NDAORALCAPSULE
Approved
Aug 2025
Lifecycle
Launch
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
ESCITALOPRAM (escitalopram) by Almatica Pharma is escitalopram, the s-enantiomer of racemic citalopram, is presumed to be linked to potentiation of serotonergic activity in the central nervous system (cns) resulting from its inhibition of cns neuronal reuptake of serotonin (5-ht). First approved in 2025.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Escitalopram is the S-enantiomer of citalopram, an oral selective serotonin reuptake inhibitor (SSRI) approved as a capsule formulation by the FDA on 2025-08-29. It works by inhibiting neuronal reuptake of serotonin in the central nervous system to potentiate serotonergic activity. The product is in launch phase under sponsor Almatica Pharma.
Growth
Recent launch stage with moderate competitive pressure (30/100) suggests growing commercial infrastructure and field team expansion opportunities at Almatica Pharma.
Mechanism of Action
escitalopram, the S-enantiomer of racemic citalopram, is presumed to be linked to potentiation of serotonergic activity in the central nervous system (CNS) resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
An Investigator-Initiated, Randomized, Double-Blind, Double-Dummy Study to Evaluate the Adjunctive Effect of CreNeuroS™ CNS Fish Oil Plus Softgels in Patients With Major Depressive Disorder Receiving Escitalopram.
Started Jun 2026
80 enrolled
Adjunct in the Treatment of Depressive Disorder
Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV
Started May 2026
186 enrolled
Major Depressive DisorderMild Neurocognitive DisorderHIV
Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)
Started Mar 2021
132 enrolled
Anxiety
Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram
Started Oct 2020
0Major Depressive Disorder
A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder
Started May 2019
273 enrolled
Anxiety Disorders,Generalized Anxiety Disorder
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.