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Also known as ICI35,868 (propofol), ICI35,868 (Diprivan)
ICI35, 868 · 1 trial · 2 indications
The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5.
The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5.
| Arm | Type | Description |
|---|---|---|
| Arm1 - Placebo | PLACEBO_COMPARATOR | - |
| Arm 2 - ICI35,868 (propofol) | ACTIVE_COMPARATOR | - |
| Arm 3 - ICI35,868 (propofol) | ACTIVE_COMPARATOR | - |
| Arm 4 - ICI35,868 (propofol) | ACTIVE_COMPARATOR | - |
| Arm 5 - ICI35,868 (propofol) | ACTIVE_COMPARATOR | - |
| Arm 6 - ICI35,868 (propofol) | ACTIVE_COMPARATOR | - |
| Arm 7 - ICI35,868 (propofol) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Infusion of placebo, same infusion rates as for arm 2 |
| ICI35,868 (propofol) | DRUG | Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute |
Inclusion Criteria: * Male or female (females of child bearing potential to confirm not pregnant via test or contraception) * Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour Exclusion Criteria: * American So...
ICI35,868 is an investigational small molecule developed by AstraZeneca PLC under the ticker AZN. It is being studied as a sedative agent for gastrointestinal endoscopy procedures, including upper and lower endoscopic tests and gastrointestinal polypectomy. It is also known by the name propofol and the brand name Diprivan.
ICI35,868 is being developed to provide minimal-to-moderate sedation during upper and lower endoscopic tests, including gastrointestinal polypectomy procedures. It is a small molecule sedative studied in a Phase 2 dose rate range finding trial conducted in Japan in adults aged 20 years and older.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of ICI35,868. The company sponsored the clinical development work for the drug, including the Phase 2 dose rate range finding study conducted in Japan in patients undergoing gastrointestinal endoscopy.
ICI35,868 is in Phase 2 development. It is investigational and has not been approved. One Phase 2 trial has been completed, and no trials are currently active. That completed study enrolled 123 participants and evaluated the drug for sedation during upper and lower endoscopic tests.
ICI35,868 has been studied in one completed Phase 2 trial, NCT01189604, titled a dose rate range finding study of propofol for minimal-to-moderate sedation on upper and lower endoscopic tests. It enrolled 123 participants in Japan, was randomized and placebo-controlled, and included patients with gastrointestinal endoscopy and gastrointestinal polypectomy conditions.
Yes. ICI35,868 is also known as propofol and by the brand name Diprivan. These names refer to the same small molecule, which AstraZeneca PLC is developing for sedation during gastrointestinal endoscopy procedures such as upper and lower endoscopic tests and gastrointestinal polypectomy.