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
350
Recruiting Now
350
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
NCT03132311 Phase 4
Recruiting
Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individual...
Condition
HIV Infections
Enrollment
400 pts
Location
Brazil
Sponsor
Oswaldo Cruz Foundation
NCT06016855 Phase 4
Recruiting
Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differ...
Condition
Digestive System Neuroendocrine Tumor G1
Enrollment
6 pts
Location
United States
Sponsor
Vanderbilt-Ingram Cancer Cente
NCT04050644 Phase 4
Recruiting
Comparison of Treatment With Preservative-free Dexamethasone 0.1% (Monofree Dexa...
Condition
Age-related Cataract
Enrollment
100 pts
Location
Belgium
Sponsor
Universitaire Ziekenhuizen KU
NCT06410833 Phase 4
Recruiting
Belimumab After Rituximab in Resistant Primary Juvenile SS
Condition
Sjogren's Syndrome
Enrollment
15 pts
Location
China
Sponsor
Peking Union Medical College H
NCT07404436 Phase 4
Recruiting
Rivaroxaban in Idiopathic Membranous Nephropathy
Condition
Idiopathic Membranous Nephropathy
Enrollment
134 pts
Location
China
Sponsor
Beijing Friendship Hospital
NCT06798714 Phase 4
Recruiting
The Effect of Colchicine on the Occurrence of Atrial Fibrillation After Cardiac ...
Condition
Coronary Artery Disease
Enrollment
140 pts
Location
Russia
Sponsor
Tomsk Cardiology Research Inst
NCT05559671 Phase 4
Recruiting
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Condition
Systemic Lupus Erythematosus
Enrollment
224 pts
Location
United States
Sponsor
NYU Langone Health
NCT03272698 Phase 4
Recruiting
ECT with Ketamine Anesthesia Vs High Intensity Ketamine with ECT Rescue for Trea...
Condition
Treatment Resistant Depression
Enrollment
62 pts
Location
Canada
Sponsor
University of Saskatchewan
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
NCT07241117 Phase 4
Recruiting
CHEST: A Collaboration With Community HEalth Centers to Implement SmarT for Asth...
Condition
Moderate to Severe Asthma
Enrollment
2,000 pts
Location
United States
Sponsor
Washington University School o
NCT06676696 Phase 4
Recruiting
Study to Compare the Outcome of Receiving Continued Immunosuppression Versus Sto...
Condition
Renal Failure , Chronic
Enrollment
202 pts
Location
Spain
Sponsor
Hospital Universitari Vall d'H
NCT07019818 Phase 4
Recruiting
Esmolol Versus Sufentanil on the Quality of Post-cholecystectomy Recovery Laparo...
Condition
Laparoscopic Cholecystectomy Surgery
Enrollment
120 pts
Location
France
Sponsor
University Hospital, Limoges
NCT06467513 Phase 4
Recruiting
To Investigate the Effect of Esketamine Hydrochloride on Pulmonary Complications
Condition
Heart Diseases
Enrollment
102 pts
Location
China
Sponsor
Zhang XIao Mei
NCT02842424 Phase 4
Recruiting
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Condition
Peripheral Arterial Disease
Enrollment
70 pts
Location
United States
Sponsor
University of Nebraska
NCT06953440 Phase 4
Recruiting
The Effect of Dexamethasone Submucosal Injection After Surgical Extraction of Lo...
Condition
Swelling/ Edema
Enrollment
66 pts
Location
Saudi Arabia
Sponsor
King Abdulaziz University
NCT06668389 Phase 4
Recruiting
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patie...
Condition
Congenital Heart Disease
Enrollment
106 pts
Location
Hong Kong
Sponsor
The University of Hong Kong
NCT06820255 Phase 4
Recruiting
DDR Genes Alteration and Response to Platinum-based Chemotherapy in Advanced Uro...
Condition
Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable
Enrollment
135 pts
Location
Italy
Sponsor
Fondazione Policlinico Univers
NCT04962776 Phase 4
Recruiting
Preoperative Coadministration of Low-concentration Carbohydrate and Nitrates Loa...
Condition
Length of Hospital Stay
Enrollment
90 pts
Location
Egypt
Sponsor
Ain Shams University
NCT05540938 Phase 4
Recruiting
Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis
Condition
Rheumatoid Arthritis
Enrollment
340 pts
Location
China
Sponsor
China-Japan Friendship Hospita
NCT06719180 Phase 4
Recruiting
Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use
Condition
Hysterectomy
Enrollment
100 pts
Location
United States
Sponsor
MediSys Health Network
NCT06767774 Phase 4
Recruiting
Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy o...
Condition
ASCVD
Enrollment
2,000 pts
Location
South Korea
Sponsor
Korea University Anam Hospital
NCT07255820 Phase 4
Recruiting
Dual vs Triple Lipid-Lowering Therapy in Type 2 Diabetes Mellitus Patients With ...
Condition
Type 2 Diabetes Mellitus
Enrollment
126 pts
Location
Pakistan
Sponsor
Bahria University
NCT06406010 Phase 4
Recruiting
Investigating the Effect of Pericapsular Nerve Group (PENG) Block on Postoperati...
Condition
Anesthesia, Local
Enrollment
90 pts
Location
Denmark
Sponsor
Matias Vested
NCT07468513 Phase 4
Recruiting
Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.
Condition
Vivax Malaria
Enrollment
100 pts
Location
Brazil, Ethiopia, Papua New Guinea
Sponsor
Menzies School of Health Resea
NCT07465913 Phase 4
Recruiting
Rocklatan vs Latanoprost Post-DSLT
Condition
Glaucoma
Enrollment
36 pts
Location
United States
Sponsor
Eye Centers of Southeast Texas
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