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
332
Recruiting Now
332
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
NCT06979726 Phase 4
Recruiting
Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of ...
Condition
Heart Failure
Enrollment
100 pts
Location
United States
Sponsor
University of Florida
NCT06367855 Phase 4
Recruiting
Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF
Condition
Spinal Stenosis Lumbar
Enrollment
60 pts
Location
Thailand
Sponsor
Potsawat Surabotsopon
NCT06636578 Phase 4
Recruiting
Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Ner...
Condition
Analgesia
Enrollment
90 pts
Location
Egypt
Sponsor
Fayoum University
NCT05854615 Phase 4
Recruiting
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI)...
Condition
Critical Limb Ischemia
Enrollment
3 pts
Location
Malaysia
Sponsor
Cell Biopeutics Resources Sdn
NCT06400940 Phase 4
Recruiting
Prospective, Post-registration, Interventional, Randomized, in Parallel Groups, ...
Condition
Intracranial Aneurysm
Enrollment
640 pts
Location
Russia
Sponsor
Federal State Budgetary Instit
NCT06667999 Phase 4
Recruiting
The Intensive Care Platform Trial
Condition
Intensive Care Patients
Enrollment
10,000 pts
Location
Denmark
Sponsor
Anders Perner
NCT05266898 Phase 4
Recruiting
Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
Condition
Papillomavirus Vaccines
Enrollment
250 pts
Location
United States
Sponsor
Louisiana State University Hea
NCT06429332 Phase 4
Recruiting
International Care Bundle Evaluation in Cerebral Hemorrhage Research
Condition
Intracerebral Hemorrhage
Enrollment
3,500 pts
Location
United States, Australia, Canada
Sponsor
Region Skane
NCT05491200 Phase 4
Recruiting
Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugre...
Condition
ST Elevated Myocardial Infarction
Enrollment
1,656 pts
Location
Belgium, Czechia, Germany
Sponsor
Research Maatschap Cardiologen
NCT06690307 Phase 4
Recruiting
Oxycodone Versus Sufentanil in Patient-controlled Intravenous Analgesia After La...
Condition
Laparoscopic Hysterectomy
Enrollment
64 pts
Location
China
Sponsor
Affiliated Hospital of Nantong
NCT04730609 Phase 4
Recruiting
Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Deli...
Condition
Shivering
Enrollment
40 pts
Location
United States
Sponsor
Mayo Clinic
NCT07572032 Phase 4
Recruiting
Delayed Initiation of ARNI and SGLT2i in Heart Failure With Corrected Aetiology ...
Condition
Heart Failure Due to Coronary Artery Disease
Enrollment
80 pts
Location
South Korea
Sponsor
Kyungsub Song
NCT07018375 Phase 4
Recruiting
Effect of Oliceridine Patient-Controlled Intravenous Analgesia on Postoperative ...
Condition
Chronic Postsurgical Pain
Enrollment
320 pts
Location
China
Sponsor
Tianjin Medical University Gen
NCT07369128 Phase 4
Recruiting
Propofol-Only Versus Dexmedetomidine-Propofol in Children Undergoing Magnetic Re...
Condition
MRI Sedation
Enrollment
105 pts
Location
United States
Sponsor
Boston Children's Hospital
NCT07487077 Phase 4
Recruiting
Extended Dosing Intervals Trial for Oral Cholera Vaccine, Kenya
Condition
Cholera Vaccination
Enrollment
1,071 pts
Location
Kenya
Sponsor
Albert B. Sabin Vaccine Instit
NCT06860711 Phase 4
Recruiting
Safety of Short-course of NSAIDs in Pediatric Patients With CKD
Condition
Chronic Kidney Disease
Enrollment
164 pts
Location
United States
Sponsor
University of Colorado, Denver
NCT03696199 Phase 4
Recruiting
Randomized Controlled Trial for Ankle Fracture Pain Control
Condition
Ankle Fractures
Enrollment
70 pts
Location
United States
Sponsor
Lahey Clinic
NCT06606821 Phase 4
Recruiting
The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery...
Condition
Coronary Artery Disease
Enrollment
124 pts
Location
Denmark
Sponsor
Tina Vilsbøll
NCT05851976 Phase 4
Recruiting
Duloxetine for LBP
Condition
Back Pain, Low
Enrollment
120 pts
Location
United States
Sponsor
Montefiore Medical Center
NCT07697404 Phase 4
Recruiting
The ED95 of Ciprofol for Laryngeal Mask Airway Insertion With Fentanyl in Childr...
Condition
Pediatric
Enrollment
180 pts
Location
China
Sponsor
Huazhong University of Science
NCT06217185 Phase 4
Recruiting
The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the T...
Condition
HER2-positive Breast Cancer
Enrollment
100 pts
Location
China
Sponsor
Hebei Medical University Fourt
NCT03855917 Phase 4
Recruiting
Strategic Treatment Reduction in Very Early Liver Disease With 4 Weeks Sofosbuvi...
Condition
Hepatitis C
Enrollment
30 pts
Location
Australia
Sponsor
Kirby Institute
NCT06003348 Phase 4
Recruiting
Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones
Condition
Calcium Phosphate Kidney Stones
Enrollment
25 pts
Location
United States
Sponsor
University of Texas Southweste
NCT04057378 Phase 4
Recruiting
Optimal Electrical Stimulus During Electroconvulsive Therapy
Condition
Depressive Disorder, Major
Enrollment
800 pts
Location
Sweden
Sponsor
Region Örebro County
NCT07177417 Phase 4
Recruiting
Characterizing the Human Airway Immune Response to FluMist Vaccination
Condition
Healthy Young Adults
Enrollment
30 pts
Location
United States
Sponsor
Washington University School o
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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer · Last Reviewed: September 2026 · Data Methodology