REGULATORY clinical trial stops

Phase I Malaria trial by National Institute of Allergy and Infectious Diseases (NIAID). Stop reason: REGULATORY.

The study remains on hold due to a funding issue after it's been lifted by the FDA.

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.

Unknown Advanced Solid Tumors trial by Grit Biotechnology. Stop reason: REGULATORY.

Due to procedural adjustments at the investigative site, domestic registration on the China health authority's platform must be finalized prior to re-submission on ClinicalTrials.gov. Therefore, we hereby withdraw the current submission.

Phase II Intracranial Meningioma trial by RTOG Foundation, Inc.. Stop reason: REGULATORY.

Recent FDA feedback requiring a study amendment.

Phase II Mycosis Fungoides trial by Virogen Biotechnology Inc.. Stop reason: REGULATORY.

This record is an earlier version (crossover design). After FDA-approved IND sponsor transfer to Virogen, the study was redesigned. This protocol will never start. The new protocol is NCT07529405.

Phase I Hepatocellular Carcinoma trial by T-ACE Medical Co., Ltd. Stop reason: REGULATORY.

The study was suspended in Taiwan following regulatory authority decision. The overall study under U.S. IND remains active.

Phase II Chronic Knee Pain trial by Campbell Clinic. Stop reason: REGULATORY.

unable to obtain IND approval from FDA

Phase II Transthyretin Amyloid Cardiopathy trial by Brigham and Women's Hospital. Stop reason: REGULATORY.

no subjects available

Phase I Pharmacokinetic trial by University of Oxford. Stop reason: REGULATORY.

The decision was made due to the expired investigational drug and regulatory changes by the Thai FDA, along with increased importation costs. The research team and investigational drug sponsor agreed to seek approval for early project termination.

Phase I Advanced Soft-tissue Sarcoma trial by Epizyme, Inc.. Stop reason: REGULATORY.

FDA and Ipsen alignelment: Due to unfeasibility and the resulting inability to meet the required enrolment targets. No safety concerns

Phase III Chikungunya Virus Infection trial by Valneva Austria GmbH. Stop reason: REGULATORY.

No participant recruited; trial initiation postponed to an unspecified future time while Valneva assesses potential pathways to address regulatory requests. Evaluation is ongoing to ensure alignment with regulatory expectations and obligations.

Phase II Contraception trial by Premier Research. Stop reason: REGULATORY.

withdrawn due to FDA feedback

Phase III Attention Deficit Hyperactivity Disorder trial by Ironshore Pharmaceuticals and Development, Inc. Stop reason: REGULATORY.

FDA release from this PMR study due to their required class-labeling, with a limitation of use for all ER stimulants in pediatric patients under 6 years of age, based on results from studies with other ER stimulants in this age group.

Phase II Metastatic Breast Cancer trial by University of Alabama at Birmingham. Stop reason: REGULATORY.

Study accrual ended early due to the FDA approval of tucatinib in metastatic HER2+ breast cancer

Phase II Neuropathic Pain trial by Okyo Pharma Ltd. Stop reason: REGULATORY.

Study ended early to expedite development and enable earlier FDA discussions. Prior Phase 2 data (240 patients) showed favorable safety and placebo-like tolerability. Closure was not due to safety concerns.

Phase I Relapsed/Refractory Multiple Myeloma trial by University of Maryland, Baltimore. Stop reason: REGULATORY.

The study was terminated due to FDA withdrawal of the drug and lack of enrollment with available BCMA therapies that were deemed safer.

Phase III HPV Infections trial by Merck Sharp & Dohme LLC. Stop reason: REGULATORY.

Following the direction of the local (India) health authority, data specified in the protocol were not collected and study was cancelled.

Phase II Malaria,Falciparum trial by University of Oxford. Stop reason: REGULATORY.

Due to US FDA hold on the challenge agent and funding concerns

Phase I COVID-19 Infection trial by Fred Hutchinson Cancer Center. Stop reason: REGULATORY.

Terminated due to FDA withdrawal of the emergency use authorization (EUA) for sotrovimab

Phase III Preterm Premature Ruptured Membranes trial by Indiana University. Stop reason: REGULATORY.

Terminated before starting due to need for IND determined by FDA.

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 B-cell Non Hodgkin Lymphoma trial by Medical College of Wisconsin. Stop reason: REGULATORY.

Treated four patients: 2 at a dose of 1x10\^6 cells/kg and 2 ad at dose of 2.5x10\^6 cells/kg. All four patients had no in-vivo expansion and no meaningful response to therapy. At this point per FDA guidance we will not be treating more patients.

Phase II Painful Bladder Syndrome trial by Urigen. Stop reason: REGULATORY.

The study was terminated due to Food and Drug Administration (FDA) recalled the heparin used in the trial because of possible contamination.

Phase I Relapsed or Refractory Non-Hodgkin's Lymphoma trial by Axter Therapeutics (Beijing) Co., Ltd. Stop reason: REGULATORY.

Due to the adjustment of the protocol and expansion of the indication population, a new clinical trial protocol was submitted to the Health Authority, so the registration was conducted as a new clinical trial and this trial was terminated.

Phase II Acute Respiratory Distress trial by University of Florida. Stop reason: REGULATORY.

Study never started due to need for additional preclinical work requested by FDA\>

Phase IV Vaping trial by Massachusetts General Hospital. Stop reason: REGULATORY.

The pilot study used apo-varenicline under temp FDA authorization. When varenicline was available an IND exemption was granted to enroll children, IRB approved a trial of varenicline in participants ages 16-25 June 27, 2022, the pilot was terminated

Phase II COVID-19 trial by Direct Biologics, LLC. Stop reason: REGULATORY.

Sponsor has withdrawn/closed the IND with the FDA. A letter dated 21NOV2022 was submitted to the FDA.

Phase II Spinal Muscular Atrophy Type 3 trial by Catalyst Pharmaceuticals, Inc.. Stop reason: REGULATORY.

Development of indication not being pursued

Phase II Post Traumatic Stress Disorder trial by University of Texas at Austin. Stop reason: REGULATORY.

Suspended (The UT IRB determined that CBD oil is being used as a drug as defined by the FDA. Therefore, an IND must be obtained for the use of CBD oil in this research study in accordance with FDA regulations, 21 CFR 312.)

Phase IV Hypovolemia trial by Kedrion S.p.A.. Stop reason: REGULATORY.

Per FDA CBER letter dated July 15, 2015, Kedrion SpA was released from the PMC to perform the study with Kedbumin 25% in pediatric patients.

Phase II Multiple Myeloma trial by Hackensack Meridian Health. Stop reason: REGULATORY.

FDA Hold Due to Updated Risks

Phase III COVID-19 trial by CanSino Biologics Inc.. Stop reason: REGULATORY.

The trial protocol was not approved by the regulatory authorities.

Phase III COVID-19 trial by CanSino Biologics Inc.. Stop reason: REGULATORY.

The trial protocol was not approved by the regulatory authorities.

Phase III Hepatocellular Carcinoma trial by BeiGene. Stop reason: REGULATORY.

Study has voluntarily discontinued due to a change in the company-level development strategy and is not because of any safety concern or the request from any health authority worldwide.

Early Phase I Muscle Damage trial by University of New Mexico. Stop reason: REGULATORY.

The researchers were not able to acquire funding to initiate the study. Also, the study was not approved by the local IRB which requested a FDA new drug application.

Phase III Covid19 trial by Instituto de Investigación Marqués de Valdecilla. Stop reason: REGULATORY.

The health authority indicates that the official vaccination schedule differs from that described in the protocol.

Phase II Multiple Myeloma trial by Celgene. Stop reason: REGULATORY.

Health Authority request due to class effect

Phase II Hyperinsulinism-Hyperammonemia Syndrome trial by Children's Hospital of Philadelphia. Stop reason: REGULATORY.

No study activity took place. The IND was withdrawn with the FDA by the Sponsor Investigator because of insurmountable hurdles in moving proposed research forward

Phase IV Transplantation trial by University of California, San Francisco. Stop reason: REGULATORY.

Because of inability to get FDA approval for

Phase I Multiple Myeloma trial by Ludwig Institute for Cancer Research. Stop reason: REGULATORY.

FDA placed on partial hold due to additional data

Phase II Covid 19 trial by University of South Alabama. Stop reason: REGULATORY.

FDA recommendations to not use outside of the hospital setting or in a clinical trial due to the risk of cardiac arrhythmias

Phase II Mesothelioma trial by National Cancer Institute (NCI). Stop reason: REGULATORY.

Due to the Food and Drug Administration's recent approval of Nivolumab plus Ipilimumab as first line treatment for Mesothelioma, the principal investigator decided to end the study early (prior to reaching enrollment goal).

Phase II Schizophrenia trial by New York State Psychiatric Institute. Stop reason: REGULATORY.

ITI-007 approved by FDA

Phase I Mild to Moderate TBI trial by VA Office of Research and Development. Stop reason: REGULATORY.

Funding withdrawn due to delay in FDA IND submission

Phase I Neoplasms trial by Traws Pharma, Inc.. Stop reason: REGULATORY.

The study was placed on hold by the FDA due to manufacturing issues and was not restarted.

Phase I Tumor Lysis Syndrome trial by Menarini Group. Stop reason: REGULATORY.

The study was stopped as per EMA waiver granted on 20July2018.

Phase IV Renal Impairment trial by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Stop reason: REGULATORY.

See termination reason in detailed description.

Phase III Chronic Pain trial by Endo USA Inc., a Keenova Therapeutics Company. Stop reason: REGULATORY.

Study Suspended 06Feb2020 per FDA Request

Phase II Epilepsy trial by GlaxoSmithKline. Stop reason: REGULATORY.

Terminated after placing the study on hold at the request of the FDA

Phase III Heart Disease trial by Bracco Diagnostics, Inc. Stop reason: REGULATORY.

FDA agreed to early termination due to difficulties enrolling patients.

Phase I Pancreas Cancer trial by University of Minnesota. Stop reason: REGULATORY.

Needed New IND per FDA

Phase I Cocaine-Related Disorders trial by Virginia Commonwealth University. Stop reason: REGULATORY.

FDA removal of drug from the market due to cancer risks

Phase II Pleural Effusion trial by Yale University. Stop reason: REGULATORY.

Local IRB recommended IND exemption from FDA, study timeline not able to be met.

Phase I Asymptomatic Myeloma trial by Yale University. Stop reason: REGULATORY.

Based on FDA requirements

Phase II Malaria trial by U.S. Army Medical Research and Development Command. Stop reason: REGULATORY.

The IND has been withdrawn from FDA

Phase I Pain trial by The Hospital for Sick Children. Stop reason: REGULATORY.

research project has been abandoned primarily because of the excessive delays associated with past challenges in obtaining approval from Health Canada

Phase IV Pregnancy trial by University of Florida. Stop reason: REGULATORY.

Due to FDA constraints on the off label use of the medications we will not be able to conduct this evaluation.

Phase II Epidermolysis Bullosa trial by Scioderm, Inc.. Stop reason: REGULATORY.

The Sponsor voluntarily recalled SD-101 and terminated the study due to GMP deficiencies identified during an FDA inspection at the site of the manufacturer.

Phase III Epidermolysis Bullosa trial by Scioderm, Inc.. Stop reason: REGULATORY.

The Sponsor voluntarily recalled SD-101 and terminated the study due to GMP deficiencies identified during an FDA inspection at the site of the manufacturer.

Phase III Sepsis and Coagulopathy trial by Asahi Kasei Pharma America Corporation. Stop reason: REGULATORY.

Sponsor will amend study design by incorporating reconfirmation of coagulopathy following discussion with FDA regarding findings from SCARLET1 study.

Phase III Hyperphosphatemia trial by Vifor Fresenius Medical Care Renal Pharma. Stop reason: REGULATORY.

The study was prematurely ended due to the modification of study requirements by the US Food and Drug Administration and the European Medicines Agency

Phase I Pulmonary Vein Stenosis trial by The Hospital for Sick Children. Stop reason: REGULATORY.

Due to Health Canada losartan recall, a new formulation being added to the protocol/ temporary suspension

Phase I Metastatic Pancreatic Cancer trial by Hitendra Patel. Stop reason: REGULATORY.

FDA indicated the same study could not be conducted under multiple INDs

Phase I Contraception trial by University of Colorado, Denver. Stop reason: REGULATORY.

IND approval from FDA was rejected and IRB approval was never granted.

Phase II Severe Thermal Injury, Greater Than 20% TBSA trial by University of Texas Southwestern Medical Center. Stop reason: REGULATORY.

This potential study was held up at the level of the FDA as they wouldn't approve and IND for the dose of vitamin C we wanted to use.

Phase II Cervix Uteri--Diseases trial by University of Texas Southwestern Medical Center. Stop reason: REGULATORY.

FDA has withdrawn the IND application- requesting protocol changes

Early Phase I Leukemia trial by New York Blood Center. Stop reason: REGULATORY.

Study NCT01656603 supersedes this study; FDA IND 6637

Phase I Hepatitis C, Chronic trial by Merck Sharp & Dohme LLC. Stop reason: REGULATORY.

The US FDA and the EU CHMP provided guidance indicating preference for intereferon-free regimens in pediatric studies of HCV infection.

Phase II Multiple Myeloma trial by Dana-Farber Cancer Institute. Stop reason: REGULATORY.

Withdrawn before enrollment due to issues around the FDA hold on PD-1/PD-L1 drugs in combination with IMIDs.

Phase II Pain, Postoperative trial by Indiana University. Stop reason: REGULATORY.

FDA IND was not obtained

Unknown Colonoscopy trial by Sheba Medical Center. Stop reason: REGULATORY.

Study terminated due to FDA alert regarding Fleet phosphosoda

Phase IV Diabetes Mellitus, Type 2 trial by NHS Tayside. Stop reason: REGULATORY.

Following Regulator inspection in 2009, study terminated as inadequate approvals were in place

Early Phase I Polyneuropathies and Other Disorders of the Peripheral Nervous System trial by M.D. Anderson Cancer Center. Stop reason: REGULATORY.

FDA IND Approval

Phase I Allergic Conjunctivitis trial by Woodmont Pharmaceuticals, Inc.. Stop reason: REGULATORY.

Sponsor withdrew IND from FDA

Phase III Hypertension trial by GlaxoSmithKline. Stop reason: REGULATORY.

No stop-reason text available in the compact dataset.

Phase I Shigellosis trial by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Stop reason: REGULATORY.

No stop-reason text available in the compact dataset.

Phase II Catheter Related Infections trial by Boston Children's Hospital. Stop reason: REGULATORY.

No participants. IND denied by FDA.

Phase I Diabetes Mellitus, Type 2 trial by GlaxoSmithKline. Stop reason: REGULATORY.

Due to changes in EMA guidelines on modified release dosage forms (Feb 2013; EMA/CHMP/EWP/280/96). The Part B formulation would not meet the new guidelines.

Phase III Opioid Dependence trial by BioDelivery Sciences International. Stop reason: REGULATORY.

FDA did not require a clinical trial for indication.

Phase III Opioid Dependence trial by BioDelivery Sciences International. Stop reason: REGULATORY.

FDA did not require a clinical trial for indication.

Unknown Fibromyalgia trial by Icahn School of Medicine at Mount Sinai. Stop reason: REGULATORY.

Due to FDA comments, changes required unavailable resources. There are no results for this study.

Phase II Pain Perception trial by University of Oklahoma. Stop reason: REGULATORY.

The device is undergoing further study in China, per FDA requirements.

Phase I Injuries and Wounds trial by NHS Lothian. Stop reason: REGULATORY.

MHRA CTA rejected due to no UK MHRA MA certificate or equivalent product info

Phase II Keloids trial by Tirgan, Michael H., M.D.. Stop reason: REGULATORY.

IND application was not approved by the US FDA - Project was never started

Phase II Recurrent Pregnancy Loss trial by University of Utah. Stop reason: REGULATORY.

Testing required by FDA for IND approval was too expensive to move forward with conduct of the study.

Phase I HIV Infection trial by Barbara Ensoli, MD. Stop reason: REGULATORY.

Enrollments were suspended due to delta-V2 Env unavailability, following the EMA/CHMP/BWP/534898/2008 guideline, not allowing the use of a retest date

Phase III Symptomatic Neurogenic Orthostatic Hypotension trial by Chelsea Therapeutics. Stop reason: REGULATORY.

Due to potential competition with a post-marketing study requested by FDA

Unknown Fibromyalgia trial by Stanford University. Stop reason: REGULATORY.

The FDA IND application is paused due to additional required testing. The IRB protocol was closed prior to research starting.

Phase III Pulmonary Arterial Hypertension trial by Novartis Pharmaceuticals. Stop reason: REGULATORY.

Novartis discontinued the development of imatinib in PAH due to requirement of regulatory authorities for additional data to secure marketing approval in PAH.

Phase III Pulmonary Arterial Hypertension trial by Novartis Pharmaceuticals. Stop reason: REGULATORY.

Novartis discontinued the development of imatinib in PAH due to requirement of regulatory authorities for additional data to secure marketing approval in PAH.

Phase I Hypercholesterolemia trial by Pfizer. Stop reason: REGULATORY.

Study was redesigned based on FDA feedback.

Unknown Diabetes trial by South Orange County Endocrinology. Stop reason: REGULATORY.

Unable to register Treatment IND with the US Food And Drug Administration's new process of establishing TLS encryption for email correspondence.