Phase III clinical trial failures

Phase III Secondary Hyperparathyroidism-Chronic Kidney Disease trial by Sanofi. Stop reason: OPERATIONAL.

The study was conducted to fulfill a post-marketing commitment (PMC).FDA acknowledged the fulfillment of this PMC.

Phase III Anatomic Stage 0 Breast Cancer AJCC v8 trial by Alliance for Clinical Trials in Oncology. Stop reason: OTHER/UNKNOWN.

Amending protocol to increase sample size

Phase II Clinical Stage II Esophageal Adenocarcinoma AJCC v8 trial by National Cancer Institute (NCI). Stop reason: OTHER/UNKNOWN.

End of Initial Phase of Multi-phase protocol

Phase II Lung Adenocarcinoma trial by National Cancer Institute (NCI). Stop reason: OTHER/UNKNOWN.

End of Initial Phase of Multi-phase protocol

Phase III Eyelid Squamous Cell Carcinoma trial by National Cancer Institute (NCI). Stop reason: OTHER/UNKNOWN.

Other - Other

Phase III COVID trial by University of Minnesota. Stop reason: EFFICACY/FUTILITY.

Stopped for futility - no safety issues.

Phase II Crohn's Disease trial by Pfizer. Stop reason: EFFICACY/FUTILITY.

The study was prematurely discontinued due to a lack of efficacy in sub-study 1

Phase III Solitary Osseous Plasmacytoma trial by Alliance for Clinical Trials in Oncology. Stop reason: OPERATIONAL.

DSMB recommendation due to slow accrual

Phase III Hyperphagia trial by Aardvark Therapeutics, Inc.. Stop reason: OTHER/UNKNOWN.

Due to operational and regulatory considerations.

Phase II PPROM trial by The University of Texas Medical Branch, Galveston. Stop reason: OPERATIONAL.

Low study recruitment

Phase III Asthma trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Sponsor decision to discontinue lebrikizumab development for the treatment of asthma.

Phase III Hyperphagia trial by Aardvark Therapeutics, Inc.. Stop reason: OTHER/UNKNOWN.

Due to operational and regulatory considerations.

Phase II Prevention of Esophageal Varices trial by Galectin Therapeutics Inc.. Stop reason: REGULATORY.

Based on FDA feedback, Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was not prematurely terminated for safety reasons.

Phase III Surgical Site Infection trial by PolyPid Ltd.. Stop reason: OPERATIONAL.

company prioritization reasons

Phase III Osteoporosis trial by University of Texas Southwestern Medical Center. Stop reason: OPERATIONAL.

No enrollment due to COVID

Phase III Degenerative Disc Disease trial by Angitia Biopharmaceuticals. Stop reason: OPERATIONAL.

Sponsor's strategic decision not related to safety concerns.

Phase III Acquired Factor X Deficiency trial by Kedrion S.p.A.. Stop reason: OTHER/UNKNOWN.

Study was discontinued for non-safety reasons and the rapidly evolving treatment landscape for AL amyloidosis.

Phase III Migraine trial by Eli Lilly and Company. Stop reason: OPERATIONAL.

Study terminated due to strategic business decision

Phase III Acute Major Bleeding trial by Octapharma. Stop reason: EFFICACY/FUTILITY.

Following Interim Analysis IDMEAC concluded:1-No safety concerns 2-Suspend enrolment: Futility based on treatment effect size at interim analysis. Enrollment was suspended on 22DEC25. Study was terminated FEB2026. Final analysis is planned in Q2 2026

Phase III Soft Tissue Sarcoma trial by Polaris Group. Stop reason: OTHER/UNKNOWN.

Lack of Efficacy, no safety concern.

Phase III Metastatic Breast Cancer trial by SOLTI Breast Cancer Research Group. Stop reason: OPERATIONAL.

The study was prematurely halted because enrollment was significantly delayed compared with the original projections due to the evolving therapeutic landscape.

Phase II Advanced Head and Neck Squamous Cell Carcinoma trial by NRG Oncology. Stop reason: OTHER/UNKNOWN.

End of Initial Phase of Multi-phase protocol; closed for protocol specified analysis

Phase III Early Alzheimer's Disease trial by Alzheon Inc.. Stop reason: OPERATIONAL.

Sponsor business decision

Phase III Agitation in Patients With Dementia of the Alzheimer's Type trial by Axsome Therapeutics, Inc.. Stop reason: OTHER/UNKNOWN.

Study AXS-05-AD-305 was terminated due to completion of overall program objectives.

Phase III NSCLC trial by Spectrum Pharmaceuticals, Inc. Stop reason: OTHER/UNKNOWN.

The study has not enrolled any patients. The study design is under discussion and will likely be redesigned in consultation with the FDA.

Phase III Pre-Eclampsia trial by The University of Texas Medical Branch, Galveston. Stop reason: EFFICACY/FUTILITY.

Futility of the study

Phase III Endometrial Carcinoma trial by National Cancer Institute (NCI). Stop reason: OTHER/UNKNOWN.

Other - Revisions to ICF

Phase III Recurrent Uterine Corpus Sarcoma trial by National Cancer Institute (NCI). Stop reason: EFFICACY/FUTILITY.

The study was targeted to accrue 130 patients, but closed early for futility.

Phase III Hereditary Hemorrhagic Telangiectasia trial by University Hospital, Bordeaux. Stop reason: OTHER/UNKNOWN.

target number of subject not reached

Phase III MPOX trial by National Institute of Allergy and Infectious Diseases (NIAID). Stop reason: EFFICACY/FUTILITY.

DSMB recommendation due to statistical futility

Phase III Breast Carcinoma trial by National Cancer Institute (NCI). Stop reason: OPERATIONAL.

Closed early due to slow accrual

Phase II Crohn's Disease trial by AstraZeneca. Stop reason: OPERATIONAL.

Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.

Phase III Asthma trial by University of Arizona. Stop reason: EFFICACY/FUTILITY.

The AZ-SWED trial was stopped by the National Heart, Lung, and Blood Institute (NHLBI) due to futility

Phase III Hyperphosphatemia Related to Chronic Kidney Disease trial by Keryx Biopharmaceuticals. Stop reason: OPERATIONAL.

Sponsor decision

Phase III Hemodynamic Instability trial by University Hospital, Bordeaux. Stop reason: OTHER/UNKNOWN.

stop due to medication error with the placebo

Phase III Aortic Valve Stenosis trial by University Hospital, Bordeaux. Stop reason: OTHER/UNKNOWN.

target number of subjects not reached

Phase III Sickle Cell Crisis trial by University Hospital, Bordeaux. Stop reason: OTHER/UNKNOWN.

Target number of inclusion not reached

Phase III NSCLC (Advanced Non-small Cell Lung Cancer) trial by ImmunityBio, Inc.. Stop reason: OPERATIONAL.

Sponsor decision

Phase II FSGS trial by Apellis Pharmaceuticals, Inc.. Stop reason: OPERATIONAL.

Study temporarily suspended due to company acquisition and ongoing strategic evaluation, with recruitment challenges including screening failures

Phase III Asthma trial by AstraZeneca. Stop reason: OPERATIONAL.

The study was discontinued due to slow recruitment, resulting from evolving clinical practices that reduced the use of maintenance oral corticosteroids for severe asthma treatment. The termination decision was not related to safety concerns.

Phase III Delayed Graft Function trial by Apellis Pharmaceuticals, Inc.. Stop reason: OTHER/UNKNOWN.

Study temporarily suspended due to company acquisition and ongoing strategic evaluation of the program

Phase II Multiple Myeloma (MM) trial by Regeneron Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor Decision

Phase III Azoospermia, Nonobstructive trial by Hospices Civils de Lyon. Stop reason: OPERATIONAL.

problems of feasibility

Phase II Hidradenitis Suppurativa (HS) trial by Boehringer Ingelheim. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase III Melanoma trial by Centre Hospitalier Universitaire de Nice. Stop reason: OTHER/UNKNOWN.

Rupture du traitement

Phase III Retinopathy of Prematurity trial by Jaeb Center for Health Research. Stop reason: OPERATIONAL.

Lack of feasibility to recruit.

Phase III Non-small Cell Lung Cancer trial by Novartis Pharmaceuticals. Stop reason: OTHER/UNKNOWN.

Results of primary analysis showed addition of canakinumab to combination treatment did not improve tumor response or overall survival; the decision to stop the trial was not due to safety concerns

Phase III Persistent Postoperative Pain trial by Benno Rehberg-Klug. Stop reason: OPERATIONAL.

insufficient funding and recruitment

Phase III Brain Injuries trial by University Hospital, Brest. Stop reason: EFFICACY/FUTILITY.

interim analysis - Results ongoing

Phase III COVID-19 trial by University Hospital, Tours. Stop reason: OTHER/UNKNOWN.

COMPETITOR TEST (RECOVERY)

Phase II Pain Management trial by Wake Forest University Health Sciences. Stop reason: OPERATIONAL.

Study initially suspended following an audit and need of amendment to address deficiencies. PI requested to terminate due to lack of support.

Phase III Chronic Kidney Disease (CKD) trial by AbbVie. Stop reason: OPERATIONAL.

Company Decision

Phase II Melanoma trial by Regeneron Pharmaceuticals. Stop reason: OPERATIONAL.

Business Decision

Phase II Myocardial Infarction, Acute trial by University Hospital, Montpellier. Stop reason: OTHER/UNKNOWN.

Inclusion period completed

Phase III Impulse Control Disorder trial by Centre Hospitalier Universitaire, Amiens. Stop reason: OTHER/UNKNOWN.

Zambon corparate has decided not to renew the production of the samples.

Phase III COPD Exacerbation trial by University Hospital, Montpellier. Stop reason: OPERATIONAL.

low enrollment at participating centers

Phase III Influenza trial by BioCryst Pharmaceuticals. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase II MAC Lung Disease trial by AN2 Therapeutics, Inc. Stop reason: OTHER/UNKNOWN.

EBO-301 truncated Phase 3 study (n=97) misses primary endpoint; results unable to confirm clinical efficacy observed in Phase 2 study.

Phase III Non-small Cell Lung Cancer (NSCLC) trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Decision to terminate study was driven by results from preceding tiragolumab study (SKYSCRAPER-06;NCT04619797) \& sponsor's strategic priorities, not due to safety risks or quality reasons for any of molecules/combinations investigated in this study.

Phase II Wound of Skin trial by Brigham and Women's Hospital. Stop reason: OPERATIONAL.

Due to the insufficient accrual rate and strategic reasons to focus our efforts on higher impact research projects.

Phase III Sleep Apnea trial by University Hospital, Limoges. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase III Thrombotic Microangiopathies trial by University Hospital, Rouen. Stop reason: OTHER/UNKNOWN.

Change in the molecule

Phase III Dravet Syndrome (DS) trial by Takeda. Stop reason: OTHER/UNKNOWN.

Due to negative results from phase 3 SKYLINE and SKYWAY studies and unrelated to patient safety it has been determined that supplementary data from TAK-935-3003 study is no longer necessary. Therefore, Takeda has made a decision to close this study

Phase III Pain Due to Certain Specified Procedures trial by University Hospital, Limoges. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase III Pulmonary Arterial Hypertension trial by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA. Stop reason: OTHER/UNKNOWN.

Study was stopped early due to loss of clinical equipoise based on robust evidence of clinical benefit of sotatercept demonstrated in previous studies.

Phase III Primary Biliary Cholangitis trial by Intercept Pharmaceuticals. Stop reason: OPERATIONAL.

Intercept made a business decision to terminate the study based on FDA's request for voluntary withdrawal of Ocaliva and the issuance of clinical hold on studies under US IND involving OCA.

Phase III Depressive Disorder, Major trial by Janssen Research & Development, LLC. Stop reason: EFFICACY/FUTILITY.

Early study termination due to insufficient efficacy.

Phase III HIV-1-infection trial by ANRS, Emerging Infectious Diseases. Stop reason: OPERATIONAL.

Low recruitment rate

Phase II Aplastic Anemia trial by Peking Union Medical College Hospital. Stop reason: OTHER/UNKNOWN.

The ethical application for the institution was not completed, and the research was not carried out.

Phase II Analgesia trial by Arthritis Innovation Corporation. Stop reason: OTHER/UNKNOWN.

Study superseded by alternative Phase 3 trial

Phase III Hamstring Contractures trial by GCS Ramsay Santé pour l'Enseignement et la Recherche. Stop reason: OPERATIONAL.

The site had difficulties to recruit. Some associated investigators can not be involved in the study anymore and others centers contacted don't have enough ressources to conduct the study. Premature end of inclusions on 07/10/2025 \& LPLV on11/27/2025

Phase III Ebola Vaccine trial by Universitätsklinikum Hamburg-Eppendorf. Stop reason: OPERATIONAL.

Public funding was withdrawn before the start of the clinical trial.

Phase III Acute-On-Chronic Liver Failure trial by Instituto Grifols, S.A.. Stop reason: OPERATIONAL.

Due to corporate business reasons only (non-safety related decision)

Phase II Endometrial Carcinoma trial by Xiaojun Chen. Stop reason: OTHER/UNKNOWN.

no enough enrolled patients

Phase III Acute Myeloid Leukemia (AML) trial by AbbVie. Stop reason: OTHER/UNKNOWN.

Strategic considerations

Phase III Transfusion-dependent Non-severe Aplastic Anemia trial by Peking Union Medical College Hospital. Stop reason: OTHER/UNKNOWN.

The registration of this research plan was incorrect. A new registration has been re-applied for.

Phase III Ovarian Cancer trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor Decision

Phase III Distal Renal Tubular Acidosis trial by Advicenne Pharma. Stop reason: OPERATIONAL.

COVID-19 pandemic negatively impacted the ability to enroll patients.

Phase III COVID-19 trial by Sanofi Pasteur, a Sanofi Company. Stop reason: OPERATIONAL.

The study was terminated as per Sponsor decision

Phase III Chronic Intracranial Subdural Hematoma trial by University Hospital, Montpellier. Stop reason: EFFICACY/FUTILITY.

successfull Interim Analysis

Phase III Acute Respiratory Distress Syndrome (ARDS) trial by Consorcio Centro de Investigación Biomédica en Red (CIBER). Stop reason: OPERATIONAL.

Persistently low recruitment of subjects

Phase II Hemangioma, Capillary trial by University Hospital, Bordeaux. Stop reason: OPERATIONAL.

Study halted prematurely due to some difficulties in recruitment of patients

Phase III Influenza trial by BioCryst Pharmaceuticals. Stop reason: OPERATIONAL.

This study was withdrawn for administrative reasons. The dose ranging plan for the program was revised".

Phase III Chronic Myeloid Leukemia trial by Sarit Assouline. Stop reason: OPERATIONAL.

Insufficient patient accrual

Phase III Metastatic Breast Adenocarcinoma trial by National Cancer Institute (NCI). Stop reason: OPERATIONAL.

Inadequate accrual rate

Phase III Charcot-Marie-Tooth Disease With Sorbitol Dehydrogenase Deficiency (CMT-SORD) trial by Applied Therapeutics, Inc.. Stop reason: OPERATIONAL.

The study was withdrawn prior to enrollment as the sponsor decided not to proceed with study initiation.

Phase III GERD (Gastroesophageal Reflux Disease) trial by Cinclus Pharma Holding AB. Stop reason: OTHER/UNKNOWN.

Strategic desicion by Sponsor

Phase II Spasticity trial by Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC. Stop reason: OPERATIONAL.

Company/sponsor business decision; not due to or related to any safety concerns

Phase III Pulmonary Hypertension trial by United Therapeutics. Stop reason: OPERATIONAL.

Sponsor's decision

Phase III Non Small Cell Lung Cancer trial by ImmunityBio, Inc.. Stop reason: OTHER/UNKNOWN.

There are no longer active subjects on QUILT-2.023. Data will be entered into clinicaltrials.gov within 1 year of the primary completion date.

Phase III Subarachnoid Hemorrhage, Aneurysmal trial by Centre Hospitalier Universitaire de Nice. Stop reason: OTHER/UNKNOWN.

The treatments are no longer available.

Phase III Diarrhea Travelers trial by Centers for Disease Control and Prevention. Stop reason: OTHER/UNKNOWN.

Unable to reach target sample size.

Phase III ALS trial by Tanabe Pharma America, Inc.. Stop reason: EFFICACY/FUTILITY.

Futility was met.

Phase III ALS trial by Tanabe Pharma America, Inc.. Stop reason: EFFICACY/FUTILITY.

Futility Analysis of parent study MT-1186-A02 was met.

Phase II Spasticity trial by Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC. Stop reason: OPERATIONAL.

Company/sponsor business decision; not due to or related to any safety concerns

Phase III Superficial Bladder Cancer trial by Abnoba Gmbh. Stop reason: OPERATIONAL.

The study was terminated because the required number of patients cannot be reached in the foreseeable future. Recruitment was not stopped due to safety issues. Follow-up for all patients was completed according protocol including safety monitoring.

Phase II Severe Preeclampsia trial by AMAG Pharmaceuticals, Inc.. Stop reason: EFFICACY/FUTILITY.

Following a recommendation from the Data and Safety Monitoring Board (DSMB), the study was stopped early for futility. There were no safety concerns raised.

Phase III Tendonitis trial by APR Applied Pharma Research s.a.. Stop reason: OPERATIONAL.

Sponsor (Endo Pharmaceuticals) decision (business reasons)

Phase III Anatomic Stage IV Breast Cancer AJCC v8 trial by NRG Oncology. Stop reason: OPERATIONAL.

Inadequate accrual rate

Phase II COVID-19 trial by Inmune Bio, Inc.. Stop reason: EFFICACY/FUTILITY.

Futility