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
374
Recruiting Now
374
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
NCT07734636 Phase 4
Recruiting
A Prompt REstart Study of Renin-Angiotensin System Inhibitors After Acute Kidney...
Condition
Acute Kidney Injury
Enrollment
60 pts
Location
United States
Sponsor
University of California, San
NCT07074444 Phase 4
Recruiting
Treatment of Clonorchiasis in Guangxi With Albendazole, Tribendimidine, and Praz...
Condition
Clonorchiasis
Enrollment
318 pts
Location
China
Sponsor
First Affiliated Hospital of G
NCT05784311 Phase 4
Recruiting
Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SP...
Condition
Pancreatic Cancer
Enrollment
344 pts
Location
Netherlands
Sponsor
Leiden University Medical Cent
NCT07744698 Phase 4
Recruiting
Metronomic Oral Paclitaxel Plus PD-1/ PD-L1 Inhibitor Maintenance in Advanced Lu...
Condition
Squamous Non-Small Cell Lung Cancer sqNSCLC
Enrollment
107 pts
Location
China
Sponsor
Anhui Provincial Cancer Hospit
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
NCT07668271 Phase 4
Recruiting
Lot-to-Lot Consistency Clinical Trial of Recombinant Human Papillomavirus 9-vale...
Condition
Infection by Human Papilloma Virus
Enrollment
720 pts
Location
China
Sponsor
Xiamen Innovax Biotech Co., Lt
NCT07026539 Phase 4
Recruiting
Effect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patie...
Condition
Type 2 Diabetes Mellitus (T2DM)
Enrollment
80 pts
Location
Denmark
Sponsor
University of Aarhus
NCT06934057 Phase 4
Recruiting
Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma
Condition
Kidney Cancer
Enrollment
50 pts
Location
France
Sponsor
Gustave Roussy, Cancer Campus,
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
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
NCT07259512 Phase 4
Recruiting
Single and Twice-daily Dosing of Ramipril on Renal Function in Chronic Kidney Di...
Condition
Chronic Kidney Disease
Enrollment
80 pts
Location
Indonesia
Sponsor
Evi Liliek Wulandari
NCT05365438 Phase 4
Recruiting
Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Pati...
Condition
Dyslipidemias
Enrollment
105 pts
Location
South Korea
Sponsor
Seoul National University Bund
NCT06594068 Phase 4
Recruiting
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in A...
Condition
Systemic Lupus Erythematosus
Enrollment
16 pts
Location
United States
Sponsor
AstraZeneca
NCT06031233 Phase 4
Recruiting
Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immu...
Condition
Oncology
Enrollment
776 pts
Location
Netherlands
Sponsor
Isala
NCT04700826 Phase 4
Recruiting
Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community ...
Condition
Atrial Fibrillation
Enrollment
3,000 pts
Location
United Kingdom
Sponsor
University of Birmingham
NCT06499415 Phase 4
Recruiting
Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in ...
Condition
Actinic Keratoses
Enrollment
232 pts
Location
Netherlands
Sponsor
Maastricht University Medical
NCT04962776 Phase 4
Recruiting
Preoperative Coadministration of Low-concentration Carbohydrate and Nitrates Loa...
Condition
Length of Hospital Stay
Enrollment
90 pts
Location
Egypt
Sponsor
Ain Shams University
NCT07477691 Phase 4
Recruiting
Immune Modulation During Palynziq® Treatment in Adults (IMPALA)
Condition
Phenylketonuria
Enrollment
12 pts
Location
United States
Sponsor
BioMarin Pharmaceutical
NCT06448676 Phase 4
Recruiting
Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabella...
Condition
Wrinkle
Enrollment
325 pts
Location
Netherlands
Sponsor
Academisch Medisch Centrum - U
NCT07174076 Phase 4
Recruiting
Prevention of Recurrence With Cordyceps Sinensis in Mycobacterium Avium Complex ...
Condition
Mycobacterium Avium Complex Pulmonary Disease
Enrollment
300 pts
Location
China
Sponsor
Bin Cao
NCT07721714 Phase 4
Recruiting
SMILE Surgery in One Eye Compared to Ray Tracing-guided LASIK Surgery in the Fel...
Condition
Myopia
Enrollment
62 pts
Location
United States
Sponsor
Stanford University
NCT06256991 Phase 4
Recruiting
Potassium Correction for RAAS Optimization in Chronic Kidney Disease
Condition
Chronic Kidney Diseases
Enrollment
44 pts
Location
Netherlands
Sponsor
University Medical Center Gron
NCT01406691 Phase 4
Recruiting
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Condition
Delayed Sleep Phase Disorder
Enrollment
20 pts
Location
United States
Sponsor
Stanford University
NCT06902285 Phase 4
Recruiting
Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty
Condition
Sleep
Enrollment
64 pts
Location
United States
Sponsor
University of Miami
NCT06427343 Phase 4
Recruiting
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric De...
Condition
Heart Failure
Enrollment
114 pts
Location
China
Sponsor
China-Japan Friendship Hospita
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