Drugs / Phenylephrine
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Phenylephrine

Small molecule

Developed for
hypotensive disorder · hypertensive disorder · cataract · infectious disease with sepsis · seasonal allergic rhinitis · common cold · ischemic stroke · respiratory tract infectious disorder
+24 more · rhinitis · acute kidney injury · allergic rhinitis · arterial disorder · brain hypoxia - ischemia · preeclampsia · syncope, familial vasovagal · Achoo syndrome · baldness, male pattern · bronchiolitis · heart failure · influenza · intraoperative floppy iris syndrome · mouth disorder · nasal cavity disorder · pulmonary arterial hypertension · telogen effluvium · vasomotor rhinitis · acute myocardial infarction · chemotherapy-induced alopecia · eye disorder · hemorrhoid · mucositis · traumatic brain injury
Investigated by
General Hospital of Ningxia Medical University · Bayer · Eyenovia Inc. · IWK Health Centre · Omeros Corporation · University of Alberta
+121 more · Ache Laboratorios Farmaceuticos S.A. · GlaxoSmithKline · KK Women's and Children's Hospital · Seoul National University Hospital · University of Wisconsin, Madison · Aristotle University Of Thessaloniki · Beijing Tiantan Hospital · Cairo University · Inje University · Johns Hopkins University · Khon Kaen University · Mayo Clinic · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institutes of Health (NIH) · Samsung Medical Center · Samuel Lunenfeld Research Institute, Mount Sinai Hospital · The Second Affiliated Hospital of Dalian Medical University · University Hospital, Ghent · University of California, San Francisco · University of Michigan · University of Roma La Sapienza · Wake Forest University Health Sciences · Xuzhou Medical University · Aarhus University Hospital · Akron Children's Hospital · Algemeen Ziekenhuis Maria Middelares · American University of Beirut Medical Center · Applied Biology, Inc. · AstraZeneca · Baylor College of Medicine · Burapha University · Cambridge University Hospitals NHS Foundation Trust · Canadian Critical Care Trials Group · Canadian Institutes of Health Research (CIHR) · Carilion Clinic · Central Hospital, Nancy, France · China International Neuroscience Institution · Colorado State University · Crystal A. Gadegbeku · DHS Consulting · Dalian Municipal Central Hospital · Daniel Alain, Inc. · Dar El Oyoun Hospital · Denver Health and Hospital Authority · Duke University · Eurofarma Laboratorios S.A. · Follea International Limited · Fonds de la Recherche en Santé du Québec · Francois Lamontagne · Georgetown University · Gyeongsang National University Hospital · Jason Chui · Johnson & Johnson Consumer and Personal Products Worldwide · KIST Medical and Teaching Hospital · Keimyung University Dongsan Medical Center · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Medical University of Vienna · Montefiore Medical Center · Murdoch University · NYU Langone Health · National Center for Research Resources (NCRR) · National Heart, Lung, and Blood Institute (NHLBI) · National and Kapodistrian University of Athens · Nepal Health Research Council · New York Medical College · New York Presbyterian Brooklyn Methodist Hospital · Northwestern University · Novartis · Organon and Co · Oslo University Hospital · Peking University First Hospital · Peking University People's Hospital · Pfizer · Pontificia Universidad Catolica de Chile · all 127 on the full record

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) BIORPHEN — 2021-03-11 fda.gov ↗
Approved EU (EMA) Omidria — 2015-07-28 europa.eu ↗
Approved US (FDA) PHENERGAN W/ CODEINE — 1952-01-21 fda.gov ↗

Trials 147 · started per year

today
US approved 1952
EU approved 2015
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 08 trials
Phase 0 NCT06539637 Sep 2023 → Nov 2025 overdue cataract DHS Consulting Recruiting No outcome recorded
Phase 0 NCT06288321 Aug 2022 → Mar 2023 retinopathy of prematurity The University of Hong Kong Completed No outcome recorded
Phase 0 NCT05011357 Sep 2021 → Aug 2024 — University of Texas Southwestern Medical Center Completed No outcome recorded
Phase 0 NCT04436731 Dec 2020 → Jun 2026 overdue obesity disorder University of Missouri-Columbia Active not recruiting No outcome recorded
Phase 0 NCT04218773 Sep 2020 → Aug 2026 hypertensive disorder, ischemic stroke Yale University Suspended No outcome recorded Stop: Business
Phase 0 NCT03972683 Apr 2019 → Jul 2021 — Colorado State University Withdrawn No outcome recorded Stop: Enrollment
Phase 0 NCT03719001 Oct 2018 → Jun 2022 vascular disorder University of California, San Francisco Completed No outcome recorded
Phase 0 NCT01791816 Feb 2013 → Dec 2022 postural orthostatic tachycardia syndrome, syncope, familial vasovagal New York Medical College Completed No outcome recorded
Phase 16 trials
Phase 1 NCT03415243 Mar 2018 common cold GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT03098680 Apr 2017 → Feb 2020 cardiovascular disorder Cambridge University Hospitals NHS Foundation Trust Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT01731444 Dec 2014 → Jun 2028 expected — University of Manitoba Recruiting No outcome recorded
Phase 1 NCT02009007 Dec 2012 → Jun 2014 brain hypoxia - ischemia, hypotensive disorder Samsung Medical Center Unknown No outcome recorded
Phase 1 NCT01092975 Mar → Nov 2010 stomatitis University of Wisconsin, Madison Terminated No outcome recorded
Phase 1 NCT00762567 Sep → Nov 2008 rhinitis Johnson & Johnson Consumer and Personal Products Worldwide Completed No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT07075224 Nov 2025 — Unither Pharmaceuticals, France Completed No outcome recorded
Phase 1/2 NCT04500899 Dec 2020 → Jun 2026 overdue mitral valve insufficiency Montefiore Medical Center Recruiting No outcome recorded
Phase 1/2 NCT02434146 May 2015 → Apr 2016 disease related to transplantation, mouth disorder, neoplasm University of Wisconsin, Madison Terminated No outcome recorded
Phase 1/2 NCT00972998 Sep → Dec 2009 — RDD Pharma Ltd Completed No outcome recorded
Phase 210 trials · 2 missed
Phase 2 NCT04972123 Jul 2021 → Aug 2023 syncope, familial vasovagal University of Wisconsin, Madison Completed Missed primary
Phase 2 NCT04089072 Dec 2019 → Oct 2024 infectious disease with sepsis Carilion Clinic Unknown No outcome recorded
Phase 2 NCT02946125 Oct → Nov 2016 — Eyenovia Inc. Completed No outcome recorded
Phase 2 NCT01533662 Mar 2011 → May 2013 — University Hospital, Toulouse Completed No outcome recorded
Phase 2 NCT01330017 Mar → May 2011 seasonal allergic rhinitis Bayer Completed Missed primary
Phase 2 NCT00639015 Nov 2007 → Jun 2008 infectious disease with sepsis University of Roma La Sapienza Completed No outcome recorded
Phase 2 NCT00481442 Jan → Mar 2007 infectious disease with sepsis University of Roma La Sapienza Completed No outcome recorded
Phase 2 NCT00373802 Jan → Jun 2005 bronchiolitis Akron Children's Hospital Completed No outcome recorded
Phase 2 NCT00227448 Jun 2003 → Apr 2005 ischemic stroke Johns Hopkins University Completed No outcome recorded
Phase 2 NCT00431392 Sep 2001 → ? — Medical University of Vienna Completed No outcome recorded
Phase 2/34 trials · 1 met primary
Phase 2/3 NCT06648850 May 2026 → Mar 2027 expected baldness, male pattern, telogen effluvium Applied Biology, Inc. Not yet recruiting No outcome recorded
Phase 2/3 NCT03833895 Feb → Sep 2019 — China International Neuroscience Institution Completed No outcome recorded
Phase 2/3 NCT02277730 May 2013 → Nov 2017 hypotensive disorder KK Women's and Children's Hospital Completed Met primary
Phase 2/3 NCT04025918 Oct 2011 → Jul 2012 hypotensive disorder KK Women's and Children's Hospital Completed No outcome recorded
Phase 323 trials · 2 met primary · 3 missed
Phase 3 NCT05118672 Mar → Aug 2025 influenza Eurofarma Laboratorios S.A. Completed No outcome recorded
Phase 3 NCT05070650 Sep 2024 → Apr 2025 common cold Sandoz Withdrawn No outcome recorded Stop: Enrollment
Phase 3 NCT05706727 Mar 2023 → Apr 2024 — KIST Medical and Teaching Hospital Completed No outcome recorded
Phase 3 NCT02904304 Dec 2020 → Jul 2021 — Ache Laboratorios Farmaceuticos S.A. Suspended No outcome recorded
Phase 3 NCT04067817 Oct → Dec 2019 hypotensive disorder The Second Affiliated Hospital of Dalian Medical University Unknown No outcome recorded
Phase 3 NCT03751631 Nov 2018 → Jan 2019 — Eyenovia Inc. Completed No outcome recorded
Phase 3 NCT02678234 Feb → Apr 2017 respiratory tract infectious disorder GlaxoSmithKline Withdrawn No outcome recorded
Phase 3 NCT02730364 Feb → Apr 2017 respiratory tract infectious disorder GlaxoSmithKline Withdrawn No outcome recorded
Phase 3 NCT03215797 Sep → Dec 2016 hypotensive disorder The Second Affiliated Hospital of Dalian Medical University Completed No outcome recorded
Phase 3 NCT01938144 Apr → Nov 2016 common cold Pfizer Withdrawn No outcome recorded
Phase 444 trials · 5 met primary · 1 missed
Phase 4 NCT07824713 Sep 2026 → Jan 2027 expected — Peking University People's Hospital Not yet recruiting No outcome recorded
Phase 4 NCT07662408 May 2026 → Mar 2027 expected — Sohag University Recruiting No outcome recorded
Phase 4 NCT06366217 Oct 2024 → Jul 2025 abnormal pupillary function University of California, San Francisco Completed Met primary
Phase 4 NCT07327320 Jun 2024 → Oct 2025 hypotensive disorder Tam Anh Research Institute Completed No outcome recorded
Phase 4 NCT05890027 Mar 2024 → Apr 2025 ptosis University of Miami Completed No outcome recorded
Phase 4 NCT06334549 Mar 2024 → Dec 2025 overdue hypotensive disorder Dalian Municipal Central Hospital Recruiting No outcome recorded
Phase 4 NCT06217796 Nov 2023 → Jan 2024 — Eyenovia Inc. Completed No outcome recorded
Phase 4 NCT05997732 Oct 2023 → Dec 2027 expected — University of Alberta Recruiting No outcome recorded
Phase 4 NCT05941494 Oct 2023 → Dec 2025 — Jason Chui Unknown No outcome recorded
Phase 4 NCT04829799 Feb 2022 → Aug 2023 — University of Florida Withdrawn No outcome recorded
Phase not applicable48 trials · 1 met primary · 4 missed
— NCT07663149 Apr → Jun 2026 — Universitas Indonesia Completed No outcome recorded
— NCT06508359 Aug 2025 → Apr 2026 — General Hospital of Ningxia Medical University Completed No outcome recorded
— NCT06158035 Jul → Dec 2025 — General Hospital of Ningxia Medical University Unknown No outcome recorded
— NCT06151470 Jul → Dec 2025 — General Hospital of Ningxia Medical University Unknown No outcome recorded
— NCT06158009 Apr → Jun 2025 — General Hospital of Ningxia Medical University Unknown No outcome recorded
— NCT06151522 Apr → Jun 2025 — General Hospital of Ningxia Medical University Unknown No outcome recorded
— NCT06914063 Mar → Jun 2025 overdue cycloplegia Superior University Active not recruiting No outcome recorded
— NCT07153601 Feb → May 2025 hypotensive disorder, pregnancy disorder Universitas Sumatera Utara Completed No outcome recorded
— NCT06158048 Jan → Apr 2025 — General Hospital of Ningxia Medical University Completed No outcome recorded
— NCT07495670 Nov 2024 → Jan 2025 diabetes mellitus, diabetic retinopathy Burapha University Completed No outcome recorded
Comparator or background therapy109 trials
Phase 0 NCT06053398 Comparator Nov 2023 → Dec 2024 hypotensive disorder University of Texas Southwestern Medical Center Completed No outcome recorded
Phase 0 NCT02759510 Comparator Jun 2016 heart failure RenJi Hospital Unknown No outcome recorded
Phase 1 NCT03680404 Comparator Oct 2018 → Feb 2020 vascular disorder The University of Texas at Arlington Completed No outcome recorded
Phase 1 NCT03139708 Background Sep 2016 → Oct 2017 — Wake Forest University Health Sciences Completed No outcome recorded
Phase 1 NCT02245230 Background Jan 2015 → Dec 2023 essential hypertension Vanderbilt University Terminated No outcome recorded Stop: Enrollment
Show all 109 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 8

DateIssuerRelease
2019-11-04 Omeros Corporation Results Omeros Corporation Announces Publication of Study Results on the Impact of OMIDRIA on Opioid Use and Pain omeros.com ↗
Patients in the OMIDRIA group were 6.7 times more likely not to require fentanyl, with 9.8 percent of OMIDRIA patients requiring fentanyl versus 42.1 percent of epinephrine patients (P = 0.006).
2019-05-07 Omeros Corporation Results Clinical Study Showing Reduced Incidence of Cystoid Macular Edema with OMIDRIA® Presented at American Society of Cataract and Refractive Surgery Annual Meeting omeros.com ↗
Cataract surgery performed using OMIDRIA had lower rates of CME than cataract surgery using postoperative steroids
2018-10-01 Omeros Corporation Regulatory Omeros Corporation Announces Reinstatement of Pass-Through Status for OMIDRIA® omeros.com ↗
CMS’ Separate Payment for Cataract Surgery Drug Resumes Today
2018-04-19 Omeros Corporation Results Additional Clinical Studies Supporting the Benefits of OMIDRIA® Presented at the American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting omeros.com ↗
Omeros Corporation (NASDAQ: OMER) announced that the results of four real-world clinical studies evaluating the benefits of OMIDRIA ® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% were presented at the American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting held in Washington, D.C. , April 13-17, 2018 .
2017-12-12 Omeros Corporation Regulatory Omeros Corporation Announces FDA Approval of OMIDRIA® for Use in Pediatric Patients omeros.com ↗
FDA approved the sNDA for OMIDRIA under priority review.
2016-11-21 Omeros Corporation Results Omeros Announces Successful Outcome of OMIDRIA® Pediatric Cataract Trial omeros.com ↗
In the trial, OMIDRIA was safe and well tolerated with adverse event rates consistent with those seen in pediatric cataract surgery and similar in the OMIDRIA and phenylephrine groups.
2016-01-15 Omeros Corporation Results Disclosure of Omidria Post-Launch Study Findings to Occur at Hawaiian Eye and Retina Conference omeros.com ↗
the use of Omidria across a wide range of patients, including those with non-complex cataracts, complex cataracts, intraoperative floppy iris syndrome (IFIS) and/or pseudoexfoliation, has resulted in statistically significant:
2014-07-08 Perrigo Company Regulatory Perrigo Announces FDA Final Approval For The Store Brand Equivalent To Advil® Congestion Relief Tablets, 200 mg/10 mg perrigo.com ↗
This approval further strengthens our leading store brand position and highlights our commitment to bringing new affordable products to the market.

All press releases naming this drug 21 releases

DateIssuerRelease

Evidence & citations 18 cited values

Every value below carries the sentence it was read from. 258 sources stand behind the page.

FieldValueCited text
Known as phenylephrine “The active substances in Fydrane are: tropicamide 0.04 mg (anticholinergic), phenylephrine hydrochloride 0.62 mg (alpha sympathomimetic) and Lidocaine hydrochloride 2 mg (amide...” NCT04396301 ↗
245

“Each vial contains a nominal 4.5 mL solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium...” NCT01579565 ↗

“Each vial contains a nominal 4.5-mL solution containing 60.75 mM phenylephrine HCl (12.37 mg/mL) and 11.25 mM ketorolac trometamol (4.24 mg/mL) formulated in a 20 mM sodium...” NCT02093689 ↗

“A fixed-dose combination of paracetamol, chlorphenamine and phenylephrine was safe and more effective than placebo in the symptomatic treatment of the common cold or flu-like...” PMID 24261438 ↗ Nov 2013

“Protocol-directed vasopressor administration based on hemodynamic monitoring data. Agents included norepinephrine, phenylephrine, epinephrine, dopamine, and vasopressin.” NCT02742974 ↗

“standard Mydrin-P (0.5% tropicamide / 0.5% phenylephrine HCl) which is the standard eyedrops used for dilation of pupil before retinopathy of prematurity examination.” NCT06288321 ↗

“Rapid-Onset Cycloplegic Drops (e.g., tropicamide with phenylephrine) to assess patient comfort, anxiety, and satisfaction with quicker onset and shorter duration.” NCT06914063 ↗

“a combination topical anesthetic, consisting of 20% lidocaine, 4% tetracaine and 2% phenylephrine (TAC Alternate Gel, Compounding Arts Pharmacy, Lafayette, LA).” NCT00846690 ↗

“The tablets of Coristina® d contain 400 mg acetylsalicylic acid, dexchlorpheniramine 1 mg, 10 mg phenylephrine, and 30 mg of caffeine.” NCT02735070 ↗

“Phenylephrine infusion will be used to target a mean arterial blood pressure to within 30% of baseline (preoperative) value” NCT02382185 ↗

“Each capsule of the active drug contains 400mg of acetaminophen, 4mg of chlorpheniramine and 4mg of phenylephrine.” NCT00940836 ↗

Show 235 more sources

Known as BAY112476 “Phenylephrine HCl (Sinus Comfort, BAY112476)” NCT04534452 ↗
Known as Biorphen “phenylephrine {Generic Name: Biorphen}” NCT06539637 ↗
Known as Mydfrin “Multiple Alternate Instillation of Cyclopentolate Hydrochloride Dilate® Micro Labs Limited Bangalore and Phenylephrine Hydrochloride Mydfrin™ 25mg/mL (2.5%) Alcon Fort Worth Texas” NCT04838665 ↗
1

NCT04500899 ↗

Known as PE HCl “Phenylephrine hydrochloride (PE HCl) is widely used” PMID 26143019 ↗ Jul 2015
Known as PEH “Over-the-counter phenylephrine hydrochloride (PEH) is used for relief of nasal congestion caused by allergic rhinitis; however, data to support its efficacy are lacking.” PMID 26560899 ↗ Nov 2015
Known as PHE “the same infusion modalities of phenylephrine (PHE) with more stable blood pressure and less bradycardia” NCT06248593 ↗
Known as Phenylenphrine “Continuous infusion of Phenylenphrine 250 μg/mL (=Phenylephrine 10mg” NCT04214145 ↗
Known as Phenylephrin “eye drops (Phenylephrin)” NCT04880928 ↗
Known as Phenylephrine HCl “Phenylephrine HCL is considered to be the vasopressor of choice in parturients due to its propensity to cause less fetal acidosis.” NCT05348980 ↗
5

“Phenylephrine HCl Extended-Release tablets 30 mg taken twice daily (12 hours apart) for 7 days.” NCT00874120 ↗

“Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days.” NCT00976209 ↗

“Oral Phenylephrine HCl for Nasal Congestion in Seasonal Allergic Rhinitis” PMID 26143019 ↗ Jul 2015

NCT04534452 ↗

NCT02730364 ↗

Known as Phenylephrine Hydrochloride “The active substances in Fydrane are: tropicamide 0.04 mg (anticholinergic), phenylephrine hydrochloride 0.62 mg (alpha sympathomimetic) and Lidocaine hydrochloride 2 mg (amide...” NCT04396301 ↗
15

“Multiple Alternate Instillation of Cyclopentolate Hydrochloride Dilate® Micro Labs Limited Bangalore and Phenylephrine Hydrochloride Mydfrin™ 25mg/mL (2.5%) Alcon Fort Worth Texas” NCT04838665 ↗

“Over-the-counter phenylephrine hydrochloride (PEH) is used for relief of nasal congestion caused by allergic rhinitis; however, data to support its efficacy are lacking.” PMID 26560899 ↗ Nov 2015

“Sodium nitroprusside (100 µg) will be infused intravenously as a bolus, followed 60 seconds later by a bolus of phenylephrine hydrochloride (150 µg).” NCT01048125 ↗

“Phenylephrine hydrochloride ophthalmic solution 10% formulated for microdose spray delivery” NCT02946125 ↗

“Phenylephrine Hydrochloride (Phenylephrine HCl) extended release tablet” NCT04534452 ↗

“RELIEF® rectal ointment (phenylephrine hydrochloride 2.5mg/g), marketed” NCT05157711 ↗

“Phenylephrine hydrochloride (PE HCl) is widely used” PMID 26143019 ↗ Jul 2015

“Drug: Phenylephrine hydrochloride infusion” NCT07824713 ↗

“10% Phenylephrine hydrochloride gel” NCT00420797 ↗

“Drug: Phenylephrine Hydrochloride” NCT05525416 ↗

Show 5 more sources

Known as Preparation H “Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.” NCT02665221 ↗
Known as RELIEF “RELIEF® rectal ointment (phenylephrine hydrochloride 2.5mg/g), marketed” NCT05157711 ↗
Known as RELIEF rectal ointment (phenylephrine hydrochloride) “RELIEF rectal ointment (phenylephrine hydrochloride)” NCT05157711 ↗
Known as Sinus Comfort “Phenylephrine HCl (Sinus Comfort, BAY112476)” NCT04534452 ↗
Action Activate “Phenylephrine is an alpha-adrenergic agonist that increases blood pressure by constricting peripheral blood vessels.” NCT00100412 ↗
Modality Small molecule “Phenylephrine and dobutamine are synthetic catecholamines, analogues of endogenous chemical messenger substances released by sympathetic nerve fibers and by adrenal medulla...” NCT00100412 ↗
Route Intravenous “The hypotheses of target organ dysfunction are evaluated using graded intravenous infusions of two drugs, phenylephrine and dobutamine, and by measuring the resultant...” NCT00100412 ↗