This section highlights FDA-related milestones and regulatory updates for drugs developed by BioXcel Therapeutics (BTAI).
Over the past two years, BioXcel Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BXCL501, BXCL501, IGALMI™, BXCL501, and BXCL501. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
BXCL501 (dexmedetomidine) FDA Regulatory Timeline and Events
BXCL501 (dexmedetomidine) is a drug developed by BioXcel Therapeutics for the following indication: For dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BXCL501 (dexmedetomidine)
- Announced Date:
- April 8, 2026
- Indication:
- For dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist
Announcement
BioXcel Therapeutics, announced the enrollment of the first patients in a U.S. Department of War (DoW)-funded Phase 2a clinical trial evaluating BXCL501 (sublingual dexmedetomidine) for the treatment of acute stress reactions (ASR), also known as acute stress disorder (ASD).
AI Summary
BioXcel Therapeutics announced the enrollment of the first patients in a U.S. Department of War (DoW)-funded Phase 2a clinical trial testing BXCL501 (sublingual dexmedetomidine) for acute stress reactions (ASR), also known as acute stress disorder (ASD). The study will assess the drug’s safety and effectiveness in people who experience severe stress after traumatic events.
The trial is led by the University of North Carolina at Chapel Hill (UNC) Institute for Trauma Recovery. Positive outcomes could influence Veterans Affairs and DoW clinical practice guidelines for managing ASR. Vimal Mehta, Ph.D., CEO of BioXcel, said the company looks forward to supporting Dr. McLean and the UNC team, and that results could benefit this patient population and support BXCL501’s potential as a “pipeline‑in‑a‑product.”
The research is supported by the DoW under award number HT9425-24-1-1108. The release states the content is the authors’ responsibility and does not necessarily reflect official DoW views.
Read Announcement- Drug:
- BXCL501 (dexmedetomidine)
- Announced Date:
- August 6, 2025
- Indication:
- For dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist
Announcement
BioXcel Therapeutics announced a publication in the peer-reviewed journal Frontiers in Pharmacology, entitled "Dexmedetomidine potently and reversibly regulates stress-mediated behaviors."
AI Summary
BioXcel Therapeutics announced in Frontiers in Pharmacology a study titled “Dexmedetomidine potently and reversibly regulates stress-mediated behaviors.” In this research, dexmedetomidine—an alpha2-adrenergic receptor agonist—showed strong, reversible effects on models of acute and repeated stress. It outperformed other agonists like clonidine and guanfacine, and maintained its effects with repeated dosing without causing withdrawal. Notably, dexmedetomidine did not impair motor skills or cognition at effective doses and even improved sleep patterns in these nonclinical tests.
The findings suggest that BXCL501, the orally dissolving film formulation of dexmedetomidine, could help treat chronic psychiatric conditions marked by stress, not just acute agitation. Leading academic centers are now studying daily BXCL501 dosing for disorders such as opioid withdrawal, acute stress disorder, and alcohol use disorder in patients with PTSD. These results enhance understanding of the drug’s mechanism and support its broader therapeutic potential.
Read Announcement- Drug:
- BXCL501 (dexmedetomidine)
- Announced Date:
- September 19, 2024
- Indication:
- For dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist
Announcement
BioXcel Therapeutics, announced its clinical prioritization and an update on its late-stage development programs for the treatment of agitation with BXCL501.
AI Summary
BioXcel Therapeutics has announced a new clinical prioritization plan for BXCL501, its investigational treatment for agitation. The company is focusing on advancing its late-stage development programs to treat agitation associated with bipolar disorders, schizophrenia, and Alzheimer’s dementia. Central to this plan is the SERENITY At-Home pivotal Phase 3 trial, which has been initiated with 200 patients. This trial is designed to evaluate the safety of a 120 mcg dose of BXCL501 in an at-home setting, targeting agitation in patients with bipolar disorders or schizophrenia. Additionally, BioXcel submitted the protocol for the TRANQUILITY In-Care pivotal Phase 3 trial to the FDA. This trial will assess both the efficacy and safety of a 60 mcg dose for agitation related to Alzheimer’s dementia. The company believes that concentrating resources on these programs opens attractive growth opportunities in areas with significant patient needs.
Read Announcement
BXCL501 (RELEASE) FDA Regulatory Events
BXCL501 (RELEASE) is a drug developed by BioXcel Therapeutics for the following indication: Opioid Withdrawal Symptoms.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BXCL501 (RELEASE)
- Announced Date:
- March 5, 2026
- Indication:
- Opioid Withdrawal Symptoms
Announcement
BioXcel Therapeutics announced positive topline results from a Phase 2 investigator-sponsored trial (IST) evaluating BXCL501 for the treatment of opioid withdrawal symptoms in adults with opioid use disorder (OUD) undergoing a methadone taper.
AI Summary
BioXcel Therapeutics reported positive topline results from a Phase 2 investigator-sponsored trial of BXCL501 for treating opioid withdrawal symptoms in adults with opioid use disorder who were undergoing a methadone taper. The study found that BXCL501 reduced withdrawal symptoms and was generally well tolerated. The trial included an active comparator and the methadone taper, making it a clinically distinct setting that extends earlier findings.
These results suggest BXCL501 could help patients manage withdrawal during changes in opioid treatment and support further clinical development. BioXcel indicated the data build on prior internal studies and may lead to larger trials to confirm effectiveness, safety, dosing, and where the medicine could fit in treatment plans. The company plans to share full data and next steps in future updates.
Read Announcement
IGALMI™ FDA Regulatory Timeline and Events
IGALMI™ is a drug developed by BioXcel Therapeutics for the following indication: Sublingual film.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IGALMI™
- Announced Date:
- January 20, 2026
- Indication:
- Sublingual film
Announcement
BioXcel Therapeutics, announced it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting with IGALMI®. The sNDA was submitted on January 14, 2026.
AI Summary
BioXcel Therapeutics announced it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration on January 14, 2026, seeking to expand IGALMI® (dexmedetomidine) for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting. The submission aims to allow use without a healthcare provider present, addressing a setting where there are currently no approved at-home options.
The sNDA is supported by results from the Phase 3 SERENITY At-Home safety trial, which met its primary endpoint and showed BXCL501 was well tolerated in outpatient use. BioXcel said the submission timing could support a potential label expansion approval as early as year-end 2026. The company is advancing pre-commercial activities, including a market opportunity assessment and evaluation of go-to-market strategies under its newly appointed Interim Chief Commercial Officer, Mark Pavao.
Read Announcement- Drug:
- IGALMI™
- Announced Date:
- January 12, 2026
- Indication:
- Sublingual film
Announcement
BioXcel Therapeutics, announced the advancement of its commercial planning for IGALMI® in the at-home setting.
AI Summary
BioXcel Therapeutics said it is advancing commercial planning to bring IGALMI® to the at-home setting and plans to submit a supplemental New Drug Application (sNDA) this month seeking approval for at‑home use to treat acute agitation linked to bipolar disorder or schizophrenia. The company is preparing for a potential launch as early as year‑end 2026.
To lead these efforts, BioXcel named Mark Pavao as Acting Chief Commercial Officer. Pavao has more than 30 years of U.S. and global commercial experience in neuroscience, including pre‑launch planning and on‑market commercialization of multiple CNS products. He will head development and execution of commercialization and go‑to‑market strategies for the at‑home option.
BioXcel says the move aims to increase access and convenience for patients, address an unmet need for home treatment of acute agitation, and build a commercial plan informed by clinical data and market feedback.Read Announcement
- Drug:
- IGALMI™
- Announced Date:
- January 7, 2026
- Indication:
- Sublingual film
Announcement
BioXcel Therapeutics, announced that it plans to submit a supplemental New Drug Application (sNDA) this month seeking the U.S. Food and Drug Administration's (FDA) approval of IGALMI® for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia.
AI Summary
BioXcel Therapeutics said it will submit a supplemental New Drug Application (sNDA) this month to the U.S. Food and Drug Administration seeking approval to use IGALMI® at home for the acute treatment of agitation in adults with bipolar disorders or schizophrenia.
The company said the accelerated timeline could allow approval as early as 2026. CEO Vimal Mehta said they are pleased with progress toward submission and are focused on launch planning to bring this treatment into the at-home setting for patients and caregivers. The company emphasized the importance of new at-home options for patients and caregivers.
If approved, the change would let healthcare providers offer IGALMI for treating sudden episodes of agitation outside hospitals. BioXcel is preparing the regulatory and commercial steps needed to support a potential launch while continuing to study safety and effectiveness in these settings.
Read Announcement- Drug:
- IGALMI™
- Announced Date:
- August 27, 2025
- Indication:
- Sublingual film
Announcement
BioXcel Therapeutics, announced that the SERENITY At-Home Pivotal Phase 3 trial evaluating the safety of BXCL501, the Company's proprietary, sublingual film formulation of dexmedetomidine, as an acute treatment for agitation associated with bipolar disorders or schizophrenia in the at-home setting, met its primary endpoint.
AI Summary
BioXcel Therapeutics announced that its SERENITY At-Home Pivotal Phase 3 trial evaluating the safety of BXCL501, a proprietary sublingual film formulation of dexmedetomidine, met its primary endpoint. BXCL501 was tested as an acute treatment for agitation related to bipolar disorders or schizophrenia in a home setting.
The 12-week trial enrolled 200 adults with a history of agitation despite stable therapy. Participants self-administered a 120 mcg dose of BXCL501 or placebo during agitation episodes. Safety was monitored by recording adverse events, and an exploratory measure used a modified global impression of severity two hours after dosing.
Topline results showed BXCL501 was generally well tolerated, with a safety profile similar to placebo in the outpatient environment. BioXcel will review detailed data on an investor call and live webcast on August 27, 2025.
Read Announcement- Drug:
- IGALMI™
- Announced Date:
- August 1, 2025
- Indication:
- Sublingual film
Announcement
BioXcel Therapeutics, announced completion of the last patient last visit (LPLV) in the pivotal Phase 3 SERENITY At-Home clinical trial.
AI Summary
BioXcel Therapeutics announced it has completed the last patient last visit (LPLV) in the pivotal Phase 3 SERENITY At-Home clinical trial. This milestone marks the end of the dosing period, with the vast majority of patients completing the full 12-week study.
The double-blind, placebo-controlled trial enrolled over 200 adults experiencing agitation related to bipolar disorder or schizophrenia. Patients self-administered a 120 mcg dose of BXCL501 (dexmedetomidine) or a placebo whenever an agitation episode occurred at home. The study was conducted at 22 sites, and no single site accounted for more than 11% of participants.
Investigators collected data from more than 2,200 agitation episodes, evaluating safety and exploratory measures two hours after dosing. Topline results are expected this month.
These findings will support BioXcel’s planned supplemental New Drug Application to expand IGALMI®’s label for at-home treatment of acute agitation.
Read Announcement- Drug:
- IGALMI™
- Announced Date:
- July 21, 2025
- Target Action Date:
- August 20, 2025
- Indication:
- Sublingual film
Announcement
BioXcel Therapeutics, Inc announced that Pre-Supplemental New Drug Application meeting with FDA scheduled for August 20, 2025
AI Summary
BioXcel Therapeutics, Inc., a neuroscience‐focused biopharma using AI, announced it has scheduled a Pre-Supplemental New Drug Application (pre-sNDA) meeting with the FDA for August 20, 2025. This meeting will focus on the content and format of their planned sNDA to expand IGALMI® (dexmedetomidine) use for at-home treatment of acute agitation in adults with bipolar disorder or schizophrenia.
The company is nearing completion of its SERENITY At-Home Phase 3 trial, which evaluates a 120 mcg dose of IGALMI® in a double-blind, placebo-controlled study. Top-line results are expected this quarter, following two favorable recommendations from the Data Safety Monitoring Board.
An estimated 23 million episodes of agitation linked to schizophrenia or bipolar disorder occur at home each year in the U.S., but no FDA-approved outpatient therapies exist. BioXcel aims to be the first to offer a safe, effective at-home option for these patients.
Read Announcement- Drug:
- IGALMI™
- Announced Date:
- July 21, 2025
- Indication:
- Sublingual film
Announcement
BioXcel Therapeutics, 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.
AI Summary
BioXcel Therapeutics has submitted a pre-supplemental New Drug Application (pre-sNDA) meeting package to the U.S. Food and Drug Administration for IGALMI® sublingual film. The company is seeking a label expansion to allow at-home, outpatient use of a 120 mcg dose to treat acute agitation in adults with schizophrenia or bipolar disorders. A meeting is scheduled for August 20, 2025, to align on the content and format of the formal sNDA filing and confirm that its development plan meets FDA expectations.
No FDA-approved therapies currently exist for acute agitation in the home setting, which sees an estimated 23 million episodes each year in the U.S. BioXcel is also nearing completion of its SERENITY At-Home Phase 3 trial and expects to report topline results later this quarter. Approval would make IGALMI the first FDA-approved at-home treatment for acute agitation in these conditions.
Read Announcement- Drug:
- IGALMI™
- Announced Date:
- June 25, 2024
- Indication:
- Sublingual film
Announcement
BioXcel Therapeutics, announced positive topline results from a post-marketing requirement (PMR) study of IGALMI™ (dexmedetomidine) sublingual film that demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with the 180 mcg dose after seven days of PRN (as-needed) treatment.
AI Summary
BioXcel Therapeutics recently announced positive topline results from its post-marketing requirement study of IGALMI™ (dexmedetomidine) sublingual film. The study showed that a 180 mcg dose, used as needed over seven days, did not lead to tachyphylaxis, tolerance, or withdrawal effects. This finding is significant because it demonstrates that repeated doses remain effective without diminishing the drug’s ability to manage agitation.
The study involved adult patients experiencing episodes of agitation, and the results indicated a consistent reduction in agitation symptoms with each dose administered. Moreover, no serious adverse events were observed, which highlights IGALMI™’s favorable safety profile. These outcomes support the use of IGALMI™ in treating agitation and add valuable data for the ongoing Phase 3 SERENITY and TRANQUILITY trials, potentially paving the way for future updates to the product labeling.
Read Announcement
BXCL501 (SERENITY) FDA Regulatory Timeline and Events
BXCL501 (SERENITY) is a drug developed by BioXcel Therapeutics for the following indication: Schizophrenia and bipolar disorders.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BXCL501 (SERENITY)
- Announced Date:
- October 14, 2025
- Indication:
- Schizophrenia and bipolar disorders
Announcement
BioXcel Therapeutics, announced positive results from the correlation study related to exploratory efficacy outcomes from the SERENITY At-Home trial.
AI Summary
BioXcel Therapeutics announced positive results from the SERENITY At-Home trial’s correlation study of exploratory efficacy outcomes. This study compared a new patient- and caregiver-rated scale to the traditional clinician-rated measure for agitation in schizophrenia and bipolar disorder.
To track repeat dosing at home, BioXcel developed a simplified, 4-point Modified Clinical Global Impression–Severity scale (mCGI-S). Patients or caregivers rate agitation as none, mild, moderate, or severe. This approach aims to mirror the established 7-point Positive and Negative Syndrome Scale–Excited Component (PEC).
In a prospective, open-label trial with 33 patients, mCGI-S scores strongly matched clinician PEC assessments. Correlation coefficients were ρ = 0.89 for patients and ρ = 0.88 for caregivers, both with p < 0.0001, demonstrating robust agreement.
No serious adverse events occurred, and the safety profile remained consistent. BioXcel plans to include these findings in its supplemental New Drug Application (sNDA) submission in early 2026.
Read Announcement- Drug:
- BXCL501 (SERENITY)
- Announced Date:
- September 10, 2025
- Indication:
- Schizophrenia and bipolar disorders
Announcement
BioXcel Therapeutics, announced positive topline exploratory efficacy data from the SERENITY At-Home Pivotal Phase 3 safety trial, which demonstrated BXCL501 had continued effects and consistent benefit with repeat dosing.
AI Summary
BioXcel Therapeutics announced positive topline exploratory efficacy data from the SERENITY At-Home pivotal Phase 3 safety trial. The study tested a 120 µg dose of BXCL501, a sublingual dexmedetomidine film, for agitation in bipolar disorder and schizophrenia. Although not powered for efficacy, BXCL501 showed a significant mean reduction in modified Clinical Global Impression–Severity (mCGI-S) scores versus placebo at two hours across 2,433 episodes (p<.05).
Complete resolution of agitation was higher with BXCL501 (50%) versus placebo (33%, p<.0001), including severe episodes (61% vs. 18%) and moderate (43% vs. 34%). Mean mCGI-S reduction was maintained over repeated dosing (1.2 after 12 doses, 1.4 after ≥13) and throughout 12 weeks, demonstrating continued effects and consistent benefit.
Based on this large body of evidence and positive FDA feedback, BioXcel plans to submit a supplemental NDA in Q1 2026 for expanded outpatient use of IGALMI® and will host a virtual KOL call with Dr. Leslie Citrome on the SERENITY At-Home program today at 2 p.m.
Read Announcement- Drug:
- BXCL501 (SERENITY)
- Announced Date:
- August 26, 2025
- Indication:
- Schizophrenia and bipolar disorders
Announcement
BioXcel Therapeutics, announced that it will host an investor call and live webcast at 8 a.m. ET, August 27, 2025 to review topline data from the SERENITY At-Home Pivotal Phase 3 trial evaluating the safety of BXCL501, the Company's proprietary, sublingual film formulation of dexmedetomidine, as an acute treatment for agitation associated with bipolar disorders or schizophrenia in the at-home setting.
AI Summary
BioXcel Therapeutics announced it will host an investor call and live webcast at 8 a.m. ET on August 27, 2025 to review topline data from the SERENITY At-Home Pivotal Phase 3 trial. The trial evaluates the safety of BXCL501, the company’s proprietary sublingual film formulation of dexmedetomidine, for treating agitation in adults with bipolar disorder or schizophrenia in a home setting.
During the 12-week study, 200 patients experiencing agitation episodes self-administered a 120 µg dose of BXCL501 or placebo. Safety measurements focused on adverse events, and patients or caregivers completed a modified global impression of severity (mCGIs) two hours after dosing to explore treatment impact.
Topline results will be shared in a morning press release and detailed during the webcast. Interested parties can join online via the provided webcast link or by phone at 877-407-5795 (U.S.) or +1 201-689-8722.
A replay and presentation materials will remain available on BioXcel’s investor website through November 26, 2025.
Read Announcement- Drug:
- BXCL501 (SERENITY)
- Announced Date:
- August 19, 2025
- Indication:
- Schizophrenia and bipolar disorders
Announcement
BioXcel Therapeutics announced completion of the database lock for its SERENITY At-Home pivotal Phase 3 safety trial for acute treatment of agitation associated with bipolar disorders or schizophrenia. Topline results from the study are expected in August.
Read Announcement- Drug:
- BXCL501 (SERENITY)
- Announced Date:
- August 18, 2025
- Target Action Date:
- Q1 2026
- Estimated Target Date Range:
- January 1, 2026 - March 31, 2026
- Indication:
- Schizophrenia and bipolar disorders
Announcement
BioXcel Therapeutics, announced that sNDA submission on track for Q1 2026
AI Summary
BioXcel Therapeutics announced that its planned supplemental New Drug Application (sNDA) to expand the IGALMI® label for at-home (outpatient) use remains on track for the first quarter of 2026. The company received positive written feedback from the FDA on its pre-sNDA package, confirming that the proposed clinical, nonclinical, and chemistry-manufacturing-and-controls information and formatting meet regulatory expectations. With FDA alignment secured, BioXcel believes the completed submission will support acceptance and review without needing an additional meeting.
The expanded label would allow IGALMI, currently approved for acute agitation in supervised settings, to be used safely by patients at home. The submission will feature data from the pivotal Phase 3 SERENITY At-Home trial, which evaluated the safety of a 120 mcg dose of BXCL501 for acute agitation in adults with bipolar disorder or schizophrenia. If accepted, this outpatient option could offer a new treatment pathway for patients experiencing agitation outside medical facilities.
Read Announcement- Drug:
- BXCL501 (SERENITY)
- Announced Date:
- August 18, 2025
- Indication:
- Schizophrenia and bipolar disorders
Announcement
BioXcel Therapeutics, announced that it has received positive pre-sNDA meeting responses from the U.S. Food and Drug Administration (FDA).
AI Summary
BioXcel Therapeutics announced it received positive pre-sNDA meeting responses from the FDA, confirming its sNDA package is sufficient to support a Q1 2026 submission. It aligned content and format to extend the IGALMI label for at-home (outpatient) use of BXCL501. Based on written feedback received August 14, 2025, the company concluded the meeting was successful.
IGALMI (BXCL501) is approved for agitation in supervised settings. The label expansion would allow at-home use for patients with bipolar disorder or schizophrenia. BioXcel will include data from the Phase 3 SERENITY At-Home trial, with topline safety results expected this month, to support the submission.
“FDA feedback confirmed our content and format and shows a shared commitment to patients’ urgent needs,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “This milestone brings us closer to offering safe, effective outpatient treatment for agitation.”
Read Announcement- Drug:
- BXCL501 (SERENITY)
- Announced Date:
- July 1, 2025
- Target Action Date:
- Q3 2025
- Estimated Target Date Range:
- July 1, 2025 - September 30, 2025
- Indication:
- Schizophrenia and bipolar disorders
Announcement
BioXcel Therapeutics, Inc announced that Topline data expected in Q3 2025.
AI Summary
BioXcel Therapeutics, Inc. announced that an independent Data Safety Monitoring Board (DSMB) has recommended continuing its SERENITY At-Home pivotal Phase 3 safety trial for BXCL501 without any changes. The review, based on unblinded safety data from 178 patients, supports the ongoing study of BXCL501 for the acute treatment of agitation in patients with bipolar disorders or schizophrenia in an at-home setting.
The trial, now fully enrolled and running over a 12-week period, is moving forward with promising safety observations. BioXcel expects to release the topline data in the third quarter of 2025, which will offer important insights into the safety and effectiveness of BXCL501. The company is focused on addressing an unmet medical need, as there are currently no FDA-approved therapies available for at-home treatment of agitation related to these conditions.
Read Announcement- Drug:
- BXCL501 (SERENITY)
- Announced Date:
- July 1, 2025
- Indication:
- Schizophrenia and bipolar disorders
Announcement
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.
AI Summary
BioXcel Therapeutics announced a second positive recommendation from an independent Data Safety Monitoring Board (DSMB) for its SERENITY At-Home Phase 3 trial. The DSMB reviewed unblinded safety data from 178 patients and advised that the study continue as planned without any changes. The trial is evaluating the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation in patients with bipolar disorders or schizophrenia, a significant unmet need, especially for at-home care. The study is double-blind and placebo-controlled, and it is fully enrolled with 200 patients participating over a 12-week period. BioXcel looks forward to the upcoming data readout, with topline results expected in the third quarter of 2025, as the company works to support a potential sNDA submission for expanding the at-home treatment option for agitation.
Read Announcement- Drug:
- BXCL501 (SERENITY)
- Announced Date:
- July 1, 2025
- Indication:
- Schizophrenia and bipolar disorders
Announcement
BioXcel Therapeutics, Inc. 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.
AI Summary
BioXcel Therapeutics, Inc. announced that an independent Data Safety Monitoring Board (DSMB) has given a second positive recommendation to continue the SERENITY At-Home pivotal Phase 3 safety trial for BXCL501. This trial is focused on using BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia, and it will proceed without any modifications. The DSMB’s decision followed a review of unblinded safety data from 178 patients, confirming that the trial can safely continue. The study is fully enrolled, and data collection over a 12‑week period is ongoing, with topline results expected in the third quarter of 2025.
This favorable recommendation emphasizes the potential of BXCL501 to address an important, unmet need for patients experiencing agitation at home, and it supports the company’s efforts towards developing effective at‐home treatment options for bipolar disorders or schizophrenia.
Read Announcement- Drug:
- BXCL501 (SERENITY)
- Announced Date:
- May 27, 2025
- Indication:
- Schizophrenia and bipolar disorders
Announcement
BioXcel Therapeutics, announced that an independent Data Safety Monitoring Board (DSMB) recommended that the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia continue without modification.
AI Summary
BioXcel Therapeutics announced that an independent Data Safety Monitoring Board (DSMB) recommended the SERENITY At-Home Phase 3 safety trial of BXCL501 continue as planned. The decision came after the DSMB reviewed unblinded safety data from the first 115 patients dosed as of May 2, 2025. This fully enrolled, double-blind, placebo-controlled study focuses on the acute treatment of agitation in patients with bipolar disorders or schizophrenia, conducted in an at-home setting.
CEO Vimal Mehta expressed enthusiasm over the DSMB’s favorable outcome and looks forward to the topline data expected in the third quarter of 2025. This data is seen as a key step toward a potential sNDA submission for expanding the label of IGALMI®, addressing an important unmet need in providing effective, at-home treatments for agitation.
Read Announcement - Drug:
- BXCL501 (SERENITY)
- Announced Date:
- March 27, 2025
- Indication:
- Schizophrenia and bipolar disorders
Announcement
BioXcel Therapeutics, provided a business update.
AI Summary
BioXcel Therapeutics provided an encouraging business update, highlighting progress in its SERENITY At-Home pivotal Phase 3 trial. The study, designed to evaluate the safety of a 120 mcg dose of BXCL501 for acute treatment of agitation in patients with bipolar disorders or schizophrenia, has enrolled 127 out of 200 required patients, reaching about 63% of its target. Topline data from the trial is anticipated in the second half of 2025 and may support a supplemental NDA submission for IGALMI® label expansion in the at-home setting.
Additionally, the company announced a strengthened cash position following a $14 million equity financing, which now brings cash on hand to approximately $35 million. CEO Vimal Mehta highlighted the trial’s potential to address an unmet need, given the significant number of agitation episodes observed annually in the U.S., reinforcing the company’s commitment to advancing its neuroscience portfolio.
Read Announcement- Drug:
- BXCL501 (SERENITY)
- Announced Date:
- March 11, 2025
- Indication:
- Schizophrenia and bipolar disorders
Announcement
BioXcel Therapeutics, 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. T
AI Summary
BioXcel Therapeutics announced it secured $14 million in equity financing that closed on March 4, 2025. Following this financing round, the company now has approximately $35 million in cash. This strengthened cash position is expected to support the advancement of its pivotal Phase 3 SERENITY At-Home trial. The trial is designed to study the safety of BXCL501, an investigational formulation of dexmedetomidine, for the acute treatment of agitation associated with bipolar disorders or schizophrenia in a home setting.
Topline data from the trial is anticipated in the second half of 2025. The company is hopeful that these results will support a potential supplemental New Drug Application (sNDA) to expand the label for IGALMI® in the at-home setting, potentially providing a new acute treatment option for patients suffering from agitation.
Read Announcement- Drug:
- BXCL501 (SERENITY)
- Announced Date:
- March 7, 2025
- Target Action Date:
- H2 2025
- Estimated Target Date Range:
- July 1, 2025 - December 31, 2025
- Indication:
- Schizophrenia and bipolar disorders
Announcement
BioXcel Therapeutics, announced that Topline data expected in second half of 2025
AI Summary
BioXcel Therapeutics announced that its SERENITY At-Home Phase 3 trial has reached 33% enrollment for evaluating BXCL501, a 120 mcg dose for the acute treatment of agitation in patients with bipolar disorders or schizophrenia in a home setting. With 23 clinical trial sites open, the study is focused on collecting safety data during a 12-week period. The company expects to share topline results in the second half of 2025. These results are intended to support a potential supplemental new drug application (sNDA) to expand the label of the FDA-approved IGALMI® sublingual film for treating agitation. BioXcel is working closely with its clinical research organization and principal investigators to optimize patient enrollment and ensure comprehensive data collection from the trial.
Read Announcement- Drug:
- BXCL501 (SERENITY)
- Announced Date:
- March 7, 2025
- Indication:
- Schizophrenia and bipolar disorders
Announcement
BioXcel Therapeutics, announced it has reached 33% enrollment in its 200-patient SERENITY At-Home trial.
AI Summary
BioXcel Therapeutics recently announced that it has reached 33% enrollment in its SERENITY At-Home trial, a pivotal Phase 3 study involving 200 patients. This trial is designed to evaluate the safety of BXCL501, an investigational orally dissolving film formulation containing dexmedetomidine, when used at home for the acute treatment of agitation in patients with bipolar disorder or schizophrenia.
The study focuses on testing the lowest approved dose of IGALMI® (120 mcg) with safety as the primary endpoint. With nearly all 23 clinical trial sites now open, the enrollment progress has reached 67 patients, and a Data Safety Monitoring Board is planned to assess safety data throughout the trial. Topline results are expected in the second half of 2025 and could support a supplemental new drug application for expanding the current label of IGALMI® for at-home use.
Read Announcement- Drug:
- BXCL501 (SERENITY)
- Announced Date:
- February 5, 2025
- Indication:
- Schizophrenia and bipolar disorders
Announcement
BioXcel Therapeutics, 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.
AI Summary
BioXcel Therapeutics provided an update on its late-stage clinical programs for its lead neuroscience asset, BXCL501. The company shared that the SERENITY At-Home Phase 3 trial for the acute treatment of agitation associated with bipolar disorder or schizophrenia has made significant progress, with most trial sites now open and patient enrollment advancing well. In addition, BioXcel has developed plans for the TRANQUILITY In-Care Phase 3 trial, targeting agitation associated with Alzheimer’s dementia. To enhance operational and financial flexibility, the company amended its existing credit agreement and raised additional equity funding. Furthermore, BioXcel strengthened its leadership by appointing new board members with expertise in clinical, financial, and legal areas. These actions underline the company’s commitment to advancing critical treatment options and creating value for patients and all stakeholders.
Read Announcement- Drug:
- BXCL501 (SERENITY)
- Announced Date:
- September 5, 2024
- Indication:
- Schizophrenia and bipolar disorders
Announcement
BioXcel Therapeutics, announced the initiation of patient enrollment in its SERENITY At-Home pivotal Phase 3 trial.
AI Summary
BioXcel Therapeutics has initiated patient enrollment in its SERENITY At-Home pivotal Phase 3 trial. This study will evaluate the safety of BXCL501, a proprietary, orally dissolving film formulation of dexmedetomidine, for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting.
The trial is designed as a double-blind, placebo-controlled study and plans to enroll about 200 patients. Each participant, or their caregiver, will self-administer a 120 mcg dose of BXCL501 or placebo when experiencing an episode of agitation during the 12-week trial period. With a total trial duration expected to be between 9 to 12 months, the study aims to collect robust safety data and assess the treatment’s potential to reduce emergency room visits, enhance patient safety, and lower overall treatment costs.
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BXCL501 (TRANQUILITY) FDA Regulatory Events
BXCL501 (TRANQUILITY) is a drug developed by BioXcel Therapeutics for the following indication: Agitation Associated with Dementia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BXCL501 (TRANQUILITY)
- Announced Date:
- March 3, 2025
- Indication:
- Agitation Associated with Dementia
Announcement
BioXcel Therapeutics 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.
AI Summary
BioXcel Therapeutics announced that the FDA has concluded the inspection of one site in its TRANQUILITY II Phase 3 trial is closed under 21 C.F.R.20.64(d)(3). The agency released the Establishment Inspection Report, assigning the site a "Voluntary Action Indicated" status. This decision supports the company’s assertions regarding the integrity and reliability of clinical data collected during the trial.
The closure of the inspection comes as part of the continued efforts to ensure that clinical processes meet regulatory standards. BioXcel’s CEO, Vimal Mehta, emphasized that this positive evaluation, along with the strong data evidence from the trial site, reinforces the potential clinical benefits of their lead treatment candidate, BXCL501. The company views this development as an important step in advancing their TRANQUILITY II trial and related clinical programs.
Read Announcement
