Phenylephrine
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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| Phase 0 | NCT03972683 | Apr 2019 → Jul 2021 | — | Colorado State University | Withdrawn | No outcome recorded Stop: Enrollment |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 3 | NCT02401191 | Mar → Jul 2015 | allergic rhinitis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01393548 | Aug 2014 → Nov 2016 | rhinitis | Ache Laboratorios Farmaceuticos S.A. | Completed | No outcome recorded |
| Phase 3 | NCT01393561 | Jul → Oct 2014 | rhinitis | Ache Laboratorios Farmaceuticos S.A. | Completed | No outcome recorded |
| Phase 3 | NCT02093689 | Feb → Aug 2014 | intraoperative floppy iris syndrome | Omeros Corporation | Terminated | No outcome recorded |
| Phase 3 | NCT01448057 | Jul 2013 → Aug 2015 | Achoo syndrome, nasal cavity disorder, respiratory tract infectious disorder | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT01600235 | Jun 2012 → Dec 2017 | ischemic stroke | Samsung Medical Center | Unknown | Met primary |
| Phase 3 | NCT04534452 | May → Jun 2012 | allergic rhinitis | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01579565 | Apr → Nov 2012 | — | Omeros Corporation | Completed | Met primary |
| Phase 3 | NCT01413958 | Aug → Oct 2011 | seasonal allergic rhinitis | Bayer | Completed | Missed primary |
| Phase 3 | NCT00976209 | Aug → Nov 2009 | seasonal allergic rhinitis, vasomotor rhinitis | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00874120 | Dec 2008 → Feb 2009 | hypertensive disorder | Bayer | Completed | Missed primary |
| Phase 3 | NCT00420797 | Feb → Nov 2007 | — | S.L.A. Pharma AG | Withdrawn | No outcome recorded |
| Phase 3 | NCT00276016 | Jan → Feb 2006 | seasonal allergic rhinitis | Organon and Co | Completed | Missed primary |
| 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 4 | NCT04991662 | Oct → Dec 2021 | — | Xuzhou Medical University | Completed | No outcome recorded |
| Phase 4 | NCT05043077 | Sep 2021 → Jan 2023 | retinopathy of prematurity | Aristotle University Of Thessaloniki | Completed | Met primary |
| Phase 4 | NCT04907474 | May → Jun 2021 | — | Eyenovia Inc. | Completed | Met primary |
| Phase 4 | NCT04602767 | Oct 2020 → May 2024 | acute kidney injury | Thomas Jefferson University | Unknown | No outcome recorded |
| Phase 4 | NCT04419662 | May 2020 → May 2021 | — | Aarhus University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04623684 | Mar → Sep 2020 | retinopathy of prematurity | Aristotle University Of Thessaloniki | Completed | No outcome recorded |
| Phase 4 | NCT03864133 | Jul 2019 → Jun 2021 | cataract | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 4 | NCT03846765 | Jul 2019 → May 2021 | — | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT03638726 | Sep 2018 → Mar 2019 | cataract | Dar El Oyoun Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03615508 | Sep 2018 → May 2019 | Horner syndrome | Denver Health and Hospital Authority | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03302039 | Oct 2017 → Oct 2018 | — | Cairo University | Completed | No outcome recorded |
| Phase 4 | NCT03248817 | Sep 2017 → May 2020 | — | Cairo University | Unknown | No outcome recorded |
| Phase 4 | NCT03767296 | Feb → Sep 2017 | — | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT02979405 | Jan → Feb 2017 | hypotensive disorder | Universidad Industrial de Santander | Completed | No outcome recorded |
| Phase 4 | NCT02748265 | Mar 2016 → Jul 2017 | — | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 4 | NCT02739399 | Feb → Jul 2016 | hypotensive disorder | Algemeen Ziekenhuis Maria Middelares | Completed | No outcome recorded |
| Phase 4 | NCT02802683 | Sep 2015 → May 2016 | hypotensive disorder | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02665221 | Jul 2015 → Sep 2016 | multiple sclerosis | NYU Langone Health | Terminated | No outcome recorded |
| Phase 4 | NCT02323399 | Feb 2015 → Dec 2024 overdue | hypotensive disorder | West-Ward Pharmaceutical | Recruiting | No outcome recorded |
| Phase 4 | NCT02354833 | Aug 2014 → Aug 2015 | — | West Virginia University | Completed | Missed primary |
| Phase 4 | NCT02177539 | May → Aug 2014 | refractive error | Pontificia Universidad Catolica de Chile | Unknown | No outcome recorded |
| Phase 4 | NCT02376192 | Jan → Dec 2014 | pregnancy disorder | IWK Health Centre | Completed | No outcome recorded |
| Phase 4 | NCT01378325 | Jul 2012 → Jan 2013 | — | American University of Beirut Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01794273 | Jul 2012 → Jul 2013 | — | University Hospital, Clermont-Ferrand | Completed | No outcome recorded |
| Phase 4 | NCT05439460 | Jan 2012 → Jun 2014 | pulmonary arterial hypertension | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT04838665 | Sep 2011 | retinopathy of prematurity | University of the Philippines | Completed | No outcome recorded |
| Phase 4 | NCT01481740 | Nov 2010 → Dec 2014 | hypotensive disorder | IWK Health Centre | Completed | Met primary |
| Phase 4 | NCT00877175 | Mar → May 2009 | — | Khon Kaen University | Completed | Met primary |
| Phase 4 | NCT00846690 | Jan → Mar 2009 | — | The University of Texas Health Science Center, Houston | Unknown | No outcome recorded |
| Phase 4 | NCT00796328 | Nov 2008 → Feb 2009 | — | IWK Health Centre | Terminated | No outcome recorded |
| Phase 4 | NCT02885168 | Feb 2008 → Apr 2009 | infectious disease with sepsis | Central Hospital, Nancy, France | Completed | No outcome recorded |
| Phase 4 | NCT00781157 | Jan → Aug 2008 | hypotensive disorder | IWK Health Centre | Completed | No outcome recorded |
| Phase 4 | NCT00501878 | May → Jul 2007 | diabetes mellitus | Khon Kaen University | Completed | No outcome recorded |
| Phase 4 | NCT00199784 | Jun 2005 → Apr 2007 | — | Oslo University Hospital | Completed | 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 |
| — | NCT06158022 | Oct 2024 → May 2025 | — | General Hospital of Ningxia Medical University | Completed | No outcome recorded |
| — | NCT06711432 | Sep 2024 → May 2026 overdue | neoplasm, stroke disorder | Zhejiang Cancer Hospital | Recruiting | No outcome recorded |
| — | NCT04576663 | Oct 2023 → Sep 2025 | — | General Hospital of Ningxia Medical University | Unknown | No outcome recorded |
| — | NCT05414877 | Sep 2023 → Dec 2024 | arterial disorder | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| — | NCT05665881 | Jan 2023 → Sep 2024 | arterial disorder | Beijing Tiantan Hospital | Completed | No outcome recorded |
| — | NCT05525416 | Jul 2022 → Feb 2023 | — | University of Alberta | Completed | No outcome recorded |
| — | NCT04928183 | Jun → Aug 2021 | isoproterenol-mediated vasodilatation | University of Alberta | Completed | No outcome recorded |
| — | NCT04214145 | Jan 2020 → Sep 2021 | — | Seoul National University Hospital | Completed | No outcome recorded |
| — | NCT05001048 | Aug 2019 → Dec 2021 | isoproterenol-mediated vasodilatation | University of Alberta | Completed | No outcome recorded |
| — | NCT04053478 | Jul 2019 → Dec 2026 expected | hypotensive disorder | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | Recruiting | No outcome recorded |
| — | NCT04133961 | Jun → Dec 2019 | — | Universiti Kebangsaan Malaysia Medical Centre | Completed | No outcome recorded |
| — | NCT04777383 | Apr 2019 → Oct 2021 | vascular disorder | University Hospital, Linkoeping | Terminated | No outcome recorded |
| — | NCT03620942 | Nov 2018 → Dec 2025 overdue | hypotensive disorder | KK Women's and Children's Hospital | Active not recruiting | Missed primary |
| — | NCT03682198 | Sep 2018 → Oct 2020 | — | University Hospital Bispebjerg and Frederiksberg | Completed | No outcome recorded |
| — | NCT03629418 | Aug 2018 → Dec 2025 overdue | acute kidney injury | Peking University First Hospital | Recruiting | No outcome recorded |
| — | NCT03507387 | Apr → Aug 2018 | — | Xuzhou Medical University | Completed | No outcome recorded |
| — | NCT02965924 | Oct 2016 → Oct 2018 | — | Mayo Clinic | Completed | No outcome recorded |
| — | NCT02909140 | Sep 2016 → Aug 2018 | cataract | Johns Hopkins University | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT02725060 | Feb 2016 → Oct 2026 expected | cardiac rhythm disease, postural orthostatic tachycardia syndrome, primary dysautonomia | Vanderbilt University Medical Center | Enrolling by invitation | No outcome recorded |
| — | NCT02585570 | Oct 2015 → Sep 2016 | — | Inje University | Completed | No outcome recorded |
| — | NCT02101047 | Aug 2015 → Dec 2016 | — | Wake Forest University Health Sciences | Withdrawn | No outcome recorded |
| — | NCT02382185 | Jan 2015 → Sep 2017 | — | York Teaching Hospitals NHS Foundation Trust | Completed | Missed primary |
| — | NCT02285634 | Nov 2014 → Dec 2016 | hypertensive disorder | Mayo Clinic | Completed | Missed primary |
| — | NCT02245191 | Jul 2014 | preeclampsia | University of Sao Paulo General Hospital | Unknown | No outcome recorded |
| — | NCT01866657 | Jun 2013 → Nov 2016 | brain hypoxia - ischemia | University Hospitals Cleveland Medical Center | Terminated | No outcome recorded Stop: Business |
| — | NCT01800877 | Apr 2013 → Dec 2014 | hypotensive disorder | Francois Lamontagne | Completed | No outcome recorded |
| — | NCT01813149 | Aug 2012 → Jun 2016 | complex regional pain syndrome | The Cleveland Clinic | Terminated | Met primary |
| — | NCT01080625 | Apr 2010 → Sep 2011 | — | Seoul National University Hospital | Completed | No outcome recorded |
| — | NCT00838695 | Jan 2009 → Dec 2010 | — | Vanderbilt University | Completed | No outcome recorded |
| — | NCT01054027 | Mar → Nov 2007 | retinopathy of prematurity | Georgetown University | Completed | No outcome recorded |
| — | NCT00379691 | Aug → Dec 2006 | hypotensive disorder | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | Completed | No outcome recorded |
| — | NCT00356265 | Jul 2006 → Nov 2010 | chronic kidney disease, hypertensive disorder | University of Michigan | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00458003 | Jul 2006 → Dec 2016 | hypotensive disorder, preeclampsia | Northwestern University | Completed | Missed primary |
| — | NCT00294606 | Feb 2006 | — | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Unknown | No outcome recorded |
| — | NCT00240058 | Jul 2005 → Jun 2006 | hypertensive disorder | Crystal A. Gadegbeku | Completed | No outcome recorded |
| — | NCT00225043 | Jun 2005 → Aug 2007 | — | New York Presbyterian Brooklyn Methodist Hospital | Completed | No outcome recorded |
| — | NCT00585091 | Oct 2003 → Aug 2007 | heart failure | University of Utah | Completed | No outcome recorded |
| — | NCT00100412 | Oct 1999 → Sep 2002 | myalgic encephalomeyelitis/chronic fatigue syndrome, persian gulf syndrome, post-traumatic stress disorder | US Department of Veterans Affairs | 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
| Date | Issuer | Release |
|---|---|---|
| 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
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 258 sources stand behind the page.
| Field | Value | Cited 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 ↗ |
| 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 ↗ |
| 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 |
| 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 ↗ |
| 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 ↗ |