Product Description
RGX-202-01 is a small molecule inhibitor of SLC6A8 that depletes intracellular PCr and ATP, resulting in apoptosis. In a completed Phase 1a study, RGX-202-01 monotherapy demonstrated objective anti-tumor activity in the relapsed/refractory KRAS-mut CRC setting without dose-limiting toxicity. (Sourced from: https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.3579)
Mechanisms of Action: SLC6A8 Inhibitor
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Merck KGaA
Company Location: GERMANY HRB 6164 I8
Company CEO: Belen Garijo
Additional Commercial Interests: Inspirna
Clinical Description
Countries in Clinic: Belgium, France, Spain, United States
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Acute Respiratory Distress Syndrome|Colorectal Cancer
Phase 1: Digestive System Cancer|Gastrointestinal Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT03597581 |
RGX-202-001 | P1 |
Completed |
Colorectal Cancer|Gastrointestinal Cancer|Digestive System Cancer |
2025-03-31 |
4% |
2025-04-04 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2023-503356-27-00 |
RGX-202-002 | P2 |
Active, not recruiting |
Acute Respiratory Distress Syndrome|Colorectal Cancer |
2026-02-26 |
2025-05-02 |
Treatments |
|
NCT05983367 |
RGX-202-002 | P2 |
Active, not recruiting |
Colorectal Cancer |
2025-01-31 |
12% |
2025-03-05 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |