Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GCS-100 · 4 trials · 2 indications
Evaluation of safety measures for long-term dosing including collection of adverse events in clinically significant changes in lab values
| Arm | Type | Description |
|---|---|---|
| Low Dose GCS-100 | EXPERIMENTAL | Low dose of GCS-100 |
| High Dose GCS-100 | EXPERIMENTAL | GCS-100 High dose |
| Placebo, saline | PLACEBO_COMPARATOR | Saline, dosed weekly for 8 weeks |
| GCS-100 low dose | EXPERIMENTAL | Low dose of GCS-100 given IV once per week for 8 weeks |
| GCS-100 high dose | EXPERIMENTAL | High dose of GCS-100 given IV once per week for 8 weeks |
| GCS-100 | EXPERIMENTAL | GCS-100: 160 mg/m2 IV (in the vein) Study Days 1-5 of each 21-day cycle |
| Name | Type | Description |
|---|---|---|
| GCS-100 | DRUG | 1.5 mg/m2 or 30 mg/m2 GCS-100. GCS-100 will be administered as IV infusions once weekly for 8 weeks with a 1 week and 4 week follow-up period and then at least every 30 days for up to a total of 1 year. |
| Placebo, Saline | DRUG | The amount (in mg) of drug to be administered will be determined based on body surface area, which will be calculated based on body weight and height. The drug dose should be calculated on Day 1. Drug should be added to an infusion bag or syringe containing 0.9% Sodium Chloride Injection, USP. Drug be infused into a large vein via a large bore catheter to avoid local irritation and administered at no more than 2 mg/mL in no less than 60 mL. |
Inclusion Criteria: 1. Subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent 2. Subject was enrolled in and completed the End of Study (Day 85) of GCS-100-CS-4002 Exclusion Criteria: 1. Subject experienced a Grade 3 or worse adverse...
Top 20 of 25 competitors
GCS-100 is an investigational small molecule being developed for Chronic Lymphocytic Leukemia and Chronic Kidney Disease. It is currently in Phase 2 clinical development and has been studied in completed trials for both conditions.
GCS-100 is being developed by Innoviva, Inc., a company traded on the NASDAQ under the ticker INVA. The drug is currently in Phase 2 clinical development.
GCS-100 is in Phase 2 clinical development. It has completed three clinical trials, including Phase 1 and Phase 2 studies, but is not yet approved by the FDA and remains investigational.
GCS-100 has been studied in three completed trials: NCT00514696 for Chronic Lymphocytic Leukemia, NCT01717248 for Chronic Kidney Disease, and NCT01843790, a Phase 2a study for Chronic Kidney Disease. An extension study, NCT02155673, was also completed.
GCS-100 is the primary name for this investigational small molecule. No alternative names have been reported for this drug in the clinical trial data.