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Olanzapine-samidorphan；
Olanzapine-samidorphan is an atypical antipsychotic that combines the antipsychotic effects of olanzapine with the weight loss effects of samidorphan.
Olanzapine-samidorphan is an atypical antipsychotic that combines the antipsychotic effects of olanzapine with the weight loss effects of samidorphan. Used for Treatment of schizophrenia.
At a glance
| Generic name | Olanzapine-samidorphan； |
|---|---|
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Drug class | atypical antipsychotic |
| Target | Dopamine receptor, Serotonin receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
Olanzapine is a serotonin-dopamine antagonist that blocks the action of dopamine and serotonin in the brain, reducing psychotic symptoms. Samidorphan is a mu-opioid receptor antagonist that blocks the action of opioids, leading to weight loss.
Approved indications
- Treatment of schizophrenia
Common side effects
- Weight gain
- Dizziness
- Headache
Key clinical trials
- Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects (PHASE3)
- Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (PHASE3)
- National Pregnancy Registry for Psychiatric Medications
- Exercise and Olanzapine-samidorphan (PHASE4)
- A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia (PHASE3)
- Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 (PHASE3)
- Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder (PHASE1)
- Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan (PHASE1)
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 |
|---|---|
| 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:
- Olanzapine-samidorphan； CI brief — competitive landscape report
- Olanzapine-samidorphan； updates RSS · CI watch RSS
- Qilu Pharmaceutical Co., Ltd. portfolio CI