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
NCT05148286 Phase 4
Recruiting
Albumin and Crystalloid Administration in Septic Shock
Condition
Septic Shock
Enrollment
2,426 pts
Location
South Korea
Sponsor
Asan Medical Center
NCT07286188 Phase 4
Recruiting
Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy
Condition
Fibroids, Uterine
Enrollment
40 pts
Location
United States
Sponsor
Northwestern University
NCT06852469 Phase 4
Recruiting
Computational Assessment of GABA Receptor Modulation in PTSD
Condition
Stress Disorders, Post-Traumatic
Enrollment
150 pts
Location
United States
Sponsor
VA Office of Research and Deve
NCT07176689 Phase 4
Recruiting
Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis...
Condition
Desmoid Tumor
Enrollment
50 pts
Location
Belgium, Germany, Italy
Sponsor
SpringWorks Therapeutics, Inc.
NCT06498089 Phase 4
Recruiting
A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the E...
Condition
Takayasu Arteritis
Enrollment
124 pts
Location
China
Sponsor
Shanghai Zhongshan Hospital
NCT07910474 Phase 4
Recruiting
FES PET/MRI for Occult Disease in Lobular Breast Cancer
Condition
Lobular Breast Carcinoma
Enrollment
30 pts
Location
United States
Sponsor
University of Wisconsin, Madis
NCT05780190 Phase 4
Recruiting
Clinical Observation of CABA System in the Treatment of End-stage Liver Disease ...
Condition
To Evaluate the Clinical Efficacy and Safety of the New ALSS
Enrollment
40 pts
Location
China
Sponsor
Qin Ning
NCT05806580 Phase 4
Recruiting
Secondary Infusion of Relma-cel Injection for Relapsed or Refractory B-cell Lymp...
Condition
Relapsed or Refractory B-cell Lymphoma
Enrollment
8 pts
Location
China
Sponsor
Ruijin Hospital
NCT07638527 Phase 4
Recruiting
Time to First Rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexa...
Condition
Postoperative Nausea and Vomiting
Enrollment
264 pts
Location
Pakistan
Sponsor
Faisalabad Medical University
NCT06223880 Phase 4
Recruiting
A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing t...
Condition
Major Depressive Disorder
Enrollment
350 pts
Location
United States
Sponsor
Axsome Therapeutics, Inc.
NCT05830500 Phase 4
Recruiting
Study of Anlotinib in Patients With Advanced Medullary Thyroid Carcinoma
Condition
Medullary Thyroid Cancer
Enrollment
360 pts
Location
China
Sponsor
Chia Tai Tianqing Pharmaceutic
NCT06384651 Phase 4
Recruiting
Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplas...
Condition
Infections
Enrollment
40 pts
Location
United States
Sponsor
The Methodist Hospital Researc
NCT06834165 Phase 4
Recruiting
Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in ...
Condition
Allergic Reactions
Enrollment
600 pts
Location
United States
Sponsor
ARS Pharmaceuticals, Inc.
NCT06764095 Phase 4
Recruiting
Enfortumab Vedotin and Pembrolizumab With Cystectomy and/or Ureterectomy for Loc...
Condition
Locally Advanced Bladder Urothelial Carcinoma
Enrollment
75 pts
Location
United States
Sponsor
Mayo Clinic
NCT05333328 Phase 4
Recruiting
OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk
Condition
Breast Cancer
Enrollment
418 pts
Location
South Korea
Sponsor
Gangnam Severance Hospital
NCT06506565 Phase 4
Recruiting
Low-Dose Ketamine Infusion During Burn Wound Care
Condition
Burn
Enrollment
140 pts
Location
United States
Sponsor
University of Tennessee
NCT07932639 Phase 4
Recruiting
Long-Term Sequential Dual Antiplatelet Therapy Based on Cilostazol in Symptomati...
Condition
Ischemic Stroke
Enrollment
480 pts
Location
China
Sponsor
Second Affiliated Hospital of
NCT07462065 Phase 4
Recruiting
Effect Clomiphene vs Clomiphene Along With Pioglitazone on Ovarian Stimulation R...
Condition
Infertility Treatment
Enrollment
62 pts
Location
Pakistan
Sponsor
PAEC General Hospital, Islamab
NCT05979545 Phase 4
Recruiting
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Condition
Blood Stream Infections
Enrollment
1,526 pts
Location
India, Malaysia, Singapore
Sponsor
National University of Singapo
NCT06928753 Phase 4
Recruiting
Real-world Effectiveness, Safety & Immunogenicity of Chikungunya Vaccination: Am...
Condition
Chikungunya Virus Infection
Enrollment
1,505 pts
Location
French Guiana, Reunion
Sponsor
Centre Hospitalier Universitai
NCT06763926 Phase 4
Recruiting
Intranasal Nafarelin For Triggering Oocyte Maturation
Condition
Fertility Preservation
Enrollment
154 pts
Location
Spain
Sponsor
Fundacion Dexeus
NCT06888050 Phase 4
Recruiting
Efficacy and Safety of Henagliflozin Proline and Metformin Hydrochloride Extende...
Condition
New-onset Type 2 Diabetes
Enrollment
268 pts
Location
China
Sponsor
Zhejiang Provincial People's H
NCT07689578 Phase 4
Recruiting
Safety and Efficacy of the Bispecific T-Cell Engager (BiTE) in Kidney Transplant...
Condition
Antibody Mediated Rejection After Kidney Transplantation
Enrollment
50 pts
Location
China
Sponsor
Turun Song
NCT07310797 Phase 4
Recruiting
Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion
Condition
Ureteral Calculi
Enrollment
500 pts
Location
Taiwan
Sponsor
Taipei Tzu Chi Hospital, Buddh
NCT07609940 Phase 4
Recruiting
Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk...
Condition
Relapsed/Refractory Multiple Myeloma (RRMM)
Enrollment
30 pts
Location
United States
Sponsor
Regeneron Pharmaceuticals
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