‘Dancing molecules’ treatment receives FDA Orphan Drug Designation
July 16, 2025
Regenerative spinal cord injury therapy repairs tissue, reverses paralysis in preclinical models
“Dancing molecules,” the promising new treatment for acute spinal cord injuries developed at Northwestern University, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA).
Developed by regenerative nanomedicine pioneer Samuel I. Stupp, the therapy harnesses molecular motion to reverse paralysis and repair tissues after traumatic spinal cord injuries. Stupp first introduced the platform in 2021 in a study published in the journal Science. In that study, a one-time injection administered 24 hours after severe injury helped mice regain the ability to walk — just four weeks after treatment.
The FDA’s Orphan Drug program is designed to encourage and support the development of treatments for rare diseases or conditions. The designation’s benefits include financial incentives such as tax credits for clinical trials, exemption from user fees and up to seven years of market exclusivity after approval.