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
348
Recruiting Now
348
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
NCT04263038 Phase 4
Recruiting
Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Su...
Condition
Pulmonary Embolism
Enrollment
276 pts
Location
Belgium, Canada, France
Sponsor
Drahomir Aujesky
NCT06090994 Phase 4
Recruiting
Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier...
Condition
Colorectal Cancer
Enrollment
756 pts
Location
China
Sponsor
Fudan University
NCT05347069 Phase 4
Recruiting
Efficacy and Safety of Aspirin in Patients With Chronic Coronary Syndromes Witho...
Condition
Stable Angina Pectoris
Enrollment
2,890 pts
Location
Japan
Sponsor
Takeshi Morimoto
NCT06712641 Phase 4
Recruiting
Aminoglycosides in Early Sepsis
Condition
Sepsis
Enrollment
1,900 pts
Location
Norway
Sponsor
University Hospital, Akershus
NCT06611696 Phase 4
Recruiting
Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis
Condition
ANCA Associated Vasculitis (AAV)
Enrollment
160 pts
Location
Japan
Sponsor
Chiba University
NCT07118579 Phase 4
Recruiting
Effects of Remimazolam and Ciprofol TIVA on PRAE in Pediatric Tonsillectomy and ...
Condition
Tonsillectomy With or Without Adenoidectomy
Enrollment
114 pts
Location
China
Sponsor
Tongji Hospital
NCT07183462 Phase 4
Recruiting
Azithromycin and Ampicillin for Late PPROM
Condition
Pregnancy Complications, Infectious
Enrollment
311 pts
Location
Israel
Sponsor
Sheba Medical Center
NCT04769362 Phase 4
Recruiting
Long-term Beta-blocker Therapy After Acute Myocardial Infarction
Condition
Myocardial Infarction
Enrollment
2,540 pts
Location
South Korea
Sponsor
Samsung Medical Center
NCT07213544 Phase 4
Recruiting
Remimazolam vs Propofol in Laser Burn Cases
Condition
Burn Scar
Enrollment
136 pts
Location
United States
Sponsor
Medical University of South Ca
NCT06368063 Phase 4
Recruiting
The Study of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Panc...
Condition
Pancreatic Cancer Resectable
Enrollment
642 pts
Location
China
Sponsor
Xi'an Jiaotong University
NCT07608328 Phase 4
Recruiting
Azithromycin to Modify Bronchiectasis Exacerbation Risk
Condition
Non-cystic Fibrosis Bronchiectasis
Enrollment
500 pts
Location
Egypt
Sponsor
Assiut University
NCT07600164 Phase 4
Recruiting
Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Brea...
Condition
HER2 + Breast Cancer
Enrollment
500 pts
Location
China
Sponsor
Peking University People's Hos
NCT06429332 Phase 4
Recruiting
International Care Bundle Evaluation in Cerebral Hemorrhage Research
Condition
Intracerebral Hemorrhage
Enrollment
3,500 pts
Location
United States, Australia, Canada
Sponsor
Region Skane
NCT07872904 Phase 4
Recruiting
FutureShape Family
Condition
Obesity
Enrollment
400 pts
Location
Denmark
Sponsor
Signe Torekov
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
NCT07320105 Phase 4
Recruiting
Postoperative Radiotherapy for Postoperative N2 Metastases of NSCLC in the Immun...
Condition
Non-Small Cell Lung Cancer
Enrollment
60 pts
Location
China
Sponsor
Fujian Cancer Hospital
NCT05725512 Phase 4
Recruiting
Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages
Condition
Recurrent Miscarriage
Enrollment
490 pts
Location
Netherlands
Sponsor
Leiden University Medical Cent
NCT07325240 Phase 4
Recruiting
24-hour Effect of Rocklatan Compared With Latanoprost in Open Angle Glaucoma and...
Condition
Open Angle Glaucoma
Enrollment
30 pts
Location
United States
Sponsor
Mayo Clinic
NCT07187713 Phase 4
Recruiting
ACE Reno, Pico Cell Matrix and Its Effect on eGFR in Chronic Kidney Diseases
Condition
Hypertensive Nephropathy
Enrollment
300 pts
Location
Egypt
Sponsor
Ace Cells Lab Limited
NCT03717623 Phase 4
Recruiting
Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Tr...
Condition
Posaconazole
Enrollment
100 pts
Location
Australia
Sponsor
Melbourne Health
NCT07476859 Phase 4
Recruiting
Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coron...
Condition
Acute Coronary Syndromes (ACS)
Enrollment
538 pts
Location
Spain
Sponsor
Fundación para la Investigació
NCT05518383 Phase 4
Recruiting
B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolesce...
Condition
Non-hodgkin Lymphoma,B Cell
Enrollment
300 pts
Location
Russia
Sponsor
Federal Research Institute of
NCT06676280 Phase 4
Recruiting
ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calciu...
Condition
Cardiovascular Diseases
Enrollment
5,000 pts
Location
South Korea
Sponsor
Jung-min Ahn
NCT07023094 Phase 4
Recruiting
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Condition
Hip Disease
Enrollment
60 pts
Location
Poland
Sponsor
Poznan University of Medical S
NCT04289142 Phase 4
Recruiting
Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients
Condition
Delirium
Enrollment
2,400 pts
Location
Canada
Sponsor
Sunnybrook Health Sciences Cen
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