AstraZeneca clinical trial failures

Phase II Ulcerative Colitis trial by AstraZeneca. Stop reason: OPERATIONAL.

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

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

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

Phase II Ulcerative Colitis trial by AstraZeneca. Stop reason: OPERATIONAL.

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

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 I Type 2 Diabetes Mellitus trial by AstraZeneca. Stop reason: SAFETY.

Safety issue was identified in the Phase2b D7860C00006 study, evaluating AZD6793 in moderate to very severe COPD participants. D7860C00005 study is temporary halted to amend the design to reflect changes implemented in the ongoing D7860C00006 study

Phase I Advanced/Recurrent Ovarian Cancer trial by AstraZeneca. Stop reason: OPERATIONAL.

The study termination is based on Sponsor decision and is not related to any safety, efficacy or quality concerns.

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

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

Phase I Advanced Solid Tumours trial by AstraZeneca. Stop reason: OPERATIONAL.

The decision to cease enrolment and proceed with the early termination of the ALAFOSS 01 (D7080C00001) study was based on strategic company portfolio prioritization.

Phase III Nasal Polyposis trial by AstraZeneca. Stop reason: EFFICACY/FUTILITY.

The study has a double-blind period and an open-label period. The study did not meet its primary endpoints after the primary LSLV and the decision was taken to terminate the study early.

Phase I Dilated Cardiomyopathy trial by AstraZeneca. Stop reason: SAFETY.

The study has been terminated due to adverse finding in a non-clinical, chronic toxicology study.

Phase I Advanced Solid Tumours trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

The study terminated because the clinical development programme for Ceralasertib has been discontinued.

Phase III Renal Insufficiency, Chronic trial by AstraZeneca. Stop reason: OPERATIONAL.

The study started enrollment in Sep 2021 and despite huge efforts the rate of patient enrollment continued to be below target such that the completion of the study within a reasonable timeframe was deemed very unlikely.

Phase II Lung Cancer trial by AstraZeneca. Stop reason: OPERATIONAL.

Enrollment delay study timeline seriously.

Phase I Heart Failure With Reduced Ejection Fraction (HFrEF) trial by AstraZeneca. Stop reason: OPERATIONAL.

The Sponsor encountered difficulties in recruiting patients for clinical trial D8330C00004 and decided to end the study earlier for business reasons not affecting the benefit-risk balance.

Phase I Renal Impairment trial by AstraZeneca. Stop reason: OPERATIONAL.

Sponsor Decision

Phase II Asthma trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

The decision was based on lung findings from a non-clinical 13-week Good Laboratory Practice (GLP) toxicology study, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development.

Phase I Healthy trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

Study no longer required.

Phase II Liver Cirrhosis trial by AstraZeneca. Stop reason: OPERATIONAL.

The study was ended earlier than planned due to a sponsor decision.

Phase III Non-cystic Fibrosis Bronchiectasis trial by AstraZeneca. Stop reason: OPERATIONAL.

Due to the decision to stop recruitment early, enrolment into the MAHALE trial was terminated in August 2022; 139 patients were screened and 100 randomised to IP.

Phase I Steatohepatitis trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

AstraZeneca have decided to not move forward with the development of the compound.

Phase III Eosinophilic Gastritis trial by AstraZeneca. Stop reason: OPERATIONAL.

The study was terminated by the Sponsor based on emerging evidence in the pathology of eosinophilic upper gastrointestinal diseases. Recruitment for the study was terminated and only a small number of patients were recruited.

Phase I Solid Tumors trial by AstraZeneca. Stop reason: EFFICACY/FUTILITY.

The study was terminated early due to lack of efficacy and absence of biomarker evidence of MEDI9253's impact on the tumors.

Phase III Hyperkalemia trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

The event rate observed in the study continued to be below primary assumptions, so that the completion of the study within a reasonable timeframe was deemed very unlikely.

Phase I Haematological Malignancies trial by AstraZeneca. Stop reason: SAFETY.

Trial terminated based on benefit-risk profile assessment

Phase II Chronic Lymphocytic Leukemia trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

AstraZeneca has made the decision to cancel the trial.

Phase I Non-Small Cell Lung Cancer trial by AstraZeneca. Stop reason: OPERATIONAL.

AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 completed their last study visit. No safety issues or clinical concerns however, have been identified for this study. Part 2 was not initiated

Phase I Opioid Use Disorder trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

Study terminated due to discontinuation of the AZD4041 clinical development program for OUD.

Phase IV COVID-19, SARS-CoV-2 trial by AstraZeneca. Stop reason: OPERATIONAL.

Removal of the commitment for Immune compromised study (D81111C00010) due to recruitment challenges.

Phase I Non-Hodgkin Lymphoma trial by AstraZeneca. Stop reason: SAFETY.

Due to safety reasons.

Phase II Chronic Kidney Disease trial by AstraZeneca. Stop reason: EFFICACY/FUTILITY.

The Sponsor decided to terminate the study early due to lack of efficacy. There were no safety concerns related to the study.

Phase I Type 2 Diabetes trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

The decision was based on the overall data profile obtained from this study which did not demonstrate sufficient differentiation to surpass the current standard of care.

Phase III Bullous Pemphigoid trial by AstraZeneca. Stop reason: EFFICACY/FUTILITY.

Independent Data Monitoring Committee recommended terminating the study following a pre-planned analysis as the efficacy results did not meet the pre-defined futility guidelines. There were no new safety concerns identified from this analysis.

Phase III Urgent Surgery trial by AstraZeneca. Stop reason: OPERATIONAL.

Business decision

Phase II Coronavirus Disease 2019 (COVID-19) trial by AstraZeneca. Stop reason: SAFETY.

Sponsor terminated after review of FDA's request to halt further dosing (30Mar2023) given that AZD7442 is not active against \>99% of the currently circulating SARS-CoV-2 variants in the USA, the benefit risk assessment may not be favorable

Phase I Urinary Bladder Neoplasms trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

This study was terminated early as per protocol Section 4.4, based on overall risk-benefit profile observed to date. No safety concerns reported. Only Substudy 1 Part A was started; Parts B \& C were not started. Entire Master Protocol was terminated.

Phase II Painful Diabetic Neuropathy trial by AstraZeneca. Stop reason: OPERATIONAL.

The study was prematurely terminated due to longer enrolment time than was anticipated.

Phase II Chronic Spontaneous Urticaria trial by AstraZeneca. Stop reason: EFFICACY/FUTILITY.

Study did not meet primary endpoint

Phase I Healthy Subjects trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

The study was terminated as no drug-drug interactions were observed in Part-A of the study and therefore Part-B of the study was not required as per protocol.

Phase IV COPD trial by AstraZeneca. Stop reason: OPERATIONAL.

Recruitment challenges

Phase III Eosinophilic Esophagitis trial by AstraZeneca. Stop reason: EFFICACY/FUTILITY.

High-level results from the MESSINA Phase III trial showed that AstraZeneca's Fasenra (benralizumab) did not meet one of the two dual-primary endpoints. Given the lack of clear benefit in this patient population, study has been terminated.

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

The study was stopped due to a higher than expected screen fail rate (83%) which lead to very low patient enrollment into the study. It should be noted that the decision to terminate the study is not related to safety concerns.

Phase II Atopic Dermatitis trial by AstraZeneca. Stop reason: EFFICACY/FUTILITY.

The study did not meet the primary endpoint.

Phase II Neurofibromatosis Type 1 trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

Selumetinib launch approval achieved in advance,strategy changesa new study will be generated in place of this study.

Phase I Advanced Solid Tumors trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

Strategic change to clinical development plan

Phase I Healthy Subjects (Indication: Asthma) trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

This decision was based on lung findings from a non-clinical 13-week GLP toxicology study, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development.

Phase I Non-alcoholic Steatohepatitis trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

Discontinuing the development of cotadutide, a daily injectable GLP-1/glucagon co-agonist, is based on strategic pipeline considerations. The premature closure is not due to any newly observed safety signals or a change in the risk/benefit profile.

Phase IV Hyperkalaemia trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

There is disconnect between dietary guidelines to limit potassium intake in dialysis and clinical practice. The number of unknowns and differences make the results unlikely to be translatable into clinical practice and will not benefit patients.

Phase I End Stage Renal Disease trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

A decision has been taken to discontinue the development of AZD8233 (PCSK9-ASO for sc administration) due to low likelihood of demonstrating a benefit significantly above the current standard of care for patients with high-risk hypercholesterolemia.

Phase IV Advanced Prostate Cancer trial by AstraZeneca. Stop reason: OPERATIONAL.

Due to the limited potential patients pool, the enrollment goal could not be achieved. After review and communication, the decision to teminate study was made.

Phase I Relapsed or Refractory Acute Myeloid Leukemia (AML) trial by AstraZeneca. Stop reason: OPERATIONAL.

Sponsor Decision

Phase I Advanced Solid Tumours trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

The study terminated because the clinical development programme for Adavosertib has been discontinued

Phase I Advanced Solid Tumors trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

Study terminated because the clinical development programme for Adavosertib has been discontinued

Phase I Advanced Solid Tumours trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

Study terminated because the clinical development programme for Adavosertib has been discontinued

Phase I Solid Tumors trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase III Type 2 Diabetes Mellitus trial by AstraZeneca. Stop reason: OPERATIONAL.

Sponsor decided to stop commercialization of QTERNMet/Qtrilmet and to stop all related ongoing activities/studies for business reasons.

Phase I Acute Myeloid Leukaemia trial by AstraZeneca. Stop reason: OPERATIONAL.

strategic decision

Phase I Heart Failure trial by AstraZeneca. Stop reason: OPERATIONAL.

Study start up timelines delayed into late autumn, and with COVID cases rising in the UK, the feasibility of successfully recruiting the study and ethical concerns about starting a study that AZ may not be able to complete.

Phase IV Type 2 Diabetes Mellitus trial by AstraZeneca. Stop reason: OPERATIONAL.

Study overall progress behind of scheduled timeline. Study was terminated early due to company decision.

Phase III COVID-19 trial by AstraZeneca. Stop reason: SAFETY.

The study was put on hold in September 2020 due to a safety concern in another trial but never restarted. In the meantime our clinical development program now includes a similar study with a different design, which we prefer to complete now.

Phase I Asthma trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

Need for evaluation of emerging pre-clinical toxicology findings

Phase II Heart Failure trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

A decision was made to stop the study early when AstraZeneca evaluated the available data and it was considered that completing the study would provide limited additional information and unlikely to change the study conclusions.

Phase II Heart Failure trial by AstraZeneca. Stop reason: OPERATIONAL.

Study stopped early due to the COVID-19 pandemic

Phase IV Diabetes Mellitus, Type 2 trial by AstraZeneca. Stop reason: OPERATIONAL.

Poor recruitment.

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

Study was terminated for business reasons; not due to safety or efficacy concerns.

Phase III Breast Cancer trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

CTP of LARES has been out of the expire date, we are trying RWS pathway for the indication expend

Phase III Sickle Cell Disease trial by AstraZeneca. Stop reason: SAFETY.

Recommendation from an independent data monitoring committee (DMC) and accepted by AstraZeneca.

Phase II Ovarian Cancer trial by AstraZeneca. Stop reason: EFFICACY/FUTILITY.

Sponsor made the decision to terminate the DUETTE study based on the interim analysis of the VIOLETTE study (NCT03330847) investigating the combination of ceralasertib and Olaparib, where study closure was recommended due to insufficient efficacy.

Phase I Dyslipidemia trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

It was decided to not run the Japanese cohorts in the study.

Phase II Asthma trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

The reason is: emerging pre-clinical toxicology findings.

Phase III Sickle Cell Disease trial by AstraZeneca. Stop reason: OPERATIONAL.

Study halted prematurely, prior to enrolment of first patient.

Phase I Type 2 Diabetes trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

The study is stopped based upon strategic considerations impacting the clinical development of exenatide once-weekly suspension in China

Phase I Heart Failure trial by AstraZeneca. Stop reason: OPERATIONAL.

Attendance at study sites carries risk of COVID-19 infection. Non-attendance at planned study site visits has unacceptable study related patient safety risk.

Phase I Chronic Obstructive Pulmonary Disease trial by AstraZeneca. Stop reason: OPERATIONAL.

The decision to terminate has been taken by the Sponsor. The decision is not due to safety concerns but reflects business prioritizations of the company.

Phase III Alzheimer's Disease trial by AstraZeneca. Stop reason: EFFICACY/FUTILITY.

As the feeder study (AZES) was stopped for futility after an independent assessment, this trial was also stopped.

Phase II Alzheimer´s Disease trial by AstraZeneca. Stop reason: EFFICACY/FUTILITY.

An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility

Phase III Alzheimer's Disease trial by AstraZeneca. Stop reason: EFFICACY/FUTILITY.

An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility.

Phase III Inadequately Controlled Asthma trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

The study was terminated due to the discontinuation of the tralokinumab asthma program (as per the results of the Phase III study \[D2210C00008\])

Phase III Differentiated Thyroid Cancer trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

Study was terminated based on the findings of primary analysis at 18 months post-RAI treatment. Patients pending 3 year follow up had end of study phone call.

Phase I Plaque Psoriasis Vulgaris trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

The study is temporarily suspended due to preclinical findings that are currently under evaluation

Phase I Cancer trial by AstraZeneca. Stop reason: OPERATIONAL.

Termination of study enrolment to Part C, Cohort 3 (08 July 2013) was based on the analysis of data from Study D2610C00004. Data were available from 33 patient

Phase I Breast Cancer trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

This decision was based upon strategic considerations impacting the clinical development of olaparib in this indication.

Phase II Squamous Non Small Cell Lung Cancer trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase I Asthma trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

Terminated based on interim review

Phase II Peripheral Artery Disease (PAD) trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase IV Chronic Obstructive Pulmonary Disease trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

Study stopped early as AZ have re-prioritised to focus on research to help bring existing and innovative medicines to more patients with asthma and COPD.

Phase II Pulmonary Disease, Chronic Obstructive trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

Actual sample size of 156 was sufficient to estimate the clinical outcomes.

Phase II Previously Untreated Stage IV Non-Squamous Non Small Cell Lung Cancer trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

The sponsor decided to terminate the study.

Phase II Gastro-oesophageal Junction Cancer trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase II Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation trial by AstraZeneca. Stop reason: OPERATIONAL.

Company decision: No Safety or Efficacy Concerns

Phase II Nonalcoholic Steatohapatitis trial by AstraZeneca. Stop reason: OPERATIONAL.

Company decision; No safety or efficacy concerns (see detailed description)

Phase I Cardiovascular Disease trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase II Plaque Psoriasis trial by AstraZeneca. Stop reason: OPERATIONAL.

Study withdrawn due to business decisions. No subjects were treated.

Phase II Dermatitis trial by AstraZeneca. Stop reason: OPERATIONAL.

Study withdrawn due to business decisions. No subjects were treated.

Phase I Diabetes, NOS trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase I Type 2 Diabetes Mellitus trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase I Core: Relapsed or Refractory Diffuse Large B-Cell Lymphoma trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

Study D2276C00001 was not started. No patients were enrolled. The sponsor decided to pursue an alternate design.

Phase II Hidradenitis Suppurativa trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

At the planned IA for decision making, no evidence was demonstrated of MEDI8968 activity in reducing (HS) severity or pain over that seen with placebo.

Phase II Previously Treated Non Small Cell Lung Cancer trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

The study was terminated early by the sponsor.

Phase IV Non-ST Elevation Acute Coronary Syndrome trial by AstraZeneca. Stop reason: OPERATIONAL.

Patient recruitment challenges, low enrolment, and a forecasted inability to complete the study in an acceptable timeframe

Phase IV Diabetes Mellitus Type 2 trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.