Last reviewed · How we verify
Asenapine - Open Label
At a glance
| Generic name | Asenapine - Open Label |
|---|---|
| Also known as | Saphris, Org 5222, SCH 900274 |
| Sponsor | Organon and Co |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
Common side effects
- Somnolence
- Weight increased
- Headache
- SOMNOLENCE
- Sedation
- Vomiting
- Increased appetite
- Nausea
- Fatigue
- HEADACHE
- Abdominal pain upper
- SEDATION
Key clinical trials
- Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Study P06125) (PHASE3)
- A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (P06522 AM1) (PHASE1)
- Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898) (PHASE3)
- Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897) (PHASE3)
- A Trial to Determine Whether Two Differing Strength Tablets (3 x 5 mg Versus 1 x 15 mg) of Sublingually Org 5222 (Asenapine) Are Safe and Equal in Subjects With Schizophrenia or Schizoaffective Disorder (P05937) (PHASE2)
- To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770) (PHASE3)
- Bio-equivalence Study Between SAPHRIS and Asenapine (PHASE1)
- An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder (PHASE4)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |