You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 17, 2025

Investigational Drug Information for Seltorexant


✉ Email this page to a colleague

« Back to Dashboard


What is the drug development status for Seltorexant?

Seltorexant is an investigational drug.

There have been 18 clinical trials for Seltorexant. The most recent clinical trial was a Phase 2 trial, which was initiated on September 16th 2020.

The most common disease conditions in clinical trials are Depressive Disorder, Depression, and Depressive Disorder, Major. The leading clinical trial sponsors are Janssen Research & Development, LLC, Minerva Neurosciences, and [disabled in preview].

There are four US patents protecting this investigational drug and one hundred international patents.

Recent Clinical Trials for Seltorexant
TitleSponsorPhase
A Study of Seltorexant in Participants With Probable Alzheimer's DiseaseJanssen Research & Development, LLCPhase 2
A Study of JNJ-42847922 (Seltorexant) in Healthy ParticipantsJanssen Research & Development, LLCPhase 1
A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and ZolpidemJanssen Research & Development, LLCPhase 1

See all Seltorexant clinical trials

Clinical Trial Summary for Seltorexant

Top disease conditions for Seltorexant
Top clinical trial sponsors for Seltorexant

See all Seltorexant clinical trials

US Patents for Seltorexant

Drugname Patent Number Patent Title Patent Assignee Estimated Expiration
Seltorexant ⤷  Try for Free Methods of treating depression using orexin-2 receptor antagonists Janssen Pharmaceutica NV (Beerse, BE) ⤷  Try for Free
Seltorexant ⤷  Try for Free Disubstituted octahydropyrrolo[3,4-c]pyrroles as orexin receptor modulators Janssen Pharmaceutica (BE) ⤷  Try for Free
Seltorexant ⤷  Try for Free Disubstituted octahydropyrrolo[3,4-c]pyrroles as orexin receptor modulators Janssen Pharmaceutica NV (BE) ⤷  Try for Free
Seltorexant ⤷  Try for Free Disubstituted octahydropyrrolo [3,4-C] pyrroles as orexin receptor modulators Janssen Pharmaceutica NV (Beerse, BE) ⤷  Try for Free
>Drugname >Patent Number >Patent Title >Patent Assignee >Estimated Expiration

International Patents for Seltorexant

Drugname Country Document Number Estimated Expiration Related US Patent
Seltorexant Australia AU2017231828 2036-03-10 ⤷  Try for Free
Seltorexant Brazil BR112018067906 2036-03-10 ⤷  Try for Free
Seltorexant Canada CA2960253 2036-03-10 ⤷  Try for Free
Seltorexant Canada CA3016706 2036-03-10 ⤷  Try for Free
Seltorexant Chile CL2018002533 2036-03-10 ⤷  Try for Free
Seltorexant China CN108883110 2036-03-10 ⤷  Try for Free
>Drugname >Country >Document Number >Estimated Expiration >Related US Patent

Seltorexant: A Promising Drug Candidate for Major Depressive Disorder and Insomnia

Last updated: January 1, 2025

Introduction to Seltorexant

Seltorexant, a novel drug candidate developed by Johnson & Johnson (J&J) in collaboration with Minerva Neurosciences, has garnered significant attention for its potential in treating major depressive disorder (MDD) and associated insomnia. Here’s a comprehensive update on its development and market projections.

Mechanism of Action

Seltorexant is a selective orexin-2 receptor antagonist. Orexin-2 receptors are involved in the regulation of wakefulness and sleep. In individuals with depression, overstimulation of these receptors can lead to hyperarousal, contributing to insomnia and exacerbating depressive symptoms. By blocking these receptors, seltorexant aims to reduce hyperarousal and improve sleep quality, thereby alleviating depressive symptoms[1][4].

Clinical Trials and Efficacy

Phase 3 Trials for MDD

In a pivotal Phase 3 trial (MDD3001), seltorexant demonstrated significant efficacy as an adjunctive treatment to background antidepressants like SSRIs and SNRIs in adults with MDD and insomnia. The trial, which enrolled 588 patients, met all primary and secondary endpoints, showing statistically significant and clinically meaningful improvements in depressive symptoms and sleep quality by study day 43[1][4].

Safety Profile

The drug was reported to be safe and well-tolerated, with rates of common side effects similar to those in the placebo group. This positive safety profile is crucial for its potential approval and market acceptance[1].

Market Projections

J&J has high expectations for seltorexant, predicting it could generate between $1 billion and $5 billion in annual sales by 2030. This forecast is primarily driven by its potential in treating MDD and insomnia, rather than its initial exploration in Alzheimer’s disease[1][5].

However, recent adjustments in J&J’s neuroscience pipeline, including the discontinuation of seltorexant’s Phase II study in Alzheimer’s disease, have slightly tempered these projections. GlobalData now forecasts seltorexant sales to reach $610 million by 2030[2].

Competitive Landscape

The market for MDD treatments is robust and growing, with several promising drugs in the pipeline. Seltorexant stands out as the most advanced orexin-2 receptor antagonist in clinical development. Other notable drugs in the pipeline include Zuranolone (SAGE Therapeutics/Biogen), REL-1017 (Relmada Therapeutics), and COMP360 (COMPASS Pathways)[4].

Additional Indications

Apart from MDD, seltorexant is also being studied for the treatment of insomnia without psychiatric disorders. This dual focus expands its potential market and underscores its versatility in addressing sleep-related issues[4].

Industry Insights

Bill Martin, Ph.D., J&J’s global therapeutic head of neuroscience, highlighted the significance of seltorexant and another J&J drug, aticaprant, in targeting specific biological mechanisms dysregulated in MDD patients. This targeted approach is seen as a major breakthrough in the treatment of depression[5].

Conclusion

Seltorexant represents a significant advancement in the treatment of MDD and associated insomnia. With its positive Phase 3 trial results and promising market projections, it is poised to become a key player in the neuroscience pipeline. Despite some adjustments in its development trajectory, seltorexant remains a highly anticipated drug candidate with the potential to transform the treatment landscape for depression.

Key Takeaways

  • Mechanism of Action: Seltorexant is a selective orexin-2 receptor antagonist.
  • Clinical Trials: Positive Phase 3 trial results for MDD and insomnia.
  • Safety Profile: Safe and well-tolerated.
  • Market Projections: Forecasted sales of $610 million by 2030.
  • Competitive Landscape: Part of a robust pipeline for MDD treatments.
  • Additional Indications: Being studied for insomnia without psychiatric disorders.

FAQs

What is seltorexant and how does it work?

Seltorexant is a selective orexin-2 receptor antagonist designed to treat major depressive disorder (MDD) and associated insomnia by blocking the overstimulation of orexin-2 receptors, which are involved in regulating wakefulness and sleep.

What were the results of the Phase 3 trial for seltorexant?

The Phase 3 trial (MDD3001) showed that seltorexant significantly improved depressive symptoms and sleep quality in adults with MDD and insomnia, meeting all primary and secondary endpoints.

Is seltorexant safe?

Yes, seltorexant was reported to be safe and well-tolerated, with side effect rates similar to those in the placebo group.

What are the market projections for seltorexant?

J&J initially forecasted seltorexant to generate between $1 billion and $5 billion in annual sales by 2030. However, current projections by GlobalData estimate sales to reach $610 million by 2030.

What other conditions is seltorexant being studied for?

Apart from MDD, seltorexant is also being studied for the treatment of insomnia without psychiatric disorders.

How does seltorexant compare to other MDD treatments in the pipeline?

Seltorexant is the most advanced orexin-2 receptor antagonist in clinical development and is part of a robust pipeline that includes other promising drugs like Zuranolone, REL-1017, and COMP360.

Sources

  1. Biopharma Dive: "J&J antidepressant eases symptoms, improves sleep in key trial"
  2. Pharmaceutical Technology: "J&J trims neuroscience pipeline – seltorexant in Alzheimer's disease dropped"
  3. GlobeNewswire: "Major Depressive Disorder Pipeline Insights Report, 2024"
  4. PR Newswire: "Major Depressive Disorder Market to Register Immense Growth by 2034"
  5. Fierce Biotech: "J&J neuroscience drugs take spotlight with lofty revenue goals"

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.