Morning Rounds: News From August 10-16

FDA Approves Tauklarify (MK-6240) for Tau Pathology Detection in Alzheimer Disease

The US Food and Drug Administration (FDA) has approved Tauklarify (florquinitau F18 injection, MK-6240), a tau-targeted PET imaging agent designed to detect neurofibrillary tangle pathology in patients being evaluated for Alzheimer disease.¹ The agent binds selectively to aggregated tau protein, complementing amyloid PET and emerging blood-based biomarkers in diagnostic workup. Approval rested on 2 pivotal phase 3 studies, including blinded read analyses of scans from more than 500 patients across 3 trials, with positive percent agreement ranging from 80% to 88% in one study and 68% to 82% in the other.¹ Safety was evaluated in more than 1700 subjects, with the most common adverse reactions being headache (0.7%), nausea (0.2%), and injection site reactions (0.1%). Tauklarify's use has not been established for non-Alzheimer tauopathies, and it should not be used with CYP12A inducers, including tobacco, within 7 days of administration. For prescribers, the approval adds a validated imaging option for confirming tau pathology during Alzheimer disease evaluation, with monitoring for its limited but distinct adverse effect profile remaining essential.

DT120 (Lysergide) Shows Rapid, Lasting Relief for Generalized Anxiety in Phase 3 Trial

A single dose of DT120 (lysergide), an orally disintegrating tablet formulation of LSD, produced significant and durable reductions in anxiety symptoms in the phase 3 Voyage trial for generalized anxiety disorder.² Patients receiving DT120 100 μg (n=107) improved significantly more than those on placebo (n=107) on the primary endpoint, change in Hamilton Anxiety Rating Scale score from baseline to week 12 (-11.6 vs -6.2; placebo-adjusted difference, 5.4 points; P<.0001; Cohen d=0.81), with separation from placebo apparent by week 1.⁴ Response rates of 50% or greater symptom improvement were more than double those on placebo (43% vs 16%), and full remission was reached by 14% of DT120 patients versus 4% on placebo. Adverse events were mild to moderate, transient, and clustered on dosing day, with no new safety signals or suicidality signal. DT120 previously received FDA Breakthrough Therapy designation for generalized anxiety disorder, and a second pivotal trial, Panorama, is expected to read out in September.

New Ingrezza Data Show Improved Quality of Life and Daily Functioning in Tardive Dyskinesia

New phase 4 data from the open-label KINECT-PRO study show Ingrezza (valbenazine) improves patient-reported quality of life and daily functioning in tardive dyskinesia, in addition to previously established reductions in movement severity.³ The study enrolled 59 patients who received once-daily doses of 40 mg, 60 mg, or 80 mg for up to 24 weeks, with 52 completing the week 24 visit; roughly 46% had schizophrenia or schizoaffective disorder and 54% had major depressive disorder or bipolar disorder.³ Primary endpoints, including the Tardive Dyskinesia Impact Scale, EuroQoL Visual Analogue Scale, and Sheehan Disability Scale, showed clinically meaningful improvement as early as week 4, sustained through week 24. About 58% of patients met the threshold for symptomatic remission by clinician assessment, with benefit observed regardless of underlying psychiatric diagnosis or baseline movement severity. Safety and tolerability were consistent with Ingrezza's known profile, and no new safety signals emerged.

Lithium Use Tied to 40% Lower Risk of Suicidal Ideation in Bipolar Disorder

A nationwide multicenter retrospective cohort study of 585 adolescents and adults with bipolar disorder found that sustained lithium use was associated with significantly lower rates of suicidal ideation and suicidal behaviors.⁴ Patients receiving lithium for at least 80% of the first 6 months of the study period showed a 43% lower likelihood of suicidal ideation (adjusted odds ratio, 0.57; 95% confidence interval, 0.38-0.86; P=.008) and a 40% lower likelihood of suicidal behaviors compared with patients without lithium exposure.⁴ No difference emerged in nonsuicidal self-injury, though lithium users reported lower hostility scores. Protective associations were more pronounced among female, adult, and higher-income patients, as well as those without comorbid anxiety, rapid cycling, or predominantly depressive episodes. The findings, drawn from 15 psychiatric centers across mainland China, reinforce lithium's role in suicide prevention beyond its established effects on completed suicide and attempts.

New CTx-1301 Data Affirm Pharmacokinetic Profile for ADHD Treatment

Cingulate has published peer-reviewed pharmacokinetic data in CNS Drugs supporting the differentiated release profile of CTx-1301, a trimodal dexmethylphenidate hydrochloride formulation for attention-deficit/hyperactivity disorder (ADHD).⁵ In a randomized, 4-period crossover study of 45 adults with ADHD, CTx-1301 (50 mg and 6.25 mg) was statistically bioequivalent to a bimodal dexmethylphenidate comparator on key exposure parameters, while producing more rapid early exposure and significantly higher concentrations later in the dosing interval.⁵ The controlled decline in plasma concentration was designed to reduce late-day wearing-off effects common with existing stimulant formulations. CTx-1301 was generally well tolerated, with tachycardia, insomnia, headache, nausea, and euphoric mood the most commonly reported adverse events, and demonstrated dose proportionality across high and low doses. The publication follows positive phase 3 efficacy and safety results and comes after the FDA issued a complete response letter in June 2026 citing chemistry, manufacturing, and controls issues rather than safety or efficacy concerns.

References

1. Walters J. FDA approves Tauklarify (MK-6240) for tau pathology detection in Alzheimer disease. Psychiatric Times. August 14, 2026. https://www.psychiatrictimes.com/view/fda-approves-tauklarify-mk-6240-for-tau-pathology-detection-in-alzheimer-disease

2. Duerr HA. DT120 (lysergide) shows rapid, lasting relief for generalized anxiety in phase 3 trial. Psychiatric Times. August 12, 2026. https://www.psychiatrictimes.com/view/dt120-lysergide-shows-rapid-lasting-relief-for-generalized-anxiety-in-phase-3-trial

3. Walters J. New Ingrezza data shows improved quality of life and daily functioning in tardive dyskinesia. Psychiatric Times. August 12, 2026. https://www.psychiatrictimes.com/view/new-ingrezza-data-shows-improved-quality-of-life-and-daily-functioning-in-tardive-dyskinesia

4. Xu N, Lv X, Deng Y, et al. Association of lithium use with suicide and self-harm among Chinese adolescents and adults with bipolar disorder: a nationwide multicenter retrospective cohort study. J Clin Psychiatry. 2026;87(3):25m16219.

5. Walters J. New CTx-1301 data affirms pharmacokinetic profile to treat ADHD. Psychiatric Times. August 11, 2026. https://www.psychiatrictimes.com/view/new-ctx-1301-data-affirms-pharmacokinetic-profile-to-treat-adhd