Drugs / ANPD001
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06344026 | Jan 2024 → Mar 2027 expected | Parkinson disease | Aspen Neuroscience | Enrolling by invitation | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-07-30 | Aspen Neuroscience | Regulatory Aspen Neuroscience Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Sasineprocel (ANPD001) to Treat Parkinson’s Disease aspenneuroscience.com ↗
RMAT designation provides increased FDA guidance and expedited development support, including potential eligibility for priority review and accelerated approval pathways for regenerative therapies that are deemed to be transformative. |
| 2026-03-18 | Aspen Neuroscience | Results Aspen Neuroscience Announces Positive 12‑Month Data from its ASPIRO Clinical Trial in a Late‑Breaking Oral Presentation at the AD/PDTM 2026 International Conference on Alzheimer’s and Parkinson’s Diseases aspenneuroscience.com ↗
The presentation highlights 12‑month safety, tolerability, and efficacy data following delivery of Sasineprocel (ANPD001), an autologous induced pluripotent stem cell (iPSC)‑derived dopaminergic neuron precursor cell therapy (DANPC), in patients with Parkinson’s disease without requiring immune suppression or permanent implantable hardware. |
| 2025-06-09 | Aspen Neuroscience | Results Aspen Neuroscience to Present at the International Society for Stem Cell Research (ISSCR) 2025 Annual Meeting aspenneuroscience.com ↗ |
| 2025-05-07 | Aspen Neuroscience | Results Aspen Neuroscience Announces 6-Month ASPIRO Phase 1/2a Clinical Trial Results of Personalized Cell Therapy for Parkinson’s Disease aspenneuroscience.com ↗
Aspen Neuroscience has released 6-month data from the first three patients dosed in the ASPIRO Phase 1/2a trial of ANPD001, an investigational autologous dopaminergic neuronal precursor cell (DANPC) therapy being studied in patients with moderate to advanced Parkinson’s Disease (PD). |
| 2025-01-13 | Aspen Neuroscience | Results Aspen Neuroscience Announces Completion of First and Second Cohorts in ASPIRO Phase 1/2a Trial for Parkinson’s Disease aspenneuroscience.com ↗
We are happy to announce that to date, ANPD001 and its delivery have been well tolerated, and no serious adverse events have been observed in the first two cohorts of patients in the ASPIRO study. |
| 2024-07-29 | Aspen Neuroscience | Results Study of ANPD001 Autologous Neuronal Cell Replacement Treatment Approach Published in Journal of Neurosurgery aspenneuroscience.com ↗
The study by the Wisconsin National Primate Research Center demonstrated the safety and feasibility of the treatment approach for ANPD001 in non-human primates. |
| 2023-10-19 | Aspen Neuroscience | Regulatory FDA Grants Fast Track Designation to ANPD001, Autologous Investigational Cell Therapy for the Treatment of Parkinson’s Disease aspenneuroscience.com ↗
Aspen Neuroscience today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for ANPD001 for the treatment of Parkinson’s disease (PD) to improve motor function. |
| 2023-08-08 | Aspen Neuroscience | Regulatory Aspen Neuroscience Announces FDA Clearance of Investigational New Drug Application for ANPD001, Autologous Cell Therapy for the Treatment of Parkinson’s Disease aspenneuroscience.com ↗ |
| 2023-07-06 | Aspen Neuroscience | Results Preclinical Safety and Efficacy Data for ANPD001 Presented by Dr. Andres Bratt-Leal at 2023 World Parkinson Congress in Barcelona aspenneuroscience.com ↗
The data suggest that after transplantation there is no evidence of migration or tumor formation, and that PD neurons function in vitro and restore dopamine signaling deficits in rodents. |
All press releases naming this drug 13 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ANPD001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06344026 ↗ |
| Route | Other | “injecting ANPD001 cells that will mature into dopamine-producing cells into the brain” NCT06344026 ↗ |