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Moban (MOLINDONE)
Molindone (Moban), a D3 dopamine receptor antagonist, is currently marketed for the treatment of schizophrenia. Its key strength lies in its distinct mechanism of action targeting the D3 receptor, which differentiates it from other antipsychotics. The primary risk is the upcoming key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | MOLINDONE |
|---|---|
| Sponsor | Chartwell Rx |
| Drug class | Typical Antipsychotic |
| Target | D(3) dopamine receptor |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1974 |
Approved indications
- Schizophrenia
Boxed warnings
- WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis – Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Molindone Hydrochloride Tablets, USP are not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).
Common side effects
- Dystonia
- Tardive Dyskinesia
- Akathisia
- Parkinson Syndrome
- Extrapyramidal Symptoms
- Tachycardia
- Nausea
- Dry mouth
- Salivation
- Urinary retention
- Constipation
- Priapism
Drug interactions
- barbiturates
- chloral hydrate
- antiparkinson drugs
Key clinical trials
- Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems (PHASE2)
- A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group
- Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4) (PHASE3)
- Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2) (PHASE3)
- Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1) (PHASE3)
- Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
- Open-Label, Extension Study to 810P202 (PHASE2)
- Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS) (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Moban CI brief — competitive landscape report
- Moban updates RSS · CI watch RSS