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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

350

Recruiting Now

350

Top Conditions in Phase 4

Obesity (8) Dexmedetomidine (5) Opioid Use (5) Atrial Fibrillation (5) Postoperative Pain (5) Diabetes Mellitus, Type 2 (4) Coronary Artery Disease (4) Ischemic Stroke (4) Anesthesia (4) Depression (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

NCT07391579 Phase 4

Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of ...

Erectile Dysfunctions

Mansoura University

NCT05028062 Phase 4

Naltrexone in AUD Reward Drinkers

Alcohol Use Disorder

University of Pennsylvania

NCT07076082 Phase 4

Vascular Trial Associated Registry Pilot

Peripheral Arterial Disease

Corewell Health West

NCT06929962 Phase 4

VA Dual Sequential Therapy

Helicobacter Pylori Infection

The First Affiliated Hospital

NCT07457060 Phase 4

Phase IV Clinical Study of Sequential Vaccination of Sabin Strain and Wild Strai...

Sinovac Biotech Co., Ltd

NCT06655441 Phase 4

The Effects of 3% Trehalose Ophthalmic Solution on Corneal Epithelial Barrier Fu...

Dry Eye Disease (DED)

Southern California College of

NCT06184633 Phase 4

DUTCH Weight Control in Atrial Fibrillation Study

Atrial Fibrillation

Rijnstate Hospital

NCT05144399 Phase 4

Accelerated Treatment of Endocarditis

Herlev Hospital

NCT05215132 Phase 4

Investigational MRI Clinical Software and Hardware

Northwestern University

NCT07022821 Phase 4

Comparison of Dexmedetomidine + Ketamine for Postoperative Pain in C-Section

Postoperative Pain

Fatima Memorial Hospital

NCT06748209 Phase 4

Establishing Mobile Transcranial Magnetic Stimulation

Treatment Resistant Major Depression

Medical University of South Ca

NCT06359106 Phase 4

Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Pat...

Oxygenation Index

China Medical University, Chin

NCT06792916 Phase 4

This Study Evaluates the Clinical Effect of Adding Spermidine Gel to Minimally I...

NCT06268704 Phase 4

Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection

Sacroiliac Joint Dysfunction

University of New Mexico

NCT06873321 Phase 4

VTE Incidence After Rivaroxaban + Aspirin or SAPT After Lower-limb Revasculariza...

Peripheral Arterial Disease

Science Valley Research Instit

NCT05551299 Phase 4

Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Pho...

Hilar Cholangiocarcinoma

University of Leipzig

NCT06501443 Phase 4

LATAM LOWERS LDL-C

Hypercholesterolaemia

Argentina, Brazil

Novartis Pharmaceuticals

NCT06751992 Phase 4

Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kid...

Kidney Transplant Recipients

Massachusetts General Hospital

NCT05004987 Phase 4

Aβ Dynamics in LLMD

Alzheimer Disease

NYU Langone Health

NCT07119021 Phase 4

Efficacy and Safety Study of Ultra-early Mobile Stroke Unit Neuroprotection Comb...

Ischemic Stroke

NCT06278987 Phase 4

Comparison of Cryoablation of Pericapsular Nerve Group (PENG) to Fascia Iliaca C...

University of Minnesota

NCT04894864 Phase 4

Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open A...

Elective Surgical Procedures

University of Crete

NCT05748093 Phase 4

Improving Osimertinib Exposure and Cost-effectiveness Using Pharmacokinetic Boos...

Non-small Cell Lung Cancer

Maastricht University Medical

NCT07235904 Phase 4

Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azath...

Ulcerative Colitis (UC)

University Hospital Schleswig-

NCT06601712 Phase 4

Post-discharge Malaria Chemoprevention Implementation Trial in Benin

Institut de Recherche Clinique

Page 4 of 14 — 350 trials total

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