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

342

Recruiting Now

342

Top Conditions in Phase 4

Obesity (6) Coronary Artery Disease (6) Heart Failure (5) Breast Cancer (4) Smoking Cessation (4) Bacteremia (3) Schizophrenia (3) Diabetes (3) Type 2 Diabetes (3) Cardiovascular Diseases (3)

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

NCT07863635 Phase 4

A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-co...

ModernaTX, Inc.

NCT07096908 Phase 4

Tirzepatide Use in People With Obesity and Type 1 Diabetes

Dasman Diabetes Institute

NCT07217678 Phase 4

Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive...

University of Miami

NCT07007143 Phase 4

STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Rep...

Mitral Regurgitation

Chinese Academy of Medical Sci

NCT06935708 Phase 4

Intrathecal Morphine Versus Epidural Analgesia for Open Colon Surgery

Colorectal Carcinoma

NCT06261840 Phase 4

Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative An...

Trichomonas Vaginitis

Tulane University

NCT06594068 Phase 4

Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in A...

Systemic Lupus Erythematosus

NCT07895420 Phase 4

Comparing Intravitreal Injection Pain Scores Using Iheezo (Chloroprocaine Hcl Op...

Retina Research Institute, LLC

NCT06848946 Phase 4

Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alon...

Glaucoma, Open-angle

Glaukos Corporation

NCT06930573 Phase 4

A Study of AK112, a PD-1/ VEGF Bispecific Antibody, for Resectable Hepatocellula...

The First Affiliated Hospital

NCT07684742 Phase 4

Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndro...

Acute Coronary Syndromes

Gyeongsang National University

NCT06587880 Phase 4

The Effect of Different Types of Mouthwash on Extraction Sockets' Healing

Extraction Socket Healing

University of Jordan

NCT07384403 Phase 4

Application of Topical Oxygen Therapy Around Customized Healing Collar

Cairo University

NCT07084402 Phase 4

Short-term Bactericidal Effect of Contezolid in MAC-PD

Mycobacterium Avium Complex Pulmonary Disease

NCT06284473 Phase 4

Ketamine as a Supplement to Local Anesthesia for Minor Procedures

Pain, Procedural

Loyola University

NCT07083063 Phase 4

Precise Endoscopic Application of Nitroglycerin in Preventing Post-ERCP Pancreat...

National Cheng-Kung University

NCT06639828 Phase 4

Phase 4 Paediatric Study to Evaluate Sonazoid Safety and Efficacy for Contrast-E...

Focal Liver Lesions

Germany, Italy, United Kingdom

NCT07224711 Phase 4

The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-C...

Vanderbilt University Medical

NCT06734598 Phase 4

Efficacy of Botox Injection of the Masticatory Muscles in Head &Neck Cancer Pati...

National Taiwan University Hos

NCT05137119 Phase 4

Staphylococcus Aureus Network Adaptive Platform Trial

Staphylococcus Aureus Bacteremia

United States, Australia, Canada

University of Melbourne

NCT07843264 Phase 4

PPI Dosing Per CYP2C19 Genotype

Gastroesophageal Reflux Disease With Esophagitis

University of Florida

NCT07124299 Phase 4

Alpha-Blockers Prior to Ureteral Access Sheath Placement in Flexible Ureteroscop...

Nephrolithiasis

Pedro de Figueiredo Buchalla

NCT07314684 Phase 4

GLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM

T2DM (Type 2 Diabetes Mellitus)

Federico II University

NCT07138560 Phase 4

BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease

Parkinson Disease

The Cleveland Clinic

NCT05786417 Phase 4

LIVEBETTER: A Trial Comparing Medications in Older Adults With Stable Angina and...

Yale University

Page 4 of 14 — 342 trials total

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