Drugs / Pseudoephedrine
last change Jul 2026 re-read 8 days ago

Pseudoephedrine

Small molecule targets SLC6A2

Developed for
allergic rhinitis · seasonal allergic rhinitis · common cold · respiratory tract infectious disorder · sinusitis · headache disorder · nasal cavity disorder · autonomic nervous system disorder
+11 more · bronchitis · enuresis · IgE responsiveness, atopic · orthostatic hypotension · otorhinolaryngologic disease · perennial allergic rhinitis · rhinitis · vasomotor rhinitis · viral respiratory tract infection · obstructive sleep apnea syndrome · pharyngitis
Investigated by
GlaxoSmithKline · Magna Pharmaceuticals, Inc. · Sanofi · Vanderbilt University · Bayer · Boehringer Ingelheim
+37 more · Eli Lilly and Company · Fraunhofer-Institute of Toxicology and Experimental Medicine · Ache Laboratorios Farmaceuticos S.A. · Adams Respiratory Therapeutics · Azidus Brasil · Celgene Corporation · Chattem, Inc. · Clinvest · Cuneyt M. Alper · Eurofarma Laboratorios S.A. · Hanmi Pharmaceutical Company Limited · Immune Enhancement Project · Institute for Pharmacology and Preventive Medicine · John Muir Health · Johnson & Johnson Consumer and Personal Products Worldwide · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Mantecorp Industria Quimica e Farmaceutica Ltd. · McNeil AB · McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. · Merck & Co., Inc. · National Center for Advancing Translational Sciences (NCATS) · National Heart, Lung, and Blood Institute (NHLBI) · National Institute on Deafness and Other Communication Disorders (NIDCD) · Novartis · Novartis Consumer Health · Organon and Co · Ortho-McNeil Neurologics, Inc. · Perrigo Company · Pfizer · Pharma Medica Research, Inc. · Ranbaxy Laboratories Limited · Reckitt Benckiser Healthcare (UK) Limited · Reckitt Benckiser Inc. · Sandoz · Simbec Research · Sino-American Tianjin Smith Kline & French Laboratories Ltd · University of Maryland, Baltimore

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Aerinaze — 2007-07-30 europa.eu ↗
Approved US (FDA) DISOPHROL — 1963-10-18 fda.gov ↗

Trials 42

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT02149901 Oct 2014 → Dec 2020 multiple system atrophy Vanderbilt University Terminated No outcome recorded Stop: Business
Phase 110 trials
Phase 1 NCT03644576 Jul → Sep 2018 — Celgene Corporation Completed No outcome recorded
Phase 1 NCT03184766 Aug 2016 → Jan 2017 — Reckitt Benckiser Healthcare (UK) Limited Completed No outcome recorded
Phase 1 NCT03429738 Apr → May 2014 headache disorder Institute for Pharmacology and Preventive Medicine Completed No outcome recorded
Phase 1 NCT01925729 Oct 2013 → Mar 2019 allergic rhinitis, otitis media Cuneyt M. Alper Completed No outcome recorded
Phase 1 NCT01577459 Apr → Jun 2012 — Merck & Co., Inc. Completed No outcome recorded
Phase 1 NCT00932256 Oct 2009 seasonal allergic rhinitis Magna Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT00881127 Jul 2005 allergic disease Sandoz Completed No outcome recorded
Phase 1 NCT00179023 Apr 2003 → Jan 2017 hypertensive disorder, obesity disorder, pure autonomic failure Vanderbilt University Completed No outcome recorded
Phase 1 NCT00223691 Mar 2002 → Jan 2017 autonomic nervous system disorder, orthostatic hypotension Vanderbilt University Completed Mixed
Phase 1 NCT02182531 Aug → Oct 1999 — Boehringer Ingelheim Completed No outcome recorded
Phase 23 trials · 1 missed
Phase 2 NCT02082054 Mar → May 2014 seasonal allergic rhinitis Magna Pharmaceuticals, Inc. Unknown No outcome recorded
Phase 2 NCT00804687 Nov 2008 → Feb 2009 allergic rhinitis Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Completed Missed primary
Phase 2 NCT00240812 ? → Nov 2002 enuresis Johnson & Johnson Consumer and Personal Products Worldwide Completed No outcome recorded
Phase 312 trials · 1 missed
Phase 3 NCT05637710 Mar 2026 → May 2027 allergic rhinitis Eurofarma Laboratorios S.A. Withdrawn No outcome recorded Stop: Business
Phase 3 NCT01744106 Nov 2012 → Apr 2016 common cold Perrigo Company Completed No outcome recorded
Phase 3 NCT01586962 May 2012 respiratory tract infectious disorder Novartis Completed No outcome recorded
Phase 3 NCT01199497 Aug 2011 → Aug 2012 nasal cavity disorder Ache Laboratorios Farmaceuticos S.A. Withdrawn No outcome recorded
Phase 3 NCT01509209 May 2011 → Apr 2013 vasomotor rhinitis Hanmi Pharmaceutical Company Limited Completed No outcome recorded
Phase 3 NCT01293201 Mar → Jun 2011 seasonal allergic rhinitis Magna Pharmaceuticals, Inc. Completed No outcome recorded
Phase 3 NCT01306721 Feb → Apr 2011 seasonal allergic rhinitis Sanofi Completed No outcome recorded
Phase 3 NCT01055756 Jan → Apr 2010 allergic rhinitis Azidus Brasil Withdrawn No outcome recorded
Phase 3 NCT00963443 Sep 2009 → Mar 2012 common cold Bayer Completed No outcome recorded
Phase 3 NCT00276016 Jan → Feb 2006 seasonal allergic rhinitis Organon and Co Completed Missed primary
Phase 49 trials · 1 met primary · 1 missed
Phase 4 NCT05720455 Jun → Dec 2025 allergic rhinitis Sanofi Completed No outcome recorded
Phase 4 NCT04332211 May 2021 → Jul 2023 otorhinolaryngologic disease University of Maryland, Baltimore Completed No outcome recorded
Phase 4 NCT03443843 Feb → May 2018 allergic rhinitis Bayer Completed No outcome recorded
Phase 4 NCT02246166 Jan → Feb 2015 common cold GlaxoSmithKline Completed Missed primary
Phase 4 NCT02175485 Jun 2014 allergic rhinitis Sanofi Completed No outcome recorded
Phase 4 NCT01202279 Oct 2009 → Apr 2010 respiratory tract infectious disorder Reckitt Benckiser Inc. Completed Met primary
Phase 4 NCT00441246 Feb → May 2007 bronchitis, respiratory tract infectious disorder, sinusitis Adams Respiratory Therapeutics Completed No outcome recorded
Phase 4 NCT00378144 Jan 2007 → Mar 2008 common cold, headache disorder, nasal cavity disorder McNeil AB Completed No outcome recorded
Phase 4 NCT00208065 May 2004 → Nov 2005 migraine disorder, sinusitis Clinvest Completed No outcome recorded
Phase not applicable7 trials
— NCT05692869 Jan → Apr 2023 — Eli Lilly and Company Completed No outcome recorded
— NCT05697328 Jan 2023 → Jul 2026 overdue — John Muir Health Recruiting No outcome recorded
— NCT04682184 Jan → Mar 2021 — Eli Lilly and Company Completed No outcome recorded
— NCT00474890 Jun → Dec 2007 IgE responsiveness, atopic, rhinitis Fraunhofer-Institute of Toxicology and Experimental Medicine Completed No outcome recorded
— NCT00334698 Jul → Sep 2006 seasonal allergic rhinitis Fraunhofer-Institute of Toxicology and Experimental Medicine Completed No outcome recorded
— NCT00837915 Jun → Aug 2002 — Ranbaxy Laboratories Limited Completed No outcome recorded
— NCT00002149 — HIV infectious disease, sinusitis Immune Enhancement Project Completed No outcome recorded
Comparator or background therapy15 trials
Phase 1 NCT00881634 Comparator Jun → Jul 2005 allergic disease Sandoz Completed No outcome recorded
Phase 1/2 NCT03383887 Comparator Dec 2017 → Jan 2020 obstructive sleep apnea syndrome Brigham and Women's Hospital Completed No outcome recorded
Phase 2 NCT01033396 Comparator Jan → May 2010 allergic rhinitis Pfizer Completed Missed primary
Phase 2 NCT00673062 Comparator May → Jul 2008 seasonal allergic rhinitis Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT00000752 Background ? → Feb 1993 HIV infectious disease, sinusitis National Institute of Allergy and Infectious Diseases (NIAID) Withdrawn No outcome recorded

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2015-03-23 Acura Pharmaceuticals Inc. Results Acura Pharmaceuticals Reports Successful Topline Results From Nexafed(R) Extended-Release Clinical Study acurapharm.com ↗
NEXAFED formulation B met FDA's standards for bioequivalence for maximum plasma concentration (Cmax) and extent of absorption (AUC).
2013-09-03 Acura Pharmaceuticals Inc. Results Research Confirms New Nasal Decongestant Product Is Highly Meth-Resistant Yet Offers Same Effectiveness as Leading Pseudoephedrine Brand acurapharm.com ↗
2008-03-06 Perrigo Company Regulatory Perrigo Company to Market Over-the-Counter Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride Extended-Release Tablets perrigo.com ↗
has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for over-the-counter Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride Extended-Release Tablets, 5 mg/120 mg.
2003-11-14 Perrigo Company Regulatory Perrigo Company Announces Approvals to Market Three New Products perrigo.com ↗
The Perrigo Company (NASDAQ: PRGO) today announced that it will begin marketing three new products following U.S. Food and Drug Administration (FDA) approvals.
2001-06-07 Perrigo Company Regulatory Perrigo Announces Approval to Market Ibuprofen and Pseudoephedrine Tablets perrigo.com ↗
The Perrigo Company (NASDAQ: PRGO) today announced that it has received approval to market and distribute Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg and 30 mg respectively, through a development agreement with Ohm Laboratories, Inc., a subsidiary of Ranbaxy Pharmaceuticals Inc.

Evidence & citations 78 cited values

Every value below carries the sentence it was read from. 60 sources stand behind the page.

FieldValueCited text
Known as Pseudoephedrine “The overall development plan is to show that the combination of tried-and-proven decongestant/antihistamine ingredients (pseudoephedrine hydrochloride and chlorpheniramine...” NCT01293201 ↗
54

“The investigational drug consists of a fixed-dose combination (FDC) that contains levocetirizine, a second-generation anti-H1 antihistamine agent, and pseudoephedrine, an oral...” NCT05637710 ↗

“Extended-Release Guaifenesin/Pseudoephedrine Hydrochloride for Symptom Relief in Support of a Wait-and-See Approach for the Treatment of Acute Upper Respiratory Tract...” PMID 28761581 ↗ Apr 2017

“Evaluation of Efficacy of Dellegra® Combination Tablet (Fexofenadine Hydrochloride 30mg /Pseudoephedrine Hydrochloride 60mg) in Allergic Rhinitis After Japanese Cedar Antigen...” NCT02175485 ↗

“Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg,...” NCT02246166 ↗

“This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult...” NCT01577459 ↗

“Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.36 mg white, scored, tablets with "M27" on scored side and plain on the other side” NCT02082054 ↗

“Oral tablet containing Pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, atropine sulfate .24mg, one tablet BID.” NCT00932256 ↗

“Rhinoebastel(ebastine 10mg/pseudoephedrine 120mg) 1 cap/day for 1 week unless progression or unacceptable toxicity develops.” NCT02065440 ↗

“one night of pseudoephedrine 120 mg plus diphenhydramine 50 mg (DAW1033D) to placebo administered prior to sleep.” PMID 33491327 ↗ Jan 2021

“Codeine 10mg/5ml + Pseudoephedrine 7.5mg/5ml + Chlorphenamine 0.5mg/5ml: 10ml three times per day during 4 days” NCT06907355 ↗

Show 44 more sources

Known as Actifed ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as Acunaso ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as Afrinol ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as Contac ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as D-pseudoephedrine sulfate ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as Dimotane plus ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as Dimotane plus l.a. ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as Efidac 24 ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as Galpseud ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as Galpseud plus ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as Galsud ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as Isoephedrine, d- ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as Neodurasina ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as Novafed ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as NSC-106567 ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as NSC-33634 ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as Otrinol ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as Otrivine mu-cron ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as PSE “The aims of this study were to characterize the multiple-dose pharmacokinetics (PK) of ozanimod's major active metabolites (CC112273 and CC1084037) and to evaluate the...” PMID 33025342 ↗ Oct 2020
2

“a combination of cetirizine (CET) and pseudoephedrine (PSE), shows an equivalent treatment effect within and outside of the grass pollen season when tested in an ECC.” PMID 21457883 ↗ Feb 2011

“30 mg Pseudoephedrine (PSE), to be taken orally” NCT01062360 ↗

Known as Pseudo-12 ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as Pseudoefedrina ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗
Known as Pseudoephedrine HCl “Mucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets)” NCT00441246 ↗
4

“Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)” NCT00881634 ↗

“Drug: Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets” NCT03429738 ↗

“Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA)” NCT00881127 ↗

NCT00240812 ↗

Known as Pseudoephedrine Hydrochloride “Evaluation of Efficacy of Dellegra® Combination Tablet (Fexofenadine Hydrochloride 30mg /Pseudoephedrine Hydrochloride 60mg) in Allergic Rhinitis After Japanese Cedar Antigen...” NCT02175485 ↗
2

“A Single-Dose, Comparative Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/30 mg Tablets Under Fasting Conditions” NCT03429738 ↗

NCT00000752 ↗

Known as Pseudoephedrine hydrochloride component of actahist ChEMBL registry synonym — accepted as the source's own label CHEMBL1590 ↗