phenylephrine

Trade name: Prefrin

Small moleculeapproved

Approved

Jan 21, 1952

Phenylephrine, sold under the brand names Neosynephrine and Sudafed PE among others, is a medication used as a decongestant for uncomplicated nasal congestion in the form of a nasal spray or oral tablet, to dilate the pupil, to increase blood pressure given intravenously in cases of low blood pressure, and to relieve hemorrhoids as a suppository. It can also be applied to the skin. — Wikipedia

Clinical trial activity

231 trials · 189 clinical orgs · 55 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Dec 1, 1996 (NCT00748059)

Timeline

1950s

Jan 21, 1952
Allergan (1948) — IND Organization
Jan 21, 1952
Earliest FDA Approval
Jan 21, 1952
Allergan (1948) — IND Organization
Jan 21, 1952
Ani Pharmaceuticals — Marketing Organization
Jan 21, 1952
Ani Pharmaceuticals — NDA Secondary Org

1970s

Aug 20, 1973
3M — NDA Secondary Org
Sep 12, 1975
Alcon — Marketing Organization

1980s

Oct 31, 1984
Actavis — Marketing Organization
Oct 31, 1984
Nostrum Laboratories — Marketing Organization
Nov 8, 1984
G & W Laboratories Inc. — Marketing Organization
Jan 4, 1985
Wockhardt — Marketing Organization
Jan 4, 1985
Xttrium Laboratories — Marketing Organization
Nov 22, 1985
Fondazione Golgi Cenci — Marketing Organization
Mar 2, 1987
Halsey — Marketing Organization

1990s

Jan 1, 1996
Earliest Phase 1 Sponsor(trial)

2000s

Jan 1, 2001
Earliest Phase 2 Sponsor(trial)
Jan 1, 2004
Earliest Phase 3 Sponsor(trial)
Dec 7, 2006
Vintage — Marketing Organization
Dec 7, 2006
Pharmaceutical Associates — Marketing Organization
Aug 25, 2009
Amneal Pharmaceuticals — Marketing Organization

2010s

May 27, 2010
Pfizer — Marketing Organization
May 27, 2010
GlaxoSmithKline — NDA Secondary Org
Dec 20, 2012
Hikma — Marketing Organization
Dec 20, 2012
West-Ward Pharmaceutical — NDA Secondary Org
Dec 20, 2012
Hikma — NDA Secondary Org
Mar 21, 2013
Paragon Biomedical — NDA Secondary Org
Mar 21, 2013
Clinipace LTD — NDA Secondary Org
May 30, 2014
Omeros Corporation — Marketing Organization
May 30, 2014
RAYNER SURGICAL — NDA Secondary Org
Jun 27, 2014
Avadel Pharmaceuticals — NDA Secondary Org
Jun 27, 2014
Exela Pharma Sciences, LLC. — Marketing Organization
Jun 27, 2014
Exela Pharma Sciences, LLC. — NDA Secondary Org
Jul 3, 2014
Perrigo — Marketing Organization
Dec 23, 2014
Hi Tech Pharmaceuticals — Marketing Organization
Jan 15, 2015
Akorn, Inc. — NDA Secondary Org
Jan 15, 2015
Akorn, Inc. — Marketing Organization
Apr 27, 2018
Cipla — Marketing Organization
Apr 27, 2018
Meitheal — Marketing Organization
Dec 21, 2018
Par Pharmaceuticals — Marketing Organization
Dec 21, 2018
Bristol-Myers Squibb — Marketing Organization
Jan 29, 2019
Fresenius — Marketing Organization
Jan 31, 2019
Sandoz — Marketing Organization
Jan 31, 2019
Novartis — Marketing Organization
Jul 1, 2019
Lupin — Marketing Organization
Oct 21, 2019
Sintetica SA — Marketing Organization
Oct 21, 2019
Eton Pharmaceuticals, Inc. — Marketing Organization
Oct 21, 2019
Dr. Reddy's Laboratories — Marketing Organization
Oct 21, 2019
Dr. Reddy's Laboratories — NDA Secondary Org

2020s

Jan 16, 2020
RiconPharma — Marketing Organization
Jan 16, 2020
Sagent Pharmaceuticals, Inc. — Marketing Organization
Jan 16, 2020
Nichi-Iko Pharmaceutical Co., Ltd. — Marketing Organization
Jun 5, 2020
Gland Pharma Ltd — Marketing Organization
Jun 5, 2020
Fosun — Marketing Organization
Jun 11, 2020
Caplin Point Laboratories — Marketing Organization
Jul 1, 2020
Accord Research — Marketing Organization
Jul 17, 2020
Provepharm Sas — Marketing Organization
Jul 17, 2020
Apollo Hospitals, Chennai, India — Marketing Organization
Nov 13, 2020
Aurobindo Pharma — Marketing Organization
Nov 13, 2020
Eugia Pharma — Marketing Organization
Aug 30, 2022
Mankind Pharma — Marketing Organization
Feb 28, 2023
Avet Lifesciences — Marketing Organization
May 5, 2023
Eyenovia Inc. — NDA Secondary Org
Jun 26, 2023
BE Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Adrenergic receptor alpha-1AGONIST
Adrenergic receptor alpha-1 agonist

Combination products

advil allergy and congestion relief
with dexchlorpheniramine maleate, ibuprofen
Also known as advil multi-symptom cold & flu
advil congestion relief
with ibuprofen
cyclomydril
with cyclopentolate
duo-medihaler
with isoprenaline
mydcombi
with tropicamide
Also known as eye injection (mydrane)
omidria
with ketorolac
phenergan vc
with promethazine hydrochloride
Also known as pherazine vc, promethazine vc plain, prometh vc plain
phenergan vc w/ codeine
with promethazine hydrochloride, codeine
Also known as pherazine vc w/ codeine, promethazine vc w/ codeine, prometh hydrochloride,phenylephrine hydrochloride w/codeine phosphate, prometh vc w/ codeine
prefrin-a
with mepyramine

Approval history

approvedJan 21, 1952

Chemistry & pharmacology

Loading structure…

SMILES

O[C@H]([C@@H](O)C(O)=O)C(O)=O.CNC[C@H](O)C1=CC=CC(O)=C1

Mol. weight: 317.2919 g/mol
Lipinski Ro5: Pass
Rule of 3: Yes
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Oral, Parenteral, Topical
Availability: Over the Counter

Oral

Yes

Parenteral

Yes

Topical

Yes

Sources

Also known as

afrin 4 hour nasal spray
afrin 4 hour nasal spray
benzenemethanol, 3-hydroxy-.alpha.-[(methylamino)methyl]-, (r)-
benzenemethanol, 3-hydroxy-.alpha.-[(methylamino)methyl]-, (r)-
benzenemethanol, 3-hydroxy-alpha-((methylamino)methyl)-, (r)-
benzenemethanol, 3-hydroxy-alpha-((methylamino)methyl)-, (r)-
benzyl alcohol, m-hydroxy-alpha-((methylamino)methyl)-, (-)-
benzyl alcohol, m-hydroxy-alpha-((methylamino)methyl)-, (-)-
biomydrin
biomydrin
cyclomydril
cyclomydril
duo-medihaler
duo-medihaler
eyn-1601
fenilefrina
fenilefrina
fenilefrine
fenilfar
fenilfar
fenox
fenox
idril n
ketorolac / phenylephrine
l-(3-hydroxyphenyl)-n-methylethanolamine
l-(3-hydroxyphenyl)-n-methylethanolamine
l-phenylephedrine
l-phenylephrine
mesatone
metaoxedrin
metaoxedrine
metaoxedrine chloride
metaoxedrine chloride
metasympatol
metasynephrine
mezaton
(-)-m-hydroxy-alpha-(methylaminomethyl)benzyl alcohol
(-)-m-hydroxy-alpha-(methylaminomethyl)benzyl alcohol
(-)-m-hydroxy-alpha-(methylaminomethyl)benzyl alcohol
(-)-m-hydroxy-α-(methylaminomethyl)benzyl alcohol
(-)-m-hydroxy-α-(methylaminomethyl)benzyl alcohol
(-)-m-oxedrine
(-)-m-synephrine
mydfrin
mydfrin
nazex
neosynephrine
neosynephrine
neosynephrine
neo-synephrine
neo-synephrine
nostril
nostril
nurofen sinus pain relief
phenyephrine
phenylephrine
phenylephrine
phenylephrine
phenylephrine
phenylephrine
phenylephrine
phenylephrine
phenylephrine
phenylephrine
(-)-phenylephrine
(-)-phenylephrine
(-)-phenylephrine
(-)-phenylephrine
(-)-phenylephrine
(-)-phenylephrine
phenylephrine bitartrate
phenylephrine bitartrate
phenylephrine bitartrate
phenylephrine hcl
phenylephrine hcl
phenylephrine hcl
phenylephrine hydrochloride
phenylephrine hydrochloride
phenylephrine hydrochloride
phenylephrine hydrochloride
phenylephrine hydrochloride
phenylephrine tannate
phenylephrinum
phenylephrinum
phenyleprhine
prefrin
prefrin
prefrin
(r)-phenylephrine
r(-)-phenylephrine
r(-)-phenylephrine

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07075224	Phase 1/Phase 2 (Phase 2)	Jul 15, 2025	Unither Pharmaceuticals
NCT06158035	N/A	Jul 1, 2025	Ningxia Medical University
NCT06158009	N/A	Apr 1, 2025	Ningxia Medical University
NCT06802224	Phase 4	Mar 1, 2025	Duke University, Henry Ford Health System, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The University of Texas, Dallas, University of California, San Francisco, University of Maryland, University of Michigan, University of Virginia, University of Washington, Wake Forest University
NCT06508359	N/A	Mar 1, 2025	Ningxia Medical University
NCT06770426	Phase 3	Feb 28, 2025	Yonsei University
NCT07153601	N/A	Feb 7, 2025	Universitas Sumatera Utara
NCT06648850	Phase 3	Jan 15, 2025	Applied Biology, Inc., Daniel Alain, Inc., Follea International Limited, University of Roma La Sapienza
NCT06158022	N/A	Jan 1, 2025	Ningxia Medical University
NCT06158048	N/A	Jan 1, 2025	Ningxia Medical University
NCT06836986	N/A	Dec 31, 2024	Dow University of Health Sciences
NCT06677970	Phase 3	Dec 1, 2024	Yonsei University
NCT06711432	N/A	Sep 18, 2024	Chinese Academy of Medical Sciences
NCT06681688	Phase 1/Phase 2 (Phase 2)	Jul 10, 2024	The Eye Associates, The Eye Centers of Racine and Kenosha
NCT06285396	N/A	Mar 18, 2024	Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, Canada
NCT06248593	Phase 4	Feb 15, 2024	Hassan II University
NCT05890027	Phase 4	Feb 15, 2024	University of Miami
NCT06083948	Phase 2/Phase 3 (Phase 3)	Dec 20, 2023	Aarhus University
NCT06053398	N/A	Oct 31, 2023	The University of Texas, Dallas
NCT05941494	Phase 4	Oct 3, 2023	University of Western Ontario

Showing 20 of 231 trials

Page 1 / 12

Organizations

Research & Development (189)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Ningxia Medical University	Academic/Hospital	11	11	1	2020
Cairo University	Academic/Hospital	8	8	4	2017
Bayer	For profit	6	6	3	2008
Vanderbilt University	Academic/Hospital	6	6	3	1996
Dalhousie University	Academic/Hospital	5	4	2	2008
Icahn School of Medicine at Mount Sinai	Academic/Hospital	5	5	2	2006
Seoul National University	Academic/Hospital	5	4	3	2010
Wake Forest University	Academic/Hospital	5	4	3	2015
Assiut University	Academic/Hospital	4	4	3	2016
Duke University	Academic/Hospital	4	2	2	2008
Eyenovia Inc.	For profit	4	4	3	2016
University of California, San Francisco	Academic/Hospital	4	3	2	2015
University of Vienna	Academic/Hospital	4	4	2	2001
Aarhus University	Academic/Hospital	3	3	2	2015
Ache Laboratorios Farmaceuticos S.A.	For profit	3	3	1	2009
Capital Medical University	Academic/Hospital	3	3	2	2019
Ghent University	Academic/Hospital	3	3	2	2017
GlaxoSmithKline	For profit	3	3	3	2011
Johnson and Johnson	For profit	3	3	2	2008
KhonKaen University	Academic/Hospital	3	3	2	2004

189 organizations

Page 1 / 10

Marketing (65)

Organization	Org type	Relationship	Date
3M	For profit	NDA2	Aug 20, 1973
Accord Research	For profit	MKTG	Jul 1, 2020
Actavis	For profit	MKTG	Oct 31, 1984
Akorn, Inc.	For profit	NDA2	Jan 15, 2015
Akorn, Inc.	For profit	MKTG	Jan 15, 2015
Alcon	For profit	MKTG	Sep 12, 1975
Alcon	For profit	SYN	Jan 15, 2015
Allergan	For profit	NDA2	—
Allergan (1948)	For profit	IND	Jan 21, 1952
Amneal Pharmaceuticals	For profit	MKTG	Aug 25, 2009
Amneal Pharmaceuticals	For profit	SYN	Jul 5, 2018
Amneal Pharmaceuticals	For profit	SYN	Jul 5, 2018
Ani Pharmaceuticals	For profit	MKTG	Jan 21, 1952
Ani Pharmaceuticals	For profit	NDA2	Jan 21, 1952
Apollo Hospitals, Chennai, India	Academic/Hospital	MKTG	Jul 17, 2020
Aurobindo Pharma	For profit	MKTG	Nov 13, 2020
Avadel Pharmaceuticals	For profit	NDA2	Jun 27, 2014
Avet Lifesciences	For profit	MKTG	Feb 28, 2023
BE Pharmaceuticals	For profit	MKTG	Jun 26, 2023
Bristol-Myers Squibb	For profit	MKTG	Dec 21, 2018
Caplin Point Laboratories	For profit	MKTG	Jun 11, 2020
Cipla	For profit	MKTG	Apr 27, 2018
Clinipace LTD	For profit	NDA2	Mar 21, 2013
Dr. Reddy's Laboratories	For profit	MKTG	Oct 21, 2019
Dr. Reddy's Laboratories	For profit	NDA2	Oct 21, 2019
Eton Pharmaceuticals, Inc.	For profit	MKTG	Oct 21, 2019
Eugia Pharma	For profit	MKTG	Nov 13, 2020
Exela Pharma Sciences, LLC.	For profit	MKTG	Jun 27, 2014
Exela Pharma Sciences, LLC.	For profit	NDA2	Jun 27, 2014
Eyenovia Inc.	For profit	NDA2	May 5, 2023
Fondazione Golgi Cenci	Academic/Hospital	MKTG	Nov 22, 1985
Fosun	For profit	MKTG	Jun 5, 2020
Fresenius	For profit	MKTG	Jan 29, 2019
G & W Laboratories Inc.	For profit	MKTG	Nov 8, 1984
Gland Pharma Ltd	For profit	MKTG	Jun 5, 2020
GlaxoSmithKline	For profit	NDA2	May 27, 2010
Halsey	For profit	MKTG	Mar 2, 1987
Hi Tech Pharmaceuticals	For profit	MKTG	Dec 23, 2014
Hi Tech Pharmaceuticals	For profit	SYN	Dec 23, 2014
Hikma	For profit	MKTG	Dec 20, 2012
Hikma	For profit	NDA2	Dec 20, 2012
Lupin	For profit	MKTG	Jul 1, 2019
Mankind Pharma	For profit	MKTG	Aug 30, 2022
Meitheal	For profit	MKTG	Apr 27, 2018
Nichi-Iko Pharmaceutical Co., Ltd.	For profit	MKTG	Jan 16, 2020
Nostrum Laboratories	For profit	MKTG	Oct 31, 1984
Novartis	For profit	MKTG	Jan 31, 2019
Omeros Corporation	For profit	MKTG	May 30, 2014
Par Pharmaceuticals	For profit	MKTG	Dec 21, 2018
Paragon Biomedical	For profit	NDA2	Mar 21, 2013
Perrigo	For profit	MKTG	Jul 3, 2014
Pfizer	For profit	MKTG	May 27, 2010
Pharmaceutical Associates	For profit	MKTG	Dec 7, 2006
Provepharm Sas	For profit	MKTG	Jul 17, 2020
RAYNER SURGICAL	For profit	NDA2	May 30, 2014
RiconPharma	For profit	MKTG	Jan 16, 2020
Sagent Pharmaceuticals, Inc.	For profit	MKTG	Jan 16, 2020
Sandoz	For profit	MKTG	Jan 31, 2019
Sandoz	For profit	SYN	Jan 31, 2019
Sintetica SA	For profit	MKTG	Oct 21, 2019
Smith, Kline & French	For profit	NDA	—
Vintage	For profit	MKTG	Dec 7, 2006
West-Ward Pharmaceutical	For profit	NDA2	Dec 20, 2012
Wockhardt	For profit	MKTG	Jan 4, 1985
Xttrium Laboratories	For profit	MKTG	Jan 4, 1985