IntraBio Inc. is pleased to share that the New Drug Application (NDA) for N-acetyl-L-leucine (IB1001) for the treatment of Niemann-Pick disease type C (NPC) was submitted to the US Food and Drug
Administration (FDA) in January 2024. The FDA has a 60-day filing review period to determine whether
the NDA is complete and accepted for review.
With the achievement of its first NDA submission, IntraBio is one step closer to its ultimate goal of
getting IB1001 approved to help meet the NPC community’s urgent unmet medical needs. IntraBio
thanks the investigators, clinical trial teams, colleagues, and most importantly, members of the Patient
Advocacy Community, and the NPC patients and families whose contributions and support throughout
the development program have been instrumental in achieving this important milestone towards making
an approved treatment available for NPC