Pseudoephedrine
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Also known as AcunasoIsoephedrined-NeodurasinaPseudoefedrinaPseudophedrineSID11111142(1S,2S)-(+)-pseudephedrine
Summary
Pseudoephedrine (CHEMBL1590) is an approved small-molecule sympathomimetic agent (ATC R01BA52); indicated across 13 conditions including seasonal allergic rhinitis and allergic rhinitis.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Small molecule
- ATC class: R01BA52 (+1 more)
- Indications: 13 conditions
- Clinical trials: 34
- Chemistry: 165.23 Da · C10H15NO
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1590 |
| Name | Pseudoephedrine |
| Type | Small molecule |
| Max phase | 4 |
| FDA approved | yes |
| PubChem CID | 7028 |
| ChEBI | CHEBI:51209 |
| ATC | R01BA52, R01BA02 |
| Molecular formula | C10H15NO |
| Molecular weight | 165.23 |
| InChIKey | KWGRBVOPPLSCSI-WCBMZHEXSA-N |
SMILES: C[C@@H]([C@H](C1=CC=CC=C1)O)NC
IUPAC name: (1S,2S)-2-(methylamino)-1-phenylpropan-1-ol
ChEBI definition: A member of the class of the class of phenylethanolamines that is (1S)-2-(methylamino)-1-phenylethan-1-ol in which the pro-S hydrogen at position 2 is replaced by a methyl group.
Pharmacological roles (ChEBI): sympathomimetic agent, anti-asthmatic drug, bronchodilator agent, vasoconstrictor agent, central nervous system drug, nasal decongestant.
Other ChEBI roles (chemical / environmental): xenobiotic, plant metabolite.
Also known as: Acunaso, Isoephedrine, d-, Neodurasina, Pseudoefedrina, Pseudoephedrine, Pseudophedrine, SID11111142, (1S,2S)-(+)-pseudephedrine, PSEUDOEPHEDRINE, pseudoephedrine
Parent form; salt/anhydrous children: CHEMBL1200724, CHEMBL1201483, CHEMBL3989855
Patent coverage: 7,260 distinct patent families (25,626 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
Broader ChEMBL bioactivity targets: 18 (assay-derived). Sample: Pyruvate kinase PKM, Thrombopoietin, Alpha-2C adrenergic receptor, Thyrotropin receptor, 5-hydroxytryptamine receptor 2A, Alpha-galactosidase A, Cytochrome P450 2D6, Polyunsaturated fatty acid lipoxygenase ALOX15, Nuclear factor NF-kappa-B p105 subunit, Cytochrome P450 2C9.
Bioactivity
ChEMBL activities: 16 potent at pChembl ≥ 5 of 25 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):
| Target | pChembl | Type | Value | Unit | Activity ID |
|---|---|---|---|---|---|
| P15917 | 7.9 | Potency | 12.6 | nM | CHEMBL_ACT_4648101 |
| TSHR | 6.9 | Potency | 125.9 | nM | CHEMBL_ACT_3919000 |
| ALOX15 | 6.4 | Potency | 398.1 | nM | CHEMBL_ACT_4445500 |
| HSD17B10 | 6.2 | Potency | 631 | nM | CHEMBL_ACT_3685662 |
| CYP2C9 | 6.1 | Potency | 794.3 | nM | CHEMBL_ACT_5057539 |
| CYP2C19 | 5.8 | Potency | 1585 | nM | CHEMBL_ACT_4021208 |
| HSD17B10 | 5.8 | Potency | 1585 | nM | CHEMBL_ACT_4837145 |
| HTR2A | 5.79 | AC50 | 1625 | nM | CHEMBL_ACT_25173509 |
| ALOX12 | 5.5 | Potency | 3162 | nM | CHEMBL_ACT_4532912 |
| THPO | 5.5 | Potency | 3162 | nM | CHEMBL_ACT_4805541 |
| THPO | 5.5 | Potency | 3162 | nM | CHEMBL_ACT_5070292 |
| PKM | 5.1 | Potency | 7943 | nM | CHEMBL_ACT_4388171 |
| PKM | 5.1 | Potency | 7943 | nM | CHEMBL_ACT_4583834 |
| RGS12 | 5.1 | Potency | 7943 | nM | CHEMBL_ACT_4805451 |
| Q27686 | 5 | Potency | 10000 | nM | CHEMBL_ACT_3692440 |
| Q27686 | 5 | Potency | 10000 | nM | CHEMBL_ACT_3701068 |
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
13 indications (4 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| seasonal allergic rhinitis | 4 | MONDO:0005324 | EFO:0003956 |
| allergic rhinitis | 4 | MONDO:0011786 | EFO:0005854 |
| common cold | 4 | MONDO:0005709 | EFO:0007214 |
| vasomotor rhinitis | 3 | MONDO:0006004 | EFO:0007533 |
| perennial allergic rhinitis | 3 | MONDO:0024332 | EFO:1001417 |
| rhinitis | 3 | MONDO:0003014 | EFO:0008521 |
| respiratory tract infectious disorder | 3 | MONDO:0024355 | MONDO:0024355 |
| orthostatic hypotension | 1 | MONDO:0005469 | EFO:0005252 |
| allergic disease | 1 | MONDO:0005271 | MONDO:0005271 |
| multiple system atrophy | 0 | MONDO:0007803 | EFO:1001050 |
3 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 34.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE3 | 11 |
| PHASE1 | 10 |
| Not specified | 7 |
| PHASE4 | 3 |
| PHASE2 | 2 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT00378144 | PHASE4 | COMPLETED | Efficacy and Safety of Sinutab on Subjects in the Setting of a Common Cold |
| NCT00648973 | PHASE4 | COMPLETED | To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses |
| NCT04332211 | PHASE4 | COMPLETED | Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy |
| NCT00276016 | PHASE3 | COMPLETED | The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579) |
| NCT00704496 | PHASE3 | COMPLETED | The Effect of Pseudoephedrine on Rhinitis and Sleep |
| NCT00963443 | PHASE3 | COMPLETED | Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold |
| NCT01062360 | PHASE3 | COMPLETED | Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine |
| NCT01085721 | PHASE3 | UNKNOWN | Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections |
| NCT01177852 | PHASE3 | WITHDRAWN | Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis |
| NCT01306721 | PHASE3 | COMPLETED | Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis |
| NCT01393548 | PHASE3 | COMPLETED | Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis |
| NCT01509209 | PHASE3 | COMPLETED | Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis |
| NCT01586962 | PHASE3 | COMPLETED | Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup in Patients Suffering a URTI |
| NCT02182518 | PHASE3 | COMPLETED | Epinastine + Pseudoephedrine SR (Slow Release) Versus Epinastine Alone in Patients With Perennial Allergic Rhinitis |
| NCT00673062 | PHASE2 | COMPLETED | Study of the Effect of SCH 900538 on Congestion in Subjects With Seasonal Allergic Rhinitis (Study P05031)(COMPLETED) |
| NCT00804687 | PHASE2 | COMPLETED | An Efficacy Study of JNJ-39220675 and Pseudoephedrine in Participants With Allergic Rhinitis |
| NCT00179023 | PHASE1 | COMPLETED | The Autonomic Nervous System and Obesity |
| NCT00223691 | PHASE1 | COMPLETED | Treatment of Orthostatic Hypotension in Autonomic Failure |
| NCT01373138 | PHASE1 | COMPLETED | Bioequivalence Study of Desloratadine and Pseudoephedrine Sulfate Extended-release Tablets Under Fasting Conditions |
| NCT01506791 | PHASE1 | COMPLETED | Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions |
| NCT01925729 | PHASE1 | COMPLETED | TransMEM Gas Exchange – Project 1, Aim 2 |
| NCT02182531 | PHASE1 | COMPLETED | Epinastine and Pseudoephedrine Fixed Combination Compared to Separate Administration in Healthy Volunteers |
| NCT03184766 | PHASE1 | COMPLETED | Ibuprofen and Pseudoephedrine Comparative Pharmacokinetic Study |
| NCT03517930 | PHASE1 | COMPLETED | A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufacturers Under Fasted Conditions in Healthy Adult Subjects |
| NCT03517943 | PHASE1 | COMPLETED | A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufactuers Under Fed Conditions in Healthy Adult Subjects |
| NCT03644576 | PHASE1 | COMPLETED | Drug-drug Interaction Study of Ozanimod With Pseudoephedrine to Evaluate the Effect on Blood Pressure and Heart Rate |
| NCT02149901 | EARLY_PHASE1 | TERMINATED | Water and Sudafed in Autonomic Failure |
| NCT05697328 | Not specified | RECRUITING | Barotrauma in Hyperbaric Oxygen Therapy |
| NCT00334698 | Not specified | COMPLETED | Study to Assess the Effect of a Combination of Cetirizine With Pseudoephedrine Versus Cetirizine Alone on Symptoms in Patients With Allergic Rhinitis |
| NCT00474890 | Not specified | COMPLETED | Study to Compare the Effect of a Combination of Cetirizine With Pseudoephedrine Versus Placebo on Symptoms in Patients With Allergic Rhinitis Within/Out of Season |
| NCT00779831 | Not specified | COMPLETED | Bioequivalence Study on Pseudoephedrine HCl 120 mg ER Tablets Under Fasting Conditions |
| NCT01028014 | Not specified | COMPLETED | Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters |
| NCT04682184 | Not specified | COMPLETED | A Study of Continuous Heart Rate Monitoring in Healthy Participants |
| NCT05692869 | Not specified | COMPLETED | A Study of Continuous Blood Pressure Monitoring in Healthy Participants |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).