Breakthrough Therapy Designation (FDA)
Definition
An FDA designation that expedites review of drugs showing preliminary clinical evidence of substantial improvement over available therapy for serious conditions. Awarded to psilocybin by USONA and Compass Pathways; does not alter DEA Schedule I status but enables prioritised review of clinical trials.
Related terms
- 1P-LSD (1-Propionyl-LSD)
- A lysergamide prodrug bearing a propionyl group on the indole N1 position; cleaved in vivo to release LSD. Sold legally in some...
- 5-MeO-DMT
- 5-Methoxy-N,N-dimethyltryptamine; present in Bufo alvarius toad venom at ~15% by weight. Active dose 1-5 mg by inhalation. Schedule I in US since...
- Ayahuasca
- A traditional Amazonian brew combining a DMT-containing plant (Psychotria viridis) with Banisteriopsis caapi containing beta-carboline MAO inhibitors (harmine, harmaline), allowing oral bioavailability...
- Beta-Carboline Alkaloids
- Harmine, harmaline, and tetrahydroharmine; reversible MAO-A inhibitors from Banisteriopsis caapi vine that form the MAOI component of ayahuasca. Detected by HPLC-UV at...
- DMT (N,N-Dimethyltryptamine)
- The simplest tryptamine hallucinogen, MW 188.27 g/mol, orally inactive due to MAO metabolism; active when smoked (25-60 mg) or combined with MAO...
- Ehrlich Reagent
- A presumptive colour test for indole-containing compounds: p-dimethylaminobenzaldehyde in HCl/ethanol. Produces purple-violet with LSD, psilocybin, and all tryptamines. Not specific; many non-drug...
- LSD (Lysergic Acid Diethylamide)
- A potent synthetic hallucinogen derived from lysergic acid, itself from ergot alkaloids of Claviceps purpurea. Active at 50-200 μg. Schedule I in...
- Psilocin
- 4-Hydroxy-N,N-dimethyltryptamine; the active deacylated metabolite of psilocybin responsible for psychedelic effects. Rapidly oxidises in solution, causing the characteristic blue bruising in Psilocybe...
- Psilocybin
- 4-Phosphoryloxy-N,N-dimethyltryptamine; a prodrug found in Psilocybe genus mushrooms. Dephosphorylated in vivo to psilocin (the active form) by alkaline phosphatase. Active at 1-4...
Explained in
- Hallucinogens: LSD, Psilocybin, DMT and the Indolealkylamine FamilyAn FDA designation that expedites review of drugs showing preliminary clinical evidence of substantial improvement over available therapy for serious condition...