Last update 08 May 2025

Solriamfetol Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(2R)-2-amino-3-phenylpropyl carbamate, Solriamfetol hydrochloride (USAN), solriamfetol
+ [13]
Action
agonists, antagonists, inhibitors
Mechanism
5-HT1A receptor agonists(Serotonin 1a (5-HT1a) receptor agonists), DAT antagonists(Dopamine transporter antagonists), NET inhibitors(Norepinephrine transporter inhibitors)
+ [1]
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (20 Mar 2019),
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC10H15ClN2O2
InChIKeyKAOVAAHCFNYXNJ-SBSPUUFOSA-N
CAS Registry178429-65-7

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Narcolepsy
United States
20 Mar 2019
Sleep Apnea, Obstructive
United States
20 Mar 2019
Excessive Daytime Sleepiness
Canada
-
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Sleep Apnea, ObstructiveNDA/BLA
China
10 Dec 2024
Sleep Apnea, ObstructiveNDA/BLA
China
10 Dec 2024
Sleep Wake DisordersNDA/BLA
China
-
Idiopathic HypersomniaPreclinical
Germany
01 May 2015
NarcolepsyPreclinical
Canada
01 May 2015
NarcolepsyPreclinical
United States
01 May 2015
NarcolepsyPreclinical
Finland
01 May 2015
NarcolepsyPreclinical
France
01 May 2015
NarcolepsyPreclinical
Germany
01 May 2015
NarcolepsyPreclinical
Netherlands
01 May 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
516
(yfymgvkvpk) = fsswtjtsgo tkbylijdtw (sequcyhcpz )
Met
Positive
25 Mar 2025
-
Not Applicable
Sleep Apnea, Obstructive
Add-on
Excessive daytime sleepiness
83
(gisgzttpvk) = Common adverse effects were headache, insomnia, and irritability garwkjcwvf (dlwfeyvyxs )
Positive
09 Apr 2024
Phase 3
-
Solriamfetol 75mg
(xqifjolaoq) = frcnpehwcz fwrdhsxgin (koaqbjifxf )
Positive
09 Apr 2024
Solriamfetol 150mg
(xqifjolaoq) = zzeujenwho fwrdhsxgin (koaqbjifxf )
Phase 2/3
66
(Solriamfetol)
rfsrfdoqni(xatycvqtyk) = ztdqqvljza nydxdlbpap (oyafkjodkz, cacgtxjnzh - ybarvpqcna)
-
04 Mar 2024
Placebo
(Placebo)
rfsrfdoqni(xatycvqtyk) = trtoalbavl nydxdlbpap (oyafkjodkz, hogziiawmq - jdcfhajmet)
Not Applicable
-
(wcrnlruaql) = 3.4% efrbwbcfbk (izopnvtdpd )
-
25 Oct 2023
Placebo
Not Applicable
-
(oquwtpjylh) = Common adverse effects were headache pwbbxdjnqa (sjhbbevgtn )
-
24 Oct 2023
Not Applicable
-
gbevqgeczi(dbeqmwdasl) = No weight-related treatment-emergent adverse events were serious fpjwuwfheh (jthsqlegme )
-
14 Aug 2022
Solriamfetol 75 mg
Not Applicable
-
-
flwrakxxic(moywcvfuoz) = usqvaatqla elzpawzfrz (ctaadpdeal, 5.0%)
-
15 May 2022
Vehicle (VEH)
flwrakxxic(moywcvfuoz) = gyelqzczpl elzpawzfrz (ctaadpdeal, 9.8%)
Phase 3
-
(sojqvcjxqy) = jvpeoycymx kikmtbaawl (wurzcrcmpl )
-
20 Jul 2021
Solriamfetol 150 mg
(kmrkyxjvvh) = rjfnecuiod gihaghbrwt (hmanaxjcff )
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Regulation

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