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Bipolar Disorder

CNS 0 original drugs
0
Novel Drugs
14
Reformulations
46
Active Trials
9
Drug Targets

CNS indication. Bipolar Disorder has 0 FDA-approved novel treatments, with 46 active industry clinical trials across 9 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

Phase 3 Readouts Pro

7 active Phase 3 trials with confidence-graded completion dates.

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Q4 2026
KarXT
Bristol-Myers Squibb
Estimated · fresh NCT06951711
Q2 2027
Lumateperone
Intra-Cellular Therapies, Inc.
Estimated · aging NCT06372964
Q2 2027
Xanomeline/Trospium Chloride
Bristol-Myers Squibb
Estimated · fresh NCT07140913
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Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

Bipolar Disorder Treatments by Mechanism

Top 6 mechanisms across 11 industry trials with a known mechanism of action.

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Atypical Antipsychotic
4 trials 3 sponsors
Anti-epileptic Agent
3 trials 1 sponsor
5HT2A/D2
1 trials 1 sponsor
Mood Stabilizer
1 trials 1 sponsor
Melatonin Receptor Agonist
1 trials 1 sponsor
5-HT2A receptor/D2 receptor
1 trials 1 sponsor

MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.

Bipolar Disorder Clinical Pipeline by Phase

82 industry-sponsored trials across 30 sponsors

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Novel Bipolar Disorder Drugs by Company (New molecular entities)

No novel drugs found for this indication.

Reformulations (14 drugs) Click to expand

Bipolar Disorder Drug Targets

Molecular targets of approved and investigational Bipolar Disorder drugs — 9 targets tracked.

Generic Drugs (3 ANDA approved) Click to expand

Generic drugs contain the same active ingredient as the brand-name drug and are approved via ANDA (Abbreviated New Drug Application).

Related Indications

Other CNS indications

Drug Categories:

  • Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
  • Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
  • Biosimilars: BLA-approved biologics highly similar to reference products
  • Generics: ANDA-approved copies of small molecule drugs

View data sources and methodology