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
342
Recruiting Now
342
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
NCT06932874 Phase 4
Recruiting
Metformin Hydrochloride Sustained-release Tablets (Ⅲ) in Patients With Type 2 Di...
Condition
Atherosclerotic Heart Disease
Enrollment
356 pts
Location
China
Sponsor
China National Center for Card
NCT06012097 Phase 4
Recruiting
Impact of Gel Aromatherapy on Pain for Patients With De Quervain Disease
Condition
De Quervain Disease
Enrollment
70 pts
Location
France
Sponsor
University Hospital, Strasbour
NCT07046676 Phase 4
Recruiting
Pharmacogenetics-Based Study on Individualized Use of Sodium Valproate
Condition
Epilepsy
Enrollment
312 pts
Location
China
Sponsor
The First Affiliated Hospital
NCT07158476 Phase 4
Recruiting
Efficacy of Methylprednisolone for Pain Control After ACL Repair
Condition
ACL Surgery
Enrollment
90 pts
Location
United States
Sponsor
St. Louis University
NCT05305313 Phase 4
Recruiting
Evaluation of Propofol Dosing Based on Total Body Weight Using Closes-loop Anaes...
Condition
Obesity, Morbid
Enrollment
46 pts
Location
India
Sponsor
Sir Ganga Ram Hospital
NCT07267559 Phase 4
Recruiting
Dual Orexin Antagonism and Emotion and Affective Processing Study
Condition
Learning
Enrollment
62 pts
Location
United Kingdom
Sponsor
University of Oxford
NCT06695910 Phase 4
Recruiting
Modulation of the Brain Fog Scale by Eicosapentaenoic Acid Monoglycerides (MAG-E...
Condition
Brain Fog
Enrollment
48 pts
Location
Canada
Sponsor
Samuel Fortin
NCT07457060 Phase 4
Recruiting
Phase IV Clinical Study of Sequential Vaccination of Sabin Strain and Wild Strai...
Condition
Poliomyelitis
Enrollment
480 pts
Location
Philippines
Sponsor
Sinovac Biotech Co., Ltd
NCT06008860 Phase 4
Recruiting
A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS...
Condition
COVID-19
Enrollment
280 pts
Location
United States
Sponsor
University of Chicago
NCT05626348 Phase 4
Recruiting
The Clinical Efficacy of Immunomodulators in RA Patients
Condition
Arthritis, Rheumatoid
Enrollment
400 pts
Location
China
Sponsor
Qilu Hospital of Shandong Univ
NCT07086443 Phase 4
Recruiting
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Th...
Condition
Diabetic Foot Ulcer
Enrollment
350 pts
Location
United States
Sponsor
Sequence LifeScience, Inc.
NCT07341776 Phase 4
Recruiting
Steroid Use in Treatment of Allergic Reactions to Food
Condition
Anaphylactic Reaction
Enrollment
160 pts
Location
Switzerland
Sponsor
Johannes Trueck
NCT07110415 Phase 4
Recruiting
Efficacy and Safety Trials of Yangxinshi Tablets in the Treatment of Patients Wi...
Condition
Coronary Heart Disease
Enrollment
2,708 pts
Location
China
Sponsor
SPH Qingdao Growful Pharmaceti
NCT06741358 Phase 4
Recruiting
Using Glialia for Treating Persistent Perceptual Postural Dizziness
Condition
Persistent Postural Perceptual Dizziness
Enrollment
30 pts
Location
Italy
Sponsor
I.R.C.C.S. Fondazione Santa Lu
NCT06513208 Phase 4
Recruiting
Ketorolac Effects on Post-operative Pain and Lumbar Fusion
Condition
Lumbar Spinal Fusion
Enrollment
140 pts
Location
United States
Sponsor
University of Maryland St. Jos
NCT07691125 Phase 4
Recruiting
Phase IV Study of rhGH Injection in Adult Short Bowel Syndrome
Condition
Short Bowel Syndrome (SBS) in Adults
Enrollment
100 pts
Location
China
Sponsor
Changchun GeneScience Pharmace
NCT07152340 Phase 4
Recruiting
The Safety and Efficacy of Sequential Hormone Therapy and IBI311 Therapy in Pati...
Condition
Thyroid Associated Ophthalmopathies
Enrollment
64 pts
Location
China
Sponsor
Shanghai Changzheng Hospital
NCT06655376 Phase 4
Recruiting
Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients ...
Condition
Bleeding
Enrollment
128 pts
Location
United States
Sponsor
Columbia University
NCT06399185 Phase 4
Recruiting
Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort
Condition
Urinary Catheter
Enrollment
1,740 pts
Location
China
Sponsor
Peking University First Hospit
NCT06509893 Phase 4
Recruiting
Ticagrelore Alone Post PCI
Condition
Coronary Artery Disease
Enrollment
5,400 pts
Location
Iran
Sponsor
Shiraz University of Medical S
NCT06642623 Phase 4
Recruiting
A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2...
Condition
Diabetes Mellitus, Type 2
Enrollment
2,862 pts
Location
South Korea
Sponsor
Yonsei University
NCT06595459 Phase 4
Recruiting
The Options 2 Study
Condition
Smoker
Enrollment
300 pts
Location
United States
Sponsor
University of Wisconsin, Madis
NCT06020716 Phase 4
Recruiting
Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - th...
Condition
Protracted Bacterial Bronchitis
Enrollment
350 pts
Location
Norway
Sponsor
Helse Stavanger HF
NCT06568549 Phase 4
Recruiting
Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRA...
Condition
Kidney Transplantation
Enrollment
350 pts
Location
United States
Sponsor
Mayo Clinic
NCT06959147 Phase 4
Recruiting
High-Voltage Long-Duration Pulsed Radiofrequency Combined With Liposomal Bupivac...
Condition
Herpes Zoster Pain
Enrollment
46 pts
Location
China
Sponsor
Shirong Tan
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