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lithium or lamotrigine
lithium or lamotrigine is a Mood stabilizer Small molecule drug developed by University of Aarhus. It is currently in Phase 3 development for Bipolar disorder, Major depressive disorder.
Lithium is a mood stabilizer that works by affecting the levels of certain neurotransmitters in the brain, such as serotonin and dopamine.
Lamotrigine is a small molecule that blocks the sodium channel alpha subunit, classified as a blocker. It has been studied for various conditions, including bipolar disorders and schizophrenia, as part of clinical trials.
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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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| 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 or lamotrigine |
|---|---|
| Sponsor | University of Aarhus |
| Drug class | Mood stabilizer |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
Lithium is thought to increase the levels of these neurotransmitters, which helps to stabilize mood and reduce the risk of depression and mania. It also has anti-inflammatory properties and can affect the functioning of the brain's reward system.
Approved indications
- Bipolar disorder
- Major depressive disorder
Common side effects
- Diarrhea
- Nausea
- Vomiting
- Tremors
- Weight gain
Key clinical trials
- A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3) (PHASE3)
- 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)
- Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure (PHASE3)
- PET and MRI Brain Imaging of Bipolar Disorder (NA)
- Adjunctive Ziprasidone in the Treatment of Bipolar I Depression (PHASE3)
- Sequential Multiple Assignment Treatment for Bipolar Disorder (PHASE4)
- Pharmacovigilance in Gerontopsychiatric Patients (PHASE3)
- Iloperidone in Mixed States of Bipolar Disorder (PHASE4)
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 or lamotrigine CI brief — competitive landscape report
- lithium or lamotrigine updates RSS · CI watch RSS
- University of Aarhus portfolio CI
Frequently asked questions about lithium or lamotrigine
What is lithium or lamotrigine?
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Related
- Drug class: All Mood stabilizer drugs
- Manufacturer: University of Aarhus — full pipeline
- Therapeutic area: All drugs in Psychiatry
- Indication: Drugs for Bipolar disorder
- Indication: Drugs for Major depressive disorder
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing