Igalmi (dexmedetomidine sublingual) / BioXcel - LARVOL DELTA

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 | Trial completion date: May 2026 ➔ Apr 2027 | Trial primary completion date: Mar 2026 ➔ Feb 2027

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

BioXcel Therapeutics Enters Into Asset Sale Agreement with Teva Pharmaceuticals (GlobeNewswire) - "This includes IGALMI (dexmedetomidine) sublingual film and the related pending supplemental New Drug Application of BXCL501 for potential at-home (outpatient) use for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults....To anchor the sale process, Teva will serve as the sole 'stalking horse bidder' for the sale of the assets contemplated by the asset sale agreement. A stalking horse asset sale agreement establishes a strong baseline offer and is intended to help maximize value for all stakeholders through the Chapter 11 auction process."

Licensing / partnership • Bipolar Disorder • Schizophrenia

Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal (clinicaltrials.gov) - P1/2 | N=225 | Completed | Sponsor: BioXcel Therapeutics Inc | Phase classification: P1b/2 ➔ P1/2

Phase classification • Addiction (Opioid and Alcohol) • Substance Abuse

SERENITY Program (The Manila Times) - "The FDA has assigned a PDUFA target action date of November 14, 2026, which, if approved, would represent the first FDA-approved treatment option for acute agitation associated with bipolar disorders or schizophrenia in the at-home setting."

PDUFA • Bipolar Disorder • Schizophrenia

TRANQUILITY Program (The Manila Times) - "The TRANQUILITY In-Care trial is designed as a double-blind, placebo-controlled study to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 for the acute treatment of agitation associated with Alzheimer’s dementia. The Company remains focused on BXCL501’s potential in this disease, supported by a favorable regulatory environment following a recent FDA approval in an adjacent indication, which is further reinforcing the need in this therapeutic area."

New P3 trial • Alzheimer's Disease

BioXcel Therapeutics Announces Virtual Event to Discuss Commercial Launch Plan Based on Market Opportunity Assessment for IGALMI in the At-Home Setting (GlobeNewswire) - "The event will center on the Company’s ongoing launch strategy initiatives ahead of the November 14 PDUFA target action date of IGALMI for the treatment of acute agitation associated with bipolar disorders and schizophrenia in the at-home setting. A presentation by Mark Pavao, the Company’s Interim Chief Commercial Officer, will outline key elements of the Company’s commercial launch plan, building on insights from the recently completed market opportunity assessment."

Commercial • Bipolar Disorder • Schizophrenia

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

Enrollment open • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

BXCL501-105: 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: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Jul 2026 ➔ Jul 2027

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

Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder (clinicaltrials.gov) - P2 | N=33 | Completed | Sponsor: BioXcel Therapeutics Inc | Active, not recruiting ➔ Completed

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

BioXcel Therapeutics, Inc…announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for approval of IGALMI for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia. (GlobeNewswire) - "The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 14, 2026."

FDA filing • PDUFA • Bipolar Disorder • Schizophrenia

TRANQUILITY PROGRAM (BioXcel Therapeutics Press Release) - "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 has selected a CRO to prepare for trial initiation...The Company sponsored a virtual KOL roundtable on February 27 focused on acute agitation in Alzheimer’s dementia and the unmet need for an FDA-approved treatment option. The event featured leading medical experts and included discussions on the latest developments in the treatment of acute agitation in Alzheimer’s dementia and the potential role of BXCL501."

Clinical • New P3 trial • Alzheimer's Disease

BASIS: BXCL501 After Stress to Increase Recovery Success (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: University of North Carolina, Chapel Hill | Initiation date: Aug 2025 ➔ Feb 2026

Trial initiation date • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: Brigham and Women's Hospital | N=30 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia • Schizophreniform Disorder

BioXcel Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for IGALMI Label Expansion in the At-Home Setting (The Manila Times) - "Submission timeline supports potential approval of IGALMI label expansion as early as year-end 2026...The sNDA was submitted on January 14, 2026....The submission follows the successful completion of the Phase 3 SERENITY At-Home safety trial, in which BXCL501 met its primary endpoint of being well-tolerated in the at-home setting, with a safety profile consistent with the approved IGALMI label. The submission is also supported by positive FDA feedback following the pre-sNDA meeting."

FDA approval • FDA filing • Bipolar Disorder • Schizophrenia

Sublingual Dexmedetomidine for Treating Opioid Withdrawal (clinicaltrials.gov) - P1/2 | N=160 | Active, not recruiting | Sponsor: New York State Psychiatric Institute | Trial completion date: Nov 2025 ➔ Aug 2026

Trial completion date • Substance Abuse

BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI (The Manila Times) - "'Based on the accelerated submission timeline, we believe IGALMI could be approved for at-home use as early as 2026.'"

FDA approval • FDA filing • Bipolar Disorder • Schizophrenia

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