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
NCT05521789 Phase 4
Recruiting
Erector Spinae Block for Thoracic Surgery
Condition
Pulmonary Neoplasm
Enrollment
70 pts
Location
United States
Sponsor
George Washington University
NCT04308278 Phase 4
Recruiting
Study to Evaluate the Efficacy of 2LEBV® and 2LXFS® on Asthenia in Patients With...
Condition
EBV Infection
Enrollment
88 pts
Location
Belgium
Sponsor
Labo'Life
NCT07419425 Phase 4
Recruiting
My Path to Quit Tobacco
Condition
Smoking Cessation
Enrollment
1,550 pts
Location
United States
Sponsor
University of Wisconsin, Madis
NCT06347874 Phase 4
Recruiting
Cryo Rib Fracture Study
Condition
Rib Fractures
Enrollment
48 pts
Location
United States
Sponsor
University of Minnesota
NCT07246525 Phase 4
Recruiting
Intermittent Preventive Treatment of Malaria in School-age Children to Decrease ...
Condition
Malaria
Enrollment
4,800 pts
Location
Uganda
Sponsor
University of California, San
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
NCT07341776 Phase 4
Recruiting
Steroid Use in Treatment of Allergic Reactions to Food
Condition
Anaphylactic Reaction
Enrollment
160 pts
Location
Switzerland
Sponsor
Johannes Trueck
NCT05838365 Phase 4
Recruiting
Immediate Versus Delayed Loading of Single Posterior Zirconia Implants
Condition
Dental Implant Failed
Enrollment
220 pts
Location
Italy
Sponsor
University of Milan
NCT07809867 Phase 4
Recruiting
Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis
Condition
Cystic Fibrosis (CF)
Enrollment
50 pts
Location
Italy
Sponsor
Istituto Giannina Gaslini
NCT06848387 Phase 4
Recruiting
Unbound Cloxacillin Concentrations During Continuous Infusion
Condition
Staphylococcal Infections
Enrollment
25 pts
Location
Sweden
Sponsor
Emeli Månsson
NCT06316232 Phase 4
Recruiting
DBS and Levodopa for Treating Freezing of Gait in Parkinson's Disease
Condition
Freezing of Gait
Enrollment
20 pts
Location
Italy
Sponsor
IRCCS Istituto delle Scienze N
NCT05515367 Phase 4
Recruiting
A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treat...
Condition
Chronic Kidney Diseases
Enrollment
1,004 pts
Location
India
Sponsor
Zydus Lifesciences Limited
NCT07507500 Phase 4
Recruiting
Dual Antiplatelet Therapy Strategies After Acute Myocardial Infarction Undergoin...
Condition
Myocardial Infarction (MI)
Enrollment
8,100 pts
Location
Ireland, Latvia, Norway
Sponsor
Instituto de Investigación San
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
NCT06468709 Phase 4
Recruiting
A Trial on the Remission Rates of Type I Autoimmune Pancreatits With High-risk o...
Condition
Type 1 AIP
Enrollment
86 pts
Location
China
Sponsor
Ruijin Hospital
NCT07112365 Phase 4
Recruiting
The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project
Condition
Dravet Syndrome
Enrollment
25 pts
Location
United States
Sponsor
The University of Texas Health
NCT07031128 Phase 4
Recruiting
Alpha Ketoglutarate Enhances Geroprotection In Surgery (AEGIS)
Condition
CABG
Enrollment
250 pts
Location
Singapore
Sponsor
National University Hospital,
NCT06909565 Phase 4
Recruiting
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and...
Condition
Percutaneous Coronary Intervention
Enrollment
6,000 pts
Location
United States
Sponsor
Duke University
NCT07273071 Phase 4
Recruiting
Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections...
Condition
Sepsis
Enrollment
360 pts
Location
Denmark
Sponsor
Theis S. Itenov
NCT07775248 Phase 4
Recruiting
Novel Extended-Release Bupivacaine Polymer for Sustained Pain Relief Following T...
Condition
Osteoarthritis (OA) of the Knee
Enrollment
150 pts
Location
United States
Sponsor
Henry Ford Health System
NCT06511778 Phase 4
Recruiting
sTErnAl heMostasiS Trial
Condition
Excessive Bleeding During Surgery
Enrollment
60 pts
Location
United States
Sponsor
WakeMed Health and Hospitals
NCT05976347 Phase 4
Recruiting
Identifying and Treating Depression in the Orthopaedic Trauma Population
Condition
Depression
Enrollment
100 pts
Location
United States
Sponsor
Wake Forest University Health
NCT06949826 Phase 4
Recruiting
Buprenorphine as a Post-operative Analgesic in Opioid-Naive Patients After Ankle...
Condition
Pain, Postoperative
Enrollment
100 pts
Location
United States
Sponsor
Jenna-Leigh Wilson
NCT06824649 Phase 4
Recruiting
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Condition
Chronic Sinusitis
Enrollment
504 pts
Location
United States
Sponsor
Medical University of South Ca
NCT07058155 Phase 4
Recruiting
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Adva...
Condition
Liver Cirrhoses
Enrollment
70 pts
Location
United States
Sponsor
The Cleveland Clinic
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: November 2026 · Data Methodology