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

NCT03136341 Phase 4

A Cross Over Pilot Study of Abobotulinum Toxin A (Dysport) as a Treatment for Ta...

David M. Simpson

NCT07240077 Phase 4

Beta-lactam Plus Levofloxacin to Enhance Therapy in Streptococcal Septicemia

Mahidol University

NCT06356012 Phase 4

Clinical Outcome and Biomarkers for Predicting Immunological Response in Patient...

HSIL, High-Grade Squamous Intraepithelial Lesions

Barretos Cancer Hospital

NCT07578012 Phase 4

Prevention With Ismigen of RTIs in Kids

Respiratory Tract Infections (RTI)

Lallemand Pharma AG

NCT07737665 Phase 4

Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bow...

IBD (Inflammatory Bowel Disease)

Mahidol University

NCT06013865 Phase 4

Empagliflozin Treatment in Kidney Transplant Recipients

Kidney Transplant

VA Office of Research and Deve

NCT06573411 Phase 4

Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropath...

Primary Membranous Nephropathy

First Affiliated Hospital, Sun

NCT07235904 Phase 4

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

Ulcerative Colitis (UC)

University Hospital Schleswig-

NCT05672836 Phase 4

ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Trans...

Aortic Valve Stenosis

Duk-Woo Park, MD

NCT06701071 Phase 4

Evaluation of a Long Versus Short Clomid Protocol for Controlled Ovarian Stimula...

Infertility, Female

University of Southern Califor

NCT07872449 Phase 4

Risankizumab for Refractory Perianal Fistulizing Crohn's Disease

NCT07924306 Phase 4

Effects of Biased Opioid Agonists on Gastrointestinal Recovery After Gynecologic...

Gynecologic Laparoscopic Surgery

Hainan Medical College

NCT06442995 Phase 4

Evaluation of the Efficacy of the Addition of Magnesium Sulfate to Morphine on t...

Urinary Retention

NCT06538077 Phase 4

BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE

Hepatic Encephalopathy

Post Graduate Institute of Med

NCT05381194 Phase 4

BPaL(M) Regimen for the Treatment of MDR/RR-TB

Multidrug- and Rifampicin-resistant Tuberculosis

Asan Medical Center

NCT05481619 Phase 4

Study of the Effect of Vedolizumab on Intestinal Microecological Changes and Its...

Ulcerative Colitis

Second Affiliated Hospital, Zh

NCT07105111 Phase 4

A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With ...

Neurocrine Biosciences

NCT07711171 Phase 4

Efficacy and Safety of Canagliflozin in the Treatment of Type 2 Diabetes With Mi...

Type 2 Diabetes Mellitus

Fudan University

NCT06594744 Phase 4

Endoscopic Variceal Ligation vs Carvedilol for the Prevention of First Esophagea...

Hepatocellular Carcinoma (HCC)

Taipei Veterans General Hospit

NCT05669534 Phase 4

Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on Pr...

University of Connecticut

NCT03087032 Phase 4

Liraglutide-bolus vs Glargine-bolus Therapy in Overweight/Obese Type 2 Diabetes ...

Type 2 Diabetes Patients

The First Affiliated Hospital

NCT06864975 Phase 4

Assessing Different FVIII Doses and Frequencies in Immune Tolerance Induction (I...

Hemophilia a with Inhibitor

NCT05602636 Phase 4

Analgesic Effect of Supraclavicular Block and Interscalene Analgesia Versus an I...

Forearm Surgery

Al-Azhar University

NCT07818707 Phase 4

Post-Prandial Carbohydrate Metabolism in Individuals With and Without Post-Baria...

Joslin Diabetes Center

NCT05966064 Phase 4

DEnosumab for the Treatment of FIbrous Dysplasia/McCune-Albright Syndrome in Adu...

Fibrous Dysplasia

Natasha Appelman-Dijkstra

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