Drugs / bemdaneprocel
bemdaneprocel
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT04802733 | May 2021 → May 2023 | Parkinson disease | BlueRock Therapeutics | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT06944522 Comparator | Jun 2025 → Mar 2027 expected | Parkinson disease | BlueRock Therapeutics | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2025-12-17 | BlueRock Therapeutics | Regulatory BlueRock Therapeutics investigative cell therapy bemdaneprocel for treating Parkinson’s disease receives Pioneering Regenerative Medical Product designation in Japan bluerocktx.com ↗ |
| 2025-10-07 | BlueRock Therapeutics | Results BlueRock Therapeutics reports positive 36-month results from Phase I trial of bemdaneprocel for treating Parkinson’s disease bluerocktx.com ↗
Bayer AG and its wholly owned, independently operated subsidiary BlueRock Therapeutics LP, a clinical stage cell therapy company, today announced positive 36-month data from exPDite, a Phase I clinical trial of bemdaneprocel, an investigational cell therapy for the treatment of Parkinson’s disease (PD). |
| 2025-04-16 | BlueRock Therapeutics | Results BlueRock Therapeutics announces publication in Nature of 18-month data from Phase 1 clinical trial for bemdaneprocel, an investigational cell therapy for Parkinson’s disease bluerocktx.com ↗
The publication, which is available online, confirms that 18 months following surgery, treatment with bemdaneprocel did not cause any serious adverse events related to cell therapy. |
| 2024-09-27 | BlueRock Therapeutics | Results BlueRock Therapeutics’ investigational cell therapy bemdaneprocel for Parkinson’s disease shows positive data at 24-months bluerocktx.com ↗
today announced positive 24-month data from exPDite, a Phase 1 clinical trial of bemdaneprocel, an investigational cell therapy for the treatment of Parkinson’s disease. |
| 2024-09-27 | Bayer | Results BlueRock Therapeutics’ investigational cell therapy bemdaneprocel for Parkinson’s disease shows positive data at 24-months bayer.com ↗
At 24 months, data from the Phase 1 exPDite trial continue to show a favorable safety profile in all 12 participants in the trial’s high and low dose cohorts |
| 2024-05-30 | BlueRock Therapeutics | Regulatory BlueRock Therapeutics receives FDA Regenerative Medicine Advanced Therapy designation for Parkinson’s disease cell therapy candidate bemdaneprocel bluerocktx.com ↗
BlueRock’s investigational cell therapy bemdaneprocel for the treatment of Parkinson’s disease has been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA). |
| 2024-05-30 | Bayer | Regulatory BlueRock Therapeutics receives FDA Regenerative Medicine Advanced Therapy designation for Parkinson’s disease cell therapy candidate bemdaneprocel bayer.com ↗ |
| 2024-03-06 | BlueRock Therapeutics | Results BlueRock Therapeutics phase I clinical trial for Parkinson’s disease continues to show positive trends at 18 months bluerocktx.com ↗
In addition, exploratory clinical endpoints improved compared to baseline assessments in both cohorts, with participants in the high dose cohort showing greater improvement than those in the low dose cohort. |
| 2024-03-06 | Bayer | Results BlueRock Therapeutics phase I clinical trial for Parkinson’s disease continues to show positive trends at 18 months bayer.com ↗
In addition, exploratory clinical endpoints improved compared to baseline assessments in both cohorts, with participants in the high dose cohort showing greater improvement than those in the low dose cohort. |
| 2023-08-28 | BlueRock Therapeutics | Results BlueRock’s Phase I study with bemdaneprocel in patients with Parkinson’s disease meets primary endpoint bluerocktx.com ↗
The study met the primary objective of demonstrating safety and tolerability in all 12 participants in the study’s low and high dose cohorts, with no serious adverse events (SAEs) reported related to bemdaneprocel through one year. |
| 2023-08-28 | Bayer | Results BlueRock’s Phase I study with bemdaneprocel in patients with Parkinson’s disease meets primary endpoint bayer.com ↗
The study met the primary objective of demonstrating safety and tolerability in all 12 participants in the study’s low and high dose cohorts, with no serious adverse events (SAEs) reported related to bemdaneprocel through one year. |
| 2023-06-28 | BlueRock Therapeutics | Results BlueRock’s neuronal stem cell therapy for Parkinson’s disease is first to show positive results in Phase I clinical study bluerocktx.com ↗
The trial showed that bemdaneprocel was well-tolerated in all 12 patients in the study to date, with no major safety events. |
| 2023-06-28 | Bayer | Results BlueRock’s neuronal stem cell therapy for Parkinson’s disease is first to show positive results in Phase I clinical study bayer.com ↗
The trial showed that bemdaneprocel was well-tolerated in all 12 patients in the study to date, with no major safety events. |
| 2021-04-07 | BlueRock Therapeutics | Regulatory BlueRock Therapeutics Receives Permission from Health Canada for DA01 Trial in Parkinson’s Disease bluerocktx.com ↗
Health Canada has given permission to initiate “Phase 1 Safety and Tolerability Study of MSK-DA01 Cell Therapy for Advanced Parkinson’s Disease (PD).” |
All press releases naming this drug 26 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bemdaneprocel | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06944522 ↗ |
| Known as | BRT-DA01 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314657 ↗ |
| Known as | DA01 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314657 ↗ |
| Known as | MSK-DA01 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04802733 ↗ |
| Modality | Cell therapy | “Human Embryonic Stem Cell-Derived Midbrain Dopamine Neuron Cell Therapy” NCT04802733 ↗ |
| Route | Other | “surgically injecting nerve cells that make dopamine into the brain” NCT04802733 ↗ |