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

348

Recruiting Now

348

Top Conditions in Phase 4

Breast Cancer (4) Sepsis (4) Antibiotic Prophylaxis (3) Septic Shock (3) Opioid Use Disorder (3) Obesity (3) Diabetes Mellitus, Type 2 (3) Acute Ischemic Stroke (3) Pain, Postoperative (3) Coronary Artery Disease (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

NCT03543839 Phase 4

Trial of Belimumab in Early Lupus

Lupus Erythematosus, Systemic

Northwell Health

NCT07259512 Phase 4

Single and Twice-daily Dosing of Ramipril on Renal Function in Chronic Kidney Di...

Chronic Kidney Disease

Evi Liliek Wulandari

NCT06356012 Phase 4

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

HSIL, High-Grade Squamous Intraepithelial Lesions

Barretos Cancer Hospital

NCT04119102 Phase 4

Duobrii in Combination With Biologics

Psoriasis Treatment Center of

NCT07405086 Phase 4

Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Ad...

Advanced Biliary Tract Carcinoma

OHSU Knight Cancer Institute

NCT04725201 Phase 4

Prospective Study on the Role of Intravenous Unfractionated Heparin Following Di...

Amputation; Traumatic, Hand

Centre hospitalier de l'Univer

NCT03821857 Phase 4

Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease

Alzheimer Disease

NCT07532941 Phase 4

Clinical Efficacy of Stopping Oral Antibiotics When Symptoms Stop, Compared to '...

Urinary Tract Infection

Murdoch Childrens Research Ins

NCT07092202 Phase 4

Firmonertinib Combined With Intrathecal Injection for the Treatment of EGFR Muta...

Leptomeningeal Metastasis

Union Hospital, Tongji Medical

NCT06558188 Phase 4

Combined Anabolic Therapy

Osteoporosis, Postmenopausal

Massachusetts General Hospital

NCT06724783 Phase 4

Comparison of Two Collagen Membranes for Bone Augmentation Around Dental Implant...

Tooth Extraction

Dr. med. dent. Malin Strasding

NCT03490929 Phase 4

CEUS for Blunt Abdominal Trauma in Children

Children's Hospital of Philade

NCT07278362 Phase 4

Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Un...

Prostate Cancer

University of Miami

NCT06733922 Phase 4

ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS

Relapsing Remitting Multiple Sclerosis (RRMS)

Novartis Pharmaceuticals

NCT03675672 Phase 4

Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodena...

Active Peptic Ulcer Disease/GI Bleeding

Chinese University of Hong Kon

NCT06811727 Phase 4

CONTinuous Infusion Versus Intermittent Dosing of ceftaZidime/AVIbactam in Criti...

Severe Infection

Ivan Šitum, MD

NCT06472518 Phase 4

Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With A...

Iliofemoral Venous Thrombosis

Nantes University Hospital

NCT07410988 Phase 4

Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Co...

Cardiac Surgery

Seoul National University Hosp

NCT06793670 Phase 4

Landiolol in Mitral Valve Surgery

Cardiac Failure

Università Vita-Salute San Raf

NCT06580782 Phase 4

Calcium Carbonate to Augment Labor Contractions

Weill Medical College of Corne

NCT06958588 Phase 4

Pulsed Electromagnetic Field Therapy or Pneumatic Compression VTE Prophylaxis

Venous Thromboembolism (VTE)

Science Valley Research Instit

NCT07674290 Phase 4

Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity

Bardet Biedl Syndrome (BBS)

NCT06049680 Phase 4

Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in...

Malnutrition, Child

NCT06613178 Phase 4

Intravenous Acetaminophen After Cardiac Surgery - Definitive Study

Post Operative Delirium

McGill University Health Centr

NCT05242315 Phase 4

Extended-Release Tacrolimus Following Liver Transplantation

Liver Transplant; Complications

University of Alberta

Page 9 of 14 — 348 trials total

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