BioXcel Therapeutics, Inc.
BTAINext catalyst
Sublingual film containing Dexmedetomidine
At-home acute treatment of agitation associated with bipolar disorders or schizophrenia
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FDA PDUFA Date Dexmedetomidine sublingual film (IGALMI)
For At-home acute treatment of agitation associated with bipolar disorders or schizophrenia. sNDA. Verified against the company announcement on 2026-10-16.
SourceUpcoming FDA decisions
Market Overview
Stock performance and key metrics
Sublingual film containing dexmedetomidine (BXCL501)
Agitation
BXCL501
Agitation,Psychomotor
Dexmedetomidine
Opioid Withdrawal
Sublingual film containing Dexmedetomidine
Agitation,Psychomotor
BXCL701
Metastatic Pancreatic Ductal Adenocarcinoma
BXCL501 (180 micrograms)
Opioid Use Disorder
BXCL701 monotherapy
Prostate Cancer
BXCL501 Sublingual Film
Bipolar I Disorder
BXCL501 (240 micrograms)
Opioid Use Disorder
BXCL701 plus Pembrolizumab
Prostate Cancer
| Drug Name | Phase | Indication | Designations | Patent |
|---|---|---|---|---|
Sublingual film containing dexmedetomidine (BXCL501) | Phase 3 | Agitation | - | - |
BXCL501 | Phase 3 | Agitation,Psychomotor | - | - |
Dexmedetomidine | Phase 2 | Opioid Withdrawal | - | - |
Sublingual film containing Dexmedetomidine | Phase 2 | Agitation,Psychomotor | - | - |
BXCL701 | Phase 2 | Metastatic Pancreatic Ductal Adenocarcinoma | - | - |
BXCL501 (180 micrograms) | Phase 2 | Opioid Use Disorder | - | - |
BXCL701 monotherapy | Phase 2 | Prostate Cancer | - | - |
BXCL501 Sublingual Film | Phase 2 | Bipolar I Disorder | - | - |
BXCL501 (240 micrograms) | Phase 2 | Opioid Use Disorder | - | - |
BXCL701 plus Pembrolizumab | Phase 2 | Prostate Cancer | - | - |
Agitation,Psychomotor
2 drugs in this indication
Agitation
2 drugs in this indication
Bipolar I Disorder
1 drug in this indication
Prostate Cancer
1 drug in this indication
Opioid Withdrawal
1 drug in this indication
Agitation Associated With Bipolar Disorder
1 drug in this indication
Source: CatalystAlert database (ClinicalTrials.gov, SEC EDGAR)
Frequently asked questions
What is in BioXcel Therapeutics, Inc.'s drug pipeline?→
CatalystAlert tracks 10 drug candidates in BioXcel Therapeutics, Inc.'s (BTAI) pipeline across Phase 3, Phase 2. Its lead program is Sublingual film containing Dexmedetomidine (Phase 2). Each drug's phase, indication and upcoming catalysts are listed on this page.
When is BioXcel Therapeutics, Inc.'s next FDA catalyst?→
BioXcel Therapeutics, Inc.'s (BTAI) next tracked catalyst is a PDUFA date expected Nov 14, 2026. See the catalyst timeline on this page for the full schedule of PDUFA dates, trial readouts and FDA events.
How do I track BTAI biotech catalysts?→
Add BTAI to your CatalystAlert watchlist for alerts ahead of each catalyst, and follow BioXcel Therapeutics, Inc.'s live catalyst calendar, drug pipeline and clinical-trial timeline on this page — sourced from ClinicalTrials.gov, FDA and SEC filings.