Igalmi (dexmedetomedine sublingual) / BioXcel - LARVOL DELTA

TRANQUILITY Program (GlobeNewswire) - "TRANQUILITY In-Care Phase 3 Trial: designed as a double-blind, placebo-controlled study to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 for acute treatment of agitation associated with Alzheimer’s dementia in the care setting: The program remains part of the Company’s broader development strategy; FDA has provided feedback on the clinical protocol; The Company is evaluating proposals from CROs to prepare for trial initiation."

New P3 trial • Alzheimer's Disease • Dementia

sNDA submission expected in early Q1 2026 for expanded usage of IGALMI in home setting based on positive data from the SERENITY At-Home trial (GlobeNewswire)

FDA filing • Bipolar Disorder • Schizophrenia

Net revenue from IGALMI was $98 thousand for the third quarter of 2025, compared to $214 thousand for the same period in 2024. (GlobeNewswire)

Sales • Bipolar Disorder • Schizophrenia

Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance | Not yet recruiting ➔ Recruiting | Trial completion date: Oct 2025 ➔ May 2026 | Trial primary completion date: Sep 2025 ➔ Mar 2026

Enrollment open • Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol) • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) (clinicaltrials.gov) - P3 | N=452 | Completed | Sponsor: BioXcel Therapeutics Inc | Active, not recruiting ➔ Completed

Trial completion • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia • Schizophreniform Disorder

Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: BioXcel Therapeutics Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry • Psychomotor Agitation • Schizophrenia • Schizophreniform Disorder

Sublingual Dexmedetomidine for Treating Opioid Withdrawal (clinicaltrials.gov) - P1/2 | N=160 | Active, not recruiting | Sponsor: New York State Psychiatric Institute | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2025 ➔ Nov 2025

Enrollment closed • Trial completion date • Substance Abuse

BioXcel Therapeutics To Announce Topline Results from SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia on August 27, 2025 (GlobeNewswire) - "The data will be disseminated in a morning press release and presented during the investor call/webcast....The trial was designed to study 200 patients with a history of agitation episodes despite being on stable treatment..."

P3 data: top line • Bipolar Disorder • Schizophrenia

BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia (Yahoo Finance) - "Based on the FDA’s feedback, the Company believes that the planned sNDA regulatory package will be sufficient to support the sNDA submission, which remains on track for the first quarter of 2026...To support the potential label expansion for at-home use, an important part of the regulatory package will be data from the pivotal Phase 3 SERENITY At-Home trial, which is a double-blind, placebo-controlled 12-week study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting."

FDA filing • Bipolar Disorder • Schizophrenia

BioXcel Therapeutics Submits Pre-Supplemental New Drug Application Meeting Package in Support of Potential Label Expansion for IGALMI (GlobeNewswire) - "BioXcel Therapeutics, Inc...announced the submission of a pre-supplemental New Drug Application (pre-sNDA) meeting package to the U.S. Food and Drug Administration (FDA) for IGALMI in support of a potential label expansion for outpatient use for the acute treatment of agitation associated with bipolar disorders or schizophrenia...The primary purpose of the pre-sNDA meeting, scheduled for August 20, 2025, is to gain alignment with the FDA regarding the content and format of the planned sNDA submission, which the Company is preparing. Additionally, the Company plans to reconfirm the understanding reached during the Type C meeting with the FDA on March 6, 2024, that FDA views the Company’s current development plans as a reasonable approach to support expanding the label to include at-home (outpatient) use of 120 mcg BXCL501 for the acute treatment of agitation associated with schizophrenia or bipolar disorders in the at-home setting."

FDA event • Bipolar Disorder • CNS Disorders • Schizophrenia

BioXcel Therapeutics Announces Last Patient Last Visit in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia (GlobeNewswire) - "BioXcel Therapeutics...announced completion of the last patient last visit (LPLV) in the pivotal Phase 3 SERENITY At-Home clinical trial. Topline data from the study are expected to be released this month and are intended to support the planned supplemental New Drug Application (sNDA) to potentially expand the label of IGALMI (dexmedetomidine) for use in the at-home (outpatient) setting. The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting."

P3 data: top line • Trial status • Bipolar Disorder • Schizophrenia

BXCL501 for Agitation in Schizophrenia (clinicaltrials.gov) - P1 | N=11 | Completed | Sponsor: Yale University | Recruiting ➔ Completed | Phase classification: P2 ➔ P1 | N=50 ➔ 11

Enrollment change • Phase classification • Trial completion • CNS Disorders • Psychiatry • Schizophrenia

Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: BioXcel Therapeutics Inc

New P2 trial • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry • Psychomotor Agitation • Schizophrenia • Schizophreniform Disorder

BioXcel Therapeutics Receives Second Positive Recommendation from Data Safety Monitoring Board (DSMB) to Continue SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia (BioXcel Therapeutics Press Release) - "BioXcel Therapeutics...announced the second positive recommendation by an independent Data Safety Monitoring Board (DSMB) to continue, without modification, the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia...The DSMB recommendation followed a review of unblinded safety data from 178 patients dosed as of the May 28, 2025 cutoff date. The trial is fully enrolled and collection of data over the 12-week period is continuing....Topline data expected in Q3 2025."

DSMB • P3 data: top line • Bipolar Disorder • Schizophrenia

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) (clinicaltrials.gov) - P3 | N=452 | Active, not recruiting | Sponsor: BioXcel Therapeutics Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia • Schizophreniform Disorder

BASIS: BXCL501 After Stress to Increase Recovery Success (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: University of North Carolina, Chapel Hill

New P2 trial • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

BioXcel Therapeutics Strengthens Cash Position to Advance SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia (GlobeNewswire) - "BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that, following the successful raise of $14 million gross proceeds in an equity financing that closed on March 4, 2025, it has approximately $35 million in cash. The strengthened cash position will support continued advancement of the Company’s pivotal Phase 3 SERENITY At-Home trial....'Patient enrollment is continuing and topline data results expected in the second half of 2025 are intended to support a potential sNDA submission to expand the label for IGALMI in the at-home setting'."

Financing • P3 data: top line • Bipolar Disorder • Schizophrenia

BioXcel Therapeutics Announces 33% Enrollment in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia (GlobeNewswire) - "BioXcel Therapeutics, Inc...today announced it has reached 33% enrollment in its 200-patient SERENITY At-Home trial. The pivotal Phase 3 trial is designed to evaluate the safety of BXCL501, the Company’s investigational, proprietary, orally dissolving film formulation of dexmedetomidine, in the at-home setting for the acute treatment of agitation associated with bipolar disorders or schizophrenia. Topline data results, which are expected in the second half of 2025, are intended to support a potential supplemental new drug application (sNDA) submission to expand the label of the FDA-approved IGALMI (dexmedetomidine) sublingual film."

Enrollment status • P3 data: top line • Bipolar Disorder • Schizophrenia

Sublingual Dexmedetomidine for Treating Opioid Withdrawal (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: New York State Psychiatric Institute | Trial completion date: Apr 2025 ➔ Jul 2025 | Trial primary completion date: Jan 2025 ➔ Apr 2025

Trial completion date • Trial primary completion date • Substance Abuse

BioXcel Therapeutics Announces FDA Closed its Inspection of Site for Phase 3 TRANQUILITY II Trial for Acute Treatment of Agitation Associated with Alzheimer’s Dementia (GlobeNewswire) - "BioXcel Therapeutics, Inc...today announced that the U.S. Food and Drug Administration (FDA) has concluded that the inspection of a single site in its TRANQUILITY II Phase 3 trial is closed under 21 C.F.R.20.64(d)(3) and released the Establishment Inspection Report. The FDA has designated 'Voluntary Action Indicated' for the site."

FDA event • Alzheimer's Disease • Dementia

BioXcel Therapeutics Provides Clinical and Business Update (GlobeNewswire) - "BioXcel Therapeutics, Inc...today provided an update on the progress of its late-stage clinical programs for lead neuroscience asset BXCL501, as well as its recent steps to enhance operational and financial flexibility and strengthen its Board leadership...The majority of trial sites have been opened and patient enrollment is progressing with the SERENITY At-Home trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia."

Trial status • Depression • Schizophrenia

Dementia Care Research and Psychosocial Factors. (PubMed, Alzheimers Dement) - "There are currently no FDA-approved treatments for acute management of agitation in elderly patients with dementia. In this study, BXCL501 60 µg and 40 µg significantly reduced the symptoms of agitation at 2 hours after administration in this patient population, as measured by PEC. At those doses, the treatments were relatively well tolerated."

Journal • Alzheimer's Disease • Cardiovascular • CNS Disorders • Dementia • Hypotension

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: BioXcel Therapeutics Inc | Active, not recruiting ➔ Recruiting | Trial completion date: Mar 2025 ➔ Sep 2025 | Trial primary completion date: Mar 2025 ➔ Sep 2025

Enrollment open • Trial completion date • Trial primary completion date • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia • Schizophreniform Disorder

Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: BioXcel Therapeutics Inc | Trial completion date: Jul 2024 ➔ Dec 2026 | Trial primary completion date: Jul 2024 ➔ Jul 2026

Trial completion date • Trial primary completion date • Bipolar Disorder • CNS Disorders • Mood Disorders • Pediatrics • Psychiatry • Schizophrenia • Schizophreniform Disorder

A Phase 3 Study of Sublingual Dexmedetomidine for Episodic Treatment of Agitation Associated with Alzheimer's Dementia (CTAD 2024) - No abstract available

Late-breaking abstract • P3 data • Alzheimer's Disease • CNS Disorders • Dementia