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lithium (mood stabilizer)
lithium (mood stabilizer) is a Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development.
Lithium is a small molecule used as a mood stabilizer in the treatment of various conditions, including bipolar affective disorder, bipolar I disorder, bipolar disorder, bipolar depression, and depression. It is studied in combination with other treatments, such as quetiapine fumarate, as part of mood stabilizer treatment.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | lithium (mood stabilizer) |
|---|---|
| Sponsor | AstraZeneca |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine (PHASE3)
- The Combination of Pharmacotherapy and Cognitive Behavioral Psychotherapy Under the Recovery Perspective. (PHASE1)
- Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR. (PHASE4)
- Sequential Multiple Assignment Randomized Trial for Bipolar Depression (PHASE4)
- Exploration of Differences in Metabolite Concentrations by NMR Spectroscopy in the Ventral Striatum, Anterior Cingulate Cortex and Prefrontal Cortex in Euthymic Patients With Unipolar and Bipolar Type II Mood Disorders, as Well as in Healthy Subjects (NA)
- Development and Application of Precision Treatment Strategies for Common Mental Disorders (NA)
- The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients (PHASE1, PHASE2)
- Definitive Selection of Neuroimaging Biomarkers for the Diagnosis and Treatment to Common Mental Disorders (NA)
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:
- lithium (mood stabilizer) CI brief — competitive landscape report
- lithium (mood stabilizer) updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about lithium (mood stabilizer)
What is lithium (mood stabilizer)?
Who makes lithium (mood stabilizer)?
What development phase is lithium (mood stabilizer) in?
Related
- Manufacturer: AstraZeneca — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing