solriamfetol

Trade name: Sunosi

Small moleculeapprovedOrphan Drug ^FDA

Approved

Mar 20, 2019

ADX-N05, originally discovered by SK Holdings, is a selective dopamine and norepinephrine reuptake inhibitor (DNRI). ADX-N05 (Solriamfetol, sold under the brand name Sunosi) is approved in the US and is under regulatory review in the EU to improve wakefulness in adult patients with hypersomnia associated with narcolepsy or obstructive sleep apnoea.The US FDA has approved solriamfetol (Sunosi, Jazz Pharmaceuticals) for the treatment of excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea.The dual-acting dopamine and norepinephrine reuptake inhibitor is approved for narcolepsy in once-daily 75 mg and 150 mg doses, and in obstructive sleep apnea in once-daily 37.5 mg, 75 mg, and 150 mg doses. — NCATS

Clinical trial activity

28 trials · 16 clinical orgs · 4 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Nov 17, 2003 (NCT00073203)

Timeline

2000s

Jan 1, 2003
Earliest Phase 2 Sponsor(trial)

2010s

Aug 20, 2012
Orphan Drug Designation
Jan 1, 2015
Jazz Pharmaceuticals — Earliest Phase 3 Sponsor(trial)
Mar 20, 2019
Jazz Pharmaceuticals — Earliest FDA Approval
Mar 20, 2019
Jazz Pharmaceuticals — Marketing Organization
Mar 20, 2019
Jazz Pharmaceuticals — NDA Organization
Mar 20, 2019
Axsome Therapeutics, Inc. — Marketing Organization
Mar 20, 2019
Axsome Therapeutics, Inc. — NDA Secondary Org

2020s

Dec 11, 2024
Hetero Labs Ltd — Marketing Organization
Feb 4, 2026
Aurobindo Pharma — Marketing Organization

Mechanism of action

Monoamine transporters; Norepininephrine & dopamineANTAGONIST
Monoamine transporters; Norepininephrine & dopamine antagonist
- Sodium-dependent dopamine transporter (Slc6a3) ↗
- Transporter (Q9WTR4) ↗
- Norepinephrine transporter
- Dopamine transporter
Norepinephrine transporterINHIBITOR
SC6A2 inhibitor
- Sodium-dependent noradrenaline transporter (SLC6A2) ↗
Dopamine transporterINHIBITOR
SLC6A3 inhibitor
- Sodium-dependent dopamine transporter (SLC6A3) ↗
Unspecified targetOTHER
Unknown
Not fully elucidated. Known to function as a dopamine and norepinephrine reuptake inhibitor and has low affinity for the dopamine transporter (Ki 14.2 uM) and norepinephrine transporter (Ki 3.7 uM).
Does not inhibit serotonin reuptake (IC50 > 100 uM). No binding to the dopamine, serotonin, norepinephrine, GABA, adenosine, histamine, orexin, benzodiazepine, muscarininc acetylcholine or nicotinic acetylcholine receptors.

Approval history

approvedMar 20, 2019

Chemistry & pharmacology

Loading structure…

SMILES

N[C@@H](COC(N)=O)CC1=CC=CC=C1

Mol. weight: 194.2304 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Sources

Also known as

adx-n05
adx-n05
jzp-110
jzp-110
r228060

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT06878976	Phase 3	Feb 20, 2025	Axsome Therapeutics, Inc.
NCT06590662	Phase 2	Sep 15, 2024	University of Montpellier
NCT06404099	Phase 2	Aug 12, 2024	Duke University, Harvard University
NCT06568367	Phase 3	Aug 1, 2024	Axsome Therapeutics, Inc.
NCT06404086	Phase 2	Jul 31, 2024	Duke University, Harvard University
NCT06413433	Phase 3	Apr 26, 2024	Axsome Therapeutics, Inc.
NCT06360419	Phase 3	Mar 18, 2024	Axsome Therapeutics, Inc.
NCT06170970	Phase 2	Mar 1, 2024	Axsome Therapeutics, Inc., Johns Hopkins University, National Multiple Sclerosis Society
NCT06103825	Phase 3	Aug 1, 2023	Ignis Therapeutics (Suzhou) Limited
NCT05838430	Phase 4	Jul 31, 2023	Axsome Therapeutics, Inc., University of Pennsylvania
NCT05972044	Phase 3	Jul 6, 2023	Axsome Therapeutics, Inc.
NCT05008341	Phase 4	Aug 27, 2021	Jazz Pharmaceuticals
NCT04788953	Phase 4	Jul 21, 2021	Harvard University, Jazz Pharmaceuticals
NCT04789174	Phase 4	May 17, 2021	Jazz Pharmaceuticals
NCT04839562	Phase 2/Phase 3 (Phase 3)	May 1, 2021	Harvard University
NCT04622293	Phase 4	Jan 1, 2021	Rochester Center for Behavioral Medicine
NCT04602936	Phase 4	Nov 15, 2020	Jazz Pharmaceuticals, University of Cincinnati
NCT03868943	Phase 2	Jul 31, 2019	National Cancer Institute (NCI), Wake Forest University
NCT03037203	Phase 2	Jan 1, 2017	Jazz Pharmaceuticals
NCT02806895	Phase 2	Jun 1, 2016	Jazz Pharmaceuticals, Maastricht University

Showing 20 of 28 trials

Page 1 / 2

Organizations

Research & Development (16)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Jazz Pharmaceuticals	For profit	13	11	3	2011
Axsome Therapeutics, Inc.	For profit	7	5	3	2023
Harvard University	Academic/Hospital	4	2	3	2021
Aerial BioPharma, LLC	For profit	2	0	1	2011
Duke University	Academic/Hospital	2	2	1	2024
Maastricht University	Academic/Hospital	2	0	1	2016
Ignis Therapeutics (Suzhou) Limited	For profit	1	1	1	2023
Johns Hopkins University	Academic/Hospital	1	1	1	2024
Johnson and Johnson	For profit	1	1	1	2003
National Cancer Institute (NCI)	Government	1	0	1	2019
National Multiple Sclerosis Society	Academic/Hospital	1	0	1	2024
Rochester Center for Behavioral Medicine	Academic/Hospital	1	1	1	2021
University of Cincinnati	Academic/Hospital	1	1	1	2020
University of Montpellier	Academic/Hospital	1	1	1	2024
University of Pennsylvania	Academic/Hospital	1	1	1	2023
Wake Forest University	Academic/Hospital	1	1	1	2019

16 organizations

Page 1 / 1

Marketing (6)

Organization	Org type	Relationship	Date
Aurobindo Pharma	For profit	MKTG	Feb 4, 2026
Axsome Therapeutics, Inc.	For profit	MKTG	Mar 20, 2019
Axsome Therapeutics, Inc.	For profit	NDA2	Mar 20, 2019
Hetero Labs Ltd	For profit	MKTG	Dec 11, 2024
Jazz Pharmaceuticals	For profit	MKTG	Mar 20, 2019
Jazz Pharmaceuticals	For profit	NDA	Mar 20, 2019