Neo-Synephrine

(Phenylephrine)

ApprovedSmall molecule

Phenylephrine is a decongestant used to relieve nasal congestion and stuffiness caused by colds, allergies, or sinus problems. It can also be used as a nasal spray or eye drops to reduce redness in the eyes.[2] Neo-Synephrine is currently approved and in use across 34 indications[4].[1]

Neo-Synephrine is one of 700 small molecule programs targeting Hypotension. It is currently in Approved.

Indications

147

Total Trials

Active Trials

699

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

HypotensionCompleted

HemorrhoidActive, not recruiting

Eye AllergyActive, not recruiting

CataractApproved

Cognitive ImpairmentApproved

HypertensionApproved

Ocular HypertensionApproved

Ovarian CystApproved

Respiratory Tract Infectious DisorderApproved

MucositisApproved

HypotensionApproved

Completed

HemorrhoidApproved

Active, not recruiting

Eye AllergyApproved

Active, not recruiting

CataractApproved

Approved

Cognitive ImpairmentApproved

Approved

HypertensionApproved

Approved

Ocular HypertensionApproved

Approved

Ovarian CystApproved

Approved

Respiratory Tract Infectious DisorderApproved

Approved

MucositisApproved

Approved

Showing 10 of 33 indications

Competition

Competitive Landscape

206 competitors in Heart Failure

#DrugCompanyPhaseTrials

Neo-Synephrine

EExela Pharma Sciences, LLC.

Brethine

1 3

Medrol

Pfizer

Preclinical

1 4

Activase

Zemplar

Savaysa

Xifaxan

2 8

Potassium Iodide

MMeda Pharmaceuticals

Preclinical

1 9

Oraverse

LLife Extension Foundation Inc.

Preclinical

1 10

Xylocaine

MMEDRx USA, Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Intensive Care Unit

NCT02118467

Q1 2027

N/ANot yet recruiting

Hypotension

NCT06508359

ApprovedRecruiting

Surgery

NCT07662408

Phase 2/3Not yet recruiting

Growth

NCT06648850

Q4 2027

Phase 1Recruiting

Injury

NCT01731444

Recruiting

Study completion

NCT02673996

Clinical

Trials by Indication[1]

Hypotension25 trials

Variable Rate Phenylephrine Infusion for Prevention of Spinal-induced Hypotension for Cesarean Delivery

Completed·—·Phase 4·NCT01378325·80 enrolled

Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension

Completed·KKasr El Aini Hospital·Phase 2·NCT03015857·200 enrolled

Ephedrine and Phenylephrine for Spinal Hypotension

Completed·—·Phase 2/3·NCT03047109·60 enrolled

Show 22 more trials

Effectiveness of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery

Completed·UUniversidad Industrial de Santander·Phase 4·NCT02979405·140 enrolled

Epinephrine Infusion for Prophylaxis Against Maternal Hypotension After Spinal Anesthesia for Cesarean Delivery

Completed·—·N/A·NCT05881915·196 enrolled

The Potency of Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension

Unknown status·GGeneral Hospital of Ningxia Medical University·N/A·NCT05035472·80 enrolled

Comparison of Phenylephrine and Norepinephrine for Spinal-induced Hypotension

Completed·TTribhuvan University Teaching Hospital, Institute Of Medicine.·Phase 3·NCT04789005·80 enrolled

Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring

Unknown status·FFudan University·N/A·NCT02532270·100 enrolled

Ephedrine Versus Phenylephrine for Spinal Block - Related Hypotension in Cesarean Delivery

Completed·CCentre of Postgraduate Medical Education··NCT06741410·94 enrolled

Up-Down Determination of the ED90 of Phenylephrine for Hypotension Prophylaxis in Cesarean Delivery

Terminated·IIWK Health Centre·Phase 4·NCT00796328·45 enrolled

Phenylephrine Dose and Mode of Administration for Spinal Anesthesia Induced Hypotension

Withdrawn·WWake Forest University Health Sciences·N/A·NCT02101047

Intravenous Bolus of Phenylephrine vs. Norepinephrine in Preventing Hypotension After Spinal Anesthesia

Completed·UUniversity Tunis El Manar·Phase 4·NCT02854787·120 enrolled

A Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent Spinal-induced Hypotension in Cesarean Deliveries

Completed·SSamuel Lunenfeld Research Institute, Mount Sinai Hospital·N/A·NCT02962986·112 enrolled

Norepinephrine Versus Phenylephrine for Preventing Spinal Anesthesia Induced Hypotension in Elderly

Completed·KKasr El Aini Hospital·Phase 4·NCT04195321·62 enrolled

Effect of Vasopressors on Spinal Anaesthesia Induced Hypotension

Completed·—·Phase 4·NCT03163914·160 enrolled

Norepinephrine vs. Phenylephrine for Hypotension in Low-Dose Spinal Anesthesia for Cesarean Delivery

Completed·TTam Anh Research Institute·Phase 4·NCT07327320·100 enrolled

Norepinephrine and Phenylephrine for Spinal Anesthesia-induced Hypotension.

Not yet recruiting·GGeneral Hospital of Ningxia Medical University·N/A·NCT06508359·2,000 enrolled

Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension

Completed·GGeneral Hospital of Ningxia Medical University·N/A·NCT05035888·80 enrolled

Norepinephrine or Phenylephrine in Bolus for Hypotension in Cesarean Delivery

Completed·HHospital dos Servidores do Estado do Rio de Janeiro·Phase 2·NCT03702400·72 enrolled

Prophylactic Phenylephrine Infusion for Preventing Hypotension During Spinal Anesthesia

Completed·UUniversity Hospital, Toulouse·Phase 2·NCT01533662·64 enrolled

Preventing Hypotension in Parturients With an Elevated Body Mass Index (BMI)

Completed·IIWK Health Centre·Phase 4·NCT01481740·178 enrolled

The Choice of Vasopressor for Treating Hypotension During General Anesthesia: a Pilot Pragmatic Cluster Cross-over Randomized Trial (the VEGA-1 Trial)

Completed·UUniversity of California, San Francisco·Approved·NCT04789330·3,626 enrolled

Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System With Improved Hemodynamic Trend Control During Spinal Anaesthesia for Caesarean Section

Active, not recruiting·KKK Women's and Children's Hospital·Preclinical·NCT03620942·173 enrolled

A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability to Improve Perioperative Outcome During Spinal Anaesthesia for Caesarean Section

Completed·KKK Women's and Children's Hospital·Preclinical·NCT02277730·252 enrolled

Closed-loop Double-vasopressor Automated System vs Manual Bolus Vasopressor to Treat Hypotension During Spinal Anaesthesia for Caesarean Section

Completed·KKK Women's and Children's Hospital·Preclinical·NCT04025918·216 enrolled

Cesarean Section11 trials

Norepinephrine for Hypotension in Cesarean Section

Completed·—·N/A·NCT04367103·180 enrolled

Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section

Completed·—·Phase 2·NCT02958215·980 enrolled

The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section

Completed·CChina International Neuroscience Institution·Phase 2/3·NCT03833895·238 enrolled

Show 8 more trials

Hemodynamic Measurements During Cesarean Section With Spinal Anesthesia

Completed·OOslo University Hospital·Phase 4·NCT00199784·80 enrolled

Best Regimen for Phenylephrine Administration During Cesarean Section

Completed·SSamuel Lunenfeld Research Institute, Mount Sinai Hospital·Phase 4·NCT00996190·60 enrolled

Ideal Dose of Phenylephrine to Treat Low Blood Pressure During Cesarean Section

Completed·SSamuel Lunenfeld Research Institute, Mount Sinai Hospital·N/A·NCT00379691·50 enrolled

Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia

Completed·XXuzhou Medical University·N/A·NCT03507387·99 enrolled

Cardiac Output Changes in Cesarean Section

Unknown status·RRenJi Hospital·Phase 1·NCT02759510·106 enrolled

Phenylephrine Versus Norepinephrine for Maintenance of Hemodynamic During Cesarean Section Under Spinal Anesthesia

Completed·—·Phase 4·NCT03849508·124 enrolled

Spinal Anesthesia Induced Hypotension During Cesarean Section

Completed·MMilton S. Hershey Medical Center·Phase 4·NCT00846651·82 enrolled

Norepinephrine vs. Phenylephrine for Spinal Hypotension in Cesarean Section

Completed·UUniversitas Sumatera Utara·N/A·NCT07153601·46 enrolled

Cesarean Delivery6 trials

Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery

Completed·—·Phase 4·NCT03328533·123 enrolled

Phenylephrine vs. Norepinephrine Infusion After Spinal Anesthesia for Cesarean Delivery

Completed·WWest Virginia University·Phase 4·NCT02354833·85 enrolled

Effect of Three Weight-adjusted Vasopressors for Elective Cesarean Delivery

Completed·XXuzhou Medical University·Phase 4·NCT04991662·78 enrolled

Show 3 more trials

Vasopressor Infusion in Cesarean Delivery

Unknown status·—·Phase 4·NCT03248791·120 enrolled

Norepinephrine and Phenylephrine for Maternal Cardiac Output During Spinal Anesthesia for Elective Cesarean Delivery

Unknown status·—·Phase 4·NCT02969239·50 enrolled

Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery

Completed·SSeoul National University Hospital·Phase 4·NCT02802683·72 enrolled

Preeclampsia5 trials

Prophylactic Norepinephrine and Phenylephrine Infusion for Hemodynamic Effects in Patients With Preeclampsia

Unknown status·GGeneral Hospital of Ningxia Medical University·N/A·NCT05035498·72 enrolled

Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia

Completed·GGeneral Hospital of Ningxia Medical University·N/A·NCT04556357·138 enrolled

Phenylephrine Versus Ephedrine in Pre-eclampsia

Terminated·—·Phase 4·NCT02025426·13 enrolled

Show 2 more trials

Phenylephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia

Unknown status·GGeneral Hospital of Ningxia Medical University·N/A·NCT04576663·95 enrolled

Maternal Cardiac Output Response to Rescue Norepinephrine and Phenylephrine Boluses in Patients With Severe Preeclampsia

Completed·GGeneral Hospital of Ningxia Medical University·N/A·NCT05035485·40 enrolled

Septic Shock5 trials

Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients

Terminated·VVanderbilt University Medical Center·Phase 4·NCT02203630·17 enrolled

Phenylephrine in Septic Shock

Completed·UUniversity of Roma La Sapienza·Phase 2·NCT00639015·32 enrolled

Phenylephrine Versus Norepinephrine in Septic Shock

Completed·UUniversity of Roma La Sapienza·Phase 2·NCT00481442·15 enrolled

Show 2 more trials

Methylene Blue as a Third-line Vasopressor in Septic Shock

Unknown status·CCarilion Clinic·Phase 2·NCT04089072·250 enrolled

Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C

Completed·—·Phase 4·NCT02885168·30 enrolled

63 more indications

Caesarean Section4 trials

Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia

Completed·AAnestesiavdelingen Baerum Sykehus·N/A·NCT01278238·120 enrolled

The Oxygenation of the Brain During Caesarean Section

Completed·NNaestved Hospital·Phase 4·NCT01509521·24 enrolled

Prophylactic Phenylephrine Co-administration During Caesarean Section

Completed·UUniversity of KwaZulu·N/A·NCT04005664·300 enrolled

Show 1 more trial

Intraoperative Phenylephrine Infusion to Reduce Postoperative Shivering in Lower Segment Caesarean Section

Completed·UUniversiti Kebangsaan Malaysia Medical Centre·N/A·NCT04133961·118 enrolled

Treatment4 trials

ED90 of Norepinephrine and Phenylephrine Boluses Under Intensive Treatment in Preeclamptic Patients

Unknown status·GGeneral Hospital of Ningxia Medical University·N/A·NCT06158035·80 enrolled

ED90 of Norepinephrine and Phenylephrine Infusions Under Intensive Treatment

Completed·GGeneral Hospital of Ningxia Medical University·N/A·NCT06158048·60 enrolled

ED90 of Norepinephrine and Phenylephrine Boluses Under Intensive Treatment

Unknown status·GGeneral Hospital of Ningxia Medical University·N/A·NCT06158009·80 enrolled

Show 1 more trial

Comparing Between CO2 and Phenylephrine Treatment in Patients With Progressive Lacunar Infarction (CARBOGEN Study)

Terminated·YYonsei University·Phase 3·NCT04839224·3 enrolled

ESS4 trials

Effects of Ephedrine, Phenylephrine, Norepinephrine and Vasopressin on Contractility of Human Myometrium and Umbilical Vessels: An In-vitro Study

Recruiting·SSamuel Lunenfeld Research Institute, Mount Sinai Hospital·N/A·NCT04053478·144 enrolled

Vasopressor Effects in Anesthetized Patients

Completed·UUniversity of Aarhus·Phase 4·NCT02713087·48 enrolled

Effects of Vasopressor on the Graft Blood Flow in TRAM

Completed·SSeoul National University Hospital·N/A·NCT05049278·20 enrolled

Show 1 more trial

Phenylephrine and Pulse Pressure Variability

Completed·UUniversity of Texas Southwestern Medical Center·Phase 1·NCT05011357·8 enrolled

Intraocular Pressure3 trials

Role of Nitric Oxide in Optic Nerve Head Blood Flow Regulation During Experimental Increase of Intraocular Pressure in Healthy Humans

Terminated·MMedical University of Vienna·N/A·NCT00914394·12 enrolled

The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients

Completed·WWake Forest University Health Sciences·Phase 1·NCT03139708·5 enrolled

Choroidal Thickness During Changes in Intraocular Pressure and Arterial Blood Pressure

Terminated·MMedical University of Vienna·N/A·NCT01333891·1 enrolled

Surgery3 trials

Effect of Phenylephrine During Shoulder Arthroscopic Surgery

Completed·IInje University·N/A·NCT02585570·66 enrolled

Effects of Adrenergic Drugs on the Fluid Balance During Surgery

Completed·SSodertalje Hospital·Phase 1/2·NCT01431612·60 enrolled

Comparison of Norepinephrine Versus Phenylephrine Infusion for Prevention of Hypotension Due to Subarachnoid Block in Elderly Patients Undergoing Orthopedic Hip Surgery:A Prospective Randomized Trial

Recruiting·SSohag University·Approved·NCT07662408·62 enrolled

Cardiac2 trials

Effects of Phenylephrine on Cardiac Preload

Completed·AAlgemeen Ziekenhuis Maria Middelares·Phase 4·NCT02739399·26 enrolled

Ephedrine, Phenylephrine and Metaraminol Effects on Maternal Cardiac Output, Uterine Blood Flow and Fetal Circulation

Unknown status·UUniversity of Sao Paulo General Hospital·N/A·NCT02245191·60 enrolled

Infusion2 trials

Noradrenaline Infusion Versus Phenylephrine Infusion in Improving Serum Lactate Level in HIPEC

Completed·SSuez Canal University·N/A·NCT04144465·30 enrolled

ED90 of Norepinephrine and Phenylephrine Infusions in Preeclamptic Patients

Completed·GGeneral Hospital of Ningxia Medical University·N/A·NCT06158022·60 enrolled

Trial2 trials

The GUARDIAN Trial - Vasopressor Sub-Study

Enrolling by invitation·TThe University of Texas Health Science Center, Houston·Phase 4·NCT04934748·6,254 enrolled

Descemet Endothelial Thickness Comparison Trial

Unknown status·OOregon Health and Science University·Phase 4·NCT02373137·38 enrolled

Oxygenation2 trials

Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia

Recruiting·UUniversity of Aarhus·Phase 2/3·NCT06083948·32 enrolled

Vasopressors for Cerebral Oxygenation

Unknown status·SSamsung Medical Center·Phase 1·NCT02009007·50 enrolled

Nitric Oxide2 trials

Role of Nitric Oxide in the Impact of Aging on Myocardial Remodeling

Completed·WWashington University School of Medicine·N/A·NCT00603720·54 enrolled

Role of Nitric Oxide in Optic Nerve Head Blood Flow Regulation During Isometric Exercise in Healthy Humans

Completed·MMedical University of Vienna·N/A·NCT00806741·18 enrolled

Spinal Anesthesia2 trials

Comparison of Phenylephrine and Ephedrine in the Treatment of Hemodynamic Disorders After Spinal Anesthesia in the Elderly

Completed·MMedical University of Warsaw·N/A·NCT03858465·50 enrolled

Phenylephrine in Spinal Anesthesia in Preeclamptic Patients

Completed·NNorthwestern University·N/A·NCT00458003·110 enrolled

Carotid Endarterectomy2 trials

Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy (MRI Part)

Unknown status·—·N/A·NCT05414877·60 enrolled

Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy (TCD Part)

Completed·—·N/A·NCT05665881·90 enrolled

Tachycardia2 trials

Tachycardia as an Indication for Prophylactic Phenylephrine Injection in Caesarean Section Under Spinal Anesthesia; an Observational Study

Unknown status·—··NCT06220942·80 enrolled

Autoimmune Basis for Postural Tachycardia Syndrome

Enrolling by invitation·VVanderbilt University Medical Center·N/A·NCT02725060·58 enrolled

Ischemic stroke2 trials

Safety and Efficacy of Therapeutic INduced HYPERTENSION in Acute Non-cardioembolic Ischemic Stroke (SETIN-HYPERTENSION)

Unknown status·SSamsung Medical Center·Phase 3·NCT01600235·170 enrolled

Induced Hypertension for Acute Ischemic Stroke

Completed·JJohns Hopkins University·Phase 2·NCT00227448·60 enrolled

Tics1 trial

Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV

Recruiting·WWest-Ward Pharmaceutical·Phase 4·NCT02323399·100 enrolled

Hemodynamic Response1 trial

Preoperative Ephedrine Attenuates the Hemodynamic Responses of Propofol During Valve Surgery: A Dose Dependent Study

Completed·KKing Faisal University·Phase 2·NCT01006863·150 enrolled

Liver Transplant1 trial

Effect of Epinephrine/ Phenylephrine for Preventing the Postreperfusion Syndrome During Reperfusion in Liver Transplantation

Completed·SSeoul National University Hospital·N/A·NCT01080625·96 enrolled

Injury1 trial

Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

Recruiting·UUniversity of Manitoba·Phase 1·NCT01731444·24 enrolled

After Cardiac Surgery1 trial

Evaluation of Patients After Cardiac Surgery: Novel Ultrasound Parameters for Quantification of Renal Perfusion & Analysis of Phenylephrines' Effect on Invasive Haemodynamics and Echocardiographic Measures

Completed·—·Phase 4·NCT04419662·30 enrolled

Cerebral Infarction1 trial

CompARing Between CO2 Phenylephrine and Phenylephrine Only Treatment in Patients With proGrEssing Cerebral infarctioN

Not yet recruiting·YYonsei University·Phase 3·NCT06770426·40 enrolled

Bronchiolitis1 trial

The Use of Nasal Phenylephrine in Infants With Bronchiolitis

Completed·—·Phase 2·NCT00373802·50 enrolled

Elderly1 trial

Norepinephrine and Phenylephrine, Which Better for Elderly?

Unknown status·TThe Second Affiliated Hospital of Dalian Medical University·Phase 3·NCT04067817·100 enrolled

Pilot Study1 trial

Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study

Completed·UUniversity of California, San Francisco·Phase 1·NCT03719001·40 enrolled

Tranexamic Acid1 trial

Phenylephrine Versus Tranexamic Acid to Control Bleeding in Patients Undergoing Inferior Turbinoplasty by Coblation

Unknown status·—·N/A·NCT05841251·80 enrolled

Nasal congestion1 trial

Effects of Phenylephrine Extended-Release Tablets on Allergy-Related Nasal Congestion (P08498 AM1)

Completed· Bayer logo

Bayer·Phase 3·NCT01413958·575 enrolled

Carvedilol1 trial

The Development of Tolerance to α1-Adrenoceptor Blockade With Chronic Carvedilol Treatment

Completed·UUniversity of Utah·N/A·NCT00585091·15 enrolled

Ophthalmic Surgery1 trial

Phenylephrine Versus Norepinephrine in Ophthalmic Surgery

Completed·UUniversity Medical Center Groningen·N/A·NCT01609491·60 enrolled

CLE1 trial

Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) Evaluation

Completed·UUniversity of Miami·Phase 4·NCT05890027·18 enrolled

Acute Kidney Injury1 trial

The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Surgery

Recruiting·UUniversity of California, San Francisco·Phase 4·NCT06802224·18,000 enrolled

Intraoperative1 trial

The Effect of Epinephrine, Norepinephrine and Phenylephrine on Intraoperative Hemodynamic Performance

Unknown status·MMedical University of Vienna·Phase 4·NCT05492968·225 enrolled

Stroke1 trial

Blood PREssure Augmentation in Large-vessel Occlusion Stroke Study

Suspended·YYale University·Phase 1·NCT04218773·40 enrolled

Hemodynamic Stability1 trial

Phenylephrine or Norepinephrine for a Better Hemodynamic Stability

Completed·TThe Second Affiliated Hospital of Dalian Medical University·Phase 3·NCT03215797·40 enrolled

Common Cold1 trial

Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold

Withdrawn· Novartis logo

Novartis·Phase 3·NCT05070650

Essential Hypertension1 trial

Cardiovascular Effects of Angiotensin (1-7) in Essential Hypertension

Terminated·VVanderbilt University·Phase 1·NCT02245230·24 enrolled

Oral Mucositis1 trial

Safety of Phenylephrine for Oral Mucositis Prevention

Terminated·UUniversity of Wisconsin, Madison·Phase 1·NCT01092975·1 enrolled

Cardiac Surgery1 trial

Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery

Recruiting·TThomas Jefferson University·Phase 4·NCT04602767·300 enrolled

Seasonal Allergic Rhinitis1 trial

The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)

Completed·OOrganon and Co·Phase 3·NCT00276016·39 enrolled

Blood Pressure1 trial

Decision Support for Intraoperative Low Blood Pressure

Completed·VVanderbilt University Medical Center·N/A·NCT02726620·22,435 enrolled

Neurosurgical Patients1 trial

Completed·NNYU Langone Health·N/A·NCT02701582·66 enrolled

CABG1 trial

The Effect of Vasopressors on Cerebral Oxygentaion During Off Pump CABG

Completed·SSeoul National University Hospital·N/A·NCT04214145·90 enrolled

Drug1 trial

The Effects of Iontophoresed Vasoactive Drugs on Cutaneus Blood Flow

Unknown status·UUniversity Hospital, Linkoeping·N/A·NCT04777383·90 enrolled

General Anesthesia1 trial

Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine, Phenylephrine or Norepinephrine.

Completed·HHelse Fonna·Phase 4·NCT03864094·128 enrolled

PTSD1 trial

Role of Sympathetic Overactivity and Angiotensin II in PTSD and CV

Suspended·EEmory University·Phase 2·NCT02560805·134 enrolled

Gestational Diabetes1 trial

Effect of Ephedrine, Phenylepinephrine, and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section: An In-vitro Study

Suspended·SSamuel Lunenfeld Research Institute, Mount Sinai Hospital·N/A·NCT06285396·96 enrolled

Influenza1 trial

A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies

Completed· GSK logo

GSK·Phase 4·NCT01332578·25 enrolled

Intensive Care Unit1 trial

Vasoactive Drugs in Intensive Care Unit

Recruiting·UUniversity of Chicago·Phase 4·NCT02118467·836 enrolled

Bone Marrow Transplant1 trial

Topical Phenylephrine Solution in Preventing Oral Mucosa in Bone Marrow Transplant Patients Receiving Cyclophosphamide and Total Body Radiation Therapy

Terminated·UUniversity of Wisconsin, Madison·Phase 1/2·NCT02434146·3 enrolled

Exercise Training1 trial

Role of Acetylcholine in Blood Flow Regulation in Healthy Adults: Effects of Age and Exercise Training

Withdrawn·—·Phase 1·NCT03972683

Growth1 trial

Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth

Not yet recruiting·AApplied Biology, Inc.·Phase 2/3·NCT06648850·800 enrolled

Vasovagal syncope1 trial

Mechanisms of Vasovagal Syncope

Completed·NNew York Medical College·Phase 1·NCT01791816·90 enrolled

Immune Response1 trial

Effects of Vasopressors on Immune Response

Completed·RRadboud University Medical Center·Phase 4·NCT02675868·40 enrolled

Pulmonary Arterial Hypertension1 trial

Management of Acute Pulmonary Hypertensive Crisis in Children With Known Pulmonary Arterial Hypertension

Completed·SStanford University·Phase 4·NCT05439460·15 enrolled

Local Anesthetic1 trial

The Effects of Height and Weight Adjusted Dose of Local Anesthetic.

Completed·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·N/A·NCT02635555·160 enrolled

Metabolism1 trial

Cerebral Flow-metabolism Coupling During Adult Surgery

Unknown status·JJason Chui·Phase 4·NCT05941494·80 enrolled

Spine Surgery1 trial

Vasopressor Outcomes in Spine Surgery

Completed·UUniversity of Texas Southwestern Medical Center·Phase 1·NCT06053398·101 enrolled

Elderly Patients1 trial

Effect of High vs. Low MAP Levels on Clinical Outcomes in Elderly Patients During Noncardiothoracic Surgery

Unknown status·HHu Anmin·N/A·NCT02857153·322 enrolled

Nausea and vomiting1 trial

Prevention of Intraoperative Nausea and Vomiting During Cesarean Section

Completed·—·N/A·NCT01216410·306 enrolled

Microcirculation1 trial

Maternal Microcirculation & SDF Imaging

Completed·IIWK Health Centre·Phase 4·NCT02376192·32 enrolled

Caesarean Delivery1 trial

Maternal Haemodynamic Changes After Crystalloid Co-loading and Phenylephrine Versus Phenylephrine Alone During Spinal Anaesthesia for Elective Caesarean Delivery

Completed·UUniversity Hospital, Basel, Switzerland·N/A·NCT04026685·66 enrolled

Brain Injury1 trial

Target Hemodynamics and Brain Injury During General Anesthesia in the Elderly

Suspended·FFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico·Phase 2/3·NCT02428062·1,812 enrolled

Obesity1 trial

Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity

Completed·UUniversity of Missouri-Columbia·Phase 1·NCT04436731·73 enrolled

Shivering Caused by Spinal Anesthesia1 trial

Effectiveness of Continuous Phenylephrine in Preventing Shivering After Spinal Anesthesia in Cesarean Section

Completed·IIndonesia University·Preclinical·NCT07663149·108 enrolled

Unspecified11 trials

The Contractile Response of the Thoracic Aorta to Vasoactive Substances

Completed·CCatharina Ziekenhuis Eindhoven··NCT06374836·70 enrolled

POTS Adrenergic Ab (CIHR Aims #1&2)

Recruiting·UUniversity of Calgary··NCT02673996·125 enrolled

Ephedrine vs Phenylephrine - ECG Changes

Terminated·UUniversity College London Hospitals·Phase 4·NCT01243970·29 enrolled

Show 8 more trials

Mechanisms of Choroidal Blood Flow Changes During Dark/Light Transitions

Completed·MMedical University of Vienna·Phase 2·NCT00431392·42 enrolled

Effect of Phenylephrine Versus Norepinephrine on Venous Return

Unknown status·AAlgemeen Ziekenhuis Maria Middelares·Phase 4·NCT03872570·40 enrolled

Influence of Continuous Administration of Phenylephrine Versus Dobutamine on Spinal Oxygen Saturation, Measured With Near-infrared Spectroscopy (NIRS).

Completed·UUniversity Hospital, Ghent·Phase 4·NCT03846765·36 enrolled

Variability in Adrenergic Response

Completed·VVanderbilt University·N/A·NCT00838695·106 enrolled

Influence of a Bolus Administration of Ephedrine and Phenylephrine on the Spinal Oxygen Saturation, Measured With NIRS.

Completed·UUniversity Hospital, Ghent·Phase 4·NCT03767296·33 enrolled

Role of Angiotensin II in Insulin-induced Microvascular Activity

Completed·MMaastricht University Medical Center·N/A·NCT01024543·18 enrolled

The Effect of Brimonidine

Completed·WWake Forest University Health Sciences·Phase 4·NCT03959176·13 enrolled

Quantification of Dynamic and Static Cerebral Autoregulation (CA) Under Anaesthesia

Completed·—·N/A·NCT03816072·66 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 21, 2013

PHENYLEPHRINE HYDROCHLORIDE

NDA NDA203510

Jun 27, 2014

VAZCULEP

NDA NDA204300

Jan 15, 2015

PHENYLEPHRINE HYDROCHLORIDE

NDA NDA207926

Oct 21, 2019

BIORPHEN

NDA NDA212909

Mar 9, 2023

IMMPHENTIV

NDA NDA203826

May 30, 2025

PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

NDA NDA216830

Sources

References

[1]
ClinicalTrials.gov — 147 trial records for Phenylephrine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Neo-Synephrine drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Phenylephrine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Phenylephrine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA216830). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Neo-Synephrine. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Exela Pharma Sciences, LLC. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adrenergic Receptor Alpha-1 Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: EExela Pharma Sciences, LLC.

Patent Landscape[6]

Patent Cliff

Nov 14, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8859623Nov 14, 2033

11471400Aug 5, 2036

11213480Sep 26, 2036

12257342Sep 26, 2036

12564561Aug 8, 2044