Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SDI-118 · 1 trial · 1 indication
Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical product whether or not considered related to the medical product. An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.
Number of participants with potentially clinically significant laboratory values (hematology/chemistry/urinalysis)
Number of participants with potentially clinically significant vital sign values
Number of participants with potentially clinically significant temperature values
Number of participants with potentially clinically significant ECG values.
Number of participants with potentially clinically significant changes in physical examination.
Number of participants with potentially clinically significant changes in neurological examination.
Number of participants with potentially clinically significant changes in Profile of Mood States (Brief) values.
Number of participants with potentially clinically significant changes in Bond-Lader VAS values.
| Arm | Type | Description |
|---|---|---|
| SDI-118 Dose 1 | EXPERIMENTAL | - |
| SDI-118 Dose 2 | EXPERIMENTAL | - |
| SDI-118 Dose 3 | EXPERIMENTAL | - |
| SDI-118 Dose 4 | EXPERIMENTAL | - |
| SDI-118 Dose 5 | EXPERIMENTAL | - |
| SDI-118 Dose 6 | EXPERIMENTAL | - |
| SDI-118 Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SDI-118 | DRUG | SDI-118 Powder in Capsule |
| Placebo | DRUG | Matching Placebo |
Inclusion Criteria: * Healthy male subjects, 18 to 50 years of age, inclusive. * Non-smokers or abstinence from tobacco for at least 3 months prior to screening. * Body mass index (BMI) between 18 and 30 kg/m2, inclusive, with a minimum weight of 50 kg and maximum of 100 kg. * Venous access suffici...
Top 3 of 5 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 3 | PHASE2 | Donanemab |
| Alto Neuroscience, Inc. | ANRO | 1 | PHASE2 | ALTO-101 |
| Bristol-Myers Squibb Company | BMY | 1 | PHASE3 | Xanomeline/Trospium Chloride |
SDI-118 is an investigational small molecule being developed for cognitive disorders. It is in Phase 1 clinical development and is not approved for any indication. The completed Phase 1 study enrolled healthy male volunteers rather than patients, so its use in cognitive disorders remains under investigation.
SDI-118 targets SV2A, a synaptic vesicle protein. SV2A is a protein target, and the Phase 1 study of SDI-118 included an assessment of receptor occupancy, which measures how much the drug binds its target. The drug is a small molecule.
SDI-118 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program for SDI-118 in cognitive disorders.
SDI-118 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulator. The Phase 1 program consists of one completed trial, and no active trials of SDI-118 are currently listed.
SDI-118 has been studied in one Phase 1 trial, NCT05486195, titled a single ascending oral dose study in healthy male subjects including an assessment of receptor occupancy and food effect. The trial was completed, enrolled 32 participants, was randomized, double-blind, and placebo-controlled, and was conducted in Belgium.