Solriamfetol
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Sunosi | — | 2020-01-16 | europa.eu ↗ |
| Approved | US (FDA) | SUNOSI | — | 2019-03-20 | fda.gov ↗ |
Trials 21 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| Phase 2 | NCT06404099 Comparator | Aug 2024 → Mar 2026 | hypersomnia, long COVID-19 | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT02806895 Comparator | Jul 2016 → May 2019 | hypersomnia, obstructive sleep apnea syndrome | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02806908 Comparator | Jun 2016 → May 2019 | hypersomnia, narcolepsy | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT02348619 Comparator | May 2015 → Nov 2016 | obstructive sleep apnea syndrome | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02348606 Comparator | May 2015 → Dec 2016 | obstructive sleep apnea syndrome | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02348593 Comparator | May 2015 → Feb 2017 | narcolepsy | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04602936 Comparator | Jun 2021 → Aug 2024 | binge eating disorder | Lindner Center of HOPE | Unknown | No outcome recorded |
| Phase 4 | NCT04789174 Comparator | May 2021 → Sep 2022 | cognitive disorder, hypersomnia, obstructive sleep apnea syndrome | Axsome Therapeutics, Inc. | Completed | No outcome recorded |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 37 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | solriamfetol | “Objectives: To evaluate the efficacy and safety of solriamfetol (JZP-110), a selective dopamine and norepinephrine reuptake inhibitor with robust wake-promoting effects, for...” PMID 30521757 ↗ Jun 201923“Solriamfetol (formerly JZP-110), a dopamine/norepinephrine reuptake inhibitor, is approved in the US to improve wakefulness in adults with excessive daytime sleepiness...” PMID 31926465 ↗ Dec 2019 “Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea.” PMID 31691827 ↗ Feb 2020 “This phase III randomized withdrawal trial evaluated solriamfetol (JZP-110) for the treatment of ES in adults with OSA.” PMID 30471270 ↗ Nov 2018 “Solriamfetol is approved (US and EU) for excessive daytime sleepiness (EDS) in narcolepsy and obstructive sleep apnea.” PMID 34191352 ↗ Jun 2021 “Solriamfetol is a wakefulness-promoting drug.” NCT03868943 ↗ |
| Known as | (R)-2-amino-3-phenylpropylcarbamate Hydrochloride | “A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate...” NCT02348606 ↗1“A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate...” NCT02348593 ↗ |
| Known as | ADX-N-05 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297620 ↗ |
| Known as | ADX-N05 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01681121 ↗ |
| Known as | JZP-110 | “Solriamfetol (formerly JZP-110), a dopamine/norepinephrine reuptake inhibitor, is approved in the US to improve wakefulness in adults with excessive daytime sleepiness...” PMID 31926465 ↗ Dec 20198“Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea.” PMID 31691827 ↗ Feb 2020 “Effect of Oral JZP-110 (ADX-N05) on Wakefulness and Sleepiness in Adults with Narcolepsy: A Phase 2b Study.” PMID 27166238 ↗ Jul 2016 “Effect of oral JZP-110 (ADX-N05) treatment on wakefulness and sleepiness in adults with narcolepsy.” PMID 26298786 ↗ Jun 2015 “Strengths of solriamfetol (JZP-110) strengths: 37.5 mg，75 mg, 150 mg” NCT06103825 ↗ |
| Known as | JZP-110 hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297620 ↗ |
| Known as | R-228060 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297620 ↗ |
| Known as | R228060 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00073203 ↗ |
| Known as | SKL-N-05 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297620 ↗ |
| Known as | SKL-N-05 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297620 ↗ |
| Known as | SOLRIAMFETOL HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297620 ↗ |
| Known as | Sunosi | “This analysis characterized changes in weight in participants with obstructive sleep apnea (OSA) or narcolepsy treated with solriamfetol (Sunosi™) 37.5 (OSA only), 75, 150, or 300 mg/d.” PMID 36084494 ↗ Aug 20221“Solriamfetol (trade name Sunosi), is a norepinephrine-dopamine reuptake inhibitor available in 75mg and 150mg tablets for oral administration during the day.” NCT05838430 ↗ |
| Known as | YKP-10A | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297620 ↗ |
| Known as | YKP-10A HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297620 ↗ |
| Action | Inhibit | “a dopamine/norepinephrine reuptake inhibitor” PMID 32588401 ↗ Jul 2020 |
| Modality | Small molecule | — CHEMBL4297620 ↗ |
| Route | Oral | “Effect of oral JZP-110 (ADX-N05) treatment on wakefulness and sleepiness in adults with narcolepsy.” PMID 26298786 ↗ Jun 2015 |