Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Selonsertib · 4 trials · 3 indications
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.
PVR is a measure of the extent to which pulmonary circulation resists cardiac output. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
The values of eGFR were calculated using the MDRD equation: eGFR = 175 x Serum Creatinine\^-1.154 × age\^-0.203 × 1.212 (if participant is black) × 0.742 (if female).
AUCinf is defined as the concentration of drug extrapolated to infinite time.
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Cmax is defined as the maximum concentration of drug.
| Arm | Type | Description |
|---|---|---|
| Selonsertib + Prednisolone | EXPERIMENTAL | Selonsertib + prednisolone for 28 days |
| Prednisolone | PLACEBO_COMPARATOR | Selonsertib placebo + prednisolone for 28 days |
| Selonsertib 2 mg | EXPERIMENTAL | Participants will receive selonsertib 2 milligrams (mg) for 24 weeks and may continue on this dose during the long-term treatment phase. |
| Selonsertib 6 mg | EXPERIMENTAL | Participants will receive selonsertib 6 mg for 24 weeks and may continue on this dose during the long-term treatment phase. |
| Selonsertib 18 mg | EXPERIMENTAL | Participants will receive selonsertib 18 mg for 24 weeks and may continue on this dose during the long-term treatment phase. |
| Placebo | EXPERIMENTAL | Participants will receive selonsertib placebo for 24 weeks, and may then be rerandomized 1:1:1 to selonsertib 2, 6, or 18 mg during the long-term treatment phase. |
| Placebo to match selonsertib | PLACEBO_COMPARATOR | Participants will receive placebo to match selonsertib for 48 weeks. |
| Moderate hepatic impairment (Cohort 1) | EXPERIMENTAL | Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of selonsertib on Day 1. |
| Severe hepatic impairment (Cohort 2) | EXPERIMENTAL | Participants with severe hepatic impairment and matched healthy controls will receive a single dose of selonsertib on Day 1. |
| Mild hepatic impairment (Cohort 3) | EXPERIMENTAL | Participants with mild hepatic impairment and matched healthy controls will receive a single dose of selonsertib on Day 1. |
| Name | Type | Description |
|---|---|---|
| Selonsertib | DRUG | 18 mg tablet administered orally once daily |
| Prednisolone | DRUG | 40 mg (4 x 10 mg tablets) administered orally once daily |
| Placebo | DRUG | Selonsertib placebo tablet administered orally once daily |
| Placebo to match selonsertib | DRUG | Tablets administered orally once daily |
Key Inclusion Criteria: * Willing and able to give informed consent prior to any study specific procedures being performed. In individuals with hepatic encephalopathy (HE) which may impair decision-making, consent will be obtained per hospital procedures (eg, by Legally Authorized Representative) *...
Selonsertib is an investigational small molecule being studied for Diabetic Kidney Disease, Pulmonary Arterial Hypertension, and Alcoholic Hepatitis (AH). It is developed by Gilead Sciences, Inc. (GILD) and is currently in Phase 2 clinical development.
Selonsertib is an investigational small molecule. Its molecular target has not been disclosed in available information, so its mechanism of action is not described here.
Selonsertib is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. The drug is currently in Phase 2 clinical trials for multiple indications.
Selonsertib is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Completed Phase 2 trials have evaluated it in Diabetic Kidney Disease, Pulmonary Arterial Hypertension, and Alcoholic Hepatitis.
Selonsertib has been studied in several completed trials, including NCT02177786 for Diabetic Kidney Disease, NCT02234141 for Pulmonary Arterial Hypertension, and NCT02854631 for Alcoholic Hepatitis. A Phase 1 pharmacokinetic study, NCT02509624, was also completed.
Yes, Selonsertib is also known as GS-4997. Clinical trial records refer to the drug as Selonsertib (GS-4997), confirming that these names refer to the same investigational compound.