FDA Status: Not yet disclosed. Aleniglipron remains in Phase 2 clinical development with no regulatory submissions or approvals reported.
EMA Status: Not yet disclosed.
PMDA (Japan) Status: Not yet disclosed.
NMPA (China) Status: Not yet disclosed.
Clinical Trial Registration: NCT06703021 is the primary trial identifier for the Phase 2 program. Additional historical NCT identifiers referenced in the placebo drug record (NCT00076336, NCT00415194, NCT00525798, NCT00591084, NCT00741936, NCT00901901, NCT00940602, NCT01136239, NCT01317849, NCT01325571) appear to relate to prior research or comparator studies rather than aleniglipron development.
Regulatory pathway, breakthrough designation status, and timelines for potential Phase 3 initiation or regulatory submissions have not been disclosed.