Bipolar Disorder
Recent clinical, regulatory, research and industry developments relating to this disease.
Mapping the genetic landscape across 14 psychiatric disorders.
Market withdrawal: Olanzapine Apotex (EMA)
Validated metabolomic biomarkers in psychiatric disorders: a narrative review.
Fine-mapping genomic loci refines bipolar disorder risk genes.
Population-Based Risk of Psychiatric Disorders Associated With Recurrent Copy Number Variants.
Severe psychiatric disorders are associated with increased risk of dementia.
Adolescent Psychedelic Use and Psychotic or Manic Symptoms.
Transcriptomic sex differences in postmortem brain samples from patients with psychiatric disorders.
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 5 clinical trials expected to report results, the earliest in Q2 2027.
- Active recent publication activity, including 1 notable finding.
- 1 safety action from EMA issued.
- Q2 2027A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
- Q2 2028A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.
- Q4 2028RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)
- Q4 2031A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years
- Q2 2032An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Research HighlightsViewHide
- 2025-12-10Mapping the genetic landscape across 14 psychiatric disorders.Grotzinger AD · 2026
Clinical MilestonesViewHide
- 2026-07-31An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum DisorderResults expected Q2 2032
- 2026-07-07A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 YearsResults expected Q4 2031
- 2026-06-23A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or LamotrigineResults expected Q2 2027
- 2026-06-22RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)Results expected Q4 2028
- 2026-01-22A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.Results expected Q2 2028
- 2025-10-06A 52-Week, Multicenter, Open-Label, Flexible-dose Study to Evaluate the Long-term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Subjects With Schizophrenia, Bipolar I Disorder, or Autism Spectrum DisorderCompleted
- 2025-08-15Efficacy And Safety of BXCL501 Evaluated For At-Home Use In A Multisite Double-Blind Placebo-Controlled Trial For Agitation Associated With Schizophrenia And Bipolar DisorderCompleted
Regulatory UpdatesViewHide
- 2025-08-12Market withdrawal — OlanzapineOlanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
- 2027-05-01ClinicalDopamine D3 Receptor Occupancy in Bipolar Depression by Cariprazine (Vraylar): Evaluating Its Antidepressant BenefitWithdrawn
- 2026-07-31ClinicalAn Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum DisorderResults expected Q2 2032
- 2026-07-07ClinicalA Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 YearsResults expected Q4 2031
- 2026-06-23ClinicalA Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or LamotrigineResults expected Q2 2027
- 2026-06-22ClinicalRNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)Results expected Q4 2028
- 2026-01-22ClinicalA Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.Results expected Q2 2028
- 2025-12-10ResearchMapping the genetic landscape across 14 psychiatric disorders.Grotzinger AD · 2026
- 2025-10-06ClinicalA 52-Week, Multicenter, Open-Label, Flexible-dose Study to Evaluate the Long-term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Subjects With Schizophrenia, Bipolar I Disorder, or Autism Spectrum DisorderCompleted
- 2025-08-15ClinicalEfficacy And Safety of BXCL501 Evaluated For At-Home Use In A Multisite Double-Blind Placebo-Controlled Trial For Agitation Associated With Schizophrenia And Bipolar DisorderCompleted
- 2025-08-12RegulatoryMarket withdrawal — OlanzapineOlanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approval — Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adol… (2015)
Approval — Adasuve is indicated for the rapid control of mild-to-moderate agitation in adult patient… (2013)
Approval — Sycrest is indicated for the treatment of moderate to severe manic episodes associated wi… (2010)
Approval — Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effectiv… (2009)
Clinical trials
The current development programme across all trial phases.
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Major themes8
- Bipolar Disorder28
- Major Depressive Disorder16
- Schizophrenia12
- Mental Disorders10
- Attention Deficit Disorder with Hyperactivity8
- Autism Spectrum Disorder6
- Brain3
- Antipsychotic Agents2
Leading journals6
- Molecular psychiatry6
- Translational psychiatry6
- JAMA psychiatry3
- Psychological medicine3
- Bipolar disorders2
- BMC psychiatry2
Leading researchers8
- Andreassen OA7
- Vieta E6
- Berk M5
- Alda M4
- Baune BT4
- Børglum AD4
- Fullerton JM4
- Hirano Y4
Affiliations (unnormalised)6
- Dalhousie University6
- Harvard Medical School6
- Karolinska Institutet6
- Stanley Center for Psychiatric Research6
- University of Oxford6
- Icahn School of Medicine at Mount Sinai5
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Disease profile
A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.
Bipolar disorder is a major affective disorder characterized by severe mood swings, including manic episodes and major depressive episodes. It tends to remit and recur over time. The literature also treats it as a heritable mental illness with a complex etiology.
The grounding supports a complex, multifactorial and heritable etiology rather than a single cause. Genome-wide studies identify many associated loci and implicate common genetic variation, including single-nucleotide polymorphisms and broader genomic influences. The literature also points to contributions from gene expression, transcriptomic, metabolomic, and gut microbiome-related factors.
Genetic findings link bipolar disorder risk to synaptic signaling pathways and to genes expressed in neurons of the prefrontal cortex and hippocampus. Cross-disorder analyses also highlight overlap with other psychiatric conditions, supporting shared biological pathways. The supplied literature further suggests involvement of gene expression regulation and broader systems such as the microbiome and metabolome, but does not define a single mechanism.
Heritable liability is a supported risk factor, with bipolar disorder described as highly genetic and multifactorial. The literature also indicates overlap with broader psychiatric genetic risk across disorders, but does not provide specific non-genetic risk factors in the supplied grounding. No additional risk factors are supported here.
Treatment guidance in the supplied grounding emphasizes pharmacological and psychological management with first-, second-, and third-line recommendations. Lithium is a co-studied drug, and the literature also notes signal enrichment in genes encoding targets of antipsychotics, calcium channel blockers, antiepileptics, and anesthetics. The grounding supports treatment at the modality or drug-class level only, without specifying regimens.
AI-generated summary grounded in MeSH and 6 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.
Reference
Authoritative identity, definition & identifiers.
A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.