Drugs / Inaxaplin
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05955872 | Jul → Sep 2023 | focal segmental glomerulosclerosis | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT05865171 | Jun 2023 → Jun 2024 | impaired renal function disease | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT06794996 | Feb 2025 → Dec 2026 expected | proteinuria | Vertex Pharmaceuticals Incorporated | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04340362 | Jun 2020 → Nov 2021 | focal segmental glomerulosclerosis | Vertex Pharmaceuticals Incorporated | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05312879 | Mar 2022 → Jun 2028 expected | proteinuria | Vertex Pharmaceuticals Incorporated | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2023-03-16 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces Publication in New England Journal of Medicine of Results from Phase 2 Study of Inaxaplin (VX-147) vrtx.com ↗
The manuscript presents results from the Phase 2 study of inaxaplin, demonstrating a statistically significant and clinically meaningful mean reduction in proteinuria of 47.6% (95% CI: 60.0%, 31.3%) at 13 weeks compared to baseline, which was the primary endpoint of the study. |
| 2022-06-08 | Vertex Pharmaceuticals Incorporated | Regulatory Vertex Announces Inaxaplin (VX-147) Granted Breakthrough Therapy Designation by U.S. FDA and Priority Medicines (PRIME) Designation by the EMA vrtx.com ↗ |
| 2021-12-01 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces Positive Results From Phase 2 Study of VX-147 in APOL1-Mediated Focal Segmental Glomerulosclerosis vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that, in a Phase 2 proof-of-concept (POC) study in patients with APOL1-mediated focal segmental glomerulosclerosis (FSGS), VX-147 on top of standard of care achieved a statistically significant, substantial and clinically meaningful mean reduction of 47.6% in the urine protein to creatinine ratio (UPCR) at Week 13 compared to baseline. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-04-01 | Vertex Pharmaceuticals Incorporated | Vertex Advances Inaxaplin (VX-147) into Phase 3 Portion of Adaptive Phase 2/3 Clinical Trial for the Treatment of APOL1-Mediated Kidney Disease vrtx.com ↗ |
| 2023-03-16 | Vertex Pharmaceuticals Incorporated | Vertex Announces Publication in New England Journal of Medicine of Results from Phase 2 Study of Inaxaplin (VX-147) vrtx.com ↗ |
| 2022-06-08 | Vertex Pharmaceuticals Incorporated | Vertex Announces Inaxaplin (VX-147) Granted Breakthrough Therapy Designation by U.S. FDA and Priority Medicines (PRIME) Designation by the EMA vrtx.com ↗ |
| 2022-03-22 | Vertex Pharmaceuticals Incorporated | Vertex Advances VX-147 Into Pivotal Clinical Development for People With APOL1-Mediated Kidney Disease vrtx.com ↗ |
| 2021-12-01 | Vertex Pharmaceuticals Incorporated | Vertex Announces Positive Results From Phase 2 Study of VX-147 in APOL1-Mediated Focal Segmental Glomerulosclerosis vrtx.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Inaxaplin | “Inaxaplin for Proteinuric Kidney Disease in Persons with Two APOL1 Variants.” PMID 36920755 ↗ Mar 2023 |
| Known as | IXP | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05865171 ↗ |
| Known as | VX-147 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05955872 ↗ |
| Action | Inhibit | “inhibit APOL1 channel function” PMID 36920755 ↗ Mar 2023 |
| Modality | Small molecule | “a small-molecule compound, inaxaplin, to inhibit APOL1 channel function” PMID 36920755 ↗ Mar 2023 |
| Route | Oral | “Tablets for oral administration.” NCT04340362 ↗ |
| Target | APOL1 | “inhibit APOL1 channel function” PMID 36920755 ↗ Mar 2023 |