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Compound · clinical trials

Lithium clinical trials

Also listed in trial records as ATC code: N05AN01, Lithionit, Litarex, N05AN01
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 5 trials in our Spain, Italy, Sweden, Denmark, Israel, USA, India, China, France, Poland, Japan, Australia, Germany and Austria registers that name Lithium as an intervention. Synced 27 Sep 2026
5Current trials
5Recruiting now
4Lead sponsors
14Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Lithium is named as an intervention in 5 current clinical trials in our Spain, Italy, Sweden, Denmark, Israel, USA, India, China, France, Poland, Japan, Australia, Germany and Austria registers. 5 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Dr. Inge Winter (2). The most-studied condition is Bipolar Depression.

Where Lithium is approved

All regulators →

Lithium was first approved in the US on 23 Dec 1980. It is approved in 2 of the 3 regulators tracked here.

USUnited States (FDA)
23 Dec 1980
Lithium Citrate
NDA018421 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
16 Mar 1994
Pms-lithium Citrate Syrup
Notice of Compliance 5378
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Trials by status

  • Recruiting5100%

Trials by phase

  • Phase 3360%
  • Phase 2120%
  • Phase 4120%
01

Clinical trials of Lithium

5 trials
StudyPhaseStatusLead sponsorRegisters
Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
NCT05913947 · ClinicalTrials.gov ↗ · Depression, Bipolar
Phase 4 Recruiting Aalborg University Hospital Denmark
Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure
NCT05603104 · ClinicalTrials.gov ↗ · Schizophrenia and Related Disorders, Major Depressive Disorder, Bipolar Depression
Phase 3 Recruiting Dr. Inge Winter Israel
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.
NCT05973786 · ClinicalTrials.gov ↗ · Bipolar Depression
Phase 3 Recruiting Dr. Inge Winter Germany, Spain, Italy, Austria
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
NCT06929273 · ClinicalTrials.gov ↗ · Bipolar Disorder Type I With Mania
Phase 3 Recruiting Bristol-Myers Squibb USA, India, China, France, Spain, Italy, Sweden, Denmark, Poland, Japan, Australia, Israel
Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy
NCT06051240 · ClinicalTrials.gov ↗ · Cognitive Impairment, Cognitive Decline, Radiotherapy Side Effect
Phase 2 Recruiting Region Stockholm Sweden

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Lithium across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

1 single-substance product containing Lithium on the HPRA medicines list.

All 1 Irish product →

Supply shortages

No entry for Lithium in the EMA, FDA or German BfArM shortage lists we track.

03

Conditions studied with Lithium

9 conditions
Bipolar Depression2Bipolar Disorder Type I With Mania1Cognitive Impairment1Cognitive Decline1Radiotherapy Side Effect1Radiotherapy; Complications1Depression, Bipolar1Schizophrenia and Related Disorders1Major Depressive Disorder1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
Dr. Inge Winter2
Bristol-Myers Squibb1
Region Stockholm1
Aalborg University Hospital1
05

By country register

RegisterTrialsRecruiting
Clinical trials in Spain22
Clinical trials in Italy22
Clinical trials in Sweden22
Clinical trials in Denmark22
Clinical trials in Israel22
Clinical trials in USA11
Clinical trials in India11
Clinical trials in China11
Clinical trials in France11
Clinical trials in Poland11
Clinical trials in Japan11
Clinical trials in Australia11
Clinical trials in Germany11
Clinical trials in Austria11

A trial with sites in more than one country appears in each of those registers.

06

Related compounds

07

Questions about Lithium trials

How many clinical trials are testing Lithium?

5 current trials in our Spain, Italy, Sweden, Denmark, Israel, USA, India, China, France, Poland, Japan, Australia, Germany and Austria registers name Lithium (also registered as ATC code: N05AN01) as a drug or biological intervention, as of the registry sync on 27 September 2026. Completed and withdrawn studies are not counted.

Are Lithium trials recruiting patients?

Yes. 5 of the 5 trials are recruiting: 2 with sites in Spain, 2 with sites in Italy, 2 with sites in Sweden, 2 with sites in Denmark, 2 with sites in Israel, 1 with sites in USA, 1 with sites in India, 1 with sites in China, 1 with sites in France, 1 with sites in Poland, 1 with sites in Japan, 1 with sites in Australia, 1 with sites in Germany and 1 with sites in Austria. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Lithium clinical trials?

Dr. Inge Winter (2), Bristol-Myers Squibb (1), Region Stockholm (1) and Aalborg University Hospital (1). The number in brackets is how many trials each organisation leads.

Is Lithium licensed in Ireland?

Yes. The HPRA medicines list includes 1 single-substance product containing Lithium, for example Lithium Chloride 0.15 mmol/ml. Solution for Injection (LiDCO Netherlands B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Lithium shortage?

Not in the lists we track: Lithium has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Lithium works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Lithium works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Lithium (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 27 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.