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JNS001 · 2 trials · 2 indications
CAARS-O: SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-O:SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | JNS001 18 mg 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks |
| JNS001 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| JNS001 | DRUG | 18 mg, 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks |
| Placebo | DRUG | Participants will receive matching placebo orally once daily for 8 weeks. |
Inclusion Criteria: * Patients (and their legally-acceptable representative if patients are 18 or 19 years old) must have signed an Informed Consent Form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study * Patients...
JNS001 is an investigational small molecule being studied for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults. It is in Phase 3 clinical development by Johnson & Johnson (NYSE: JNJ). The drug is not approved and remains under investigation for this psychiatric condition.
JNS001 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's efficacy and safety in adults with Attention-Deficit Hyperactivity Disorder.
JNS001 is in Phase 3 clinical development. Two Phase 3 trials have been completed, including a study of efficacy and safety and a long-term safety study, both in adults with Attention-Deficit Hyperactivity Disorder. The drug remains investigational and is not yet approved.
JNS001 has been studied in two completed Phase 3 trials. NCT01323192 evaluated efficacy and safety in 284 adults with ADHD in Japan. NCT01357993 assessed long-term safety in 253 adults with ADHD in Japan. Both trials were uncontrolled and not randomized or double-blinded.
JNS001 is not FDA approved. It is an investigational drug in Phase 3 clinical development for Attention-Deficit Hyperactivity Disorder. The completed trials were conducted in Japan, and no approval status has been established in the United States or elsewhere.