BioXcel Therapeutics Submits Pre-Supplemental New Drug Application Meeting Package to FDA for Label Expansion

Strategic Insights -

BioXcel Therapeutics, Inc. has 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(r) in support of a potential label expansion for outpatient use for the acute treatment of agitation associated with bipolar disorders or schizophrenia. The pre-sNDA meeting, scheduled for August 20, 2025, aims to gain alignment with the FDA regarding the content and format of the planned sNDA submission. This development is a significant step towards expanding the label for IGALMI(r), a medication that has shown promise in treating agitation associated with schizophrenia or bipolar disorders.

Key Takeaways:

  • BioXcel Therapeutics has submitted a pre-sNDA meeting package to the FDA for IGALMI(r) to support label expansion for outpatient use.
  • The pre-sNDA meeting is scheduled for August 20, 2025, and aims to gain alignment with the FDA on the content and format of the planned sNDA submission.
  • The company plans to reconfirm the understanding reached during the Type C meeting with the FDA in March 2024 regarding the development plans for expanding the label.
  • IGALMI(r) has shown promise in treating agitation associated with schizophrenia or bipolar disorders, and the label expansion would enable at-home use.
  • The sNDA submission is planned 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.
  • BioXcel Therapeutics has not received FDA approval for IGALMI(r) and the pre-sNDA meeting package is a significant step towards potential label expansion.

Statistics:

  • 1 pre-sNDA meeting requested with the FDA to gain alignment on the content and format of the sNDA submission.
  • 1 Type C meeting previously held with the FDA on March 6, 2024, to discuss development plans for expanding the label.
  • 120 mcg dose of BXCL501 planned for at-home (outpatient) use for the acute treatment of agitation associated with schizophrenia or bipolar disorders.
  • 1 potential label expansion for outpatient use for the acute treatment of agitation associated with bipolar disorders or schizophrenia.

Sources:

  • BioXcel Therapeutics' FORM 8-K filing with the SEC on July 21, 2025.
  • BioXcel Therapeutics' press release announcing the submission of the pre-sNDA meeting package to the FDA on July 21, 2025.