Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3884961 · 3 trials · 4 indications
Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) with AE's graded as mild, moderate, or severe.
GCase (glucocerebrosidase)
GCase (glucocerebrosidase)
GCase (glucocerebrosidase)
GCase (glucocerebrosidase)
| Arm | Type | Description |
|---|---|---|
| LY3884961 | EXPERIMENTAL | LY3884961 is an advanced therapy investigational medicinal product administered as a single intravenous infusion. |
| Low Dose | EXPERIMENTAL | - |
| High Dose | EXPERIMENTAL | - |
| Dose Level 1 | EXPERIMENTAL | - |
| Dose Level 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| LY3884961 | GENETIC | • LY3884961 is a replication-incompetent recombinant adeno-associated virus (AAV) vector. The vector is composed of a ss DNA genome packaged in an AAV-derived protein capsid. |
| Methylprednisolone | DRUG | Single IV pulse administered as concomitant medication. |
| Sirolimus | DRUG | Loading dose, followed by maintenance doses, followed by dose tapering; administered as concomitant medication. |
| Prednisone | DRUG | Administered orally as concomitant medication, followed by dose tapering. |
Inclusion Criteria: 1. Age greater or equal to 18 years at the time of informed consent. 2. Bi-allelic pathogenic GBA1 variants must be centrally confirmed. 3. On ERT or SRT for at least 2 years and on a stable, maximum tolerated dose, for at least 3 months prior to screening. 4. Capable of giving ...
LY3884961 is an investigational gene therapy being developed for Parkinson Disease, Gaucher Disease Type 2, and Gaucher Disease. It is in Phase 1 clinical trials for these conditions, which are being studied in patients with specific genetic mutations or disease manifestations.
LY3884961 is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the NYSE under the ticker LLY. The drug is currently in Phase 1 clinical development for rare disease indications.
LY3884961 is in Phase 1 clinical development. It is an investigational gene therapy and has not been approved by regulatory authorities. It is being studied in early-stage clinical trials for Parkinson Disease and Gaucher Disease.
LY3884961 is being studied in three active Phase 1 clinical trials: NCT04127578 for Parkinson's Disease with GBA1 mutations, NCT04411654 for Type 2 Gaucher Disease in infants, and NCT05487599 for peripheral manifestations of Gaucher Disease. These trials are not yet recruiting participants.
Yes, LY3884961 is also known as PR001. Clinical trials reference the drug under both names, with PR001 used in trial titles and LY3884961 as the formal drug identifier.