Drugs / VRG50635
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06286475 | Feb → Mar 2024 | — | Verge Genomics | Completed | No outcome recorded |
| Phase 1 | NCT06215755 | Jan 2024 → Jul 2025 | amyotrophic lateral sclerosis | Verge Genomics | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-06-16 | Verge Genomics | Results Verge Labs Unveils vBx: A Breakthrough Foundation Model for Precision Neurology vergelabs.com ↗
When vBx-1.0 ran zero-shot on baseline patient blood samples before treatment, it identified that the PIKfyve-driven biological program was already suppressed at baseline in the same patients who later could not tolerate the drug. |
| 2025-04-07 | Verge Genomics | Results Digital biomarkers detect short-term ALS progression in VRG50635 trial run-in vergelabs.com ↗
Statistically significant measures of disease progression were identified across multiple endpoints after just eight weeks of monitoring pre-treatment, with the potential to reshape ALS clinical trial design. |
| 2023-06-15 | Verge Genomics | Results Positive Phase 1 safety and tolerability data for VRG50635 vergelabs.com ↗
VRG50635 was dosed up to the maximum single and repeated doses planned, demonstrating a favorable safety, tolerability, and pharmacokinetic profile supportive of advancement into a proof-of-concept study in people with amyotrophic lateral sclerosis (ALS). |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-16 | Verge Genomics | Verge Labs Unveils vBx: A Breakthrough Foundation Model for Precision Neurology vergelabs.com ↗ |
| 2025-04-07 | Verge Genomics | Digital biomarkers detect short-term ALS progression in VRG50635 trial run-in vergelabs.com ↗ |
| 2023-11-29 | Verge Genomics | VRG50635 proof-of-concept study initiated in patients with ALS vergelabs.com ↗ |
| 2023-06-15 | Verge Genomics | Positive Phase 1 safety and tolerability data for VRG50635 vergelabs.com ↗ |
| 2022-10-31 | Verge Genomics | First-in-human dosing of VRG50635 begins in Phase 1 trial vergelabs.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VRG50635 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06215755 ↗ |
| Action | Inhibit | “PIKfyve inhibition” PMID 41708347 ↗ Feb 2026 |
| Modality | Small molecule | “VRG50468 is the active metabolite of VRG50635, a small molecule PIKfyve inhibitor pro-drug in development for treating amyotrophic lateral sclerosis (ALS).” PMID 41708347 ↗ Feb 2026 |
| Route | Oral | “VRG50635 will be administered as oral capsules once daily” NCT06215755 ↗ |
| Target | PIKFYVE | “PIKfyve inhibitor” PMID 41708347 ↗ Feb 2026 |