Browse by Phase
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
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
NCT07618299 Phase 4
Recruiting
Evaluation of the Excretion of Fosfomycin Into Breast Milk Following a Single In...
Condition
Healthy Lactating Women
Enrollment
24 pts
Location
South Africa
Sponsor
Meitheal Pharmaceuticals, Inc.
NCT06819254 Phase 4
Recruiting
Pilot Study of Fisetin to Improve Fatigue Among Older Adult Cancer Survivors
Condition
Fatigue
Enrollment
60 pts
Location
United States
Sponsor
Wake Forest University Health
NCT06449339 Phase 4
Recruiting
Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease
Condition
Portal Hypertension
Enrollment
474 pts
Location
Hong Kong
Sponsor
Chinese University of Hong Kon
NCT05420454 Phase 4
Recruiting
A Study for the Neoadjuvant Treatment of Breast Cancer
Condition
Breast Cancer
Enrollment
1,576 pts
Location
China
Sponsor
Second Affiliated Hospital, Zh
NCT04538053 Phase 4
Recruiting
BonE and Joint Infections - Simplifying Treatment in Children Trial
Condition
Bone Infection
Enrollment
214 pts
Location
Australia, Ireland, New Zealand
Sponsor
Murdoch Childrens Research Ins
NCT04300686 Phase 4
Recruiting
A Pilot Study in Severe Patients With Takayasu Arteritis.
Condition
Takayasu Arteritis
Enrollment
40 pts
Location
China
Sponsor
Shanghai Zhongshan Hospital
NCT07552766 Phase 4
Recruiting
A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric U...
Condition
Fracture Arm
Enrollment
90 pts
Location
United States
Sponsor
Nemours Children's Clinic
NCT05320796 Phase 4
Recruiting
The Bioavailability and Effect on Pouch pH of Esomeprazole After Gastric Bypass
Condition
Obesity
Enrollment
50 pts
Location
Switzerland
Sponsor
Prof Urs Zingg
NCT06289686 Phase 4
Recruiting
Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation
Condition
Rotator Cuff Tears
Enrollment
100 pts
Location
United States
Sponsor
Brooke Army Medical Center
NCT05867329 Phase 4
Recruiting
Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Ac...
Condition
Ulcerative Colitis Acute
Enrollment
700 pts
Location
United States
Sponsor
Berinstein, Jeffrey
NCT04729686 Phase 4
Recruiting
The Pericapsular Nerve Block in Total Hip Arthroplasty
Condition
Hip Osteoarthritis
Enrollment
78 pts
Location
United States
Sponsor
LifeBridge Health
NCT05515354 Phase 4
Recruiting
Smoking Cessation and Menstrual Cycle Phase
Condition
Nicotine Dependence
Enrollment
1,200 pts
Location
Canada
Sponsor
Centre for Addiction and Menta
NCT07761351 Phase 4
Recruiting
A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-...
Condition
Lung Cancer (Diagnosis)
Enrollment
550 pts
Location
Germany, Switzerland, United Kingdom
Sponsor
Intuitive Surgical
NCT05114096 Phase 4
Recruiting
Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Deli...
Condition
Preterm Birth
Enrollment
3,254 pts
Location
Canada
Sponsor
McMaster University
NCT06232473 Phase 4
Recruiting
Patient Education and Duloxetine, Alone and in Combination, for Patients With Mu...
Condition
Functional Disorder
Enrollment
424 pts
Location
Denmark
Sponsor
Aarhus University Hospital
NCT05854641 Phase 4
Recruiting
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI)...
Condition
Critical Limb Ischemia
Enrollment
10 pts
Location
Malaysia
Sponsor
Cell Biopeutics Resources Sdn
NCT07268222 Phase 4
Recruiting
Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Se...
Condition
Mild Autonomous Cortisol Secretion (MACS)
Enrollment
150 pts
Location
Greece
Sponsor
Laikο General Hospital, Athens
NCT03621553 Phase 4
Recruiting
Vitamin D Homeostasis in Sarcoidosis
Condition
Sarcoidosis
Enrollment
90 pts
Location
United States
Sponsor
University of Texas Southweste
NCT06643780 Phase 4
Recruiting
RANK-ligand Inhibition to Combat Sarcopenia With Underlying Osteoporosis
Condition
Sarcopenia in Elderly
Enrollment
120 pts
Location
China
Sponsor
Prince of Wales Hospital, Shat
NCT06311513 Phase 4
Recruiting
Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction
Condition
Anterior Cruciate Ligament Injuries
Enrollment
40 pts
Location
United States
Sponsor
Hospital for Special Surgery,
NCT06825013 Phase 4
Recruiting
Bronchodilators and Lung Mechanics During Exercise in COPD
Condition
COPD
Enrollment
25 pts
Location
Canada
Sponsor
Dr. J. Alberto Neder
NCT04537689 Phase 4
Recruiting
Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psori...
Condition
Plaque Psoriasis
Enrollment
40 pts
Location
Singapore
Sponsor
Singapore General Hospital
NCT05780190 Phase 4
Recruiting
Clinical Observation of CABA System in the Treatment of End-stage Liver Disease ...
Condition
To Evaluate the Clinical Efficacy and Safety of the New ALSS
Enrollment
40 pts
Location
China
Sponsor
Qin Ning
NCT05644717 Phase 4
Recruiting
Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type...
Condition
Liver Fat
Enrollment
164 pts
Location
Pakistan
Sponsor
Getz Pharma
NCT05341817 Phase 4
Recruiting
The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of ...
Condition
Abortion in First Trimester
Enrollment
144 pts
Location
Singapore
Sponsor
KK Women's and Children's Hosp
ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer · Last Reviewed: November 2026 · Data Methodology