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Disease

Bipolar Disorder

Late-stage therapeutic developmentActively researchedCooling momentum
46
Publications
24
Clinical trials
12
Related conditions
1
Related treatments
2026
Latest publication
Current focus
Therapeutic developmentGenetics & risk factorsInflammation & immunity
Latest activity
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Recent clinical, regulatory, research and industry developments relating to this disease.

Validated metabolomic biomarkers in psychiatric disorders: a narrative review.

Research2025-07-09Molecular medicine (Cambridge, Mass.)

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Major developments
Major safety communicationImportant
Olanzapine 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.2025-08-12
Research Highlights1View
Clinical Milestones8View
Regulatory Updates1View
  • 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.
Activity timeline10

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Aripiprazoleapproved

Approval — Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adol… (2015)

Loxapineapproved

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)

Olanzapineapproved

Approval — Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effectiv… (2009)

Research-associated treatments

Clinical trials

14 sponsors · 3 new · 2 completed in the last 12 months (net +3)

The current development programme across all trial phases.

Clinical programme
24
All trials
6
Active
18
Late-stage
6
Completed
Late-stage studies
Recruiting
Recently completed

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2015emaApprovalAripiprazole· Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Accord is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Accord is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older. source ↗
2015emaApprovalAripiprazole· Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Sandoz is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Sandoz is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older. source ↗
2015emaApprovalAripiprazole· Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Mylan Pharma is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Mylan Pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older. source ↗
2015emaApprovalAripiprazole· Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Zentiva is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older. source ↗
2013emaApprovalLoxapine· Adasuve is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms. source ↗
2010emaApprovalAsenapine maleate· Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. source ↗
2009emaApprovalOlanzapine· Adults Olanzapine 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. source ↗
2009emaApprovalOlanzapine· Adults Olanzapine 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. source ↗
Safety updates
2025emaMarket withdrawalOlanzapine· Olanzapine 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. source ↗

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

46 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time
19782026
Most influential
Recent publications
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

12 matches

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.

Overview

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.

Causes

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.

Pathophysiology

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.

Risk factors

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.

Current standard of care

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.

Defined in MeSH

A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.

References & data sources
  • 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.