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Sublingual film containing Igalmi
Sublingual film containing Igalmi is a Atypical antipsychotic Small molecule drug developed by BioXcel Therapeutics Inc. It is currently FDA-approved for Acute agitation associated with schizophrenia or bipolar disorder. Also known as: Dexmedetomidine, BXCL501.
Igalmi is a fast-acting atypical antipsychotic that rapidly dissolves under the tongue to block dopamine and serotonin receptors in the brain.
A sublingual film containing Igalmi is being studied for various conditions, including Bipolar Disorder, Schizophrenia, and Agitation in ClinicalTrials.gov. The sublingual film is made of a gelatin film, an absorbable material, according to ChEMBL.
At a glance
| Generic name | Sublingual film containing Igalmi |
|---|---|
| Also known as | Dexmedetomidine, BXCL501 |
| Sponsor | BioXcel Therapeutics Inc |
| Drug class | Atypical antipsychotic |
| Target | Dopamine D2 receptor, Serotonin 5-HT2A receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | FDA-approved |
Mechanism of action
Igalmi (risperidone) is formulated as a sublingual film that bypasses first-pass hepatic metabolism, allowing faster absorption and onset of action compared to oral tablets. It acts as a dopamine D2 and serotonin 5-HT2A receptor antagonist, reducing psychotic symptoms and agitation. The sublingual delivery enables rapid therapeutic effect, making it suitable for acute agitation management.
Approved indications
- Acute agitation associated with schizophrenia or bipolar disorder
Common side effects
- Somnolence
- Akathisia
- Extrapyramidal symptoms
- Headache
- Dizziness
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sublingual film containing Igalmi CI brief — competitive landscape report
- Sublingual film containing Igalmi updates RSS · CI watch RSS
- BioXcel Therapeutics Inc portfolio CI
Frequently asked questions about Sublingual film containing Igalmi
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Related
- Drug class: All Atypical antipsychotic drugs
- Target: All drugs targeting Dopamine D2 receptor, Serotonin 5-HT2A receptor
- Manufacturer: BioXcel Therapeutics Inc — full pipeline
- Therapeutic area: All drugs in Psychiatry
- Indication: Drugs for Acute agitation associated with schizophrenia or bipolar disorder
- Also known as: Dexmedetomidine, BXCL501
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing