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
374
Recruiting Now
374
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
NCT06229990 Phase 4
Recruiting
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous...
Condition
Acute Kidney Injury
Enrollment
80 pts
Location
Thailand
Sponsor
Chiang Mai University
NCT05746143 Phase 4
Recruiting
The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion
Condition
Spine Fusion
Enrollment
140 pts
Location
United States
Sponsor
University of Southern Califor
NCT07423650 Phase 4
Recruiting
Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy
Condition
Pancreatoduodenectomy
Enrollment
93 pts
Location
Romania
Sponsor
Iuliu Hatieganu University of
NCT07247084 Phase 4
Recruiting
A Study of Tirzepatide (LY3298176) Compared With Standard of Care in Adult Parti...
Condition
Obesity
Enrollment
3,000 pts
Location
United Kingdom
Sponsor
Eli Lilly and Company
NCT07811518 Phase 4
Recruiting
Latent Infection Freshmen Tracking for Tuberculosis
Condition
Latent Tuberculosis Infection (LTBI)
Enrollment
3,000 pts
Location
China
Sponsor
Affiliated Hospital of Nantong
NCT07266467 Phase 4
Recruiting
Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegal...
Condition
Kidney Transplant
Enrollment
290 pts
Location
China
Sponsor
First Affiliated Hospital Xi'a
NCT05709626 Phase 4
Recruiting
PRasugrEl Monotherapy Following prImary percUtaneous Coronary Intervention for S...
Condition
ST-segment Elevation Myocardial Infarction (STEMI)
Enrollment
2,258 pts
Location
Japan
Sponsor
Kindai University
NCT05173740 Phase 4
Recruiting
Rehabilitation for Survivors of Out-of-hospital Cardiac Arrest
Condition
Cardiac Arrest
Enrollment
214 pts
Location
Denmark
Sponsor
Rigshospitalet, Denmark
NCT07569926 Phase 4
Recruiting
Impact of Fluciclovine (18F) PET (Positron Emission Tomography) on the Managemen...
Condition
Prostate Cancer
Enrollment
142 pts
Location
United States
Sponsor
Blue Earth Diagnostics
NCT03048084 Phase 4
Recruiting
Seizure Treatment in Glioma
Condition
Glioma
Enrollment
120 pts
Location
Netherlands
Sponsor
Leiden University Medical Cent
NCT06782295 Phase 4
Recruiting
The Use of CCK vs PS in Revision TKAs
Condition
Aseptic Loosening of Prosthetic Joint
Enrollment
170 pts
Location
United States
Sponsor
Rush University Medical Center
NCT07789639 Phase 4
Recruiting
A Clinical Study to Evaluate the Efficacy and SPF of Two Test Materials Accordin...
Condition
Epidermis
Enrollment
60 pts
Location
United States
Sponsor
Good Molecules, LLC
NCT07326553 Phase 4
Recruiting
Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
Condition
Diabete Mellitus
Enrollment
30 pts
Location
United States
Sponsor
BioXTek
NCT07016269 Phase 4
Recruiting
A Study to Evaluate the Efficacy and Safety of CnU Cap. 500 mg in Patients With ...
Condition
Biliary Dyspepsia
Enrollment
358 pts
Location
South Korea
Sponsor
Myungmoon Pharma. Co. Ltd.
NCT04427241 Phase 4
Recruiting
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
Condition
Disorder of Consciousness
Enrollment
12 pts
Location
South Korea
Sponsor
Konkuk University Medical Cent
NCT07095205 Phase 4
Recruiting
PET Imaging Using the Tracer [18F]VAT to Assess the Antidepressant Effect of Nic...
Condition
Major Depressive Disorder (MDD)
Enrollment
14 pts
Location
United States
Sponsor
Stony Brook University
NCT07721142 Phase 4
Recruiting
Integrated Clinical Study of Traditional Chinese and Western Medicine for Refrac...
Condition
Rheumatoid Arthritis (RA)
Enrollment
300 pts
Location
China
Sponsor
Shanghai Guanghua Hospital of
NCT07762170 Phase 4
Recruiting
Success Rates and Safety of Steroid Injections in Managing Spinal and Sacro-Ilia...
Condition
Back Pain Lower Back
Enrollment
500 pts
Location
Canada
Sponsor
Igor Wilderman. MD
NCT05728775 Phase 4
Recruiting
REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Non...
Condition
Anesthesia
Enrollment
7,188 pts
Location
China
Sponsor
Nanfang Hospital, Southern Med
NCT05058612 Phase 4
Recruiting
Midodrine for the Early Liberation of Vasopressor Support in the ICU (LIBERATE M...
Condition
Vasoplegia
Enrollment
870 pts
Location
Canada
Sponsor
University of Alberta
NCT06624436 Phase 4
Recruiting
Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Exper...
Condition
Sepsis
Enrollment
52 pts
Location
Netherlands
Sponsor
Radboud University Medical Cen
NCT07138144 Phase 4
Recruiting
Efficacy, Safety, and ToLerability of Switching to A Two-Drug Regimen With DTG/3...
Condition
HIV Infections
Enrollment
156 pts
Location
Mexico
Sponsor
José Antonio Mata Marín
NCT06245109 Phase 4
Recruiting
Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthri...
Condition
Knee Osteoarthritis
Enrollment
180 pts
Location
United States
Sponsor
Northwestern University
NCT04783857 Phase 4
Recruiting
Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smok...
Condition
Smoking
Enrollment
171 pts
Location
United States
Sponsor
University of Minnesota
NCT06986824 Phase 4
Recruiting
Perineal Massage Using A Pelvic Wand During Pregnancy
Condition
Pregnancy Related
Enrollment
140 pts
Location
United States
Sponsor
Beth Israel Deaconess Medical
Page 1 of 15 — 374 trials total
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