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
NCT04460235 Phase 4
Recruiting
Clinical Trial Assessing the Immunogenicity of an Anti-pneumococcal Vaccination ...
Condition
Vaccine
Enrollment
160 pts
Location
France
Sponsor
Poitiers University Hospital
NCT07124650 Phase 4
Recruiting
Sore Throat After Open Neck Elective Surgery
Condition
Postoperative Sore Throat, Cough, Hoarseness
Enrollment
764 pts
Location
Russia
Sponsor
Saint Petersburg State Univers
NCT07580950 Phase 4
Recruiting
The Research of Integrated Traditional Chinese and Western Medicine on Hypothala...
Condition
Functional Hypothalamic Amenorrhea
Enrollment
210 pts
Location
China
Sponsor
Peking Union Medical College H
NCT07306988 Phase 4
Recruiting
Eradication of Helicobacter Pylori Improves Metabolic Syndrome Through Modulatio...
Condition
HELICOBACTER PYLORI INFECTIONS
Enrollment
120 pts
Location
China
Sponsor
Nanjing First Hospital, Nanjin
NCT06467786 Phase 4
Recruiting
Study on the Therapeutic Effect of Irinotecan Liposomes in Small Cell Lung Cance...
Condition
Small Cell Lung Cancer
Enrollment
24 pts
Location
China
Sponsor
Tang-Du Hospital
NCT04863222 Phase 4
Recruiting
Clinical and Radiographic Success of MTA vs Biodentine
Condition
Indirect Pulp Cap
Enrollment
646 pts
Location
United States
Sponsor
Geisinger Clinic
NCT07089602 Phase 4
Recruiting
Trial Assessing the Efficacy of Human Placental Membrane Products and Standard o...
Condition
Diabetic Foot
Enrollment
650 pts
Location
United States
Sponsor
BioLab Holdings
NCT06455969 Phase 4
Recruiting
Adaptions and Resiliency to Multi-Stressor OpeRations
Condition
Musculoskeletal Injury
Enrollment
120 pts
Location
United States
Sponsor
Bradley Nindl
NCT07761351 Phase 4
Recruiting
A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-...
Condition
Lung Cancer (Diagnosis)
Enrollment
550 pts
Location
Switzerland, United Kingdom
Sponsor
Intuitive Surgical
NCT06004986 Phase 4
Recruiting
DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema
Condition
Atopic Dermatitis
Enrollment
216 pts
Location
Netherlands
Sponsor
Academisch Medisch Centrum - U
NCT07145866 Phase 4
Recruiting
Varenicline and Accelerated Transcranial Magnetic Stimulation (TMS) for Quitting...
Condition
Nicotine Dependence
Enrollment
30 pts
Location
United States
Sponsor
Massachusetts General Hospital
NCT07178145 Phase 4
Recruiting
Epicardial Adipose Tissue Composition and Heart Failure With Preserved Ejection ...
Condition
Heart Failure Preserved Ejection Fraction
Enrollment
192 pts
Location
United States
Sponsor
University of Virginia
NCT06242795 Phase 4
Recruiting
Hypertonic Saline in NCFB
Condition
Bronchiectasis
Enrollment
20 pts
Location
United States
Sponsor
University of North Carolina,
NCT07381556 Phase 4
Recruiting
Cyclosporine Or Methotrexate for Pediatric Alopecia Areata: Routine Clinical Car...
Condition
Alopecia Areata(AA)
Enrollment
50 pts
Location
Netherlands
Sponsor
Erasmus Medical Center
NCT06597201 Phase 4
Recruiting
Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution...
Condition
End Stage Renal Disease (ESRD)
Enrollment
400 pts
Location
China
Sponsor
Chengdu Qingshan Likang Pharma
NCT05638867 Phase 4
Recruiting
NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After P...
Condition
Coronary Artery Disease
Enrollment
3,944 pts
Location
China
Sponsor
China National Center for Card
NCT05030545 Phase 4
Recruiting
Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot C...
Condition
Primary Aldosteronism
Enrollment
40 pts
Location
United States
Sponsor
Brigham and Women's Hospital
NCT06642272 Phase 4
Recruiting
A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Rand...
Condition
Diabetes Mellitus, Type 2
Enrollment
17,200 pts
Location
Denmark
Sponsor
Herlev and Gentofte Hospital
NCT06095128 Phase 4
Recruiting
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
Condition
Ulcerative Colitis
Enrollment
65 pts
Location
United States, Canada
Sponsor
Takeda
NCT03765567 Phase 4
Recruiting
Placement of Antibiotic Powder in Wounds During the Emergency Room
Condition
Open Fracture
Enrollment
200 pts
Location
United States
Sponsor
The University of Texas Health
NCT06187311 Phase 4
Recruiting
Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in P...
Condition
Atrial Fibrillation
Enrollment
940 pts
Location
South Korea
Sponsor
Korea University Anam Hospital
NCT07209475 Phase 4
Recruiting
Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
Condition
Diabetic Foot Ulcer (DFU)
Enrollment
248 pts
Location
United States
Sponsor
Royal Biologics
NCT04938765 Phase 4
Recruiting
Effect of Magnesium Sulfate Bolus on Intraoperative Neuromonitoring
Condition
Intraoperative Neurophysiological Monitoring
Enrollment
50 pts
Location
United States
Sponsor
Loma Linda University
NCT05892744 Phase 4
Recruiting
Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
Condition
Major Depressive Disorder
Enrollment
50 pts
Location
United States
Sponsor
University of Texas at Austin
NCT06855537 Phase 4
Recruiting
Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques
Condition
Coronary Arterial Disease (CAD)
Enrollment
2,190 pts
Location
China
Sponsor
Beijing Anzhen Hospital
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