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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

NCT05942027 Phase 4
Recruiting
Role of Coenzyme Q10 in Chronic Kidney Disease
Condition
Chronic Kidney Diseases
Enrollment
44 pts
Location
Egypt
Sponsor
Tanta University
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NCT05023369 Phase 4
Recruiting
This is a Study to Verify if Periarticular Hip Injection of Corticosteroid After...
Condition
Femoral Neck Fractures
Enrollment
110 pts
Location
Switzerland
Sponsor
Ente Ospedaliero Cantonale, Be
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NCT06613854 Phase 4
Recruiting
Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in ...
Condition
Type 2 Diabetes Mellitus (T2DM)
Enrollment
90 pts
Location
Slovenia
Sponsor
University Medical Centre Ljub
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NCT06610305 Phase 4
Recruiting
Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Prem...
Condition
Major Depressive Disorder
Enrollment
75 pts
Location
United States
Sponsor
University of North Carolina,
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NCT04667494 Phase 4
Recruiting
Ultrasound Therapy In Cardiac Amyloidosis
Condition
Amyloidosis Cardiac
Enrollment
70 pts
Location
United States
Sponsor
Brigham and Women's Hospital
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NCT06647342 Phase 4
Recruiting
The Effect of Reduced Bleomycin in Electrochemotherapy Treatment
Condition
Cutaneous Metastasis
Enrollment
55 pts
Location
Denmark
Sponsor
Julie Gehl
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NCT05418556 Phase 4
Recruiting
OPTIMIZE-APT: Tailored Versus Conventional Antiplatelet Therapy After Intravascu...
Condition
Coronary Artery Disease
Enrollment
3,944 pts
Location
South Korea
Sponsor
Asan Medical Center
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NCT07257679 Phase 4
Recruiting
Gentle Touch for Post-Mastectomy Lymphedema
Condition
Lymphedema, Breast Cancer
Enrollment
36 pts
Location
Italy
Sponsor
I.R.C.C.S. Fondazione Santa Lu
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NCT07419854 Phase 4
Recruiting
Restoring Facial Volume After GLP-1 Weight Loss With Radiesse
Condition
Volume Loss (Soft Tissue Ptosis or Atrophy )
Enrollment
48 pts
Location
United States
Sponsor
Kalpna Kay Durairaj, MD, FACS
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NCT07150624 Phase 4
Recruiting
The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcho...
Condition
Hepatocellular Carcinoma (HCC)
Enrollment
96 pts
Location
China
Sponsor
Anhui Provincial Hospital
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NCT05303805 Phase 4
Recruiting
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Condition
Leg Ulcer
Enrollment
50 pts
Location
Czechia
Sponsor
Charles University, Czech Repu
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NCT07268820 Phase 4
Recruiting
Heartburn, Gastroesophageal Reflux Disease
Condition
GERD
Enrollment
160 pts
Location
South Korea
Sponsor
Incheon St.Mary's Hospital
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NCT06246396 Phase 4
Recruiting
Antihypertensive Mechanisms of Minocycline in Resistant Hypertension
Condition
Hypertension, Resistant to Conventional Therapy
Enrollment
120 pts
Location
United States
Sponsor
University of Florida
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NCT07316166 Phase 4
Recruiting
Suprainguinal Fascia Iliaca Block With vs Without Dexmedetomidine
Condition
Postoperative Pain Management
Enrollment
120 pts
Location
United States
Sponsor
Rhode Island Hospital
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NCT04860141 Phase 4
Recruiting
Efficacy of Preoperative Administration of Gabapentin in 3rd Molar Dental Extrac...
Condition
Dental Pain and Sensation Disorder
Enrollment
98 pts
Location
United States
Sponsor
Loma Linda University
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NCT06270498 Phase 4
Recruiting
Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Pati...
Condition
Chronic Heart Failure
Enrollment
60 pts
Location
Italy
Sponsor
Raffaele De Caterina
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NCT07571252 Phase 4
Recruiting
Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery
Condition
Post Operative Pain
Enrollment
72 pts
Location
Puerto Rico
Sponsor
University of Puerto Rico
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NCT07352358 Phase 4
Recruiting
Randomized Trial of Anticoagulation Plus Batroxobin for Acute Cerebral Venous Th...
Condition
Cerebral Venous Thrombosis
Enrollment
72 pts
Location
China
Sponsor
Xuanwu Hospital, Beijing
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NCT07225387 Phase 4
Recruiting
Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of...
Condition
Lupus Nephritis
Enrollment
30 pts
Location
United States
Sponsor
NephroNet, Inc.
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NCT07124299 Phase 4
Recruiting
Alpha-Blockers Prior to Ureteral Access Sheath Placement in Flexible Ureteroscop...
Condition
Nephrolithiasis
Enrollment
140 pts
Location
Brazil
Sponsor
Pedro de Figueiredo Buchalla
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NCT07691138 Phase 4
Recruiting
Stopping PPI Therapy in Inactive IBD
Condition
Ulcerative Colitis (UC)
Enrollment
80 pts
Location
United Kingdom
Sponsor
University of Nottingham
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NCT06925152 Phase 4
Recruiting
COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Ab...
Condition
Complex Obstetric Surgery
Enrollment
120 pts
Location
United States
Sponsor
University of Tennessee
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NCT07211347 Phase 4
Recruiting
Percutaneous Blockade of the Stellate Ganglion in Electrical Storm
Condition
Electrical Storm
Enrollment
64 pts
Location
Brazil
Sponsor
University of Sao Paulo Genera
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NCT05788094 Phase 4
Recruiting
ACT vs CQ With Tafenoquine for P. Vivax Mono-infection
Condition
Malaria
Enrollment
606 pts
Location
Thailand
Sponsor
Shoklo Malaria Research Unit
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NCT04895956 Phase 4
Recruiting
Intra-sheath vs Extra-sheath Injection for De Quervain's Tenosynovitis
Condition
De Quervain Tenosynovitis
Enrollment
80 pts
Location
United States
Sponsor
University of California, Davi
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Page 12 of 14 — 348 trials total
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