BioXcel Therapeutics Gains FDA Alignment on sNDA for At-Home Use of BXCL501

August 18, 2025

DENVER, Colo., Aug 18, 2025 (247marketnews.com)- BioXcel Therapeutics (NASDAQ:BTAI) took a significant regulatory step forward this week with a positive outcome from its pre-supplemental New Drug Application (sNDA) interaction with the U.S. Food and Drug Administration (FDA). The agency provided written feedback indicating that the Company’s planned submission package for BXCL501, the active ingredient in IGALMI, is sufficient to proceed with an sNDA aimed at expanding the drug’s use into the at-home treatment setting for patients experiencing agitation associated with bipolar I or II disorder or schizophrenia.

The FDA’s written comments, received on August 14, 2025, confirmed alignment on the required clinical, nonclinical, and manufacturing components of the sNDA package. As a result, BioXcel has cancelled a previously scheduled pre-sNDA meeting, citing that all key objectives have been addressed. The company reaffirmed its intention to submit the sNDA in Q1 2026, pending completion of the full application and final FDA review.

From Hospital to Home: A Major Label Expansion in Sight

Currently, IGALMI is FDA-approved for acute treatment of agitation in medically supervised settings. The upcoming sNDA seeks to extend that indication to the at-home (outpatient) setting, a move that would represent a significant market expansion and address a critical gap in psychiatric care.

There are currently no FDA-approved options for at-home treatment of acute agitation in these populations. If approved, BXCL501 would become the first drug available for self-administration during agitation episodes outside of clinical supervision, a potential paradigm shift in managing psychiatric emergencies.

Vimal Mehta, Ph.D., BioXcel’s CEO, commented, “We are pleased with the pre-sNDA meeting feedback we received from the FDA, which confirmed agreement on the content and format for our planned sNDA submission, and reflects a shared commitment to addressing the urgent needs of patients living with bipolar disorder or schizophrenia.”

Key Study: SERENITY At-Home Trial

The sNDA submission will be anchored by data from the SERENITY At-Home Phase 3 trial, a randomized, double-blind, placebo-controlled study evaluating the safety of a 120 mcg dose of BXCL501 over a 12-week period. The trial enrolled 200 patients with a history of agitation episodes, all of whom were living at home, either alone or with caregivers. Participants self-administered the drug as needed and were monitored for safety outcomes and caregiver-reported effectiveness measures.

The design and protocol of the trial were previously agreed upon in a Type C meeting with the FDA in March 2024. The Company recently announced last patient last visit (LPLV) for the study, with topline data expected later this month, a potentially critical catalyst for investors and stakeholders awaiting efficacy and safety insights.

Regulatory Momentum and Fast Track Status

BXCL501 already holds Fast Track Designation from the FDA for this indication, a designation that underscores the high unmet need in this area and allows for a more streamlined regulatory process. The recent FDA feedback further strengthens confidence in the submission pathway and may lay the foundation for IGALMI to become the first and only FDA-approved therapy for managing acute psychiatric agitation at home.

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