Drugs / CAP-003
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT07011771 | Aug 2025 → Jun 2026 | Parkinson disease | Capsida Biotherapeutics, Inc. | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-06-11 | Capsida Biotherapeutics, Inc. | Regulatory Capsida Receives FDA IND Clearance for Its IV-Administered Gene Therapy for Parkinson’s Disease Associated with GBA Mutations capsida.com ↗
This is the second wholly owned clinical program developed by Capsida with a cleared IND. |
| 2025-04-03 | Capsida Biotherapeutics, Inc. | Results Capsida Presents New Data from GLP Toxicology Study in NHPs Demonstrating Potential Best-in-Class Profile of CAP-003 in Patients with Parkinson’s Disease Associated with GBA Mutations (PD-GBA) capsida.com ↗
Capsida Biotherapeutics (“Capsida”) today announced new data from the three-month cohort of a GLP toxicology study in non-human primates (NHPs) with CAP-003, its intravenously (IV) delivered gene therapy for Parkinson’s disease associated with GBA mutations (PD-GBA). |
| 2024-10-07 | Capsida Biotherapeutics, Inc. | Results New Data Demonstrate Substantial Therapeutic Potential of Capsida’s IV Gene Therapy for Parkinson’s Disease Associated with GBA Mutations capsida.com ↗
Capsida Biotherapeutics (“Capsida”) presented new IND-enabling data on its intravenously (IV) delivered gene therapy for Parkinson’s disease associated with GBA mutations (PD-GBA), CAP-003, that demonstrate its substantial therapeutic potential. |
| 2024-05-10 | Capsida Biotherapeutics, Inc. | Results Capsida Biotherapeutics to Present Preclinical Data for Parkinson’s Disease Associated with GBA Mutations Showing High Levels of GCase Enzyme Supplementation Following IV Administration capsida.com ↗
Capsida Biotherapeutics (“Capsida”) today announced new preclinical data that demonstrate the potential of its next-generation intravenously (IV) administered gene therapy candidate, CAP-003, to safely and effectively treat Parkinson’s disease (PD) associated with GBA mutations (PD-GBA). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-06-11 | Capsida Biotherapeutics, Inc. | Capsida Receives FDA IND Clearance for Its IV-Administered Gene Therapy for Parkinson’s Disease Associated with GBA Mutations capsida.com ↗ |
| 2025-04-03 | Capsida Biotherapeutics, Inc. | Capsida Presents New Data from GLP Toxicology Study in NHPs Demonstrating Potential Best-in-Class Profile of CAP-003 in Patients with Parkinson’s Disease Associated with GBA Mutations (PD-GBA) capsida.com ↗ |
| 2024-10-07 | Capsida Biotherapeutics, Inc. | New Data Demonstrate Substantial Therapeutic Potential of Capsida’s IV Gene Therapy for Parkinson’s Disease Associated with GBA Mutations capsida.com ↗ |
| 2024-05-10 | Capsida Biotherapeutics, Inc. | Capsida Biotherapeutics to Present Preclinical Data for Parkinson’s Disease Associated with GBA Mutations Showing High Levels of GCase Enzyme Supplementation Following IV Administration capsida.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CAP-003 | “Participants will have a single intravenous infusion of CAP-003 and visit the clinic regularly for 2 years for checkups and tests.” NCT07011771 ↗ |
| Modality | Gene therapy (AAV / viral vector) | “CAP-003 gene therapy” NCT07011771 ↗ |
| Route | Intravenous | “single intravenous infusion of CAP-003” NCT07011771 ↗ |