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Drug

Lithium

In clinical development
Emerging researchLate-stage developmentSteady momentum

Also known as Li - Lithium.

RxNorm6448ChEMBLCHEMBL1201333ATCN05AN01UNII9FN79X2M3F
6
Research papers
6
Active clinical trials
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)

Clinical trial2026-07-24Results expected Q2 2028 · ClinicalTrials.gov

A Pilot, Multicentre, Controlled, Open-label Study Evaluating 24 Months of Lithium Carbonate Treatment in Patients With TBR1-related Neurocognitive Disorder

Clinical trial2026-05-22Results expected Q3 2027 · ClinicalTrials.gov

Preventing Relapse After Successful Electroconvulsive Therapy for Depression. A Randomized Controlled Trial on Lithium as add-on to Personalized Maintenance ECT.

Clinical trial2026-05-05Results posted · ClinicalTrials.gov

A Phase 1, 6-part, Open-label, Fixed-sequence Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Single-dose Pharmacokinetics of KarXT and Effects of KarXT on the Single-dose Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants

Clinical trial2026-01-23Completed · ClinicalTrials.gov

A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Clinical trial2026-01-22Results expected Q2 2028 · ClinicalTrials.gov

Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression: a Pragmatic Head-to-head Open, Randomized Multicenter Study: The 9th Study of the Danish University Antidepressant Group (DUAG 9)

Clinical trial2026-01-21Results expected Q3 2028 · ClinicalTrials.gov

A Randomised, Controlled Trial to Investigate 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.

Clinical trial2025-09-26Results expected Q2 2028 · ClinicalTrials.gov

Electroconvulsive Therapy and Concomitant Lithium in Depression: a Double-blind Randomized Controlled Pilot Study

Clinical trial2025-05-30Primary completion · ClinicalTrials.gov

Lithium normalizes ASD-related neuronal, synaptic, and behavioral phenotypes in DYRK1A-knockin mice.

Research2024-12-05Molecular psychiatry

Immunogenetics of lithium response and psychiatric phenotypes in patients with bipolar disorder.

Research2024-04-03Translational psychiatry

Real-world effectiveness of pharmacological treatments for bipolar disorder: register-based national cohort study.

Research2023-10-01The British journal of psychiatry : the journal of mental science

Patterns of pharmacotherapy for bipolar disorder: A GBC survey.

Research2023-07-18Bipolar disorders

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Lithium
Aliases & brands
Li - Lithium
RxNorm CUI
6448
ChEMBL ID
CHEMBL1201333
ATC codes
N05AN01
UNII
9FN79X2M3F

Clinical trials

85 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
85
registered trials across all phases
LATEST COMPLETION 2026
6
Active studies
6
Recruiting
67
Late-stage (III+)
56
Completed
23
Discontinued
PHASE DISTRIBUTIONn = 85
Early Phase 11Phase 16Phase 1 / 23Phase 28Phase 2 / 32Phase 320Phase 431Phase N / A14

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression: a Pragmatic Head-to-head Open, Randomized Multicenter Study: The 9th Study of the Danish University Antidepressant Group (DUAG 9)

RecruitingPH IVAalborg University Hospitaln=1222028

A Randomised Pragmatic Trial Comparing the Clinical and Cost Effectiveness of Lithium and Quetiapine Augmentation in Treatment Resistant Depression

Unknown statusPH IVKing's College Londonn=2762021

A Randomized, Open Label Trial of Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified.

CompletedPH IVTadashi Hasegawan=502019

Algorithm Guided Treatment Strategies for Bipolar Depression

Unknown statusPH IVShanghai Mental Health Centern=3602018

Biomarkers in Mononuclear Blood Cells for Lithium Treatment Response of Bipolar Disorder

TerminatedPH IVKeming Gaon=242018

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1, 6-part, Open-label, Fixed-sequence Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Single-dose Pharmacokinetics of KarXT and Effects of KarXT on the Single-dose Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants

CompletedPH IKaruna Therapeutics, Inc., a Bristol Myers Squibb companyn=1332026

Preventing Relapse After Successful Electroconvulsive Therapy for Depression. A Randomized Controlled Trial on Lithium as add-on to Personalized Maintenance ECT.

CompletedN/AUniversiteit Antwerpenn=962024

Effects of Lithium Therapy on Blood-based Therapeutic Targets in Parkinson's Disease.

CompletedPH IState University of New York at Buffalon=192023

Effect of Low-dose Lithium Therapy on Long COVID Symptoms: a Randomized Controlled Trial.

CompletedPH IIState University of New York at Buffalon=522023

Treatment of Psychosis and Agitation in Alzheimer's Disease

CompletedPH IINew York State Psychiatric Instituten=772020

A Randomized, Open Label Trial of Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified.

CompletedPH IVTadashi Hasegawan=502019

Research activity

6 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20192025
Most influential

Prevalence and associations of challenging, difficult or distressing experiences using classic psychedelics.

Journal of affective disorders · 2023 · 89 cites

Patterns of pharmacotherapy for bipolar disorder: A GBC survey.

Bipolar disorders · 2024 · 62 cites

Second life batteries lifespan: Rest of useful life and environmental analysis.

Journal of environmental management · 2019 · 29 cites

Real-world effectiveness of pharmacological treatments for bipolar disorder: register-based national cohort study.

The British journal of psychiatry : the journal of mental science · 2023 · 24 cites

Immunogenetics of lithium response and psychiatric phenotypes in patients with bipolar disorder.

Translational psychiatry · 2024 · 11 cites

Lithium normalizes ASD-related neuronal, synaptic, and behavioral phenotypes in DYRK1A-knockin mice.

Molecular psychiatry · 2025 · 2 cites
Recent papers

Lithium normalizes ASD-related neuronal, synaptic, and behavioral phenotypes in DYRK1A-knockin mice.

Molecular psychiatry · 2025 · 2 cites

Patterns of pharmacotherapy for bipolar disorder: A GBC survey.

Bipolar disorders · 2024 · 62 cites

Immunogenetics of lithium response and psychiatric phenotypes in patients with bipolar disorder.

Translational psychiatry · 2024 · 11 cites

Prevalence and associations of challenging, difficult or distressing experiences using classic psychedelics.

Journal of affective disorders · 2023 · 89 cites

Real-world effectiveness of pharmacological treatments for bipolar disorder: register-based national cohort study.

The British journal of psychiatry : the journal of mental science · 2023 · 24 cites

Second life batteries lifespan: Rest of useful life and environmental analysis.

Journal of environmental management · 2019 · 29 cites
Major research themes8
Bipolar Disorder3Antipsychotic Agents2Lithium2Autism Spectrum Disorder1Clozapine1Hallucinogens1Longevity1Protein Serine-Threonine Kinases1
Journals, researchers & institutions
Top journals
  • Bipolar disorders1
  • Journal of affective disorders1
  • Journal of environmental management1
  • Molecular psychiatry1
  • The British journal of psychiatry : the journal of mental science1
  • Translational psychiatry1
Leading researchers
  • Amante García B1
  • Andreassen OA1
  • Andreazza AC1
  • Ashton MM1
  • Bae M1
  • Bae YC1
  • Baune BT1
  • Berk M1
Leading institutions
free-text, unnormalised
  • Bloorview Research Institute1
  • Center for Healthy Minds1
  • Center for Psychiatry Research1
  • Center for Synaptic Brain Dysfunctions1
  • College of Medicine1
  • Dauten Family Center for Bipolar Treatment Innovation1

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas
Bipolar Disorder3

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Clozapine

Studied across the same disease area as Lithium in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials