Floatz Rating
BB70/100
Confidence
Indicative
Sponsor
Dr. Inge Winter
Modality
Small molecule
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
74High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT05603104CT.gov Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure | — | Recruiting | — | — | — |
NCT06662526CT.gov Lithium for Prevention of Cognitive Declining in Mood Illnesses | — | Not Yet Recruiting | — | — | — |
NCT06054321CT.gov Psychopharmacotherapy for Depressive Patients | — | Recruiting | — | — | — |
NCT05531591CT.gov RCT of Brain Longitudinal Biomarker Study (OPT-Neuro RCT) | — | Completed | — | — | — |
NCT03290963CT.gov Effect of Lithium Versus Placebo in Adults With Treatment-Resistant Depression Who Are Receiving Ketamine | — | Withdrawn | — | — | — |
NCT02960763CT.gov Optimizing Outcomes of Treatment-Resistant Depression in Older Adults | — | Completed | — | — | — |
NCT01896349CT.gov Interpersonal Psychotherapy for Treatment Resistant Depression | — | Unknown | — | — | — |
NCT01134731CT.gov Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation | — | Completed | — | — | — |
NCT01189812CT.gov Safety and Efficacy Study of Citalopram and Lithium for the Treatment of Depressive Mood Disorder Symptoms | — | Completed | — | — | — |
NCT00789854CT.gov Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients | — | Completed | — | — | — |
Show 4 more trialsShow fewer
NCT00548964CT.gov Continuation Ketamine in Major Depression | — | Completed | — | — | — |
NCT00437385CT.gov Evaluation of Three Continuation Therapies After ECT Concerning Efficacy and Cognition in Severly Depressed Patients | — | Completed | — | — | — |
NCT00581009CT.gov The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients | — | Completed | — | — | — |
NCT00000375CT.gov Continuation Electroconvulsive Therapy Vs Medication to Prevent Relapses in Patients With Major Depressive Disorder | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Major Depressive Disorder
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Lithium, Elemental (this asset) | Dr. Inge Winter | Approved | BB · 70 |
| Selegiline | Corium Innovations, Inc. | P4 | BBB |
| Risperidone | Johns Hopkins University | P4 | BBB |
| Edivoxetine | Eli Lilly and Company | P3 | BBB |
| (1S,2R)-MILNACIPRAN | Allergan | P4 | BBB |
| Brexpiprazole | Nova Scotia Health Authority | P4 | BBB |
| Vortioxetine | Mayo Clinic | P4 | BBB |
| Amitriptyline | e-Therapeutics PLC | P4 | BBB |
| Citalopram | Xinyu Zhou | P4 | BBB |
+42 more in the Major Depressive Disorder cohort
Other indications for Lithium, Elemental
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Bipolar I Disorder | — | P4 | BBB · 77 |
| Bipolar Depression | — | P4 | BBB · 75 |
| Manic Bipolar Affective Disorder | — | P4 | BBB · 75 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Lithium, Elemental in Major Depressive Disorder. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/lithium-elemental-major-depressive-disorder
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