Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MSK-DA01, BRT-DA01
bemdaneprocel · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group A | ACTIVE_COMPARATOR | Bemdaneprocel will be administered on Day 0 |
| Group B | SHAM_COMPARATOR | Sham surgery will be performed on Day 0 |
| Name | Type | Description |
|---|---|---|
| bemdaneprocel | BIOLOGICAL | Investigational cell therapy comprising midbrain dopaminergic neuron progenitors derived from human embryonic stem cells |
| Sham surgery | PROCEDURE | Sham surgery will be performed on Day 0 |
Inclusion Criteria: * Diagnosis of clinically established PD as defined by the International Parkinson and Movement Disorders Society * Individual of any sex ≥45 to ≤75 years of age at informed consent * Robust and clear response to DA therapy as defined by MDS-UPDRS Part III * ≥4 and \<12 years fr...
Bemdaneprocel is an investigational cell therapy being developed by Bayer AG for Parkinson's disease. It is designed as a cell-based treatment rather than a conventional small molecule or antibody, and it is currently in Phase 3 clinical development. It has not been approved by the FDA.
Bemdaneprocel is being studied as a treatment for Parkinson's disease in adults. The ongoing Phase 3 trial enrolls adults aged 45 years and older with Parkinson's disease. Because it remains investigational, it is not yet available as a marketed therapy for Parkinson's disease.
Bemdaneprocel is developed by Bayer AG, which trades over the counter in the United States under the ticker BAYRY. Bayer is the sponsor of the clinical program evaluating the cell therapy in Parkinson's disease.
Bemdaneprocel is in Phase 3 clinical development. The program includes one active Phase 3 trial that is currently recruiting participants, with no completed trials to date. It is an investigational therapy and has not received FDA approval.
Bemdaneprocel is being evaluated in the Phase 3 trial NCT06944522, titled A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease. The trial is recruiting 102 participants across the United States, Australia, and Canada and is randomized, double-blind, and active-controlled.
The Phase 3 trial NCT06944522 is a randomized, double-blind, active-controlled study of bemdaneprocel in adults with Parkinson's disease. It plans to enroll 102 participants aged 45 years and older of any sex, and it is currently recruiting in the United States, Australia, and Canada.