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...
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| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 11 | PHASE3 | Savolitinib, Baxdrostat, Zibotentan/Dapagliflozin, Dapagliflozin, AZD4248 |
| Eli Lilly and Company | LLY | 4 | PHASE3 | Retatrutide, Orforglipron, LY3841136, SGLT2 inhibitor |
| Novartis AG Sponsored ADR | NVS | 4 | PHASE3 | Zigakibart, OJR520 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 3 | PHASE3 | DCR-PHXC, NNC0519-0130, Semaglutide |
| Amgen Inc. | AMGN | 1 | PHASE3 | Etelcalcetide |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Mezagitamab |
| ProKidney Corp. Class A | PROK | 3 | PHASE3 | Rilparencel |
| Humacyte, Inc. | HUMA | 1 | PHASE3 | Symvess |
| Fresenius Medical Care AG Sponsored ADR | FMS | 6 | PHASE2 | Difelikefalin |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | GSK4771261 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | Vonsetamig |
| Merck & Co., Inc. | MRK | 1 | PHASE1 | MK-2828 |
| United Therapeutics Corporation | UTHR | 2 | PHASE1 | 10 GE Xenokidney, GGTA1 KO Thymokidney |
| Pfizer Inc. | PFE | 1 | PHASE1 | PF-07328948 |
| OPKO Health, Inc. | OPK | 1 | PHASE2 | CTAP101 |
| Incyte Corporation | INCY | 1 | PHASE1 | INCB123667 |
GCS-100 is an investigational small molecule being studied for chronic lymphocytic leukemia and chronic kidney disease. It is developed by Innoviva, Inc. (NASDAQ: INVA). The drug is currently in Phase 2 clinical development for these conditions, with completed trials in both indications.
GCS-100 is a small molecule that targets galectin-3, a protein involved in fibrosis and inflammation. By inhibiting galectin-3, GCS-100 aims to reduce tissue scarring and inflammatory processes associated with chronic kidney disease and chronic lymphocytic leukemia.
GCS-100 is being developed by Innoviva, Inc., a biopharmaceutical company traded on NASDAQ under the ticker INVA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in chronic kidney disease and chronic lymphocytic leukemia.
GCS-100 is in Phase 2 clinical development. It has completed three clinical trials, including two Phase 2 studies and one Phase 1 study. No trials are currently active, and the drug remains investigational, not yet approved by regulatory authorities.
GCS-100 has been studied in three completed clinical trials. NCT00514696 was a Phase 2 safety study in chronic lymphocytic leukemia with 12 participants. NCT01717248 was a Phase 1 safety study in chronic kidney disease with 29 participants. NCT01843790 was a Phase 2a study with 120 participants, and NCT02155673 was a Phase 2 extension study with 92 participants, both in chronic kidney disease.
GCS-100 is also known by its chemical name, modified citrus pectin. It is a small molecule that has been studied under the name GCS-100 in clinical trials for chronic kidney disease and chronic lymphocytic leukemia. No other alternative names have been reported.