NP001 FDA Approval Status
Last updated by Judith Stewart, BPharm on Nov 13, 2024.
FDA Approved: No
Brand name: NP001
Generic name: sodium chlorite
Dosage form: Infusion
Company: Neuvivo, Inc.
Treatment for: Amyotrophic Lateral Sclerosis
NP001 (sodium chlorite) is an innate immune modulator in development for the treatment of amyotrophic lateral sclerosis.
- Amyotrophic lateral sclerosis (ALS), also known as motor neurone disease (MND), is a progressive and fatal chronic inflammatory neurodegenerative disease characterized by muscle weakness due to the deterioration of cortical and spinal motor neurons, affecting a patient's ability to walk, talk, eat, and breathe. The current life expectancy of people with ALS is about 2-5 years after symptoms appear, with death usually resulting from respiratory failure.
- ALS disease progression is thought to be associated with systemic inflammation and abnormal inflammatory macrophage/microglia activity within affected spinal cord and brain regions. Macrophages (white blood cells) can be toxic in one state (M1), producing inflammatory cytokines (TNF-α) and other pro-inflammatory factors, and neuroprotective in a second state (M2) and associated with the reversal of inflammation and the suppression of uncontrolled immune responses. In ALS, the appearance of new M1 macrophages in the spinal cord indicates disease progression.
- NP001 is an immunotherapy that works by regulating inflammation. In the body it is converted to a compound that can transform the inflammatory M1 macrophages to the non-inflammatory, wound healing M2 macrophages, to stop damage to motor neurons.
- NP001 has been granted Orphan Drug and Fast Track Designations by the U.S. Food and Drug Administration (FDA) and is eligible for Accelerated Approval and Priority Review, which could shorten the time to a potential approval. A New Drug Application (NDA) for NP001 in ALS was filed in October 2024.
Development timeline for NP001
Further information
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