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
NCT07006168 Phase 4
Recruiting
Effects Of Intra-Operative Intra-Articular Cocktail Injection In Patella Open Re...
Condition
Patella Fracture
Enrollment
56 pts
Location
Hong Kong
Sponsor
The University of Hong Kong
NCT07639424 Phase 4
Recruiting
Study to Evaluate a New Cartilage Regeneration Platform for Knee Cartilage Repai...
Condition
Cartilage Defects of the Knee
Enrollment
104 pts
Location
South Korea
Sponsor
ROKIT Healthcare
NCT04014803 Phase 4
Recruiting
Aspirin and a PoTent P2Y12 Inhibitor Versus Aspirin and Clopidogrel in Patients ...
Condition
Coronary Artery Disease
Enrollment
3,500 pts
Location
South Korea
Sponsor
Samsung Medical Center
NCT06384456 Phase 4
Recruiting
Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following DRF Fi...
Condition
Distal Radius Fractures
Enrollment
90 pts
Location
Canada
Sponsor
University Health Network, Tor
NCT03671967 Phase 4
Recruiting
PipEracillin Tazobactam Versus mERoPENem for Treatment of Bloodstream Infections...
Condition
Beta Lactam Resistant Bacterial Infection
Enrollment
1,084 pts
Location
Canada, Israel
Sponsor
Rambam Health Care Campus
NCT05722405 Phase 4
Recruiting
Ixazomib Plus Low-dose Lenalidomide Versus Ixazomib Alone for Maintenance Treatm...
Condition
Multiple Myeloma
Enrollment
100 pts
Location
China
Sponsor
Second Affiliated Hospital, Zh
NCT07781722 Phase 4
Recruiting
Tacrolimus as Prophylaxis of Post-ERCP Pancreatitis
Condition
Post-ERCP Pancreatitis
Enrollment
520 pts
Location
Netherlands
Sponsor
Amsterdam UMC, location VUmc
NCT07205757 Phase 4
Recruiting
Adding Lidocaine to Custodiol Mixture
Condition
CAD
Enrollment
70 pts
Location
Egypt
Sponsor
Fayoum University Hospital
NCT06819436 Phase 4
Recruiting
Effect of Dexamethasone on Post-spinal Hypotension
Condition
Post Spinal Anaesthesia Hypotension
Enrollment
170 pts
Location
Pakistan
Sponsor
Shaheed Mohtarma Benazir Bhutt
NCT07280702 Phase 4
Recruiting
Deucravacitinib-TNFi Combination Therapy for Difficult-to-Control Psoriatic Dise...
Condition
Psoriatic Arthritis (PsA)
Enrollment
128 pts
Location
United States
Sponsor
University of Texas Southweste
NCT05702931 Phase 4
Recruiting
Semaglutide Treatment for Hyperglycaemia After Renal Transplantation
Condition
Hyperglycemia
Enrollment
104 pts
Location
Denmark
Sponsor
Copenhagen University Hospital
NCT07527156 Phase 4
Recruiting
Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure
Condition
Acute Heart Failure (AHF)
Enrollment
12 pts
Location
Czechia
Sponsor
Institute for Clinical and Exp
NCT06293677 Phase 4
Recruiting
Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neut...
Condition
Febrile Neutropenia
Enrollment
30 pts
Location
Switzerland
Sponsor
Centre Hospitalier Universitai
NCT05421741 Phase 4
Recruiting
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Condition
Osteomyelitis Tibia
Enrollment
242 pts
Location
United States
Sponsor
Wake Forest University Health
NCT06655272 Phase 4
Recruiting
OM 85 to Prevent Respiratory Infections in Older At Risk Patients
Condition
Respiratory Tract Infections (RTI)
Enrollment
360 pts
Location
Italy
Sponsor
Campus Bio-Medico University
NCT07930988 Phase 4
Recruiting
Typhoid Conjugate Vaccine Introduction in Madagascar (TyMA): Evaluation of the R...
Condition
Salmonella Typhi Infection
Enrollment
60,000 pts
Location
Madagascar
Sponsor
Rita Soares Barbosa Cardona
NCT04728516 Phase 4
Recruiting
The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in AC...
Condition
Acute Coronary Syndrome
Enrollment
2,600 pts
Location
China
Sponsor
Qilu Hospital of Shandong Univ
NCT04638647 Phase 4
Recruiting
Secukinumab Open Label Roll-over Extension Protocol
Condition
Autoimmunity, Inflammation
Enrollment
1,000 pts
Location
United States, Belgium, Brazil
Sponsor
Novartis Pharmaceuticals
NCT06282510 Phase 4
Recruiting
Nasal Antisepsis for C. Auris Prevention
Condition
Candida Auris Infection
Enrollment
120 pts
Location
United States
Sponsor
Mary K Hayden
NCT06541535 Phase 4
Recruiting
Fluid Administration in Ketoacidosis (DRINK)
Condition
Diabetic Keto-acidosis
Enrollment
300 pts
Location
France
Sponsor
Centre Hospitalier Universitai
NCT05247125 Phase 4
Recruiting
The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Strok...
Condition
Ischemic Stroke, Acute
Enrollment
80 pts
Location
Russia
Sponsor
Federal State Budgetary Instit
NCT07025148 Phase 4
Recruiting
Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose ...
Condition
Coronary Arterial Disease (CAD)
Enrollment
40 pts
Location
United States
Sponsor
University of Florida
NCT07718126 Phase 4
Recruiting
Pre-hepatectomy Rehabilitation in Obese MASLD-Complicated Living Liver Donors Wi...
Condition
Metabolic Dysfunction-Associated Steatohepatitis
Enrollment
60 pts
Location
China
Sponsor
West China Hospital
NCT07169825 Phase 4
Recruiting
Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA in Patients With Comp...
Condition
Lu-177 PSMA
Enrollment
25 pts
Location
United States
Sponsor
M.D. Anderson Cancer Center
NCT07142343 Phase 4
Recruiting
A Study to Test the Safety of Pozelimab in Pediatric Participants 1 to 5 Years o...
Condition
CHAPLE Disease
Enrollment
5 pts
Location
Turkey (Türkiye)
Sponsor
Regeneron Pharmaceuticals
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