Trial reportDrug design, development and therapy2025
Pharmacokinetics, Pharmacodynamic, Safety and Tolerability of Fazamorexant, a Novel Dual Orexin Receptor Antagonist: Report of the First-in-Human Study.
Trial report in Drug design, development and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed.
- Neuropsychiatric drug development in China: Current status and emerging trends.Molecular psychiatry · 2026Review
- Tropanes in natural products, syntheses, and drugs: some insights from the new millennium.Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents · 2026Review
- Single-dose pharmacokinetics, tolerability, and physiologically based pharmacokinetic modeling of Fazamorexant in Chinese patients with hepatic impairment and in healthy controls.Frontiers in pharmacology · 2026Article
- Targeting the Orexin System in the Pharmacological Management of Insomnia and Other Diseases: Suvorexant, Lemborexant, Daridorexant, and Novel Experimental Agents.International journal of molecular sciences · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: This is the first-in-human study to investigate the pharmacokinetic and pharmacodynamic profiles, safety, and tolerability of Fazamorexant (a novel dual orexin receptor antagonist) in healthy subjects. Methods: Here, we summarize pharmacokinetic, pharmacodynamic, and safety data from the randomized, double-blind placebo-controlled studies in healthy adults: single ascending doses (2-80 mg; N = 64), multiple ascending doses (10-60 mg; N = 40). Results: Following single and multiple dosing, the pharmacokinetic profile was characterized by quick absorption and elimination, with median t Conclusion: Fazamorexant at a single dose of 2-80 mg or 10-60 mg at multiple doses presented satisfactory safety and tolerability in healthy subjects. The findings in this comprehensive first-in-humans study support the continued investigation of Fazamorexant as a therapeutic option for insomnia therapy.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.