Pfizer clinical trial failures

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 I Healthy trial by Pfizer. Stop reason: OPERATIONAL.

The study was terminated for business reasons; there were no safety concerns.

Phase II Esophagitis trial by Pfizer. Stop reason: OPERATIONAL.

Pfizer has made an internal business decision to terminate the B1791094 study. This decision was not due to safety concerns or requests from any regulatory authorities.

Phase I Neoplasm Metastasis trial by Pfizer. Stop reason: OPERATIONAL.

Pfizer has made an internal business decision to not continue further development of PF-07265807. This decision was not due to major safety concerns or requests from any regulatory authorities.

Phase I Solid Tumor trial by Pfizer. Stop reason: OPERATIONAL.

The study was prematurely discontinued due to strategic reasons. The PF-07284892 program will continue

Phase I Carcinoma, Pancreatic Ductal trial by Pfizer. Stop reason: OPERATIONAL.

The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns.

Phase I Peripheral T Cell Lymphoma trial by Pfizer. Stop reason: OPERATIONAL.

The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns

Phase I Diffuse Large B-Cell Lymphoma trial by Pfizer. Stop reason: OPERATIONAL.

Business/Administrative decision to pursue other programs/assets within the oncology portfolio. Not due to any detected safety signals or requests from regulatory authorities.

Phase I Shingles trial by Pfizer. Stop reason: OPERATIONAL.

Strategic decision made by the company

Phase II Multiple Myeloma trial by Pfizer. Stop reason: OPERATIONAL.

A business decision was made by Pfizer to terminate the study and not proceed with the Phase 2 expansion of this study. The reason for study termination is not due to any safety concerns or requests from regulatory authorities.

Phase I Carcinoma, Non Small Cell Lung trial by Pfizer. Stop reason: OPERATIONAL.

The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns

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

The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns

Phase II Sickle Cell Disease trial by Pfizer. Stop reason: OTHER/UNKNOWN.

Study terminated as data obtained from this non-placebo-controlled trial may not be informative for the interpretation of the benefits and risks of osivelotor

Phase I Malignant Melanoma trial by Pfizer. Stop reason: OPERATIONAL.

The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns.

Phase II Heart Failure trial by Pfizer. Stop reason: SAFETY.

Following a prespecified interim analysis, and in consultation with the independent Data Monitoring Committee, the Sponsor terminated the study

Phase II Lupus Erythematosus, Systemic trial by Pfizer. Stop reason: OPERATIONAL.

Pfizer has made an internal business decision to not continue this study. This decision was not due to safety concerns or clinical effect reasons or requests from any regulatory authorities.

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

Emerging clinical data evaluated by Pfizer and shared with regulatory authorities indicates that the risk profile of voxelotor in people with SCD exceeds the benefits observed in previously generated global research and requires further assessment.

Phase II Melanoma trial by Pfizer. Stop reason: OPERATIONAL.

Study terminated due to inability to recruit the target number of patients. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.

Phase I Ulcerative Colitis trial by Pfizer. Stop reason: OPERATIONAL.

The study was terminated due to business decision. The decision to terminate the trial was not based on any safety concerns associated with PF-07054894.

Phase I Neoplasms trial by Pfizer. Stop reason: OTHER/UNKNOWN.

Study terminated as part of strategic considerations and not based on safety concerns.

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

Study terminated based on internal business considerations and was not based on safety reasons

Phase I Healthy Volunteers trial by Pfizer. Stop reason: OPERATIONAL.

The study was prematurely discontinued due to a business decision. The decision to terminate the study is not related to a safety concern.

Phase I Carcinoma, Non-Small-Cell Lung trial by Pfizer. Stop reason: OPERATIONAL.

Study was terminated due to portfolio re-prioritization and strategic considerations. The decision was not based on any safety concerns and/or regulatory interactions

Phase I Respiratory Syncytial Virus Infections trial by Pfizer. Stop reason: OPERATIONAL.

Study discontinued due to business reasons. There were no safety concerns in the decision to stop study and no changes to sponsor's assessment of the risk-benefit profile for participants who received sisunatovir in the study

Phase I Biological Availability trial by Pfizer. Stop reason: OPERATIONAL.

Sponsor business decision to terminate study. Decision not due to major safety concerns or requests from any regulatory authorities.

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

Sponsor decision to terminate study based on results of parent study GBT2104-131.

Phase I Healthy trial by Pfizer. Stop reason: OPERATIONAL.

Study was terminated early . This decision was not due to any safety concerns associated with PF-07899895 but rather due to a business decision.

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

Emerging clinical data evaluated by Pfizer and shared with regulatory authorities indicates that the risk profile of voxelotor in people with SCD exceeds the benefits observed in previously generated global research and requires further assessment.

Phase I HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer trial by Pfizer. Stop reason: OPERATIONAL.

Per business decision, but not due to safety concerns or regulatory request.

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

Emerging clinical data evaluated by Pfizer and shared with regulatory authorities indicates that the risk profile of voxelotor in people with SCD exceeds the benefits observed in previously generated global research and requires further assessment.

Phase II Respiratory Syncytial Virus Infection trial by Pfizer. Stop reason: OPERATIONAL.

Study discontinued due to business reasons. There were no safety concerns in the decision to stop study and no changes to sponsor's assessment of the risk-benefit profile for participants who received sisunatovir in the study.

Phase I Malignant Melanoma trial by Pfizer. Stop reason: OPERATIONAL.

Pfizer has made an internal business decision to not continue further development of PF-07284890. This decision was not due to major safety concerns or requests from any regulatory authorities.

Phase I Healthy trial by Pfizer. Stop reason: OPERATIONAL.

The Sponsor has decided to terminate the above referenced clinical study for business reasons. There were no safety concerns that led to this decision and there was no impact to participant safety.

Phase III Duchenne Muscular Dystrophy trial by Pfizer. Stop reason: OTHER/UNKNOWN.

All participants who have received fordadistrogene movaparvovec in any Pfizer study will now be assessed for long-term safety in 1 combined study: C3391003

Phase I Neoplasms trial by Pfizer. Stop reason: OPERATIONAL.

The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns.

Phase I Diffuse Large B-Cell Lymphoma trial by Pfizer. Stop reason: OPERATIONAL.

The trial terminated due to the inability to recruit the planned number of subjects. The decision was not based on any safety and/or efficacy concerns

Phase II Sickle Cell Disease trial by Pfizer. Stop reason: SAFETY.

Emerging clinical data evaluated by Pfizer and shared with regulatory authorities indicates that the risk profile of voxelotor in people with SCD exceeds the benefits observed in previously generated global research and requires further assessment.

Phase I Overweight trial by Pfizer. Stop reason: OTHER/UNKNOWN.

The sponsor has made the decision to discontinue development of danuglipron (PF-06882961). As such, this study was discontinued prior to PF-06882961 administration.

Phase I COVID-19 trial by Pfizer. Stop reason: OPERATIONAL.

The trial prematurely terminated due to the inability to recruit the planned number of subjects. The decision to terminate the trial was not based on any safety concerns.

Phase II Alopecia Areata trial by Pfizer. Stop reason: OPERATIONAL.

For business reasons

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

Emerging clinical data evaluated by Pfizer and shared with regulatory authorities indicates that the risk profile of voxelotor in people with SCD exceeds the benefits observed in previously generated global research and requires further assessment.

Phase I Squamous Cell Carcinoma of the Head and Neck trial by Pfizer. Stop reason: OTHER/UNKNOWN.

Study termination was based on strategic considerations and not due to specific safety reasons or a request from a regulatory authority.

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

Per the results of the planned interim analysis, the study met futility criteria for efficacy so the trial was terminated. This decision was made for efficacy reasons only and is not due to any safety concerns.

Phase I Ovarian Neoplasms trial by Pfizer. Stop reason: OPERATIONAL.

Pfizer has made an internal business decision to not continue further development of PF-07260437. This decision was not due to major safety concerns or requests from any regulatory authorities.

Phase I Healthy trial by Pfizer. Stop reason: OPERATIONAL.

sponsor decision

Phase II Migraine trial by Pfizer. Stop reason: OPERATIONAL.

Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.

Phase I Neoplasms Malignant trial by Pfizer. Stop reason: OTHER/UNKNOWN.

Termination of further treatment on the study due to the availability of commercial supply or a rollover study (NCT05160922) that will allow active subjects to continue receiving treatment.

Phase I Gastrointestinal Tumors trial by Pfizer. Stop reason: OTHER/UNKNOWN.

Study was terminated due to strategic considerations and not due to safety.

Phase I Obesity trial by Pfizer. Stop reason: OTHER/UNKNOWN.

The decision to terminate clinical development of lotiglipron is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.

Phase I Advanced Solid Tumors trial by Pfizer. Stop reason: OPERATIONAL.

The study has been terminated based on a strategic evaluation within the current Pfizer oncology portfolio. This decision is not due to any safety concerns or requests from any regulatory authorities.

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

Study was terminated due to poor accrual and associated recrutiment challenges

Phase II Leiomyosarcoma trial by Pfizer. Stop reason: OPERATIONAL.

Pfizer decided to terminate the study for administrative reasons. The termination was neither due to safety concerns nor a request from the regulatory authorities.

Phase I Ovarian Cancer trial by Pfizer. Stop reason: OPERATIONAL.

A business decision was made by Pfizer to terminate and remove the Phase 2 expansion of this study for administrative reasons. The reason for study termination is not due to any safety concerns or requests from regulatory authorities.

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

The decision to terminate clinical development of lotiglipron is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.

Phase IV ALK or ROS1-positive NSCLC trial by Pfizer. Stop reason: OPERATIONAL.

The trial is terminated based on business decision, not due to safety concerns or regulatory requirements.

Phase I Advanced or Metastatic Solid Tumors trial by Pfizer. Stop reason: OPERATIONAL.

Strategic business decision

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

The decision to terminate clinical development of lotiglipron is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.

Phase II Respiratory Syncytial Virus (RSV) trial by Pfizer. Stop reason: OTHER/UNKNOWN.

Part A and Part B were completed but Pfizer terminated Part C due to strategic consideration. There were no safety concerns in the decision to stop Part C and no changes to the risk-benefit for participants who received RV521 in the study.

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

Business decision to terminate the trial after the completion of Part 1: Cohort 1 (severe renal impairment). The decision to terminate the trial was not due to any potential safety concerns.

Phase III Advanced Non-squamous NSCLC trial by Pfizer. Stop reason: OTHER/UNKNOWN.

The study was terminated as part of the decision by Pfizer to halt its biosimilars programs in China.

Phase I COVID-19 trial by Pfizer. Stop reason: REGULATORY.

Decision to terminate study was due to slow enrolment and FDA input that available data may be enough for dosing recommendations for severe renal disease (subject to review by FDA).

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

Study was terminated as it did not demonstrate sufficient pharmacological effect. Termination was not related to safety reasons.

Phase I Lymphoma trial by Pfizer. Stop reason: OPERATIONAL.

A business decision was made by Pfizer to terminate the study. Termination was not due to any safety concerns, requests from regulatory authorities, changes to the benefit/risk profile or any new concerns regarding the investigational product.

Phase I Breast Neoplasms trial by Pfizer. Stop reason: OTHER/UNKNOWN.

The trial was terminated based on the stage in drug development and assessment of PF-06804103 relative to the leading external competition. The decision was not due to a safety concern.

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

The study was terminated due to the review of the asset (VBIR-2) within the Sponsor's oncology portfolio; the study was not terminated because of safety concerns.

Phase IV Sickle Cell Disease trial by Pfizer. Stop reason: OPERATIONAL.

The study has been stopped due to Sponsor's business reasons. The termination is not a result of any safety concerns or change in the benefit-risk ratio.

Phase II Diabetes Mellitus trial by Pfizer. Stop reason: OTHER/UNKNOWN.

The decision to terminate clinical development of PF-07081532 is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.

Phase I Advanced Cancer trial by Pfizer. Stop reason: OTHER/UNKNOWN.

The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522)

Phase I Non-small-cell Lung Cancer trial by Pfizer. Stop reason: OPERATIONAL.

Pfizer has made an internal business decision to not continue further development of PF-07209960. This decision was not based on safety or regulatory considerations

Phase I Asthma trial by Pfizer. Stop reason: OPERATIONAL.

Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.

Phase I Healthy trial by Pfizer. Stop reason: OPERATIONAL.

The Sponsor has decided to terminate the above referenced clinical study for business reasons. There were no safety concerns that led to this decision and there was no impact to participant safety.

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

See termination reason in detailed description.

Phase I Breast Neoplasms trial by Pfizer. Stop reason: OPERATIONAL.

The decision to stop enrollment was due to strategic considerations and not due to any specific safety reasons or request from a regulatory authority.

Phase I Advanced Cancers trial by Pfizer. Stop reason: OPERATIONAL.

The study stopped due to lack of enrollment

Phase II Trigeminal Neuralgia trial by Pfizer. Stop reason: OPERATIONAL.

Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.

Phase III Temporomandibular Disorders (TMD) trial by Pfizer. Stop reason: OPERATIONAL.

Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.

Phase I Hematologic Malignancies trial by Pfizer. Stop reason: OPERATIONAL.

Pfizer decided terminating study for administrative reasons on 22Mar2022 (stopping enrollment as of 15Apr2022). The decision wasn't due to safety concerns or requests from regulatory authorities.

Phase III Sickle Cell Disease trial by Pfizer. Stop reason: OTHER/UNKNOWN.

Data will not inform further development of Voxelotor

Phase II COVID-19 Infection trial by Pfizer. Stop reason: OPERATIONAL.

Lack of enrollment due to evolution of COVID-19 pandemic with reduction in patients at risk for severe disease and growing number of effective alternative therapies

Phase II Focal Segmental Glomerulosclerosis (FSGS) trial by Pfizer. Stop reason: EFFICACY/FUTILITY.

The study was terminated due to lack of efficacy at both tested doses on 5th December 2022. The decision to terminate the study is not related to a safety concern.

Phase I Renal Cell Cancer trial by Pfizer. Stop reason: OPERATIONAL.

The study was terminated by the Sponsor due to business decision and not due to any safety concerns with PF-07263689. There are no changes to the risk-benefit for participants who have received PF-07263689 in the study.

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

The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522)

Phase IV Gastroesophageal Reflux Disease trial by Pfizer. Stop reason: OPERATIONAL.

Study was terminated early due to the infeasibility of enrolling the required number of participants per protocol in the 1 \<2 years of age cohort.

Phase II Gram-negative Bacterial Infection trial by Pfizer. Stop reason: OPERATIONAL.

Following regulatory consultation, the Sponsor has decided to terminate the study and analyze the current dataset. The decision to terminate was solely based on a business decision, not due to safety concerns.

Phase II Meningococcal Vaccine trial by Pfizer. Stop reason: SAFETY.

The Sponsor decided to discontinue the study based on Sponsor's careful review of available safety data in concert with the recommendation of an independent Data Monitoring Committee.

Phase II Achondroplasia trial by Pfizer. Stop reason: EFFICACY/FUTILITY.

The study was terminated due to lack of efficacy at any of the tested doses on 18th November 2022. The decision to terminate the study is not related to a safety concern.

Phase II Achondroplasia trial by Pfizer. Stop reason: EFFICACY/FUTILITY.

The study was terminated due to lack of efficacy at any of the tested doses on 18th November 2022. The decision to terminate the study is not related to a safety concern.

Phase III Serious Bacterial Infection trial by Pfizer. Stop reason: OPERATIONAL.

Recruitment of patients with serious infections caused by gram-negative bacteria producing MBL has been challenging. Date study terminated: 16-Dec-2022.

Phase III Dilated Cardiomyopathy trial by Pfizer. Stop reason: EFFICACY/FUTILITY.

The Sponsor terminated the study due to futility. The decision to stop the study was not based on safety concerns.

Phase II Raynaud's Phenomenon Secondary to Systemic Sclerosis trial by Pfizer. Stop reason: OPERATIONAL.

Business decision

Phase II Microvascular Obstruction trial by Pfizer. Stop reason: OPERATIONAL.

Business decision

Phase II Sickle Cell Disease trial by Pfizer. Stop reason: OTHER/UNKNOWN.

Data will not inform further development of Voxelotor

Phase II Acute Heart Failure With Reduced Ejection Fraction trial by Pfizer. Stop reason: OPERATIONAL.

Business decision

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

This decision was based on business considerations and not due to specific safety reasons or a request from a regulatory authority.

Phase I Prostatic Neoplasms trial by Pfizer. Stop reason: OPERATIONAL.

Due to strategic evaluation of PF-06753512 (VBIR-1) within context of Pfizer's oncology portfolio, decision not based on any safety or regulatory concerns.

Phase III Low-grade Serous Ovarian Cancer trial by Pfizer. Stop reason: OPERATIONAL.

Per recommendation of the DMC, enrollment into the study was discontinued in April 2016 after the planned interim efficacy analysis showed the hazard ratio for PFS crossed the predefined futility boundary.

Phase I Avelumab in Combination With Talazoparib Will be Investigated in Patients With Locally Advanced (Primary or Recurrent) or Metastatic Solid Tumors trial by Pfizer. Stop reason: OTHER/UNKNOWN.

The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the investigational treatments have been moved to a continuation study (NCT05059522).

Phase II Locally Advanced or Metastatic Solid Tumors trial by Pfizer. Stop reason: OTHER/UNKNOWN.

The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the investigational treatments have been moved to a continuation study (NCT05059522)

Phase I Non-small Cell Lung Cancer trial by Pfizer. Stop reason: OTHER/UNKNOWN.

The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the investigational treatments have been moved to a continuation study (NCT05059522).

Phase II COVID-19 trial by Pfizer. Stop reason: OPERATIONAL.

Enrollment ceased due to a very low rate of hospitalization or death observed in the standard-risk patient population