Tag Archives: FDA

Developing the “Dancing Molecule”

Northwestern University scientists have developed an injectable nanomaterial, dubbed “dancing molecules”, that cross the blood-brain barrier and shield brain tissue from post-stroke damage. Published January 2026 in Neurotherapeutics, the therapy uses tiny, constantly moving molecular assemblies, known as supramolecular therapeutic peptides (STPs), delivered intravenously that self-organize into nanofibers inside injured brain tissue. In mice, a single IV dose given after blood flow was restored significantly reduced inflammation, tissue death, and harmful immune response with no observed toxicity.

In July 2025, Amphix Bio, the company behind the treatment, posted on LinkedIn: “We are thrilled to announce the FDA has granted an Orphan Drug Designation to AMFX-200, our lead candidate based on the Supramolecular Therapeutic Peptide (STP) platform, for the treatment of acute spinal cord injury. This will accelerate our efforts to bring this novel neuro-regenerative therapeutic to the clinic.”*

* I cannot find any record of human trials of this stroke treatment, as of yet. Additionally, key limitations remain, as results are preclinical only, dosing must be precise to prevent blood clotting, and long-term human safety is unproven.

From Roasting to Recovery, the Different Iterations of Charcoal

Activated charcoal, long used in emergency rooms to treat poisoning, is emerging as a potential tool for preventing and treating brain injury. A March 2025 Canadian multicenter study published in the Canadian Journal of Emergency Medicine found that poisoned patients treated with activated charcoal had a 9.2% lower risk of increased toxicity, critical for preventing the brain damage that often follows severe overdoses.

Regular charcoal and activated charcoal are fundamentally different, as the former can actually cause brain damage. According to the Consumer Product Safety Commission, approximately 20 Americans die annually from carbon monoxide poisoning linked to charcoal grills used indoors, with survivors often suffering permanent neurological damage. The potential risk occurs because cooking charcoal undergoes simple carbonization, while activated charcoal receives additional treatment at extreme temperatures, creating a surface area exceeding 500 square meters per gram – five times greater than regular charcoal. This porous structure enables it to adsorb toxins before they reach the bloodstream and brain.

Currently, the Food and Drug Administration does not approve of activated charcoal as a food addictive or coloring agent, and in New York and other cities, it is banned for use in food and drinks. (Concern is due to the fact the activated charcoal is reported to cause constipation and nutritional deficits, as it can harden in the intestines.) Specifically related to traumatic brain injury, though, NIH-funded researchers at Rice University have developed oxidized activated charcoal nanoparticles that restore cerebral blood flow in animal models. According to StatPearls, the NIH’s clinical reference guide, updated in 2025, “Activated charcoal is most efficacious when given within one hour of ingestion of the toxin.”