Browse by Phase
Phase 2 / Phase 3 Clinical Trials
Phase 2/3 combined trials bridge efficacy assessment and large-scale comparison, enrolling larger cohorts while still gathering dose-response data.
Total Trials
119
Recruiting Now
119
Top Conditions in Phase 2 / Phase 3
Frequently Asked Questions — Phase 2 / Phase 3 Trials
What distinguishes a Phase 2/3 combined trial?
Phase 2/3 combined trials bridge efficacy assessment and large-scale comparative confirmation in a single expanding protocol. The Phase 2 portion identifies optimal dosing and collects early efficacy signals, while the Phase 3 portion expands enrollment and applies the primary statistical analysis to a larger population. This design reduces time from dose selection to pivotal evidence.
How large are Phase 2/3 combined trials?
Phase 2/3 trials are larger than standalone Phase 2 studies but may be smaller than fully powered Phase 3 trials. Enrollment typically ranges from 200 to 1,000 participants, depending on the condition, endpoint, and statistical requirements. Interim analyses allow sample size adjustment if early results indicate more statistical power is needed.
Who benefits most from Phase 2/3 trial designs?
Phase 2/3 designs particularly benefit patients with serious or rare conditions where standard treatments are inadequate. Because the Phase 2 and Phase 3 portions run as one continuous protocol, patients who enroll in Phase 2 may transition into the Phase 3 portion without interruption—a continuity of care advantage compared to sequential separate studies.
Active Phase 2 / Phase 3 Studies
NCT06014801 Phase 2, Phase 3
Recruiting
Low-intensity Versus Medium-intensity Continuous Kidney Replacement Therapy for ...
Condition
Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
Enrollment
400 pts
Location
Japan
Sponsor
Jikei University School of Med
NCT05860465 Phase 2, Phase 3
Recruiting
Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Trea...
Condition
Locally Advanced or Metastatic Breast Cancer
Enrollment
254 pts
Location
China
Sponsor
Shanghai Pharmaceuticals Holdi
NCT06996730 Phase 2, Phase 3
Recruiting
A Study of Donanemab, RG6289, or the Combination of Donanemab and RG6289 in Pres...
Condition
Autosomal Dominant Alzheimers Disease
Enrollment
240 pts
Location
Colombia
Sponsor
Banner Health
NCT06607419 Phase 2, Phase 3
Recruiting
Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnos...
Condition
B-Cell Lymphoblastic Leukemia
Enrollment
90 pts
Location
China
Sponsor
Shanghai Jiao Tong University
NCT06633900 Phase 2, Phase 3
Recruiting
Naltrexone for Overdose Prevention
Condition
Overdose Accidental
Enrollment
100 pts
Location
United States
Sponsor
University of California, San
NCT07655817 Phase 2, Phase 3
Recruiting
Oral Versus Intravenous Magnesium on Emergence Delirium
Condition
Magnesium
Enrollment
360 pts
Location
Egypt
Sponsor
Tanta University
NCT07284784 Phase 2, Phase 3
Recruiting
A Study of Buntanetap in Participants With PD
Condition
Parkinson's Disease (PD)
Enrollment
500 pts
Location
United States
Sponsor
Annovis Bio Inc.
NCT06030843 Phase 2, Phase 3
Recruiting
The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome...
Condition
Empagliflozin in Cardiorenal Syndrome Type 1
Enrollment
200 pts
Location
Thailand
Sponsor
Chulalongkorn University
NCT02836158 Phase 2, Phase 3
Recruiting
Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Pa...
Condition
Primary Central Nervous System Lymphoma
Enrollment
100 pts
Location
China
Sponsor
Navy General Hospital, Beijing
NCT02395497 Phase 2, Phase 3
Recruiting
Human Penile Allotransplantation
Condition
Amputation
Enrollment
60 pts
Location
United States
Sponsor
Johns Hopkins University
NCT06958627 Phase 2, Phase 3
Recruiting
The Impact of Intelligent Patient Management Model on Medication Adherence of Py...
Condition
HER2 Positive Breast Cancer
Enrollment
964 pts
Location
China
Sponsor
Cancer Institute and Hospital,
NCT05878951 Phase 2, Phase 3
Recruiting
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overa...
Condition
Urinary Incontinence
Enrollment
66 pts
Location
United States
Sponsor
Northwestern University
NCT07084662 Phase 2, Phase 3
Recruiting
Xinlikang Capsule for Chemotherapy-induced Fatigue and Immune Disorders in Diffu...
Condition
Diffuse Large B-Cell Lymphoma (DLBCL)
Enrollment
80 pts
Location
China
Sponsor
Sun Yat-sen University
NCT07544056 Phase 2, Phase 3
Recruiting
A Study of BEBT-209 Plus Chemotherapy in Patients With Locally Advanced or Metas...
Condition
Locally Advanced Triple-negative Breast Cancer
Enrollment
446 pts
Location
China
Sponsor
BeBetter Med Inc
NCT06212336 Phase 2, Phase 3
Recruiting
ISTH/ANRS 0409s INTEGRATE Lassa Fever Study
Condition
Lassa Fever
Enrollment
1,755 pts
Location
Liberia, Nigeria
Sponsor
Irrua Specialist Teaching Hosp
NCT06214572 Phase 2, Phase 3
Recruiting
Radiation Therapy in Unresectable Gall Bladder Cancer
Condition
Gall Bladder Cancer
Enrollment
249 pts
Location
India
Sponsor
Tata Memorial Centre
NCT06785571 Phase 2, Phase 3
Recruiting
The Evaluation of the Effectiveness and Safety of Nalbuphine Hydrochloride Injec...
Condition
Respiratory Insufficiency
Enrollment
204 pts
Location
China
Sponsor
Union Hospital, Tongji Medical
NCT07625332 Phase 2, Phase 3
Recruiting
Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Tr...
Condition
Spinal Cord Injury
Enrollment
60 pts
Location
United States
Sponsor
Northwell Health
NCT07669584 Phase 2, Phase 3
Recruiting
PKB171 Against Placebo in Couples With Mild Male Factor Infertility
Condition
Infertility Due to Azoospermia
Enrollment
732 pts
Location
Spain
Sponsor
Prokrea BCN, S.L.
Page 5 of 5 — 119 trials total
ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer · Last Reviewed: September 2026 · Data Methodology