What's next in psychiatry — October 27, 2026

This edition covers five milestones expected between the fourth quarter of 2026 and 2027: an FDA decision on treating acute agitation at home, two psychedelic applications (psilocybin and LSD) heading to the FDA, the xanomeline-trospium program in Alzheimer's disease psychosis, and a NICE quality standard on aggressive behaviour. All dates below were announced by regulators, public bodies or companies; none guarantees the outcome.

1. Sublingual dexmedetomidine (IGALMI) for acute agitation at home

[Pending regulatory decision] [United States] [FDA target action date (PDUFA): November 14, 2026, per BioXcel Therapeutics]
What it is: a supplemental NDA accepted by the FDA to extend sublingual dexmedetomidine film, currently administered under the supervision of a healthcare provider, to the acute treatment of agitation associated with schizophrenia or bipolar disorder in the at-home (outpatient) setting.
What problem it solves: according to the company, there is no FDA-approved treatment for this agitation at home; today these episodes often end in the emergency department.
Critical take: use without a clinician present requires watching for hypotension, somnolence and QT prolongation; in addition, the company filed for Chapter 11 on August 27, 2026, and on October 27, 2026 Teva announced it had completed the acquisition of BioXcel's assets (including IGALMI and worldwide rights to BXCL501) after approval by the U.S. Bankruptcy Court, without acquiring BioXcel Therapeutics itself; the FDA decision on at-home use remains pending.

Sources

• [Official release] BioXcel Therapeutics, April 1, 2026. https://bioxceltherapeutics.gcs-web.com/news-releases/news-release-details/bioxcel-therapeutics-announces-food-drug-administration
• [Official release] BioXcel Therapeutics, Form 8-K filed with the SEC, August 27, 2026. https://www.sec.gov/Archives/edgar/data/0001720893/000110465926102570/tm2624233d1_8k.htm
• [Official release] BioXcel Therapeutics, August 28, 2026. https://ir.bioxceltherapeutics.com/node/14071/pdf
• [Official release] Teva, October 27, 2026. https://rss.globenewswire.com/news-release/2026/10/27/3388911/0/en/teva-acquires-worldwide-rights-to-bxcl501-further-expanding-innovative-neuroscience-pipeline.html

2. Synthetic psilocybin COMP360 in treatment-resistant depression: completing the FDA filing

[Pending regulatory decision] [United States] [Estimated date: fourth quarter of 2026 to complete the NDA, per Compass Pathways]
What it is: Compass is submitting the COMP360 NDA on a rolling basis after two phase 3 trials (COMP005 and COMP006); according to the company's release, 39% of participants in COMP006 and 25% in COMP005 achieved a MADRS reduction greater than 25% at week 6, with benefit maintained on average through at least week 26. It holds a National Priority Voucher that could shorten review to 1–2 months; the company targets launch in the first half of 2027, subject to FDA approval and DEA rescheduling.
What problem it solves: treatment-resistant depression has few approved options; today clinicians turn to augmentation, intranasal esketamine, ECT or transcranial magnetic stimulation.
Critical take: company-sponsored, functional unblinding is hard to avoid with a psychedelic, treatment needs hours of supervision and psychological support, and the company itself warns the voucher may not speed review.

Sources

• [Official release] Compass Pathways, Form 8-K filed with the SEC, August 5, 2026. https://www.sec.gov/Archives/edgar/data/0001816590/000181659026000059/q22026pressrelease.htm
• [Official release] Compass Pathways, August 5, 2026. https://secure.businesswire.com/news/home/20260805927238/en/Compass-Pathways-Announces-Second-Quarter-and-First-Half-2026-Financial-Results-and-Business-Highlights

3. Orally disintegrating LSD (DT120, formerly MM120) in generalized anxiety disorder: pre-NDA meeting

[Pending regulatory decision] [United States] [Estimated date: fourth quarter of 2026 (pre-NDA meeting) and first half of 2027 (NDA), per Definium Therapeutics]
What it is: after three positive phase 3 trials (Voyage and Panorama in GAD; Emerge in major depression), Definium (formerly MindMed) has its pre-NDA meeting scheduled for Q4 2026. In Panorama (245 participants randomized 2:1:2 to 100 µg, 50 µg or placebo, single dose, double-blind), HAM-A at week 12 fell 9.8 points with 100 µg vs 4.7 with placebo (difference −5.1; d = 0.64); response 32% vs 14%.
What problem it solves: in GAD, SSRIs/SNRIs and psychotherapy leave many patients short of remission; a single dose with an effect sustained to 12 weeks could change the treatment model.
Critical take: company-reported data not yet peer reviewed, perceptual illusions on dosing day in 68% of the 100 µg arm (compromised blinding), and at least 8 hours of supervision on dosing day.

Sources

• [Official release] Definium Therapeutics, September 14, 2026. https://www.businesswire.com/news/home/20260914329364/en/Definium-Therapeutics-Announces-Positive-Topline-Results-from-Phase-3-Panorama-Study-of-DT120-ODT-in-Generalized-Anxiety-Disorder
• [Official release] Definium Therapeutics, Form 8-K filed with the SEC, September 14, 2026. https://www.sec.gov/Archives/edgar/data/0001813814/000110465926107275/tm2625365d1_ex99-1.htm

4. Xanomeline-trospium (Cobenfy) in Alzheimer's disease psychosis: the ADEPT program

[Ongoing trial] [International] [Estimated date: from early 2027, spread across the year, per Bristol Myers Squibb on its July 30, 2026 earnings call]
What it is: phase 3 trials ADEPT-1, ADEPT-2 (NCT06126224; randomized, double-blind, placebo-controlled) and ADEPT-4 of the muscarinic agonist xanomeline plus trospium in moderate to severe psychosis associated with Alzheimer's disease. In December 2025, BMS extended ADEPT-2 after finding trial-execution irregularities at a small number of sites, whose data it excluded from the primary analysis; in July 2026 it delayed the program again because of slower enrollment.
What problem it solves: no drug is FDA-approved for Alzheimer's disease psychosis (pimavanserin is approved only for Parkinson's disease psychosis); in dementia, antipsychotics carry a boxed warning for increased mortality.
Critical take: the result may be negative, the successive delays (site irregularities and slow enrollment) lower confidence, and peripheral anticholinergic tolerability in frail older adults will be decisive.

Sources

• [Registry] NCT06126224, ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT06126224
• [Official release] Bristol Myers Squibb, December 3, 2025. https://www.businesswire.com/news/home/20251203856535/en/Bristol-Myers-Squibb-Announces-Continuation-of-ADEPT-2-Phase-3-Study-in-Psychosis-Associated-with-Alzheimers-Disease
• [Coverage] Fierce Pharma, July 30, 2026. https://www.fiercepharma.com/pharma/bristol-myers-delays-cobenfy-alzheimers-psychosis-readout-again-amid-another-quarterly-beat

5. NICE: quality standard on aggressive behaviour in health and social care

[Guideline in preparation] [United Kingdom] [Estimated date: January 2027 for the quality standard, per the Homecare Association; NICE expects January 28, 2027 for the related guideline]
What it is: a new quality standard (GID-QS10196) on aggressive behaviour in people receiving health or social care, replacing QS154 (violent and aggressive behaviours in people with mental health problems); public consultation ran from August 19 to September 16, 2026. In parallel, NICE is developing the guideline "Aggressive behaviour in people receiving NHS or social care: prevention and management", a full update of NG10, with expected publication on January 28, 2027.
What problem it solves: prevention and management of aggression (de-escalation, restraint, rapid tranquillisation) vary widely between services; quality standards set auditable indicators.
Critical take: it is an NHS quality-of-care document, not new evidence, and outside the UK it serves as a good-practice reference.

Sources

• [Official release] NICE, quality standard in development GID-QS10196. https://www.nice.org.uk/guidance/indevelopment/gid-qs10196
• [Official release] NICE, products in development on mental health services (guideline expected publication: January 28, 2027). https://www.nice.org.uk/guidance/conditions-and-diseases/mental-health-behavioural-and-neurodevelopmental-conditions/mental-health-services/products
• [Official release] NICE, final scope of guideline GID-NG10432. https://www.nice.org.uk/guidance/gid-ng10432/documents/final-scope
• [Coverage] Homecare Association, August 18, 2026. https://www.homecareassociation.org.uk/resource/nice-consultation-aggressive-behaviour-in-people-receiving-nhs-or-social-care2.html

*What's next in psychiatry — October 27, 2026*

1. Sublingual dexmedetomidine for acute agitation at home: FDA target action date Nov 14, 2026 (Teva completed the acquisition of BioXcel's assets after court approval).
2. Psilocybin COMP360 in treatment-resistant depression: complete NDA expected Q4 2026; possible expedited review.
3. LSD DT120 in generalized anxiety: pre-NDA meeting Q4 2026; NDA in H1 2027.
4. Xanomeline-trospium in Alzheimer's psychosis: ADEPT data from early 2027.
5. NICE quality standard on aggressive behaviour: expected January 2027.

Dates from regulators, public bodies and companies; none guarantees the outcome.

Full text and audio: https://boletinesmedicos.com/en/psychiatry/2026-10-27-viene.html
MedBulletins · boletinesmedicos.com

What's next in psychiatry (Q4 2026 – 2027), five milestones with announced dates:

• Nov 14, 2026: FDA target action date for sublingual dexmedetomidine for acute agitation at home in schizophrenia and bipolar disorder. BioXcel, in Chapter 11, sold these assets to Teva, which completed the acquisition after court approval; the FDA decision remains pending.
• Q4 2026: Compass expects to complete the NDA for psilocybin COMP360 in treatment-resistant depression; it holds a National Priority Voucher.
• Q4 2026: pre-NDA meeting for LSD DT120 in generalized anxiety, after three positive phase 3 trials not yet peer reviewed.
• From early 2027: ADEPT program data for xanomeline-trospium in Alzheimer's disease psychosis.
• January 2027: NICE quality standard on aggressive behaviour.

Critical take on each item and links to official sources:
https://boletinesmedicos.com/en/psychiatry/2026-10-27-viene.html

#Psychiatry #MentalHealth #Psychedelics #FDA #EvidenceBasedMedicine

What's next in psychiatry: FDA target date Nov 14 for at-home dexmedetomidine in agitation; psilocybin NDA due Q4 2026; LSD for anxiety heads to NDA; ADEPT Alzheimer's psychosis data from 2027; NICE aggression standard Jan 2027.
https://boletinesmedicos.com/en/psychiatry/2026-10-27-viene.html