Phenylephrine clinical trials
Phenylephrine is named as an intervention in 12 current clinical trials in our Canada, China, South Korea, Japan, Denmark, Singapore and Egypt registers. 9 are recruiting patients now. The most common phase is Not applicable. The sponsor with the most trials is Samuel Lunenfeld Research Institute, Mount Sinai Hospital (2). The most-studied condition is Hypotension.
Where Phenylephrine is approved
All regulators →Of the three regulators tracked here, the first to approve Phenylephrine was the US, on 20 Dec 2012.
- 1 EU orphan designation, most recently for treatment of ileal pouch anal anastomosis (IPAA) related faecal incontinence (20 Nov 2001, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Phenylephrine patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Phenylephrine, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 5 listed patents; the last listed expires 8 Aug 2044 (US 12564561).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Phenylephrine
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Phenylephrine works
All drug targets →- Adrenergic receptor alpha-1 agonist AgonistTarget: Adrenergic receptor alpha-1✓ In ChEMBL and the Guide to Pharmacology
- Allergic rhinitisPhase 3
- Brain infarctionPhase 3
- CataractPhase 3
- Common coldPhase 3
- Hypotensive disorderPhase 3
- Ischemic strokePhase 3
- Retinopathy of prematurityPhase 3
- Seasonal allergic rhinitisPhase 3
- Stroke disorderPhase 3
- Cognitive impairmentPhase 2/3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1215, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 485, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Phenylephrine
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 4 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Phenylephrine
- ChEMBL
- CHEMBL1215
- DrugBank
- DB00388
- PubChem CID
- 6041
- CAS number
- 59-42-7
- FDA UNII
- 1WS297W6MV
- Wikidata
- Q421910
- Wikipedia
- Phenylephrine
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Phenylephrine
12 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Phenylephrine across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
4 single-substance products containing Phenylephrine on the HPRA medicines list.
- Minims Phenylephrine Hydrochloride 2.5% w/v eye drops, solutionBausch + Lomb Ireland Limited · PA23259/016/001 · Marketed
- Phenylephrine 100 micrograms/ml solution for injection/infusionLaboratoire Aguettant · PA1968/007/002 · Marketed
- Phenylephrine 50 micrograms/ml, solution for injection in pre-filled syringeLaboratoire Aguettant · PA1968/007/001 · Marketed
- Phenylephrine Hydrochloride 10 mg/ml solution for injection/infusionAthlone Pharmaceuticals Limited · PA1418/011/001 · Marketed
Supply shortages
- Neosynephrin-POS 5%Germany (BfArM) · Production problem · 29 Apr 2026 to 30 Nov 2026
- Neosynephrin-POS 10%Germany (BfArM) · Production problem · 27 Apr 2026 to 30 Nov 2026
- Neosynephrin-POS 10%Germany (BfArM) · Production problem · 27 Apr 2026 to 30 Nov 2026
Conditions studied with Phenylephrine
14 conditionsAll 14 conditions
| Condition (as registered) | Trials |
|---|---|
| Hypotension | 3 |
| Anesthesia | 2 |
| Acute Ischemic Stroke | 2 |
| Blood Pressure | 1 |
| Tumor | 1 |
| Stroke | 1 |
| Blood Loss, Surgical | 1 |
| Postural Tachycardia Syndrome | 1 |
| Postpartum Hemorrhage | 1 |
| Surgery With General Anesthesia | 1 |
| Noncardiac Surgery | 1 |
| Hypotension During Surgery | 1 |
| Patients Undergoing Orthopedic Hip Surgery Under Spinal Anesthesia | 1 |
| Orthopedic Hip Sugery in Eldely Patients | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Phenylephrine trials
How many clinical trials are testing Phenylephrine?
12 current trials in our Canada, China, South Korea, Japan, Denmark, Singapore and Egypt registers name Phenylephrine as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Phenylephrine trials recruiting patients?
Yes. 9 of the 12 trials are recruiting: 5 with sites in Canada, 1 with sites in China, 1 with sites in South Korea, 1 with sites in Denmark and 1 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Phenylephrine clinical trials?
Samuel Lunenfeld Research Institute, Mount Sinai Hospital (2), Yonsei University (2), The University of Texas Health Science Center, Houston (1) and Zhejiang Cancer Hospital (1), among 10 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Phenylephrine licensed in Ireland?
Yes. The HPRA medicines list includes 4 single-substance products containing Phenylephrine, for example Minims Phenylephrine Hydrochloride 2.5% w/v eye drops, solution (Bausch + Lomb Ireland Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Phenylephrine shortage?
The registers we track list 3 entries for Phenylephrine: 3 German notices. Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Phenylephrine works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Phenylephrine works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Phenylephrine (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.