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Sudafed PE (phenylephrine)
Sudafed PE (generic name: phenylephrine) is a Alpha-1 adrenergic agonist (decongestant/vasopressor) Small molecule drug developed by Generic (multiple manufacturers). It is currently FDA-approved (first approved 1976) for Allergic conjunctivitis, Allergic rhinitis, Common cold. Also known as: Sudafed PE, Neo-Synephrine.
Sudafed PE is a medication used as a decongestant for uncomplicated nasal congestion. It works as an adrenergic receptor alpha-1 agonist, a small molecule that targets this specific receptor.
At a glance
| Generic name | phenylephrine |
|---|---|
| Also known as | Sudafed PE, Neo-Synephrine |
| Sponsor | Generic (multiple manufacturers) |
| Drug class | Alpha-1 adrenergic agonist (decongestant/vasopressor) |
| Target | Alpha-1A adrenergic receptor, Alpha-1B adrenergic receptor, Alpha-1D adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1976-01-01 (United States) |
Approved indications
- Allergic conjunctivitis
- Allergic rhinitis
- Common cold
- Cough
- Dilated pupil
- Fever
- Headache disorder
- Hemorrhoids
- Influenza-like symptoms
- Maintenance of intraoperative mydriasis
- Nasal congestion
- Nasal discharge
- Postoperative ocular pain in intraocular lens replacement surgery
- Prevention of Posterior Synechiae
- Prevention of intraoperative miosis
- Proctitis
- Pruritus ani
- Rectal pain
- Red eye
- Rhinitis
Common side effects
Key clinical trials
- A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Immedia (Phase 1)
- A Phase 1, Randomized, Open-Label, Single-Dose, 4-Way Crossover Study to Assess the Relative Bioavailability of Four 80 mg Febuxostat XR Formulations (Phase 1)
- A Single-Dose, Randomized, Double-Blind, Placebo-Controlled, Positive-Controlled, Four-Way Crossover Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects (Phase 1)
- Contribution of the Kinematic Theory in the Early Differential Diagnosis of the Parkinson's Disease (N/A)
- Assessing Patient Comfort, Anxiety, and Satisfaction During Cycloplegic Refraction: Comparing Conventional Drops With Rapid-Onset Cycloplegics (NA)
- What Are the Changes in Cardiac Deformation Variables and Hemodynamic Parameters Following Changes in Cardiac Loading Conditions and After Administration of Two Different Inotropic Drugs. (NA)
- An Observational Study to Test the Effect of the Vasoactive Drugs Phenylephrine and Ephedrine on the Stroke Volume and Microvascular Blood Flow of Healthy Volunteers (N/A)
- Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa: a Doubleblind, Randomized, F (Phase 1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sudafed PE CI brief — competitive landscape report
- Sudafed PE updates RSS · CI watch RSS
- Generic (multiple manufacturers) portfolio CI
Frequently asked questions about Sudafed PE
What is Sudafed PE?
Sudafed PE (phenylephrine) is a Alpha-1 adrenergic agonist (decongestant/vasopressor) drug developed by Generic (multiple manufacturers), indicated for Allergic conjunctivitis, Allergic rhinitis, Common cold.
What is Sudafed PE used for?
Sudafed PE is indicated for Allergic conjunctivitis, Allergic rhinitis, Common cold, Cough, Dilated pupil.
Who makes Sudafed PE?
Sudafed PE is developed and marketed by Generic (multiple manufacturers) (see full Generic (multiple manufacturers) pipeline at /company/unknown).
What is the generic name of Sudafed PE?
phenylephrine is the generic (nonproprietary) name of Sudafed PE.
Is Sudafed PE also known as anything else?
Sudafed PE is also known as Sudafed PE, Neo-Synephrine.
What drug class is Sudafed PE in?
Sudafed PE belongs to the Alpha-1 adrenergic agonist (decongestant/vasopressor) class. See all Alpha-1 adrenergic agonist (decongestant/vasopressor) drugs at /class/alpha-1-adrenergic-agonist-decongestant-vasopressor.
When was Sudafed PE approved?
Sudafed PE was first approved on 1976-01-01 in United States.
What development phase is Sudafed PE in?
Sudafed PE is FDA-approved (marketed).
What does Sudafed PE target?
Sudafed PE targets Alpha-1A adrenergic receptor, Alpha-1B adrenergic receptor, Alpha-1D adrenergic receptor and is a Alpha-1 adrenergic agonist (decongestant/vasopressor).
Related
- Drug class: All Alpha-1 adrenergic agonist (decongestant/vasopressor) drugs
- Target: All drugs targeting Alpha-1A adrenergic receptor, Alpha-1B adrenergic receptor, Alpha-1D adrenergic receptor
- Manufacturer: Generic (multiple manufacturers) — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Allergic conjunctivitis
- Indication: Drugs for Allergic rhinitis
- Indication: Drugs for Common cold
- Also known as: Sudafed PE, Neo-Synephrine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing