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Seltorexant Dose 1
Seltorexant Dose 1 is a Small molecule drug developed by Janssen Research & Development, LLC. It is currently in Phase 1 development. Also known as: JNJ-42847922.
Seltorexant, also known as JNJ-42847922, is a medication being studied for various conditions including depressive disorder and its potential for abuse. The exact mechanism of action of Seltorexant is currently unknown.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Janssen Research & Development, LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Seltorexant Dose 1 |
|---|---|
| Also known as | JNJ-42847922 |
| Sponsor | Janssen Research & Development, LLC |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy (PHASE3)
- A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder (PHASE2)
- A Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy (PHASE2)
- A Study to Evaluate the Efficacy and Safety of JNJ-42847922 as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy (PHASE2)
- A Study to Evaluate the Effect of Renal Impairment on JNJ-42847922 in Adult Participants (PHASE1)
- A Study of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Participants (PHASE1)
- A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Response to Selective Serotonin Reuptake Inhibitor (SSRI) and Psychotherapy (PHASE1)
- A Study of Oral Seltorexant as an add-on Medication to an Antidepressant on On-road Driving Performance in Participants With Major Depressive Disorder (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:
- Seltorexant Dose 1 CI brief — competitive landscape report
- Seltorexant Dose 1 updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI
Frequently asked questions about Seltorexant Dose 1
What is Seltorexant Dose 1?
Who makes Seltorexant Dose 1?
Is Seltorexant Dose 1 also known as anything else?
What development phase is Seltorexant Dose 1 in?
Related
- Manufacturer: Janssen Research & Development, LLC — full pipeline
- Also known as: JNJ-42847922
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing