Data updated: May 26, 2026
ESCITALOPRAM (escitalopram oxalate)
Trial Activity: Mature 12 active trials
CNS
Approved 2025-08-29
Development Insights
Otsuka Pharmaceutical Development & Commercialization, Inc. conducting 6 trials (5%)
84 indications explored (Broad Platform)
→ major depressive disorder (33 trials)
→ depression (17 trials)
→ major depression (9 trials)
1
Indication
--
Phase 3 Trials
0
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2025-08-29
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
ESCITALOPRAM Approval History
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
What ESCITALOPRAM Treats
1 FDA approvalsOriginally approved for its first indication in 2025 .
- Other (1)
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Clinical Trial Registry
122 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05004987 | 21-00535 | Ph 4 | recruiting | Aβ Dynamics in LLMD |
| NCT06705478 | A5402 | Ph 2 | recruiting | Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV |
| NCT07478796 | 213/25 | Ph 4 | recruiting | TDM-Guided Treatment With SSRIs in Hospitalized Adults and Children |
| NCT05017311 CAN-BIND-17 | 1027397 | Ph 4 | recruiting | Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D) |
| NCT06216535 | STU-2023-0494 R61HL167909-01A1 | Ph 2 | recruiting | Escitalopram in Asthma Patients With Frequent Exacerbation |
| NCT05603104 INTENSIFY | 2022-502185-24-00 (EU CT #) | Ph 3 | recruiting | Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure |
| NCT05289830 results posted | CASE6220 | Ph 2 | terminated | Escitalopram to Placebo in Patients With Localized Pancreatic Cancer |
| NCT05973786 INTENSIFY BD | 2023-506605-19-00 (EU CT#) | Ph 3 | recruiting | The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment. |
| NCT03527043 results posted | 1608017504 | Ph 2 | terminated | Impact of Escitalopram on Sperm DNA Fragmentation |
| NCT05536414 JUNIPER | 405-201-00062 | Ph 2 | completed | Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder |
| NCT00958633 results posted | H09-01017 | Ph 3 | terminated | Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder. |
| NCT03852160 | CR108567 2018-001890-26, 54135419TRD3011 | Ph 3 | withdrawn | A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression |
| NCT06828887 | LV232-MDD-II-01 | Ph 2 | recruiting | Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LV232 Capsules in the Treatment of MDD |
| NCT03108846 S-CitAD | S-CitAD R01AG052510 | Ph 3 | active not recruiting | Escitalopram for Agitation in Alzheimer's Disease |
| NCT04336228 | H-18038325 | Ph 4 | active not recruiting | The Role of Serotonin in Compulsive Behavior in Humans: Underlying Brain Mechanisms |
| NCT04623099 PrEcISE | Strawn PrEcISE R01HD099775 | Ph 4 | recruiting | Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE) |
| NCT04245748 DOTS-AD | Strawn DOTS-AD | Ph 4 | recruiting | Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD) |
| NCT04245436 AtLAS-A | Strawn AtLAS-A | Ph 4 | recruiting | Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A) |
| NCT03909217 TECAS | 2018YFC1705801 | Ph 2, Ph 3 | completed | Treating Depression With Transcutaneous Electrical Cranial-auricular Acupoint Stimulation (TECAS). |
| NCT02620150 results posted | 823405 | Ph 4 | completed | SSRI Effects on Depression and Immunity in HIV/AIDS |
| NCT01479829 results posted | 203368 | Ph 4 | completed | Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression |
| NCT04352101 results posted | IRB00117673 1R21MH121891 | Ph 4 | completed | Bupropion Versus Escitalopram on Reward Circuitry and Motivational Deficits |
| NCT04476030 results posted | 217-MDD-305 | Ph 3 | completed | A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder |
| NCT05950061 | KRL/02/19/1 | Ph 3 | completed | Sertraline Versus Escitalopram in South Asian Participants With Moderate to Severe Major Depressive Disorder |
| NCT04763135 MIR-P | 69HCL20_0032 2020-002994-90 | Ph 3 | terminated | Mirtazapine in Cancer-related Poly-symptomatology |
| NCT03779789 VESPA | 2016-0234923 2018-001444-66 | Ph 4 | completed | Vortioxetine in the Elderly vs. Selective Serotonin Reuptake Inhibitors (SSRIs): a Pragmatic Assessment |
| NCT03652870 ADepT-PD | 18/0279 | Ph 3 | completed | Antidepressants Trial in Parkinson's Disease |
| NCT03993457 PRECISE-D results posted | STU-2019-0623 | Ph 4 | terminated | Promoting Enhanced Pharmacotherapy Choice Through Immunomarkers Evaluation in Depression |
| NCT04162522 | 19-5371 | Ph 3 | completed | Canadian Biomarker Integration Network for Depression (CAN-BIND) - Validation Study |
| NCT05737511 | 02/2023 | Ph 4 | not yet recruiting | Efficacy of Hydroxyzine for Patients With Panic Disorder |
| NCT02623205 results posted | 2014-2911-F | Ph 4 | completed | Advancing Personalized Antidepressant Treatment Using PET/MRI |
| NCT03924323 results posted | SCT-MD-60 | Ph 4 | completed | A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder |
| NCT02674529 SONRISA results posted | STUDY19070392/PRO16050131 | Ph 2, Ph 3 | completed | Study of Neural Responses Induced by Antidepressant Effects |
| NCT04697693 results posted | 8111 | Ph 4 | terminated | Antidepressant Response in Older Adults With Comorbid PTSD and MDD |
| NCT03812588 results posted | 7738 | Ph 4 | completed | Contact: Developing New Clinical Management Strategies |
| NCT03522844 TAME | 2017-1464 | Ph 4 | completed | Treatments for Anxiety: Meditation and Escitalopram |
| NCT01123707 results posted | 31-08-257 2010-018860-17 | Ph 3 | terminated | To Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD) |
| NCT01111565 results posted | 31-08-263 2010-018859-97 | Ph 3 | terminated | Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD) |
| NCT01111552 results posted | 31-08-256 2010-018858-12 | Ph 3 | terminated | Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD) |
| NCT01111539 results posted | 31-08-255 2010-018796-21 | Ph 3 | terminated | Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD) |
| NCT02332291 CAARE results posted | 141137 | Ph 4 | completed | Connectivity Affecting the Antidepressant REsponse Study |
| NCT03912974 | BASEC 2019-00223 | Ph 1 | completed | Effects of SERT Inhibition on the Subjective Response to Psilocybin in Healthy Subjects |
| NCT04388202 LEAP-SE | LEAP-SE 1R44MH123373-01 | Ph 4 | withdrawn | Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram |
| NCT01728194 results posted | 1205012392 1R01MH097735-01 | Ph 4 | completed | Emotional and Cognitive Control in Late-Onset Depression |
| NCT01401595 NES results posted | 806753 | Ph 3 | completed | Brain Imaging and Treatment Studies of the Night Eating Syndrome |
| NCT02082392 results posted | #6652 | Ph 4 | completed | Developing New Clinical Management Strategies |
| NCT03487211 CORTEX | ShaheedZABMU | Ph 2, Ph 3 | completed | Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia |
| NCT02191397 results posted | 114589 | Ph 3 | completed | Study to Evaluate the Efficacy, Safety and Tolerability of Bupropion Hydrochloride Extended-release Tablet, and Escitalopram Oxalate Capsule in Subjects With Major Depressive Disorder |
| NCT02869035 | NP1 | Ph 1 | completed | Treatment Outcome in Major Depressive Disorder |
| NCT01902004 results posted | R-01 MH097892 R01MH097892 | Ph 4 | completed | Brain Aging and Treatment Response in Geriatric Depression |
Showing 50 of 122 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ESCITALOPRAM FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment