Clinical Trials / Browse by Phase / Phase 4

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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

65

Recruiting Now

65

Top Conditions in Phase 4

Post-operative Pain (2) Asthma (2) COPD (2) Atrial Fibrillation (2) STEMI - ST Elevation Myocardial Infarction (2) Opioid Use Disorder (2) Opioid Use (2) Postoperative Pain (2) Ulcerative Colitis (2) Post Operative Pain (1)

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

NCT05644496 Phase 4

ZYNRELEF for Pain Management in Total Knee Arthroplasty

Post Operative Pain

Baptist Health South Florida

NCT04713670 Phase 4

Comparison of Vonoprazan-based Versus Lansoprazole-based Triple Therapy, High Do...

H. Pylori Infection

National Taiwan University Hos

NCT04875702 Phase 4

Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout

Massachusetts General Hospital

NCT06269770 Phase 4

Tapentadol vs Tramadol in Total Knee Arthroplasty

Total Knee Replacement

University of Thessaly

NCT06976424 Phase 4

Comparison of a Face Cream Plus a Laser Procedure and Face Cream Alone in Treatm...

Khyber Teaching Hospital

NCT06952660 Phase 4

Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic C...

Cervical Cancer

United States, Puerto Rico

NCT07244003 Phase 4

Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes ...

T2DM (Type 2 Diabetes Mellitus)

Hangzhou Zhongmei Huadong Phar

NCT07187583 Phase 4

Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps

Chronic Rhinosinusitis With Nasal Polyps

Rigshospitalet, Denmark

NCT07031128 Phase 4

Alpha Ketoglutarate Enhances Geroprotection In Surgery (AEGIS)

National University Hospital,

NCT07316166 Phase 4

Suprainguinal Fascia Iliaca Block With vs Without Dexmedetomidine

Postoperative Pain Management

Rhode Island Hospital

NCT06152653 Phase 4

The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC (TEAM)

University of California, San

NCT07087912 Phase 4

Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vac...

Rheumatoid Arthritis (RA)

University of Sao Paulo Genera

NCT05137119 Phase 4

Staphylococcus Aureus Network Adaptive Platform Trial

Staphylococcus Aureus Bacteremia

United States, Australia, Canada

University of Melbourne

NCT05626530 Phase 4

Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients

Cytomegalovirus Infections

Tufts Medical Center

NCT06195241 Phase 4

Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm

Benign Essential Blepharospasm

Montefiore Medical Center

NCT07320105 Phase 4

Postoperative Radiotherapy for Postoperative N2 Metastases of NSCLC in the Immun...

Non-Small Cell Lung Cancer

Fujian Cancer Hospital

NCT07205757 Phase 4

Adding Lidocaine to Custodiol Mixture

Fayoum University Hospital

NCT07266545 Phase 4

RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar De...

Unipolar Depression

NCT06140537 Phase 4

Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardio...

Kidney Transplant; Complications

University of Colorado, Denver

NCT04771156 Phase 4

Ketorolac in Palatoplasty

Cleft Lip and Palate

The University of Texas Health

NCT06572228 Phase 4

Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Be...

United States, Canada, Denmark

Regeneron Pharmaceuticals

NCT05612594 Phase 4

Adipose Dysfunction, Imaging, Physiology, and Outcomes With Sodium Glucose Cotra...

Yale University

NCT04436978 Phase 4

What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation...

Acute Coronary Syndrome

Belgium, Netherlands

St. Antonius Hospital

NCT06007547 Phase 4

Prophylactic Minimally Invasive Surfactant Evaluation

Respiratory Distress Syndrome, Newborn

Endeavor Health

NCT04245748 Phase 4

Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD)

Anxious Depression

University of Cincinnati

Page 1 of 3 — 65 trials total

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