecule.