Admin_Adham
Jump to Key Points This digest highlights FDA actions in August related to therapeutics and diagnostics for neuropsychiatric illness. For information on approvals in other specialties during 2026, see our FDA Drug Approvals page.
FDA OK’s Phase 1 Trial for Investigational Generalized Anxiety Disorder (GAD) Drug
The FDA raised no objection to a planned phase 1 program for PT00114, an investigational neuropeptide for GAD. Manufacturer Protagenic Therapeutics said in a statement that the company’s investigational new drug application builds on studies conducted outside the US that showed PT00114 was well tolerated with no serious adverse events.
First-in-Class Narcolepsy Drug Approved
Oveporexton (Orzeyful, Takeda) received approval for narcolepsy type 1 in adults — the first drug to directly restore orexin signaling, the biological deficit behind the disorder. The twice-daily tablet was associated with improvements in daytime sleepiness, cataplexy, sleep paralysis, hallucinations, and disrupted sleep in two clinical trials and had received FDA Breakthrough Therapy designation and Priority Review.
New Blood Test for Rule-In, Rule-Out AD Assessment
The FDA cleared the Elecsys Phospho-Tau (217P) Plasma test (Roche, developed with Eli Lilly and Company) to identify amyloid pathology in adults aged 55 years or older with signs of cognitive decline. It is the first test cleared for both rule-in and rule-out assessment using the same cutoffs across primary and specialty care, the company said in a statement.
- FDA cleared phase 1 PT00114 program for GAD; prior non-US studies: well tolerated, no SAEs.
- Oveporexton approved for adult narcolepsy type 1; first orexin-signaling restoration therapy.
- Oveporexton improved sleepiness, cataplexy, sleep paralysis, hallucinations, disrupted sleep.
- Elecsys Phospho-Tau (217P) Plasma test cleared for amyloid pathology rule-in/rule-out in adults ≥55.
- PrecivityAD2 cleared for AD assessment in adults as young as 40 with cognitive impairment.
Agency OK’s Alzheimer’s Test for Younger Adults
A mass-spectrometry blood test to help diagnose Alzheimer’s disease received FDA clearance. PrecivityAD2 (C2N Diagnostics) is the only test currently available in adults as young as 40 years with signs of cognitive impairment, the company said in a statement. The FDA-cleared version is expected later this year, while a laboratory-developed version remains available now.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
