Phase 3 Clinical Trials in 2026

Q: How many Phase 3 trials started in 2026?

61 Phase 3 clinical trials were started in 2026 according to ClinicalTrials.gov data tracked by ReadTheTrial.

Q: What is Phase 3 in clinical trials?

Phase 3 trials are large-scale pivotal studies with 300-3,000+ participants for FDA approval.

Q: Are any 2026 Phase 3 trials recruiting?

Yes, 29 Phase 3 trials from 2026 are still recruiting.

2026 Phase 3 Research Overview

Phase 3 clinical trials started in 2026 provide a snapshot of the medical research landscape. In total, 61 such trials were initiated. 29 of these are still actively recruiting. Leading sponsors include Hoffmann-La Roche, National Cancer Institute (NCI), Merck Sharp & Dohme LLC.

Phase 3 Trials

Recruiting

Trial Status

NOT YET RECRUITING: 31 trials
RECRUITING: 29 trials
ACTIVE NOT RECRUITING: 1 trial

Phase 3 Trials Started in 2026

A Phase 3 Study With an Open-Label Extension in Pediatric Participants to Evaluate the Safety, Efficacy, and Pharmacokinetics of Diroximel Fumarate and Dimethyl Fumarate for the Treatment of Relapsing Forms of Multiple Sclerosis

NCT07483632 · NOT YET RECRUITING · Phase 3 · Biogen

A Phase III, Randomized, Open-label Study Evaluating the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Patients With Resected Stage II-III KRAS G12C-Positive Non-small Cell Lung Cancer

NCT07541170 · NOT YET RECRUITING · Phase 3 · Hoffmann-La Roche

Multicenter Randomised Controlled Trial: Benefit of Intra-pocket Echo-guided Axillary Puncture Compared With Percutaneous Echo-guided Axillary Puncture and Cephalic Vein Dissection for the Primary Implantation of Intracardiac Electronic Devices.

NCT07273929 · NOT YET RECRUITING · Phase 3 · Hospices Civils de Lyon

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. Once Weekly Versus Placebo in Children and Adolescents With Type 2 Diabetes

NCT07282613 · NOT YET RECRUITING · Phase 3 · Novo Nordisk A/S

A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase III Study to Evaluate the Efficacy and Safety of Letrozole SIE Compared to Femara® (Both in Combination With the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women With HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer (SIE-3)

NCT07340658 · NOT YET RECRUITING · Phase 3 · Rovi Pharmaceuticals Laboratories

A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment For High Anatomic Stage ER-pos/HER2-neg Breast Cancer With RS</=25 (RxFINE-Low)

NCT07391774 · NOT YET RECRUITING · Phase 3 · National Cancer Institute (NCI)

Phase III Double Blinded Trial of Immune-Based Therapy With a Live Biotherapeutic MO-03 or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma [BioFront Trial]

NCT07383441 · NOT YET RECRUITING · Phase 3 · SWOG Cancer Research Network

Feasibility of Circulating Tumor DNA Based Minimal Residual Disease-Guided Adjuvant Therapy in Locally Advanced Gastric Cancer With Neoadjuvant Treatment: An Open-Label, Randomized, Multi-Centered Phase III Trial

NCT07508956 · NOT YET RECRUITING · Phase 3 · Shanghai Zhongshan Hospital

A Randomized, Open-label, Multicenter, Phase III Clinical Trial to Evaluate the Safety and Efficacy of SYS6010 in Combination With Osimertinib in Patients With EGFR-mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer

NCT07376382 · NOT YET RECRUITING · Phase 3 · CSPC Megalith Biopharmaceutical Co.,Ltd.

A Multi-site Randomized Controlled Trial of Psilocybin for Treatment-Resistant Depression (TRD) in Veterans

NCT07226232 · NOT YET RECRUITING · Phase 3 · VA Office of Research and Development

Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)

NCT07220252 · NOT YET RECRUITING · Phase 3 · TG Therapeutics, Inc.

Tributyrin Treatment in Mild Alzheimer Disease: Assessment of Butyrate Effects Via the Gut-Brain

NCT06797817 · NOT YET RECRUITING · Phase 3 · Universidad de Almeria

A Randomized, Open-Label, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2934 Injection Versus Investigator-Selected Regimens in Patients With Relapsed/Refractory Multiple Myeloma

NCT07569757 · NOT YET RECRUITING · Phase 3 · Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease

NCT07492641 · NOT YET RECRUITING · Phase 3 · BeOne Medicines

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40-Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral DT120 Compared to Placebo in the Treatment of Adults With Major Depressive Disorder - Ascend

NCT07592689 · RECRUITING · Phase 3 · Definium Therapeutics US, Inc.

A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)

NCT07513376 · RECRUITING · Phase 3 · Merck Sharp & Dohme LLC

A Registry-Based Randomised Controlled Trial With Heart 4 Data - SELEnium and CoQ10 NuTrition for Heart Failure: H4D-SELEQT-HF

NCT07234422 · NOT YET RECRUITING · Phase 3 · Netherlands Heart Institute

A Randomized, Open-label, Phase 3 Study to Evaluate 9MW2821 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer Who Have Previously Received Taxane-based Chemotherapy With or Without Immunotherapy and an Antibody-drug Conjugate With a Topoisomerase Inhibitor Payload

NCT07556848 · NOT YET RECRUITING · Phase 3 · Mabwell (Shanghai) Bioscience Co., Ltd.

Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea

NCT07332442 · RECRUITING · Phase 3 · Yale University

Multicenter, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart Failure (NYHA Class III-IV)

NCT07496372 · NOT YET RECRUITING · Phase 3 · HELP Therapeutics Co., Ltd.

A Two-part, Seamless, Multicenter, Randomized, Open-label, Adaptive Phase II/III Study of the Blood-brain Barrier Penetrant RO7771950 Versus Tucatinib, Both in Combination With Trastuzumab and Capecitabine, in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2-Postivie Breast Cancer, With or Without Central Nervous System Metastases

NCT07413939 · NOT YET RECRUITING · Phase 3 · Hoffmann-La Roche

A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator's Choice of Non-platinum Chemotherapy in Participants With Pretreated Locally Advanced/Metastatic Urothelial Carcinoma

NCT07419295 · RECRUITING · Phase 3 · Merck Sharp & Dohme LLC

Efficacy and Safety of Butylphthalide in the Treatment of Multiple System Atrophy（ENMSA）: A Multicenter, Randomised, Double-blinded, Placebo-controlled Trial

NCT07518810 · NOT YET RECRUITING · Phase 3 · Second Affiliated Hospital, School of Medicine, Zhejiang University

Evaluating Adjuvant Atezolizumab or Atezolizumab and Hyaluronidase-TQJS to Prevent Recurrence in Stage I Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase III Trial (AASI-NSCLC)

NCT07388524 · NOT YET RECRUITING · Phase 3 · National Cancer Institute (NCI)

Optimal Personalized Treatment of Early Breast Cancer Using Multi-parameter Analysis: Focus on YOUNGer Women

NCT07106632 · NOT YET RECRUITING · Phase 3 · UNICANCER

A Randomized Controlled Phase III Clinical Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer

NCT07518173 · NOT YET RECRUITING · Phase 3 · Sichuan Baili Pharmaceutical Co., Ltd.

Clinical Study Evaluating the Effect of Nicorandil as Anti-inflammatory and Immune Modulatory in Patients With Rheumatoid Arthritis

NCT07516769 · NOT YET RECRUITING · Phase 3 · Tanta University

Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes

NCT07428746 · NOT YET RECRUITING · Phase 3 · Emory University

A Randomized, Open-label, Multicenter, Phase 3 Trial of Ivonescimab Alone or With Ligufalimab Versus Pembrolizumab in First-line Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

NCT07264075 · NOT YET RECRUITING · Phase 3 · Groupe Oncologie Radiotherapie Tete et Cou

CDK4/6 Inhibitors Intensification for Chemotherapy Omission in Small Size High-risk ER-positive Breast Cancer（Cinnamon）

NCT07432178 · NOT YET RECRUITING · Phase 3 · Fudan University

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes

NCT07351058 · RECRUITING · Phase 3 · Hoffmann-La Roche

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight Without Type 2 Diabetes

NCT07351045 · RECRUITING · Phase 3 · Hoffmann-La Roche

Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma: The BATTMAN Trial

NCT07152821 · RECRUITING · Phase 3 · Canadian Cancer Trials Group

A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma

NCT07393282 · NOT YET RECRUITING · Phase 3 · Regeneron Pharmaceuticals

Virtual Auricular Acupressure and Baduanjin Qigong Exercise for Preventing Menstrual Pain in Females: A Randomized Clinical Trial

NCT07497711 · NOT YET RECRUITING · Phase 3 · Nanyang Technological University

Application of Bevacizumab Combined With Fractionated Stereotactic Radiotherapy (FSRT-Bev) Versus Hippocampus-Avoidant Whole-Brain Radiotherapy With Simultaneous Integrated Boost (HA-WBRT-SIB) in Patients With Extensive Brain Metastases From Lung Adenocarcinoma: A Phase III Randomized Controlled Trial Evaluating Intracranial Control Efficacy and Neurocognitive Function

NCT07481786 · RECRUITING · Phase 3 · Sun Yat-sen University

A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Adjuvant Placebo Plus MK-3475A in Participants With Completely Resected Stage IIA-IIIB (N2), KRAS G12C-mutant Non-small Cell Lung Cancer Following Receipt of Either Neoadjuvant Pembrolizumab Plus Chemotherapy or Adjuvant Chemotherapy (KANDLELIT-013)

NCT07431827 · RECRUITING · Phase 3 · Merck Sharp & Dohme LLC

Explore the Relationship Between Single Nucleotide Polymorphisms and Alectinib Response and Toxicity in Patients With Non-Small Cell Lung Cancer.

NCT05987956 · ACTIVE NOT RECRUITING · Phase 3 · Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 Study of Pumitamig Monotherapy Compared to Durvalumab in Participants With Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy.

NCT07361497 · RECRUITING · Phase 3 · Bristol-Myers Squibb

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against FXI, for Primary Prophylaxis of Cancer-Associated Thrombosis for Participants With Solid Tumors Undergoing Cancer Treatment (ROXI-CAT-I)

NCT07410117 · RECRUITING · Phase 3 · Regeneron Pharmaceuticals

A Randomized, Controlled, Open-label, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of KN026 Combined With HB1801 and Chemotherapy Versus Trastuzumab Combined With Pertuzumab and Chemotherapy as Adjuvant Therapy in Resectable HER2-positive Breast Cancer

NCT07441460 · RECRUITING · Phase 3 · Shanghai JMT-Bio Inc.

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis

NCT07299019 · RECRUITING · Phase 3 · Zenas BioPharma (USA), LLC

An Open-Label, Randomized, Multicenter, Phase II/III Clinical Study to Evaluate HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With HLX87 (HER2 ADC) as First-Line Treatment in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer

NCT07294508 · RECRUITING · Phase 3 · Shanghai Henlius Biotech

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept in Adult Participants With Active Primary Sjögren's Disease

NCT07404865 · RECRUITING · Phase 3 · Vor Biopharma

A Phase 2b/3, Adaptive, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy

NCT07210723 · RECRUITING · Phase 3 · Kardigan, Inc.

A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Moderate to Severe Obstructive Sleep Apnea, and Obesity or Overweight

NCT07369011 · RECRUITING · Phase 3 · Eli Lilly and Company

Phase 3 Clinical Study on the Efficacy and Safety of SBRT Combined With Becotatug Vedotin (MRG003) in EGFR-Positive Metastatic Tumor Patients With Oligometastases

NCT07481799 · RECRUITING · Phase 3 · Ming-Yuan Chen

A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti CD38 Antibody

NCT07258511 · RECRUITING · Phase 3 · Janssen Research & Development, LLC

Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)

NCT07481747 · RECRUITING · Phase 3 · Hudson Biotech

A Multicenter, Randomized, Double-blinded, Parallel, Positive-controlled, Phase III Comparative Study to Evaluate GS101 Injection Versus Dupixent® in Participants With Moderate-to-Severe Atopic Dermatitis

NCT07386743 · NOT YET RECRUITING · Phase 3 · Jiangsu Genscend Biopharmaceutical Co., Ltd

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Efficacy and Safety of Dimethyl Fumarate in Preserving Islet β-Cell Function in Patients With Type 1 Diabetes Mellitus

NCT07258394 · RECRUITING · Phase 3 · Nanjing Medical University

A Randomized Phase III Trial of Carboplatin, Paclitaxel, Pembrolizumab Versus Carboplatin, Paclitaxel, Bevacizumab Versus Carboplatin, Paclitaxel, Pembrolizumab, Bevacizumab in the Treatment of pMMR, TP53 Mutated Advanced or Recurrent Endometrial Cancer

NCT07198074 · RECRUITING · Phase 3 · National Cancer Institute (NCI)

Beamion LUNG-3: A Randomized, Controlled, Multi-center Trial Evaluating Zongertinib as an Adjuvant Monotherapy Compared With Standard of Care in Patients With Early-stage, Resectable Non-small Cell Lung Cancer (Stage II-IIIB) Harboring Tyrosine Kinase Domain Activating HER2 Mutations

NCT07195695 · RECRUITING · Phase 3 · Boehringer Ingelheim

A Randomized, Phase 3, Open-label Study to Investigate Pharmacokinetics, Safety, and Efficacy of Subcutaneous Compared to Intravenous Frexalimab in Adult Participants With Multiple Sclerosis

NCT07325292 · RECRUITING · Phase 3 · Sanofi

A Multicenter, Randomized, Controlled, Open-label, Group-Sequential, Phase 3 Study to Investigate the Efficacy, Safety, and Tolerability of Intravenous Gammagard Liquid (Immune Globulin Infusion, 10%) for Primary Infection Prophylaxis Compared With Secondary Infection Prophylaxis in Adult Subjects With Multiple Myeloma Receiving B-Cell Maturation AntigenxCD3-Directed Bispecific Antibody Therapy

NCT06980480 · RECRUITING · Phase 3 · Takeda

Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis

NCT06654882 · RECRUITING · Phase 3 · Duke University

AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

NCT07222566 · RECRUITING · Phase 3 · Pfizer

Fully Closed-Loop Glucose Control in Adults With Type 1 Diabetes Using Tirzepatide: a Randomized, Multi-center, Open-label, Non-inferiority, Parallel Trial

NCT07284511 · NOT YET RECRUITING · Phase 3 · Melissa-Rosina Pasqua

An Open-Label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab Plus Carfilzomib Versus Standard of Care Combination Regimens in Patients With Relapsed/Refractory Multiple Myeloma

NCT07222761 · RECRUITING · Phase 3 · Regeneron Pharmaceuticals

A Randomized Phase 2/3 Study of BMS-986504 in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

NCT07063745 · RECRUITING · Phase 3 · Bristol-Myers Squibb

EarLy Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT): a Parallel Group, Randomized, Double Blind, Placebo Controlled Trial

NCT07191145 · NOT YET RECRUITING · Phase 3 · Sunnybrook Health Sciences Centre

Frequently Asked Questions

How many Phase 3 trials started in 2026?

61 Phase 3 clinical trials were started in 2026 according to ClinicalTrials.gov data tracked by ReadTheTrial.

What is Phase 3 in clinical trials?