Lithobid

(Lithium carbonate)

ApprovedSmall molecule

Lithium carbonate is used to treat bipolar disorder by helping to stabilize mood and reduce the severity of manic episodes. It can also be used to reduce the risk of suicide in people with depression or bipolar disorder.[2] Lithobid is currently approved and in use across 48 indications[4].[1]

Lithobid is one of 935 small molecule programs targeting Glioma. It is currently in Approved.

Indications

Total Trials

Active Trials

934

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

GliomaActive, not recruiting

Corticobasal Degeneration DisorderApproved

NeutropeniaApproved

Bipolar I DisorderActive, not recruiting

Frontotemporal DementiaActive, not recruiting

Familial Adenomatous PolyposisActive, not recruiting

Depressive DisorderApproved

Mood DisorderActive, not recruiting

Cognitive ImpairmentActive, not recruiting

StrokeActive, not recruiting

GliomaPhase 2

Active, not recruiting

Corticobasal Degeneration DisorderApproved

Approved

NeutropeniaApproved

Approved

Bipolar I DisorderApproved

Active, not recruiting

Frontotemporal DementiaPhase 2

Active, not recruiting

Familial Adenomatous PolyposisPhase 2

Active, not recruiting

Depressive DisorderApproved

Approved

Mood DisorderApproved

Active, not recruiting

Cognitive ImpairmentPreclinical

Active, not recruiting

StrokePhase 3

Active, not recruiting

Showing 10 of 48 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Lithobid

SSolvay Pharmaceuticals

Approved

1 2

Halaven

Eisai

Preclinical

38 3

Adriamycin

GGynecologic Oncology Group

Preclinical

87 4

Gemzar

GGynecologic Oncology Group

Preclinical

22 5

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 6

MS Contin

Merck & Co.

Preclinical

2 7

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 8

Chirocaine

PPurdue Pharma LP

Preclinical

1 9

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 10

Chantix

PPrism Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Post-ApprovalRecruiting

Cardiopulmonary Bypass

NCT05593627

Q4 2026

Phase 2/3Recruiting

Cornelia De Lange Syndrome

NCT06789783

Q3 2027

Phase 1/2Recruiting

Adolescent

NCT05814640

Q4 2027

Post-ApprovalRecruiting

Bipolar Disorder

NCT06184581

Clinical

Trials by Indication[1]

Bipolar Disorder10 trials

Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00667745·283 enrolled

Effects of Lithium on Suicide Prevention in Adolescents and Young Adults With Bipolar Disorder in China

Recruiting·PPeking University··NCT06424613·600 enrolled

Maintenance Therapies in Bipolar Disorders

Completed·UUniversity of Pittsburgh·Phase 3·NCT00000369

Show 7 more trials

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated·UUniversity of New Mexico··NCT02893371·1,037,352 enrolled

Olanzapine Versus Comparator in the Treatment of Bipolar Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00485680·140 enrolled

Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder

Unknown status·PPeking University·Phase 4·NCT03148535·100 enrolled

Effect of Regulated Add -on Sodium Chloride Intake on Stabilization of Serum Lithium Concentration in Bipolar Disorder

Completed·—·Phase 4·NCT04222816·60 enrolled

Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode

Completed·FFederal University of Rio Grande do Sul·Phase 4·NCT02918097·78 enrolled

Safety and Efficacy Study of Lithium in Bipolar Disorder

Unknown status·JJDS Pharmaceuticals·Phase 3·NCT00422331·206 enrolled

Lithium Versus Lamotrigine in Bipolar Disorder, Type II

Recruiting·UUniversity Hospital Bispebjerg and Frederiksberg·Phase 4·NCT06184581·200 enrolled

Spinal Cord Injury4 trials

Safety and Pharmacokinetics Study of Oral Lithium in Patients With Chronic Spinal Cord Injury

Completed·TThe University of Hong Kong·Phase 1·NCT00431171·20 enrolled

Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury

Completed·CChina Spinal Cord Injury Network·Phase 1/2·NCT01471613·16 enrolled

Umbilical Cord Blood Mononuclear Cell Transplant to Treat Chronic Spinal Cord Injury

Completed·CChina Spinal Cord Injury Network·Phase 1/2·NCT01354483·20 enrolled

Show 1 more trial

Study to Evaluate the Efficacy of Lithium Carbonate in Spinal Cord Injury Patients With Neuropathic Pain

Completed·CChina Spinal Cord Injury Network·Phase 2·NCT01855594·60 enrolled

Amyotrophic Lateral Sclerosis3 trials

Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

Terminated·MMassachusetts General Hospital·Phase 2/3·NCT00818389·84 enrolled

A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Completed·—·Phase 2·NCT00790582·109 enrolled

Platform Trial to Assess the Efficacy of Multiple Drugs in Amyotrophic Lateral Sclerosis (ALS)

Recruiting·SStichting TRICALS Foundation·Phase 3·NCT06008249·171 enrolled

Mood Disorder2 trials

Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

Completed·UUniversity of Pittsburgh·Phase 4·NCT00177567·60 enrolled

Safety and Efficacy Study of Citalopram and Lithium for the Treatment of Depressive Mood Disorder Symptoms

Completed·CColumbia Northwest Pharmaceuticals·Phase 2·NCT01189812·80 enrolled

Adolescent2 trials

Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents

Completed·WWashington University School of Medicine·Phase 3·NCT00057681·379 enrolled

Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)

Recruiting·FFirst Affiliated Hospital of Chongqing Medical University·Phase 1/2·NCT05814640·520 enrolled

43 more indications

Cerebellar Ataxia2 trials

Safety and Tolerability of Lithium in Spinocerebellar Ataxia 2 (SCA2)

Completed·FFederico II University·Phase 2·NCT00998634·20 enrolled

Lithium Treatment for Patients With Spinocerebellar Ataxia Type I

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1·NCT00683943·13 enrolled

Gene Expression2 trials

In Vivo Lithium Treatment Effects on Gene Expression Levels in Lymphoblastoid Cell Lines From Human Healthy Subjects

Completed·NNova Scotia Health Authority·Phase 1·NCT01565759·2 enrolled

Investigation of Lithium on Signal Transduction, Gene Expression and Brain Myo-Inositol Levels in Manic Patients

Completed·WWayne State University·Phase 4·NCT00870311·28 enrolled

Thyroid Cancer2 trials

An Initial Study of Lithium in Patients With Medullary Thyroid Cancer

Terminated·UUniversity of Wisconsin, Madison·Phase 2·NCT00582712·5 enrolled

Effect of Lithium Carbonate on Low-Dose Radioiodine Therapy in Early Thyroid Cancer

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00251316·34 enrolled

Major Depression2 trials

Antidepressant Therapy for Bipolar II Major Depression

Completed·—·Phase 4·NCT00641927·90 enrolled

Antidepressant Therapy in Treating Bipolar Type II Major Depression

Completed·UUniversity of Pennsylvania·Phase 4·NCT00602537·140 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00883493·421 enrolled

Cognitive impairment1 trial

Evaluation of Lithium as a Glycogen-Synthase-Kinase-3 (GSK-3) Inhibitor in Mild Cognitive Impairment

Completed·UUniversity of Dundee·N/A·NCT02601859·11 enrolled

Medication1 trial

A Lithium-Based Medication to Improve Neurological Outcomes After Surgical Carotid Reconstruction

Terminated·NNegovsky Reanimatology Research Institute·Phase 3·NCT05126238·107 enrolled

Whole-Brain Radiotherapy1 trial

Ph I Study of Lithium During Whole Brain Radiotherapy For Patients With Brain Metastases

Terminated·VVanderbilt-Ingram Cancer Center·Phase 1·NCT00469937·9 enrolled

Tic Disorder1 trial

Indicated Prevention of Psychotic Disorders With Low-dose Lithium

Completed·MMelbourne Health·Phase 4·NCT00202306·30 enrolled

Familial adenomatous polyposis1 trial

The CHAMP-study: The CHemopreventive Effect of Lithium in Familial AdenoMatous Polyposis

Completed·—·Phase 2·NCT05402891·12 enrolled

Morbidity1 trial

Valproate Efficacy in Cocaine-Bipolar Comorbidity

Completed·UUniversity of Miami·Phase 1/2·NCT00240110·152 enrolled

Glioma1 trial

Temodar (Temozolomide), Bevacizumab, Lithium and Radiation for High Grade Glioma

Terminated·NNYU Langone Health·Phase 2·NCT01105702·28 enrolled

Small Cell Lung Cancer1 trial

Neuroprotective Effects of Lithium in Patients With Small Cell Lung Cancer Undergoing Radiation Therapy to the Brain

Completed·WWashington University School of Medicine·Phase 1/2·NCT01553916·19 enrolled

Breast Cancer1 trial

Efficacy of Lithium Against Chemotherapy Induced Neutropenia in Breast Cancer Patients

Completed·—·Phase 3·NCT05221593·50 enrolled

Autism Spectrum Disorder1 trial

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

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT04623398·22 enrolled

Adult1 trial

A Study of Lithium and Enlicitide in Healthy Adult Participants (MK-0616-034)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06719544·16 enrolled

Osteosarcoma1 trial

Clinical Trial of Lithium Carbonate Combined With Neo-adjuvant Chemotherapy to Treat Osteosarcoma

Unknown status·SSun Yat-sen University·Phase 4·NCT01669369·400 enrolled

Prostate Cancer1 trial

Evaluation of Lithium and It's Effect on Clinically Localized Prostate Cancer

Completed·UUniversity of Kansas Medical Center·Phase 1·NCT02198859·11 enrolled

Treatment1 trial

Lithium for the Treatment of Pediatric Mania

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 2·NCT00442039·61 enrolled

Spinocerebellar ataxia type 31 trial

Safety and Efficacy of Lithium Carbonate in Patients With Spinocerebellar Ataxia Type 3

Completed·HHospital de Clinicas de Porto Alegre·Phase 2/3·NCT01096082·62 enrolled

Completed·FFred Hutchinson Cancer Center·N/A·NCT00408681·20 enrolled

Frontotemporal Dementia1 trial

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

Completed·—·Phase 2·NCT02862210·17 enrolled

Depression1 trial

Bipolar II Depression: Lithium, SSRI, or the Combination

Completed·LLindner Center of HOPE·Phase 3·NCT00276965·139 enrolled

Withdrawal1 trial

Lithium Cannabis Withdrawal Study

Completed·SSydney South West Area Health Service·Phase 2·NCT00114439·25 enrolled

Spinal Cord Injuries1 trial

Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries

Completed·CChina Spinal Cord Injury Network·Phase 2·NCT00750061·40 enrolled

Major Depressive Episode1 trial

Randomized, Placebo-controlled Multicenter Trial of Lithium Plus Treatment as Usual (TAU) for Acute Suicidal Ideation and Behavior in Patients With Suicidal Major Depressive Episode

Unknown status·TTechnische Universität Dresden·N/A·NCT02039479·254 enrolled

Acute Myeloid Leukemia1 trial

Lithium Carbonate and Tretinoin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed·PPaolo Caimi, MD·Phase 1·NCT01820624·12 enrolled

Neuroendocrine Tumors1 trial

Lithium for Low-Grade Neuroendocrine Tumors

Completed·UUniversity of Wisconsin, Madison·Phase 2·NCT00501540·15 enrolled

Thoracic Surgery1 trial

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

Completed·—·Phase 4·NCT04479566·51 enrolled

Adult Subject1 trial

A 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

Active, not recruiting·AAlzamend Neuro, Inc.·Phase 1·NCT06921590·6 enrolled

Cardiopulmonary Bypass1 trial

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

Recruiting·—·Phase 4·NCT05593627·62 enrolled

Cornelia de Lange syndrome1 trial

Cornelia De Lange Syndrome: Assessing Positive Effects of Lithium Treatment

Recruiting·UUniversity of Milan·Phase 2/3·NCT06789783·34 enrolled

Multiple Sclerosis1 trial

A Pilot Study of Lithium in Progressive Multiple Sclerosis

Completed·VVA Office of Research and Development·Phase 1/2·NCT01259388·23 enrolled

Monotherapy1 trial

Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00789854·688 enrolled

Cognition1 trial

Lithium As a Treatment to Prevent Impairment of Cognition in Elders

Completed·—·Phase 4·NCT03185208·83 enrolled

Acute Kidney Injury1 trial

Lithium in Acute Kidney Injury

Unknown status·LLifespan·Phase 4·NCT03056248·50 enrolled

Multiple System Atrophy1 trial

Lithium in Multiple System Atrophy

Terminated·FFederico II University·Phase 2·NCT00997672·10 enrolled

Alzheimer's Disease1 trial

Disease-modifying Properties of Lithium in the Neurobiology of Alzheimer's Disease

Unknown status·UUniversity of Sao Paulo·Phase 2·NCT01055392·80 enrolled

Stroke1 trial

The Neurotrophic Effects of Lithium Carbonate Following Stroke: A Feasibility Study

Completed·SSunnybrook Health Sciences Centre·Phase 3·NCT01112813·12 enrolled

Randomized Controlled Trial1 trial

Lithium for Fracture Treatment: a Double Blind Randomized Controlled Trial (LiFT)

Unknown status·SSunnybrook Health Sciences Centre·Phase 2·NCT02999022·160 enrolled

Post-Traumatic Stress Disorder1 trial

Lithium Augmentation for Hyperarousal Symptoms of Post Traumatic Stress Disorder: Pilot Study

Withdrawn·VVA Eastern Colorado Health Care System·Phase 1·NCT01754883

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

LITHIUM CARBONATE

NDA NDA016834

Jan 1, 1982

ESKALITH

NDA NDA016860

Jan 1, 1982

LITHOTABS

NDA NDA016980

Jan 1, 1982

LITHONATE

NDA NDA016782

Jan 1, 1982

LITHOBID

NDA NDA018027

Jan 1, 1982

ESKALITH

NDA NDA017971

Jan 29, 1982

LITHIUM CARBONATE

NDA NDA018558

Mar 29, 1982

ESKALITH CR

NDA NDA018152

Jul 18, 1985

LITHANE

NDA NDA018833

Jan 28, 1987

LITHIUM CARBONATE

NDA NDA017812

Sources

References

[1]
ClinicalTrials.gov — 68 trial records for Lithium carbonate. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Lithobid drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Lithium carbonate compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Lithium carbonate. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA017812). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Solvay Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Glycogen Synthase Kinase-3 Inhibitor; Inositol-1(or 4)-Monophosphatase 1 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SSolvay Pharmaceuticals

Lithobid

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q3 2027

Q4 2027

Trials by Indication[1]

Bipolar Disorder10 trials

Spinal Cord Injury4 trials

Amyotrophic Lateral Sclerosis3 trials

Mood Disorder2 trials

Adolescent2 trials

Cerebellar Ataxia2 trials

Gene Expression2 trials

Thyroid Cancer2 trials

Major Depression2 trials

Efficacy and Safety1 trial

Cognitive impairment1 trial

Medication1 trial

Whole-Brain Radiotherapy1 trial

Tic Disorder1 trial

Familial adenomatous polyposis1 trial

Morbidity1 trial

Glioma1 trial

Small Cell Lung Cancer1 trial

Breast Cancer1 trial

Autism Spectrum Disorder1 trial

Adult1 trial

Osteosarcoma1 trial

Prostate Cancer1 trial

Treatment1 trial

Spinocerebellar ataxia type 31 trial

CAR1 trial

Safety and Efficacy1 trial

Graft-versus-host-disease (GVHD)1 trial

Frontotemporal Dementia1 trial

Depression1 trial

Withdrawal1 trial

Spinal Cord Injuries1 trial

Major Depressive Episode1 trial

Acute Myeloid Leukemia1 trial

Neuroendocrine Tumors1 trial

Thoracic Surgery1 trial

Adult Subject1 trial

Cardiopulmonary Bypass1 trial

Cornelia de Lange syndrome1 trial

Multiple Sclerosis1 trial

Monotherapy1 trial

Cognition1 trial

Acute Kidney Injury1 trial

Multiple System Atrophy1 trial

Alzheimer's Disease1 trial

Stroke1 trial

Randomized Controlled Trial1 trial

Post-Traumatic Stress Disorder1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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