Regulatory advances in psychiatry
FDA updates flagged no suicidal‑ideation link for GLP‑1s across 91 trials (removing warnings), approved a Phase 2b/3 psilocybin trial for PTSD, granted priority review to narcolepsy drug oveporexton, and fast‑tracked an Alzheimer’s psychosis therapy — and Mindset Pharma announced Phase 3 psilocybin progress. (x.com) (x.com)
The FDA formally requested removal of suicidal‑behavior and ideation language from GLP‑1 receptor agonist labels (affecting Saxenda, Wegovy, and Zepbound) in a Drug Safety Communication dated January 13, 2026. (fda.gov) The agency’s decision followed a comprehensive meta‑analysis across placebo‑controlled GLP‑1 development programs that pooled 91 trials and roughly 107,910 participants to estimate risk. (pharmacytimes.com) The FDA’s review also incorporated observational analyses, including a retrospective cohort comparing GLP‑1s to SGLT2 inhibitors that reported no increased risk of intentional self‑harm, which factored into the label‑change request. (pharmacytimes.com) Compass Pathways’ IND for COMP360 was accepted by the FDA on January 7, 2026, clearing the way for a combined Phase 2b/3 program in PTSD. (businesswire.com) The planned COMP360 PTSD study is a multicenter, randomized trial with a 12‑week randomized double‑blind phase followed by a 40‑week open‑label extension to assess durability and long‑term safety. (marketchameleon.com) Compass separately reported that its COMP360 Phase‑3 program for treatment‑resistant depression reached a second positive pivotal readout (COMP006), with the 25 mg arm showing a mean MADRS difference of −3.8 versus control (p<0.001) and clinically meaningful responder rates reported. (ir.compasspathways.com) Takeda announced FDA acceptance of an NDA and Priority Review for oveporexton (TAK‑861) on February 10, 2026, with a PDUFA target action date set in the third quarter of 2026 and the filing supported by two global Phase‑3 programs (FirstLight and RadiantLight). (takeda.com) MapLight Therapeutics received Fast Track designation from the FDA for ML‑007C‑MA for Alzheimer’s disease psychosis on January 5, 2026; the program is in an ongoing Phase‑2 VISTA study with planned enrollment of about 300 participants and topline readout expected in the second half of 2027. (biospace.com) Mindset Pharma was acquired by Otsuka in 2023 and its lead psilocybin‑like candidate MSP‑1014 moved through UK regulatory pathways into adaptive Phase‑II studies (dose‑finding and proof‑of‑concept designs were registered and approved in 2023), positioning the program within Otsuka’s broader psychedelics portfolio. (otsuka.co.jp)
