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
348
Recruiting Now
348
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
NCT07460518 Phase 4
Recruiting
Tranexamic Acid for Bleeding Reduction During TURP Surgery
Condition
Benign Prostatic Hyperplasia
Enrollment
80 pts
Location
Morocco
Sponsor
Hamza Najout
NCT05207358 Phase 4
Recruiting
Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Ne...
Condition
Lupus Nephritis
Enrollment
30 pts
Location
Romania
Sponsor
Institutul Clinic Fundeni
NCT06108648 Phase 4
Recruiting
Efficacy of Lavender Essential Oil Chest Wraps in Infants With Bronchiolitis
Condition
Bronchiolitis
Enrollment
400 pts
Location
Switzerland
Sponsor
University Hospital, Geneva
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
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
NCT07678268 Phase 4
Recruiting
Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Compared With D...
Condition
HIV Infection
Enrollment
78 pts
Location
Mexico
Sponsor
Instituto Mexicano del Seguro
NCT07717684 Phase 4
Recruiting
Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic In...
Condition
Intravenous Anesthesia
Enrollment
66 pts
Location
Brazil
Sponsor
Universidade Federal de Sergip
NCT07616687 Phase 4
Recruiting
Optimal Care With Guselkumab in Crohn's Disease / OPTIM Study A Prospective Open...
Condition
Crohn Disease (CD)
Enrollment
210 pts
Location
France
Sponsor
Groupe d'Etude Therapeutique d
NCT07870538 Phase 4
Recruiting
A Neuropsychobiological Approach to Optimize Patient Selection for GLP-1-based P...
Condition
Obesity & Overweight
Enrollment
96 pts
Location
Belgium
Sponsor
Universitaire Ziekenhuizen KU
NCT03855046 Phase 4
Recruiting
Complex Treatment of a Chronic Anal Fissure
Condition
Fissure in Ano
Enrollment
340 pts
Location
Russia
Sponsor
State Scientific Centre of Col
NCT02922894 Phase 4
Recruiting
Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury
Condition
Sleep Apnea
Enrollment
100 pts
Location
United States
Sponsor
John D. Dingell VA Medical Cen
NCT06625073 Phase 4
Recruiting
Randomized Trial of SGLT2i in Heart Transplant Recipients
Condition
Heart Transplant
Enrollment
200 pts
Location
United States
Sponsor
VA Office of Research and Deve
NCT07235683 Phase 4
Recruiting
Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Res...
Condition
CMV
Enrollment
40 pts
Location
Canada
Sponsor
University Health Network, Tor
NCT07819682 Phase 4
Recruiting
Dexamethasone and Duration of Spinal Anesthesia
Condition
Dexamethasone
Enrollment
110 pts
Location
Pakistan
Sponsor
Holy Family Hospital, Pakistan
NCT07895394 Phase 4
Recruiting
Immunogenicity and Safety of Respiratory Syncytial Virus Vaccine in Lung Transpl...
Condition
Vaccination
Enrollment
80 pts
Location
South Korea
Sponsor
Seoul National University Hosp
NCT06930573 Phase 4
Recruiting
A Study of AK112, a PD-1/ VEGF Bispecific Antibody, for Resectable Hepatocellula...
Condition
HCC
Enrollment
30 pts
Location
China
Sponsor
The First Affiliated Hospital
NCT07391579 Phase 4
Recruiting
Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of ...
Condition
Erectile Dysfunctions
Enrollment
500 pts
Location
Egypt
Sponsor
Mansoura University
NCT06848946 Phase 4
Recruiting
Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alon...
Condition
Glaucoma, Open-angle
Enrollment
132 pts
Location
United States
Sponsor
Glaukos Corporation
NCT06693570 Phase 4
Recruiting
Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care A...
Condition
Venous Leg Ulcer (VLU)
Enrollment
150 pts
Location
United States
Sponsor
Kerecis Ltd.
NCT04657822 Phase 4
Recruiting
Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior ...
Condition
Sickle Cell Disease
Enrollment
130 pts
Location
United States, Belgium, Brazil
Sponsor
Novartis Pharmaceuticals
NCT07478796 Phase 4
Recruiting
TDM-Guided Treatment With SSRIs in Hospitalized Adults and Children
Condition
Depression - Major Depressive Disorder
Enrollment
180 pts
Location
Poland
Sponsor
Poznan University of Medical S
NCT07287137 Phase 4
Recruiting
Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
Condition
COVID -19
Enrollment
54 pts
Location
United States
Sponsor
Henry M. Jackson Foundation fo
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
NCT05550194 Phase 4
Recruiting
VZV in the Enteric Nervous System: Pathogenesis and Consequences
Condition
Achalasia
Enrollment
40 pts
Location
United States
Sponsor
Vanderbilt University Medical
NCT05916339 Phase 4
Recruiting
AWARE: Management of ADHD in Autism Spectrum Disorder
Condition
ADHD
Enrollment
500 pts
Location
United States, Canada
Sponsor
Daniel Coury
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