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Lu AA21004
Lu AA21004 is a multimodal antidepressant that acts as a serotonin reuptake inhibitor, serotonin 5-HT1A receptor agonist, and serotonin 5-HT7 receptor antagonist.
Lu AA21004 is a multimodal antidepressant that acts as a serotonin reuptake inhibitor, serotonin 5-HT1A receptor agonist, and serotonin 5-HT7 receptor antagonist. Used for Major depressive disorder.
At a glance
| Generic name | Lu AA21004 |
|---|---|
| Also known as | Vortioxetine |
| Sponsor | H. Lundbeck A/S |
| Drug class | Multimodal antidepressant; serotonin reuptake inhibitor with 5-HT1A agonist and 5-HT7 antagonist activity |
| Target | Serotonin transporter (SERT), 5-HT1A receptor, 5-HT7 receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry/Neurology |
| Phase | Phase 3 |
Mechanism of action
The drug combines inhibition of serotonin reuptake (increasing synaptic serotonin) with direct agonism at the 5-HT1A autoreceptor (which enhances serotonergic neurotransmission) and antagonism at the 5-HT7 receptor (which may contribute to antidepressant and anxiolytic effects). This multimodal mechanism is designed to provide faster onset and improved efficacy compared to selective serotonin reuptake inhibitors alone.
Approved indications
- Major depressive disorder
Common side effects
- Nausea
- Headache
- Diarrhea
- Dizziness
- Insomnia
Key clinical trials
- Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study (PHASE2)
- Adjunctive Vortioxetine in Schizophrenia (PHASE4)
- Vortioxetine Adjunctive Treatment in Bipolar Depression (PHASE4)
- Comparison of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Burning Mouth Syndrome (PHASE3)
- Tolerability, Safety and Efficacy of Vortioxetine (PHASE4)
- Vortioxetine in the Elderly vs. Selective Serotonin Reuptake Inhibitors (SSRIs): a Pragmatic Assessment (PHASE4)
- Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets (PHASE1)
- Vortioxetine to Prevent Return of Symptoms in Children With Depression (PHASE3)
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:
- Lu AA21004 CI brief — competitive landscape report
- Lu AA21004 updates RSS · CI watch RSS
- H. Lundbeck A/S portfolio CI