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Drug

Lithium carbonate

Approved · FDA
Emerging researchLate-stage development
Also known as Carbonic acid, dilithium salt, Dilithium carbonate, Eskalith, Eskalith-CR+5 more

Carbonic acid, dilithium salt, Dilithium carbonate, Eskalith, Eskalith-CR, Lithii carbonas, Lithobid, Lithonate, Lithotabs, Lithiumcarbonate.

RxNorm42351ChEMBLCHEMBL1200826UNII2BMD2GNA4V
1
Research papers
6
Active clinical trials
8
Regulatory events
Latest activity
beta

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

Label change: LITHIUM CARBONATE (ANDA076832)

Regulatory2026-07-13FDA

A Randomized, Balanced, Phase 1/2A, Multiple-dose, Open-label, Two-treatment, Two-period, Two-sequence, Crossover, Relative Bioavailability Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder

Clinical trial2026-04-20Results expected Q4 2026 · ClinicalTrials.gov

Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial (the LiLa-Bipolar RCT)

Clinical trial2026-03-20Results expected Q4 2027 · ClinicalTrials.gov

Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD): a Pragmatic Clinical Trial

Clinical trial2026-01-27Results expected Q4 2026 · ClinicalTrials.gov

Effect of Lithium Carbonate on Postoperative Sleep and Cognitive Function in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass

Clinical trial2025-12-31Primary completion · ClinicalTrials.gov

A Randomized, Balanced, Phase 1, Multiple-dose, Open-label, Two-treatment, Two-period, Two-sequence, Crossover, Relative Bioavailability Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Healthy Adult Subjects

Clinical trial2025-12-01Primary completion · ClinicalTrials.gov

Evaluation of Brain and Cognitive Changes in Older Adults With MCI Taking Lithium to Prevent Alzheimer Type Dementia

Clinical trial2025-09-11Results posted · ClinicalTrials.gov

A Multi-arm, Adaptive, Group-sequential Trial NETwork to Evaluate Drug Efficacy in Patients With Amyotrophic Lateral Sclerosis (ALS)

Clinical trial2025-09-01Terminated · ClinicalTrials.gov

Label change: LITHIUM CARBONATE (ANDA076832)

Regulatory2020-02-14FDA

Label change: LITHIUM CARBONATE (ANDA076832)

Regulatory2020-02-14FDA

Label change: LITHIUM CARBONATE (ANDA076832)

Regulatory2020-02-14FDA

Efficacy and safety of lithium carbonate treatment of chronic spinal cord injuries: a double-blind, randomized, placebo-controlled clinical trial.

Research2011-11-22Spinal cord

Profile

Identifiers & mechanism

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

Canonical name
Lithium carbonate
Aliases & brands
Carbonic acid, dilithium saltDilithium carbonateEskalithEskalith-CRLithii carbonasLithobidLithonateLithotabsLithiumcarbonate
RxNorm CUI
42351
ChEMBL ID
CHEMBL1200826
UNII
2BMD2GNA4V
Regulatory jurisdictions
fda

Regulatory timeline

8 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2004-10-28
Latest approval
2004-10-28
Authorities
FDA
Total events
8
fdaU.S. Food and Drug Administration· 8 events
2026-07-13Label change
Label change: LITHIUM CARBONATE (ANDA076832)
Evidence ↗
2020-02-14Label change
Label change: LITHIUM CARBONATE (ANDA076832)
Evidence ↗
2020-02-14Label change
Label change: LITHIUM CARBONATE (ANDA076832)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

67 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
67
registered trials across all phases
LATEST COMPLETION 2025
6
Active studies
5
Recruiting
34
Late-stage (III+)
45
Completed
16
Discontinued
PHASE DISTRIBUTIONn = 67
Early Phase 11Phase 19Phase 1 / 27Phase 216Phase 2 / 34Phase 312Phase 415Phase N / A3

Late-stage studies

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

Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial (the LiLa-Bipolar RCT)

RecruitingPH IVUniversity Hospital Bispebjerg and Frederiksbergn=2002027

Effect of Lithium Carbonate on Postoperative Sleep and Cognitive Function in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass

RecruitingPH IVChina Medical University, Chinan=622026

Evaluation of Brain and Cognitive Changes in Older Adults With MCI Taking Lithium to Prevent Alzheimer Type Dementia

CompletedPH IVAriel Gildengers, MDn=832024

A Prospected Randomized Multicenter Clinical Trial of Lithium Carbonate Combined With Neo-adjuvant Chemotherapy to Treat Osteosarcoma

Unknown statusPH IVSun Yat-sen Universityn=4002023

Effect of Lithium Carbonate on Postoperative Sleep in Patients Undergoing Videoassisted Thoracic Surgery

CompletedPH IVChina Medical University, Chinan=512022

Recent completions

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

A Clinical Study to Evaluate the Effect of Enlicitide on the Pharmacokinetics of Lithium in Healthy Adult Participants

CompletedPH IMerck Sharp & Dohme LLCn=162025

The Chemopreventive Effect of Lithium on Adenoma Development in Patients With Familial Adenomatous Polyposis (FAP); a Pilot Study

CompletedPH IIAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)n=122024

Effect of Lithium in Patients With Autism Spectrum Disorder and Phelan-McDermid Syndrome (SHANK3 Haploinsufficiency): Pilot Study.

CompletedPH IIIAssistance Publique - Hôpitaux de Parisn=222024

Evaluation of Brain and Cognitive Changes in Older Adults With MCI Taking Lithium to Prevent Alzheimer Type Dementia

CompletedPH IVAriel Gildengers, MDn=832024

Investigation of the Effects of in Vivo Lithium Treatment on Gene Expression Levels Using Lymphoblastoid Cell Lines From Human Healthy Subjects

CompletedPH INova Scotia Health Authorityn=22023

Low-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal Dementia

CompletedPH IIColumbia Universityn=172022

Research activity

1 papers

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

Journals, researchers & institutions
Top journals
  • Spinal cord1
Leading researchers
  • Chen JY1
  • Cheng WS1
  • Gao F1
  • Li JJ1
  • So KF1
  • Wang ZM1
  • Wu J1
  • Yang ML1
Leading institutions
free-text, unnormalised
  • China Rehabilitation Research Center1
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
  • Regulatory event sources are credited in the Regulatory Timeline above.