Seltorexant History and Updates

48 events · 2018 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
48
Trial Milestones
0
Pivotal Publications
Seltorexant — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications201820192020202120222023202420252026202720282029Trial: NCT07573176 2026-05-04 → 2028-08-24 (primary completion)Trial: NCT06559306 2024-07-25 → 2026-12-30 (primary completion)Trial: NCT05307692 2022-05-19 → 2023-11-10 (primary completion)Trial: NCT05236868 2022-02-03 → 2022-03-01 (primary completion)Trial: NCT05106153 2021-12-17 → 2023-05-12 (primary completion)Trial: NCT04951609 2021-09-02 → 2024-04-08 (primary completion)Trial: NCT04533529 2020-09-16 → 2023-04-25 (primary completion)Trial: NCT04532749 2020-09-15 → 2022-05-24 (primary completion)Trial: NCT04513912 2020-09-15 → 2023-10-03 (primary completion)Trial: NCT04553042 2020-09-14 → 2020-12-20 (primary completion)Trial: NCT04451187 2020-07-16 → 2023-03-16 (primary completion)Trial: NCT03796026 2019-01-04 → 2019-06-07 (primary completion)Trial: NCT03682380 2018-10-01 → 2019-08-23 (primary completion)Trial: NCT03494907 2018-04-09 → 2018-08-13 (primary completion)Trial: NCT03438461 2018-02-09 → 2018-05-30 (primary completion)Results posted — 2024-11-25 Trial results posted: NCT05307692 A Study of Seltorexant in Participants With Probable Alzheimer's DiseaseResults posted — 2025-06-04 Trial results posted: NCT04532749 A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With InsomnResults posted — 2026-05-12 Trial results posted: NCT04533529 A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomntoday (2026-07-07)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-07-07Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Seltorexant since 2018, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (3)

2026
2025
2023

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06559306
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptom

Past events

2026
Results posted· ClinicalTrials.gov
Trial results posted: NCT04533529
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomn
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07573176
A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
2025
Results posted· ClinicalTrials.gov
Trial results posted: NCT04532749
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomn
2024
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06559306
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptom
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT04951609
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Respons
2023
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT04513912
A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depre
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT04533529
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomn
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT04451187
A Study of Oral Seltorexant as an add-on Medication to an Antidepressant on On-road Driving Performance in Participants With Major Depressiv
2022
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT04532749
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomn
2021
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05106153
A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT04951609
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Respons
2020
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT04533529
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomn
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT04532749
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomn
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT04513912
A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depre
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT04451187
A Study of Oral Seltorexant as an add-on Medication to an Antidepressant on On-road Driving Performance in Participants With Major Depressiv
2019
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT03796026
A Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Participants With Obstructive Sleep Apn
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT03796026
A Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Participants With Obstructive Sleep Apn
2018
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT03682380
A Study of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Participants
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT03494907
A Study to Evaluate the Effects of Single-dose Seltorexant on Electrocardiogram Intervals in Healthy Adult Participants
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT03438461
A Study to Evaluate the Relative Oral Bioavailability of Seltorexant (JNJ-42847922) After Administration of 3 Different Formulations in Heal
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT03494907
A Study to Evaluate the Effects of Single-dose Seltorexant on Electrocardiogram Intervals in Healthy Adult Participants
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT03438461
A Study to Evaluate the Relative Oral Bioavailability of Seltorexant (JNJ-42847922) After Administration of 3 Different Formulations in Heal

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.