Browse by Phase
Phase 4 Clinical Trials
Phase 4 trials (post-market surveillance) occur after a drug has been approved. They monitor long-term effectiveness and safety in general patient populations.
Total Trials
350
Recruiting Now
350
Top Conditions in Phase 4
Frequently Asked Questions — Phase 4 Trials
What is the purpose of a Phase 4 post-market clinical trial?
Phase 4 trials occur after a drug has received regulatory approval. They monitor long-term effectiveness and safety in real-world patient populations, detect rare adverse events too infrequent to appear in earlier trials, study effectiveness in subgroups (elderly, pediatric, renally impaired), and may explore new indications for the approved drug. Some Phase 4 studies are mandated by the FDA as a condition of approval.
Who sponsors Phase 4 trials?
Phase 4 trials are primarily sponsored by pharmaceutical and biotech companies that hold the drug's marketing authorization. Some are mandated by the FDA or EMA—particularly when approval was based on surrogate endpoints and confirmatory long-term data is required. Independent academic institutions and registry-based programs also conduct Phase 4 studies.
Are Phase 4 trials safer than Phase 1–3 trials?
Phase 4 trials involve drugs that have already demonstrated an acceptable safety profile in earlier phases and received regulatory approval. As a result, the risk profile for participants is generally better characterized than in early-phase trials. However, these studies are still clinical research designed partly to detect long-term or rare adverse events not observed in pre-approval trials.
Active Phase 4 Studies
NCT07263035 Phase 4
Recruiting
Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Fa...
Condition
Heart Failure
Enrollment
600 pts
Location
United States
Sponsor
Lakeland Regional Health Syste
NCT07671989 Phase 4
Recruiting
Period Pills for Menstrual Regulation: A New Reproductive Health Option
Condition
Menstrual Regulation
Enrollment
100 pts
Location
United States
Sponsor
University of California, San
NCT07611890 Phase 4
Recruiting
Dexmedetomidine vs Lignocaine for Reducing Intubation-Induced Hemodynamic Respon...
Condition
Laryngoscopic Stress Response
Enrollment
70 pts
Location
Pakistan
Sponsor
Rawalpindi Institute of Cardio
NCT03232918 Phase 4
Recruiting
Oxytocin and Fetal Heart Rate Changes
Condition
Fetal Bradycardia Complicating Labor and Delivery
Enrollment
730 pts
Location
United States
Sponsor
Unyime Ituk
NCT06793982 Phase 4
Recruiting
Platelet Rich Plasma Versus Corticosteroids in Hip Osteoarthritis Pain
Condition
Hip Osteoarthritis
Enrollment
54 pts
Location
United States
Sponsor
LifeBridge Health
NCT02817360 Phase 4
Recruiting
NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients
Condition
Heart Diseases
Enrollment
2,400 pts
Location
Austria, Netherlands, New Zealand
Sponsor
Martin Huelsmann
NCT07150624 Phase 4
Recruiting
The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcho...
Condition
Hepatocellular Carcinoma (HCC)
Enrollment
96 pts
Location
China
Sponsor
Anhui Provincial Hospital
NCT03438526 Phase 4
Recruiting
The Basel BOMP-AID Randomized Trial
Condition
Hypoactive Delirium
Enrollment
190 pts
Location
Switzerland
Sponsor
University Hospital, Basel, Sw
NCT06562543 Phase 4
Recruiting
A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populati...
Condition
Colorectal Cancer
Enrollment
78 pts
Location
United States, Puerto Rico
Sponsor
Takeda
NCT07172893 Phase 4
Recruiting
A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
Condition
Diabetic Foot Ulcer (DFU)
Enrollment
150 pts
Location
United States
Sponsor
HealthTech Wound Care
NCT06520904 Phase 4
Recruiting
Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Opti...
Condition
Coronary Artery Disease
Enrollment
396 pts
Location
China
Sponsor
First Affiliated Hospital of X
NCT05703919 Phase 4
Recruiting
Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonar...
Condition
COPD Exacerbation
Enrollment
1,888 pts
Location
Denmark
Sponsor
Central Denmark Region
NCT05408247 Phase 4
Recruiting
A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol ...
Condition
Alcohol Use Disorder (AUD)
Enrollment
280 pts
Location
Australia
Sponsor
University of Sydney
NCT06967012 Phase 4
Recruiting
A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Trea...
Condition
Epilepsies, Partial
Enrollment
30 pts
Location
China
Sponsor
Affiliated Hospital of Nantong
NCT04875819 Phase 4
Recruiting
Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization ...
Condition
Hiv
Enrollment
55 pts
Location
Denmark
Sponsor
Thomas Benfield
NCT04647227 Phase 4
Recruiting
SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
Condition
Hemophilia A With Inhibitor
Enrollment
55 pts
Location
United States
Sponsor
American Thrombosis and Hemost
NCT06144177 Phase 4
Recruiting
Induction in the Dark
Condition
Anesthesia Induction
Enrollment
240 pts
Location
United States
Sponsor
Medical University of South Ca
NCT05995600 Phase 4
Recruiting
Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin As Secondar...
Condition
Antiphospholipid Syndrome
Enrollment
200 pts
Location
South Korea
Sponsor
Seoul National University Hosp
NCT06706284 Phase 4
Recruiting
Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spin...
Condition
Spinal Cord Injuries
Enrollment
50 pts
Location
United States
Sponsor
Marzieh Salehi
NCT04811014 Phase 4
Recruiting
Young Houston Emergency Opioid Engagement System
Condition
Opioid-use Disorder
Enrollment
250 pts
Location
United States
Sponsor
The University of Texas Health
NCT05764733 Phase 4
Recruiting
Bone, Exercise, Alendronate, and Caloric Restriction
Condition
Bone Loss
Enrollment
900 pts
Location
United States
Sponsor
Wake Forest University Health
NCT06614036 Phase 4
Recruiting
Remimazolam Versus Midazolam for Sedation During Upper GI Endoscopy: a Randomize...
Condition
Sedation for Diagnostic Gastroscopy
Enrollment
148 pts
Location
Netherlands
Sponsor
Koen Munters
NCT07523815 Phase 4
Recruiting
Artificial Intelligence Assisted Workflow Versus Conventional Workflow in Guided...
Condition
Partially Edentulous Mandible
Enrollment
20 pts
Location
Egypt
Sponsor
Sandra Moussa Botros El Tarzi
NCT07158814 Phase 4
Recruiting
Safety of RSV Preventive Monoclonal Antibody
Condition
Fever
Enrollment
524 pts
Location
United States
Sponsor
Duke University
NCT06609447 Phase 4
Recruiting
The Efficacy and Safety of Combining Probiotic VSL#3 With Vedolizumab for the Tr...
Condition
Ulcerative Colitis
Enrollment
100 pts
Location
China
Sponsor
Second Affiliated Hospital, Sc
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