Summary
Empagliflozin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Schizophrenia would be drug repurposing rather than first-in-human development. This does not mean it is approved for Schizophrenia. ClinicalTrials.gov lists 1 registered trial linking Empagliflozin to Schizophrenia: 1 is currently recruiting. The most advanced is Phase 3 (NCT05669742). It plans or enrolled 40 participants. Registered activity dates to 2023. The literature layer holds 2 publications for this pair: 2 clinical trial publications. The dated items are from 2026. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Schizophrenia ranks 499 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous full remission rare (<10%); after first episode, ~80% relapse within 5 years without maintenance antipsychotic; functional disability accumulates over time; 20% achieve good long-term outcome.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 29.0 (trials 5.0, literature 4.0, tier 15, approved bonus 5.0) |
| Registered trials | 1 total: 1 recruiting, 0 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 2 (2 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | ATP2A2 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT05669742 | Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients 2023 | recruiting | Phase 3 | 40 |
Published literature
- Clinical trial publication Empagliflozin as an Alternative to Metformin for Antipsychotic-Related Weight Gain: Double-Blind Randomized Controlled TrialDolati A, Ahmadimoghaddam D, Zamanirafe M et al. · Human psychopharmacology · 2026 · PMID 42135901
- Clinical trial publication Effects of Empagliflozin and Lifestyle Intervention on Improving Body Weight and Other Metabolic Parameters in Atypical Antipsychotics-treated Patients with Schizophrenia Spectrum Disorders-A Double-blind Randomized Placebo-controlled TrialWong SY, Chan SC, Mo YF et al. · Schizophrenia bulletin · 2026 · PMID 42104798
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ATP2A2. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Empagliflozin approved for Schizophrenia?
Empagliflozin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Schizophrenia would be drug repurposing rather than first-in-human development. This does not mean it is approved for Schizophrenia. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Empagliflozin in clinical trials for Schizophrenia?
ClinicalTrials.gov lists 1 registered trial linking Empagliflozin to Schizophrenia: 1 is currently recruiting. The most advanced is Phase 3 (NCT05669742). It plans or enrolled 40 participants. Registered activity dates to 2023.
What does the evidence show for Empagliflozin in Schizophrenia?
Trials of Empagliflozin in Schizophrenia are registered but none has completed, so there is no outcome evidence from those studies yet; the record is a signal of research interest. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ATP2A2. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.