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
NCT07695298 Phase 4
Recruiting
A Prospective Longitudinal Analysis of Faricimab (Vabysmo 6mg) For Choroidal Neo...
Condition
Presumed Ocular Histoplasmosis
Enrollment
25 pts
Location
United States
Sponsor
Cincinnati Eye Institute, Sout
NCT06952998 Phase 4
Recruiting
Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Foot Ulcers...
Condition
Foot Ulcers, Diabetic
Enrollment
38 pts
Location
Spain
Sponsor
Biotechnology Institute IMASD
NCT05270733 Phase 4
Recruiting
Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcr...
Condition
Psoriasis
Enrollment
56 pts
Location
United States
Sponsor
University Hospitals Cleveland
NCT06571149 Phase 4
Recruiting
Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke...
Condition
Ischemic Stroke
Enrollment
906 pts
Location
Austria, Belgium, Canada
Sponsor
Insel Gruppe AG, University Ho
NCT04935021 Phase 4
Recruiting
Clinical Study of ATTR-CM
Condition
Transthyroxine Amyloidosis Cardiomyopathy
Enrollment
100 pts
Location
China
Sponsor
Second Affiliated Hospital, Zh
NCT05586776 Phase 4
Recruiting
Decolonization to Reduce After-Surgery Events of Surgical Site Infection
Condition
Surgical Site Infection
Enrollment
2,700 pts
Location
United States
Sponsor
University of California, Irvi
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
NCT07675850 Phase 4
Recruiting
Efficacy and Safety of Eleveld PK/PD Model-based Dosing During General Anesthesi...
Condition
Remimazolam
Enrollment
68 pts
Location
South Korea
Sponsor
Seoul National University Hosp
NCT07925450 Phase 4
Recruiting
Iron Treatment for Iron Deficiency Anemia in Children and Young Adults With Croh...
Condition
Crohn's Disease
Enrollment
150 pts
Location
United States
Sponsor
Weill Medical College of Corne
NCT07758335 Phase 4
Recruiting
The Efficacy of Lactobacillous Probiotic and Trace Elements in the Management of...
Condition
Ulcerative Colitis (UC)
Enrollment
132 pts
Location
Egypt
Sponsor
National Hepatology & Tropical
NCT07307235 Phase 4
Recruiting
Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult C...
Condition
Type 2 Diabetes
Enrollment
1,316 pts
Location
China
Sponsor
Shanghai Zhongshan Hospital
NCT06364540 Phase 4
Recruiting
Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions i...
Condition
Pain, Acute
Enrollment
150 pts
Location
United States
Sponsor
Antonios Likourezos
NCT07293715 Phase 4
Recruiting
Permissive Versus Strict Intrapartum Glucose Management in Type 1 and Type 2 Dia...
Condition
Pregnancy, High Risk
Enrollment
44 pts
Location
United States
Sponsor
Ohio State University
NCT07396441 Phase 4
Recruiting
Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on ...
Condition
Juvenile Open Angle Glaucoma
Enrollment
60 pts
Location
Malaysia
Sponsor
Universiti Sains Malaysia
NCT06644261 Phase 4
Recruiting
Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pu...
Condition
Pudendal Neuralgia
Enrollment
40 pts
Location
United States
Sponsor
University of Louisville
NCT06875258 Phase 4
Recruiting
PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy f...
Condition
Erectile Dysfunction Following Radical Prostatectomy
Enrollment
198 pts
Location
Netherlands
Sponsor
The Netherlands Cancer Institu
NCT06676384 Phase 4
Recruiting
Which of the Commonly Available and Approved Drugs in Addition to Standard of Ca...
Condition
IgA Nephropathy
Enrollment
585 pts
Location
India
Sponsor
Christian Medical College, Vel
NCT07140484 Phase 4
Recruiting
Sotatercept in Pulmonary Arterial Hypertension
Condition
Pulmonary Artery Hypertension
Enrollment
27 pts
Location
Canada
Sponsor
University of Alberta
NCT07459049 Phase 4
Recruiting
"Effect of Ibuprofen on Acute Inflammatory Response After One-Stage Periodontal ...
Condition
Periodontitis
Enrollment
30 pts
Location
Iraq
Sponsor
University of Baghdad
NCT04863222 Phase 4
Recruiting
Clinical and Radiographic Success of MTA vs Biodentine
Condition
Indirect Pulp Cap
Enrollment
646 pts
Location
United States
Sponsor
Geisinger Clinic
NCT05803941 Phase 4
Recruiting
Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With ...
Condition
Prostate Cancer
Enrollment
700 pts
Location
United States, Austria, Belgium
Sponsor
Novartis Pharmaceuticals
NCT06010628 Phase 4
Recruiting
Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)
Condition
Stroke, Ischemic
Enrollment
1,440 pts
Location
China
Sponsor
General Hospital of Shenyang M
NCT07401992 Phase 4
Recruiting
Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoria...
Condition
Psoriasis (PsO)
Enrollment
62 pts
Location
Mexico
Sponsor
Hospital Universitario Dr. Jos
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
NCT07147530 Phase 4
Recruiting
Effectiveness and Safety of the Electrically Powered Orthopedic Exercise Device ...
Condition
Hip Disease
Enrollment
30 pts
Location
South Korea
Sponsor
Yonsei University
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