Bipolar Disorder Drug Pipeline: 13 Assets by Phase

How many bipolar disorder drugs are in each phase of development?

Douglas Insights counts 4 bipolar disorder candidates in Phase III, 31% of the 13 assets in development; Phase II holds 8 and Phase I holds 1.

Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each bipolar disorder asset appears in exactly one row. The 64 trials still recruiting or running carry 32% of the 202 registered trials in scope.

Which approved bipolar disorder medicines are still in trials?

5 medicines already on the market are still being tested in bipolar disorder Phase IV trials; Quetiapine has the most, with 12 registered trials.

Post-approval bipolar disorder trials test new doses, new patient groups and head-to-head comparisons. They set the standard of care that every candidate in development will be measured against, so the paid review profiles each one.

How many bipolar disorder trials are recruiting patients now?

45 bipolar disorder trials are recruiting patients and 8 more have not started recruiting yet, out of 202 interventional trials in scope; together they make up 26% of the trial base.

Terminated, suspended and withdrawn bipolar disorder trials stay in the trial base so that a stalled programme is visible, but a candidate whose only trials stopped is no longer counted as in development.

Which companies lead the bipolar disorder pipeline?

AbbVie leads the bipolar disorder pipeline with 2 candidates; the top 5 sponsors hold 46% of the 13 assets, and 12 sponsors run at least one.

Industry sponsors lead 58 of the 202 bipolar disorder trials (29%); universities, hospitals and public funders lead the rest. A sponsor is credited with an asset when it is the lead sponsor on most of that asset's industry trials.

Which drug types and mechanisms dominate the bipolar disorder pipeline?

Mechanism and drug-type classification for the 13 bipolar disorder candidates is done by the research desk asset by asset, each with a cited source, and is published in the paid review together with the white-space map.

What bipolar disorder trial readouts are coming next?

1 bipolar disorder candidates in Phase II or later have a registered primary completion date in the next 12 months; the next three are below, each linked to its registry record.

Primary completion is the date a sponsor expects the last patient to finish the main measurement, so data usually follow within months. Dates marked estimated are the sponsor's own forecast on the registry and often move.

How many bipolar disorder readouts fall in each quarter?

6 bipolar disorder candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 2, due in Q4 2027.

Each candidate is counted once, at its next readout. The paid catalyst calendar names every readout with its trial, sponsor and design, adds filings and regulatory decisions, and runs 24 months ahead.

Which countries host the most bipolar disorder trials?

United States hosts the most bipolar disorder trials, with sites in 113 of the 202 studies (56%); trials in scope run in 47 countries in all.

A multinational bipolar disorder trial is counted once in every country where it has a site, so the shares add up to more than 100%. Country spread shows where sponsors are building the evidence that regulators in each market will ask for.

Where are bipolar disorder drugs being tested?

113 of the 202 bipolar disorder trials (56%) have a site in the United States, 42 (21%) in Europe and 14 (6.9%) in China; 12 of the 13 candidates in development are tested in the US.

Each region's trials are the evidence its regulator will review: the FDA in the United States, the EMA (with the MHRA and Swissmedic) in Europe, the NMPA in China and the PMDA in Japan. A multinational bipolar disorder trial counts once in every region where it has a site, so the shares add up to more than 100%. A candidate tested only outside the US and Europe is often a licensing opportunity for sponsors in those markets.

What has changed in the bipolar disorder pipeline since the last update?

Since 4 Oct 2026, the bipolar disorder pipeline count moved by 0 assets to 13, Phase III moved by 0 and the trial base by 0.

How does Douglas Insights count the bipolar disorder pipeline?

Douglas Insights read 202 interventional trials registered on ClinicalTrials.gov for the conditions "Bipolar Disorder", "bipolar depression" and updated since 4 Oct 2021, then grouped every drug or biologic named in them into 13 unique candidates.

1. Code names, generic names and brand names of the same molecule are merged into one candidate, and every merge is reviewed by the research desk.
2. A candidate counts when it has a trial that is recruiting, running, or completed in the last 24 months, and at least one industry-sponsored trial.
3. Its phase is the highest phase among those trials; placebo, standard-of-care and comparator arms are not candidates.
4. Each figure on this page is drawn from one frozen dataset that passes ten checks before release, and the owner approves every edition.

Read the full approach on the research methodology page, or browse other Pharmaceuticals research.

Frequently asked questions about the bipolar disorder pipeline

Research & citation

This review was researched, written and reviewed by the Douglas Insights Research Desk under the Douglas Insights editorial standards. Material errors are logged in the corrections log. No section is sponsored.

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