pseudoephedrine

Trade name: Benylin

Small moleculeapproved

Approved

Jun 1, 1963

Pseudoephedrine, sold under the brand name Sudafed among others, is a sympathomimetic medication which is used as a decongestant to treat nasal congestion. It has also been used off-label for certain other indications, like treatment of low blood pressure. At higher doses, it may produce various additional effects including stimulant, appetite suppressant, and performance-enhancing effects. In relation to this, non-medical use of pseudoephedrine has been encountered. The medication is taken by mouth. — Wikipedia

Clinical trial activity

73 trials · 60 clinical orgs · 76 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Aug 1, 1999 (NCT02182531)

Timeline

1960s

Jun 1, 1963
Earliest FDA Approval
Oct 18, 1963
Schering-Plough — First NDA Organization
Oct 18, 1963
Schering-Plough — NDA Organization
Oct 18, 1963
Schering-Plough — NDA Secondary Org

1970s

Aug 29, 1975
Sanofi-Aventis — NDA Secondary Org

1980s

Mar 31, 1981
Bayer — NDA Secondary Org
Mar 23, 1982
Schering — Marketing Organization
Jul 13, 1983
West-Ward Pharmaceutical — Marketing Organization
Sep 2, 1983
Sandoz — Marketing Organization
Nov 7, 1983
Upsher-Smith Laboratories — Marketing Organization
Jan 13, 1984
Watson Pharmaceuticals — Marketing Organization
Apr 20, 1984
Fondazione Golgi Cenci — Marketing Organization
Aug 24, 1984
AH Robins — Marketing Organization
Aug 24, 1984
AH Robins — NDA Secondary Org
Nov 16, 1984
Wockhardt — Marketing Organization
Dec 12, 1984
Teva — Marketing Organization
Jan 31, 1985
Mylan — Marketing Organization
Feb 12, 1985
Newtron Pharmaceuticals — Marketing Organization
Mar 18, 1985
Graham Dm — NDA Secondary Org
Mar 22, 1985
STI Pharma, LLC — Marketing Organization
Mar 22, 1985
Animas Corporation — Marketing Organization
Apr 11, 1985
Fosun — Marketing Organization
Mar 6, 1986
Fisons — Marketing Organization
Mar 6, 1986
Fisons — NDA Secondary Org
Jan 22, 1987
Copley Pharmaceuticals — Marketing Organization
Jun 19, 1987
UCB — NDA Secondary Org
Aug 2, 1988
Century Pharmaceuticals — Marketing Organization
Aug 2, 1988
Century Pharmaceuticals — NDA Secondary Org
Sep 19, 1989
Pfizer — Marketing Organization
Sep 19, 1989
GlaxoSmithKline — NDA Secondary Org

1990s

Oct 31, 1991
McNeil — Marketing Organization
Oct 31, 1991
Johnson and Johnson — Marketing Organization
Dec 15, 1992
Johnson and Johnson — NDA Secondary Org
Mar 25, 1994
Auxillium — Marketing Organization
Mar 25, 1994
Auxillium — NDA Secondary Org
Mar 29, 1996
Alza — Marketing Organization
Mar 29, 1996
Alza — NDA Secondary Org
Dec 24, 1997
Sanofi — NDA Secondary Org
Jan 1, 1999
Earliest Phase 1 Sponsor(trial)
Jan 1, 1999
Earliest Phase 2 Sponsor(trial)
Feb 26, 1999
Perrigo — Marketing Organization
Nov 29, 1999
Bayer — Marketing Organization

2000s

Jan 1, 2000
Earliest Phase 3 Sponsor(trial)
Mar 1, 2001
Novartis — Marketing Organization
Mar 1, 2001
Novartis — NDA Secondary Org
Apr 17, 2001
Ohm Laboratories, Inc. — Marketing Organization
Apr 17, 2001
Ranbaxy — Marketing Organization
Apr 8, 2002
Contract Pharmacal — Marketing Organization
Feb 21, 2003
P&L Development — Marketing Organization
Jan 28, 2004
Heritage Pharma — Marketing Organization
Jun 22, 2004
Reckitt Benckiser Pharmaceutical — Marketing Organization
Jun 22, 2004
Reckitt Benckiser Pharmaceutical — NDA Secondary Org
Mar 3, 2005
Merck — Marketing Organization
Apr 14, 2005
Barr Laboratories — Marketing Organization
Feb 1, 2006
Organon — NDA Secondary Org
Mar 5, 2008
PL Developments — Marketing Organization

2010s

Nov 12, 2010
Impax Laboratories — Marketing Organization
Jun 8, 2011
Cypress Pharmaceutical — Marketing Organization
Jun 8, 2011
Currax Pharmaceuticals — NDA Secondary Org
Feb 27, 2013
Avanthi Pharma — Marketing Organization
Apr 29, 2014
Paddock Laboratories — Marketing Organization
Apr 29, 2014
Padagis Us — Marketing Organization
Jul 21, 2014
Pharmaceutical Associates — Marketing Organization
Jul 21, 2014
Vintage — Marketing Organization
Oct 28, 2014
Tris Pharma, Inc. — Marketing Organization
Nov 18, 2014
Dr. Reddy's Laboratories — Marketing Organization
Jan 29, 2015
Sun Pharmaceuticals — Marketing Organization
May 14, 2015
Chartwell Pharmaceuticals — NDA Secondary Org
May 14, 2015
Mikart — Marketing Organization
May 27, 2015
Actavis — Marketing Organization
May 27, 2015
Allergan PLC (2015) — Marketing Organization
Aug 3, 2015
Mayne Pharma — Marketing Organization
Sep 20, 2016
Acella Pharmaceuticals — Marketing Organization
Feb 27, 2017
Taro Pharmaceuticals — Marketing Organization
May 15, 2017
Torrent Pharmaceuticals Limited — Marketing Organization
Jun 9, 2017
Aurobindo Pharma — Marketing Organization

2020s

Apr 17, 2020
Lannett Company, Inc. — Marketing Organization
Apr 17, 2020
Chartwell Pharmaceuticals — Marketing Organization
Jun 16, 2020
Wes Pharma Inc — Marketing Organization
Jun 16, 2020
Eywa Pharma — Marketing Organization
Jul 14, 2020
Alkem Labs Ltd — Marketing Organization
Sep 30, 2020
Esteve Labs — Marketing Organization
Sep 30, 2020
Bionpharma Inc — Marketing Organization
Nov 5, 2020
Rhodes Pharmaceuticals, L.P. — Marketing Organization
Aug 22, 2022
Granules India — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Norepinephrine transporterRELEASING AGENT
SLC6A2 releasing agent
- Sodium-dependent noradrenaline transporter (SLC6A2) ↗

Combination products

advil allergy sinus
with dexchlorpheniramine maleate, ibuprofen
Also known as children's advil allergy sinus
advil cold and sinus
with ibuprofen
Also known as children's advil col, children's motrin col, ibuprohm cold and sinus, sine-aid ib
aleve-d sinus & col
with naproxen
allegra-d 12 hour allergy and congestion
with fexofenadine
Also known as allegra-d 24 hour allergy and congestion, fexofenadine hcl; pseudoephedrine hcl
benylin
with diphenhydramine
chlor-trimeton
with dexchlorpheniramine maleate
Also known as isoclor
clarinex d 24 hour
with desloratadine
Also known as clarinex-d 12 hour, desloratadine and pseudoephedrine sulfate 24 hour
claritin
with loratadine
Also known as claritin-d 24 hour
dimetane-dx
with dextromethorphan, brompheniramine maleate
Also known as bromfed-dm
disophrol
with dexbrompheniramine
Also known as brompheril, disobrom, drixoral
drixoral plus
with acetaminophen, dexbrompheniramine
efidac 24 pseudoephedrine hydrochloride/brompheniramine maleate
with brompheniramine maleate
hycofenix
with hydrocodone, guaifenesin
mucinex
with guaifenesin
rezira
with hydrocodone
semprex
with acrivastine
tavist allergy/sinus/headache
with acetaminophen, clemastine
triacin-c
with codeine, triprolidine
trinalin
with azatadine
triprolidine and pseudoephedrine
with triprolidine
Also known as allerfe, corphe, histafe, myfe, trilitron
zutripro
with hydrocodone, dexchlorpheniramine maleate
zyrtec-d 12 hour
with cetirizine

Approval history

approvedJun 1, 1963

Chemistry & pharmacology

Loading structure…

SMILES

CN[C@@H](C)[C@@H](O)c1ccccc1.Cl

Mol. weight: 201.7 g/mol
Lipinski Ro5: Pass
Rule of 3: Yes
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Over the Counter

Oral

Yes

Parenteral

Topical

Sources

Also known as

(+)-(1s,2s)-pseudoephedrine
(+)-(1s,2s)-pseudoephedrine
acetaminophen - phenylpropanolamine - phenyltoloxamine
acetaminophen, phenylpropanolamine, phenyltoloxamine drug combination
actifed
actifed
actifed
afrinol
afrinol
contac
contac
demosin
desloratadine / pseudophedrine sulphate
dimotane plus
dimotane plus l.a.
d-isoephedrine
d-isoephedrine
d-pseudoephedrine
d-pseudoephedrine
d-psi-2-methylamino-1-phenyl-1-propanol
d-psi-2-methylamino-1-phenyl-1-propanol
d-psi-ephedrine
d-psi-ephedrine
galpseud
galpseud
galpseud plus
isoephedrine
isoephedrine
l-(+)-pseudoephedrine
l-(+)-pseudoephedrine
l(+)-psi-ephedrine
l(+)-psi-ephedrine
novafed
novafed
otrivine mu-cron
pseudo-12
pseudo-12
pseudoefedrina
pseudoefedrina
pseudoephedrine
pseudoephedrine
pseudoephedrine
pseudoephedrine
pseudoephedrine
pseudoephedrine
pseudoephedrine
pseudoephedrine
pseudoephedrine
pseudoephedrine
(+)-pseudoephedrine
(+)-pseudoephedrine
(+)-pseudoephedrine
pseudoéphédrine
pseudoéphédrine
pseudoephedrine d-form
pseudoephedrine d-form
pseudoephedrine hcl
pseudoephedrine hcl
pseudoephedrine hcl
pseudoephedrine hydrochloride
pseudoephedrine hydrochloride
pseudoephedrine hydrochloride
pseudoephedrine hydrochloride
pseudoephedrine hydrochloride
pseudoephedrine polistirex
pseudoephedrine polistirex
pseudoephedrine polistirex
pseudoephedrine polistirex
pseudoephedrine sulfate
pseudoephedrine sulfate
pseudoephedrine sulfate
pseudoephedrine sulfate
pseudoephedrine sulfate
pseudoephedrine - triprolidine
pseudoephedrine, triprolidine drug combination
pseudoephedrinum
pseudoephedrinum
pseudophed
pseudophedrine sulphate
psi-ephedrin
psi-ephedrin
(+)-psi-ephedrine
(+)-psi-ephedrine
psi-ephedrine
psi-ephedrine
rinasek
sch-4855
sinutab
sinutab
sudafed
sudafed
sudafed
sudafed 12 hour
sudafed 12 hour
sudafed 12 hr decongest
sudafed 24 hour
sudafed 24 hour
sudafed plus
sudafed-sa
(+) threo-2-(methylamino)-1-phenyl-1-propanol
(+) threo-2-(methylamino)-1-phenyl-1-propanol
(+)-threo-ephedrine
(+)-threo-ephedrine
trans-ephedrine
trans-ephedrine
trifed
ψ-ephedrine
ψ-ephedrine

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT05692869	N/A	Jan 31, 2023	Eli Lilly
NCT05697328	N/A	Jan 31, 2023	John Muir Physician Network Clinical Research Center
NCT04682184	N/A	Jan 13, 2021	Eli Lilly
NCT04563208	Phase 2	Dec 9, 2020	Ezintsha, SynaVir, University of the Witwatersrand
NCT04332211	N/A	Jun 1, 2020	University of Maryland
NCT03644576	Phase 1	Jul 11, 2018	Celgene
NCT03517943	Phase 1	Apr 24, 2018	Bayer
NCT03517930	Phase 1	Apr 17, 2018	Bayer
NCT03443843	Phase 4	Feb 21, 2018	Bayer
NCT02963701	Phase 1	Dec 1, 2016	Boehringer Ingelheim
NCT03184766	Phase 1	Aug 10, 2016	Reckitt Benckiser Pharmaceutical, Simbec-Orion
NCT02246166	Phase 4	Jan 1, 2015	GlaxoSmithKline, Smith Kline and French
NCT03706300	Phase 1	Dec 31, 2014	Dr. Reddy's Laboratories, QPS
NCT02149901	Early Phase 1 (Phase 1)	Oct 1, 2014	National Center for Advancing Translational Science (NCATS), National Heart, Lung, and Blood Institute (NHLBI), Vanderbilt University
NCT01393548	Phase 3	Aug 1, 2014	Ache Laboratorios Farmaceuticos S.A.
NCT01393561	Phase 3	Jul 1, 2014	Ache Laboratorios Farmaceuticos S.A.
NCT02175485	Phase 4	Jun 1, 2014	Sanofi
NCT03429738	Phase 1	Apr 27, 2014	Institut für Pharmakologie und Präventive Medizin, Pharma Medica
NCT02082054	Phase 2	Mar 1, 2014	Magna Pharmaceuticals, Inc.
NCT01925729	N/A	Oct 1, 2013	National Institute on Deafness and Other Communication Disorders (NIDCD), University of Pittsburgh

Showing 20 of 73 trials

Page 1 / 4

Organizations

Research & Development (60)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Dr. Reddy's Laboratories	For profit	9	9	1	2004
Bayer	For profit	5	5	3	2005
Ache Laboratorios Farmaceuticos S.A.	For profit	4	4	1	2011
Boehringer Ingelheim	For profit	4	4	2	1999
Johnson and Johnson	For profit	4	3	2	2004
Lotus Labs	For profit	4	0	1	2004
Magna Pharmaceuticals, Inc.	For profit	4	4	3	2009
McNeil	For profit	4	1	3	2005
Ranbaxy	For profit	4	4	1	2002
GlaxoSmithKline	For profit	3	1	3	2006
Pharma Medica	For profit	3	0	1	2005
Vanderbilt University	Academic/Hospital	3	3	1	2002
Azidus	For profit	2	2	1	2010
Eli Lilly	For profit	2	2	1	2021
EMS S/A	For profit	2	1	1	2011
Merck	For profit	2	2	2	2006
National Institute of Allergy and Infectious Diseases (NIAID)	Government	2	1	2	1999
Sandoz	For profit	2	2	1	2005
Sanofi	For profit	2	2	2	2011
SFBC Anapharm	For profit	2	0	1	2006

60 organizations

Page 1 / 3

Marketing (106)

Organization	Org type	Relationship	Date
AH Robins	For profit	MKTG	Aug 24, 1984
AH Robins	For profit	NDA2	Aug 24, 1984
Acella Pharmaceuticals	For profit	SYN	Sep 20, 2016
Acella Pharmaceuticals	For profit	MKTG	Sep 20, 2016
Actavis	For profit	MKTG	May 27, 2015
Alkem Labs Ltd	For profit	MKTG	Jul 14, 2020
Allergan PLC (2015)	For profit	MKTG	May 27, 2015
Alpharma	For profit	MKTG	—
Alza	For profit	MKTG	Mar 29, 1996
Alza	For profit	NDA2	Mar 29, 1996
Animas Corporation	For profit	MKTG	Mar 22, 1985
Aurobindo Pharma	For profit	MKTG	Jun 9, 2017
Aurobindo Pharma	For profit	MKTG	Jun 9, 2017
Auxillium	For profit	MKTG	Mar 25, 1994
Auxillium	For profit	NDA2	Mar 25, 1994
Avanthi Pharma	For profit	MKTG	Feb 27, 2013
Barr Laboratories	For profit	MKTG	Apr 14, 2005
Bayer	For profit	MKTG	Nov 29, 1999
Bayer	For profit	NDA2	Mar 31, 1981
Bionpharma Inc	For profit	MKTG	Sep 30, 2020
Burroughs Wellcome	For profit	NDA2	—
Century Pharmaceuticals	For profit	MKTG	Aug 2, 1988
Century Pharmaceuticals	For profit	NDA2	Aug 2, 1988
Chartwell Pharmaceuticals	For profit	NDA2	May 14, 2015
Chartwell Pharmaceuticals	For profit	MKTG	Apr 17, 2020
Contract Pharmacal	For profit	MKTG	Apr 8, 2002
Copley Pharmaceuticals	For profit	MKTG	Jan 22, 1987
Currax Pharmaceuticals	For profit	NDA2	Jun 8, 2011
Cypress Pharmaceutical	For profit	MKTG	Jun 8, 2011
Dow Chemical	For profit	MKTG	—
Dr. Reddy's Laboratories	For profit	MKTG	Sep 27, 2006
Dr. Reddy's Laboratories	For profit	SYN	Aug 14, 2006
Dr. Reddy's Laboratories	For profit	MKTG	Nov 18, 2014
Dr. Reddy's Laboratories	For profit	SYN	Dec 4, 2018
Esteve Labs	For profit	MKTG	Sep 30, 2020
Eywa Pharma	For profit	MKTG	Jun 16, 2020
Fisons	For profit	MKTG	Mar 6, 1986
Fisons	For profit	NDA2	Mar 6, 1986
Fondazione Golgi Cenci	Academic/Hospital	MKTG	Apr 20, 1984
Fosun	For profit	MKTG	Apr 11, 1985
GlaxoSmithKline	For profit	NDA2	Sep 19, 1989
Graham Dm	For profit	NDA2	Mar 18, 1985
Granules India	For profit	MKTG	Aug 22, 2022
Heritage Pharma	For profit	MKTG	Jan 28, 2004
Impax Laboratories	For profit	MKTG	Nov 12, 2010
Johnson and Johnson	For profit	NDA2	Dec 15, 1992
Johnson and Johnson	For profit	MKTG	Oct 31, 1991
Lannett Company, Inc.	For profit	MKTG	Apr 17, 2020
Lumara Health	For profit	MKTG	—
Mayne Pharma	For profit	MKTG	Aug 3, 2015
McNeil	For profit	MKTG	Oct 31, 1991
Merck	For profit	MKTG	Mar 3, 2005
Mikart	For profit	MKTG	May 14, 2015
Mylan	For profit	SYN	Apr 30, 2004
Mylan	For profit	MKTG	Jan 31, 1985
Newtron Pharmaceuticals	For profit	MKTG	Feb 12, 1985
Novartis	For profit	MKTG	Mar 1, 2001
Novartis	For profit	NDA2	Mar 1, 2001
Ohm Laboratories, Inc.	For profit	MKTG	Apr 17, 2001
Organon	For profit	NDA2	Feb 1, 2006
Organon	For profit	SYN	Feb 1, 2006
P&L Development	For profit	MKTG	Feb 21, 2003
PL Developments	For profit	MKTG	Mar 5, 2008
Padagis Us	For profit	MKTG	Apr 29, 2014
Paddock Laboratories	For profit	MKTG	Apr 29, 2014
Paddock Laboratories	For profit	SYN	Apr 29, 2014
Parke-Davis	For profit	NDA2	—
Perrigo	For profit	MKTG	Feb 26, 1999
Perrigo	For profit	SYN	Nov 5, 2003
Perrigo	For profit	SYN	Nov 16, 2018
Perrigo	For profit	SYN	Jan 30, 2003
Perrigo	For profit	MKTG	Feb 25, 2010
Pfizer	For profit	MKTG	Sep 19, 1989
Pharmaceutical Associates	For profit	MKTG	Jul 21, 2014
Ranbaxy	For profit	MKTG	Apr 17, 2001
Reckitt Benckiser Pharmaceutical	For profit	MKTG	Jun 22, 2004
Reckitt Benckiser Pharmaceutical	For profit	NDA2	Jun 22, 2004
Rhodes Pharmaceuticals, L.P.	For profit	MKTG	Nov 5, 2020
STI Pharma, LLC	For profit	MKTG	Mar 22, 1985
Sandoz	For profit	MKTG	Sep 2, 1983
Sanofi	For profit	NDA2	Dec 24, 1997
Sanofi-Aventis	For profit	NDA2	Aug 29, 1975
Schering	For profit	MKTG	Mar 23, 1982
Schering-Plough	For profit	NDA	Oct 18, 1963
Schering-Plough	For profit	NDA2	Oct 18, 1963
Schwarz Pharma	For profit	NDA2	—
Sun Pharmaceuticals	For profit	SYN	Jan 29, 2015
Sun Pharmaceuticals	For profit	SYN	Apr 28, 2020
Sun Pharmaceuticals	For profit	MKTG	Jan 29, 2015
Sun Pharmaceuticals	For profit	SYN	Sep 28, 2005
Superpharm	For profit	MKTG	—
Taro Pharmaceuticals	For profit	MKTG	Feb 27, 2017
Taro Pharmaceuticals	For profit	SYN	Feb 27, 2017
Teva	For profit	SYN	Feb 25, 2008
Teva	For profit	MKTG	Dec 12, 1984
Torrent Pharmaceuticals Limited	For profit	MKTG	May 15, 2017
Tris Pharma, Inc.	For profit	MKTG	Oct 28, 2014
UCB	For profit	NDA2	Jun 19, 1987
UCB	For profit	SYN	Jun 19, 1987
Upsher-Smith Laboratories	For profit	MKTG	Nov 7, 1983
Vintage	For profit	MKTG	Jul 21, 2014
Watson Pharmaceuticals	For profit	MKTG	Jan 13, 1984
Wes Pharma Inc	For profit	MKTG	Jun 16, 2020
West-Ward Pharmaceutical	For profit	MKTG	Jul 13, 1983
Wockhardt	For profit	MKTG	Nov 16, 1984
Wockhardt	For profit	SYN	Jun 7, 1985