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
BioXcel Therapeutics (Nasdaq: BTAI) has completed the last patient visit in its pivotal Phase 3 SERENITY At-Home clinical trial, evaluating IGALMI庐 (dexmedetomidine) for treating agitation in bipolar disorders or schizophrenia patients at home. The study collected data from over 2,200 agitation episodes across more than 200 patients at 22 sites nationwide.
The double-blind, placebo-controlled trial tested a 120 mcg dose of BXCL501 and aims to support a supplemental New Drug Application (sNDA) to expand IGALMI's label for outpatient use. Topline data is expected this month. If approved, IGALMI would become the first FDA-approved therapy for the estimated 23 million annual episodes of bipolar or schizophrenia-related agitation occurring at home in the U.S.
BioXcel Therapeutics (Nasdaq: BTAI) ha completato l'ultima visita del paziente nel suo studio clinico pivotale di Fase 3 SERENITY At-Home, che valuta IGALMI庐 (dexmedetomidina) per il trattamento dell'agitazione in pazienti con disturbi bipolari o schizofrenia a domicilio. Lo studio ha raccolto dati da oltre 2.200 episodi di agitazione in pi霉 di 200 pazienti in 22 centri distribuiti a livello nazionale.
Il trial in doppio cieco controllato con placebo ha testato una dose di 120 mcg di BXCL501 e mira a supportare una richiesta supplementare di approvazione del farmaco (sNDA) per ampliare l'indicazione di IGALMI all'uso ambulatoriale. I dati principali sono attesi per questo mese. Se approvato, IGALMI diventerebbe la prima terapia approvata dalla FDA per i circa 23 milioni di episodi annuali di agitazione correlata a disturbi bipolari o schizofrenia che si verificano a domicilio negli Stati Uniti.
BioXcel Therapeutics (Nasdaq: BTAI) ha completado la 煤ltima visita del paciente en su ensayo cl铆nico pivotal de Fase 3 SERENITY At-Home, que eval煤a IGALMI庐 (dexmedetomidina) para tratar la agitaci贸n en pacientes con trastornos bipolares o esquizofrenia en casa. El estudio recopil贸 datos de m谩s de 2,200 episodios de agitaci贸n en m谩s de 200 pacientes en 22 sitios a nivel nacional.
El ensayo doble ciego controlado con placebo prob贸 una dosis de 120 mcg de BXCL501 y tiene como objetivo apoyar una solicitud suplementaria de nuevo medicamento (sNDA) para ampliar la indicaci贸n de IGALMI para uso ambulatorio. Se esperan los datos principales este mes. Si se aprueba, IGALMI se convertir铆a en la primera terapia aprobada por la FDA para los aproximadamente 23 millones de episodios anuales de agitaci贸n relacionados con trastornos bipolares o esquizofrenia que ocurren en casa en EE. UU.
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鞚挫 毵龟瞼 鞙勳暯 雽�臁� 鞁滍棙鞐愳劀電� 120mcg 鞖╇焿鞚� BXCL501鞚� 韰岇姢韸疙枅鞙茧┌, IGALMI鞚� 鞕鸽灅 頇橃瀽 靷毄 頇曤寑毳� 鞙勴暅 氤挫订 鞁犾暯 鞁犾箔(sNDA)鞚� 歆�鞗愴晿電� 瓴冹潉 氇╉憸搿� 頃╇媹雼�. 欤检殧 雿办澊韯半姅 鞚措矆 雼棎 氚滍憸霅� 鞓堨爼鞛呺媹雼�. 鞀轨澑霅� 瓴届毎 IGALMI電� 氙戈淡 雮� 臧�鞝曥棎靹� 氚滌儩頃橂姅 鞐瓣皠 鞎� 2,300毵� 瓯挫潣 鞏戧饭靹� 鞛レ暊 霕愲姅 臁绊槃氤� 甏�霠� 齑堨“頃棎 雽�頃� FDA 鞀轨澑鞚� 氚涭潃 斓滌磮鞚� 旃橂鞝�臧� 霅� 瓴冹瀰雼堧嫟.
BioXcel Therapeutics (Nasdaq : BTAI) a termin茅 la derni猫re visite patient de son essai clinique pivot de phase 3 SERENITY At-Home, 茅valuant IGALMI庐 (dexm茅d茅tomidine) pour le traitement de l'agitation chez les patients atteints de troubles bipolaires ou de schizophr茅nie 脿 domicile. L'茅tude a recueilli des donn茅es sur plus de 2 200 茅pisodes d'agitation chez plus de 200 patients dans 22 sites 脿 travers le pays.
L'essai en double aveugle contr么l茅 par placebo a test茅 une dose de 120 mcg de BXCL501 et vise 脿 soutenir une demande d'autorisation de mise sur le march茅 suppl茅mentaire (sNDA) pour 茅tendre l'indication d'IGALMI 脿 un usage ambulatoire. Les donn茅es principales sont attendues ce mois-ci. En cas d'approbation, IGALMI deviendrait la premi猫re th茅rapie approuv茅e par la FDA pour les quelque 23 millions d'茅pisodes annuels d'agitation li茅s aux troubles bipolaires ou 脿 la schizophr茅nie survenant 脿 domicile aux 脡tats-Unis.
BioXcel Therapeutics (Nasdaq: BTAI) hat den letzten Patientenbesuch in seiner entscheidenden Phase-3-Studie SERENITY At-Home abgeschlossen, die IGALMI庐 (Dexmedetomidin) zur Behandlung von Unruhe bei Patienten mit bipolaren St枚rungen oder Schizophrenie zu Hause untersucht. Die Studie sammelte Daten von 眉ber 2.200 Unruhe-Episoden bei mehr als 200 Patienten an 22 Standorten landesweit.
Die doppelblinde, placebokontrollierte Studie testete eine 120 mcg Dosis von BXCL501 und zielt darauf ab, eine erg盲nzende Zulassungsanmeldung (sNDA) zur Erweiterung der IGALMI-Kennzeichnung f眉r die ambulante Anwendung zu unterst眉tzen. Die wichtigsten Ergebnisse werden f眉r diesen Monat erwartet. Bei Zulassung w盲re IGALMI die erste von der FDA zugelassene Therapie f眉r die gesch盲tzten 23 Millionen j盲hrlichen Episoden von Unruhe im Zusammenhang mit bipolaren St枚rungen oder Schizophrenie, die zu Hause in den USA auftreten.
- Study completion marks significant milestone towards potential FDA approval for at-home use
- Large dataset collected with over 2,200 agitation episodes
- Well-distributed patient enrollment across 22 sites with no site bias
- Addresses large unmet need with 23 million annual agitation episodes occurring at home
- Topline data results not yet available
- FDA approval for at-home use still pending
- Currently no approved therapies in this setting, indicating potential regulatory challenges
Insights
BioXcel completed pivotal Phase 3 safety trial for IGALMI in at-home agitation treatment, with topline data expected this month.
BioXcel Therapeutics has reached a significant clinical milestone with the completion of their SERENITY At-Home Phase 3 safety trial. This study evaluated BXCL501 (IGALMI庐/dexmedetomidine) at a 120 mcg dose for treating acute agitation in bipolar disorders or schizophrenia patients in the outpatient setting.
The trial design shows methodological rigor - it was double-blind and placebo-controlled, involving over 200 patients across 22 sites nationwide. The patient distribution was well-balanced between bipolar disorders and schizophrenia populations, with no single site recruiting more than 11% of participants, which strengthens the study's validity by minimizing site-specific biases.
Data from more than 2,200 agitation episodes were collected throughout the 12-week study period, providing a substantial dataset to evaluate the safety profile of BXCL501 in the at-home setting. This volume of episodes suggests robust real-world testing conditions for the medication.
The timing is particularly noteworthy - with topline data expected this month and plans to file a supplemental New Drug Application (sNDA) to expand IGALMI's label for at-home use. If successful, this would position IGALMI as the first FDA-approved therapy for at-home treatment of agitation in these psychiatric conditions, addressing a significant unmet need affecting an estimated 23 million episodes annually in the U.S.
This label expansion could substantially increase the drug's addressable market, as the current approval is limited to healthcare facility settings. The completion of this safety trial on schedule is a positive execution signal from management.
Vast majority of patients dosed completed the full 12-week study
Data from more than 2,200 agitation episodes collected
Topline data readout anticipated this month
NEW HAVEN, Conn., Aug. 01, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today 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庐 (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. The SERENITY At-Home study enrolled more than 200 patients across 22 sites nationwide, with no single site enrolling more than
鈥淭his marks a major milestone in our efforts to bring a much-needed at-home (outpatient) treatment option to the millions of individuals who experience agitation related to bipolar disorders or schizophrenia,鈥� said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. 鈥淲e鈥檙e grateful to the patients, caregivers, investigators, CRO, and our internal teams who made this possible in a very timely manner. With this final visit complete, we look forward to sharing topline results soon. This is another critical step toward advancing BXCL501 (IGALMI庐) as the first FDA-approved therapy for this indication in the home setting.鈥�
There are an estimated 23 million episodes of bipolar or schizophrenia-related agitation annually in the U.S. that occur at home 1-3, and there are currently no FDA-approved therapies for acute treatment in this setting.
About the SERENITY At-Home Phase 3 Trial听
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. The trial is designed to evaluate 200 patients with a history of agitation episodes residing at home either alone or with caregivers/informants. Patients are self-administering 120 mcg of BXCL501 or placebo when agitation episodes occur over the 12-week trial period, with safety data (adverse events) collected during the trial. In addition, patients or caregivers/informants will complete a modified global impression of severity (mCGIs) and a clinical global impression of change (mCGI-C) two hours after dosing as an exploratory endpoint to evaluate use in the outpatient setting.听
About BXCL501
Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI庐 (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer鈥檚 dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.听
About IGALMI庐听(dexmedetomidine) sublingual film
INDICATION
IGALMI庐听(dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children.
IMPORTANT SAFETY INFORMATION
IGALMI can cause serious side effects, including:
- Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients.听IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint.
- Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations.
- Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI.
- Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours.
The most common side effects听of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing.
These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects.
Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids.
Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit听听or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201-1088 or听.
Please see full prescribing information at听.
About听BioXcel听Therapeutics,听Inc.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company鈥檚 drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit听.
Forward-Looking听Statements
This current report includes 鈥渇orward-looking statements鈥� within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this current report other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: the Company鈥檚 upcoming data release and sNDA submission. When used herein, words including 鈥渁nticipate,鈥� 鈥渂elieve,鈥� 鈥渃an,鈥� 鈥渃ontinue,鈥� 鈥渃ould,鈥� 鈥渄esigned,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥渇orecast,鈥� 鈥済oal,鈥� 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥渕ight,鈥� 鈥減lan,鈥� 鈥減ossible,鈥� 鈥減otential,鈥� 鈥減redict,鈥� 鈥減roject,鈥� 鈥渟hould,鈥� 鈥渢arget,鈥� 鈥渨ill,鈥� 鈥渨ould鈥� and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company鈥檚 current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including the factors discussed under the caption 鈥淩isk Factors鈥� in its most recent Quarterly Report on Form 10-Q, as such factors may be updated from time to time in its other filings with the SEC. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management鈥檚 estimates as of the date of this current report. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company鈥檚 views as of any date subsequent to the date of this current report.
Contact听Information听
Corporate/Investors听
Russo Partners听
Nic Johnson听
听
1.303.482.6405听
Media听
Russo Partners听
David Schull听
听
1.858.717.2310听
Source: BioXcel Therapeutics, Inc.听
IGALMI庐听is a registered trademark of BioXcel Therapeutics, Inc.听
References
- Data on file relating to agitation episodes associated with schizophrenia or bipolar I or II disorder. BioXcel Therapeutics, Inc. New Haven, CT December 2020. Episode estimations may not reflect potential treatable episodes, and actual addressable market may be smaller.
- Data from Wu EQ, Shi L, Birnbaum H, et al. Annual prevalence of diagnosed schizophrenia in the USA: a claims data analysis approach. Psychol Med. 2006;36(11):1535-1540. Estimates based on whether indications are approved for at-home use for the intended patient population and such patients are treatable. Episode estimations may not reflect potential treatable episodes, and actual addressable market may be smaller.
- National Institute of Mental Health. Prevalence of bipolar disorder in adults. November 2017. Accessed December 16, 2022. . Episode estimations may not reflect potential treatable episodes, and actual addressable market may be smaller.
FAQ
What is the significance of BioXcel's SERENITY At-Home Phase 3 trial completion?
How many patients participated in BTAI's SERENITY At-Home trial?
When will BioXcel Therapeutics (BTAI) release the SERENITY trial results?
What is the market opportunity for IGALMI in the at-home setting?
What dose of BXCL501 was tested in the SERENITY At-Home trial?
