Drugs / Pseudoephedrine
last change Jul 2026 re-read 2 minutes 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 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT02149901 Oct 2014 → Dec 2020 multiple system atrophy Vanderbilt University Terminated No outcome recorded
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 No outcome recorded
Phase 1 NCT02182531 Aug → Oct 1999 Boehringer Ingelheim Completed No outcome recorded
Phase 23 trials
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 No outcome recorded
Phase 2 NCT00240812 ? → Nov 2002 enuresis Johnson & Johnson Consumer and Personal Products Worldwide Completed No outcome recorded
Phase 312 trials
Phase 3 NCT05637710 Mar 2026 → May 2027 allergic rhinitis Eurofarma Laboratorios S.A. Withdrawn No outcome recorded
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 No outcome recorded
Phase 49 trials
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 No outcome recorded
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 No outcome recorded
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
Also used as a comparator or background therapy in 15 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00881634 Comparator Jun → Jul 2005 allergic disease Sandoz Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT03383887 Comparator Dec 2017 → Jan 2020 obstructive sleep apnea syndrome Brigham and Women's Hospital Completed No outcome recorded
Phase 23 trials
Phase 2 NCT01033396 Comparator Jan → May 2010 allergic rhinitis Pfizer Completed No outcome recorded
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
Phase 35 trials
Phase 3 NCT01393548 Comparator Aug 2014 → Nov 2016 rhinitis Ache Laboratorios Farmaceuticos S.A. Completed No outcome recorded
Phase 3 NCT01177852 Background Oct 2011 → Apr 2012 rhinitis Ache Laboratorios Farmaceuticos S.A. Withdrawn No outcome recorded
Phase 3 NCT01228630 Background Aug 2011 → Apr 2012 perennial allergic rhinitis Azidus Brasil Completed No outcome recorded
Phase 3 NCT00704496 Comparator Jun 2007 → Sep 2009 perennial allergic rhinitis Milton S. Hershey Medical Center Completed No outcome recorded
Phase 3 NCT01062360 Comparator Dec 2005 → May 2007 common cold, pharyngitis Bayer Completed No outcome recorded
Phase 43 trials
Phase 4 NCT06907355 Background May → Nov 2025 respiratory tract infectious disorder Pontificia Universidad Catolica de Chile Completed No outcome recorded
Phase 4 NCT00648973 Comparator Nov 2006 → May 2007 nasal cavity disorder Johnson & Johnson Consumer and Personal Products Worldwide Completed No outcome recorded
Phase 4 NCT00377403 Background Oct 2006 → May 2009 respiratory tract infectious disorder, sinusitis Washington University School of Medicine Completed No outcome recorded
Phase not applicable2 trials
NCT02065440 Comparator Sep 2011 → Feb 2014 Seoul National University Hospital Unknown No outcome recorded
NCT01028014 Comparator Apr 2010 → Apr 2011 urethral disorder University of Alabama at Birmingham Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2009-11-03 Teva Branded Pharmaceutical Products R&D, Inc. Teva Introduces Fexofenadine HCL and Pseudoephedrine HCL Extended-Release Tablets; An Alternative to Allegra-D® 12 Hour Tablets tevapharm.com

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

“fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).” NCT01199497

“Fexofenadine 60 mg combined with pseudoephedrine 120 mg single dose” NCT01033396

“Loratadine + pseudoephedrineNCT01228630

NCT00881634

NCT03429738

NCT01062360

NCT01393548

NCT02182531

NCT01744106

NCT01055756

NCT00208065

NCT00837915

NCT01509209

NCT00673062

NCT04682184

NCT00377403

NCT01306721

NCT03644576

NCT00378144

NCT02182518

NCT00804687

NCT00474890

NCT03184766

NCT05720455

NCT00276016

NCT00179023

NCT04332211

NCT01177852

NCT00704496

NCT00963443

NCT00441246

NCT01085721

NCT00334698

NCT00648973

NCT01586962

NCT02149901

NCT03443843

NCT05697328

NCT00002149

NCT00223691

NCT05692869

NCT01028014

NCT00881127

NCT01925729

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