Clinical Trials Sponsored by Shionogi

Total 125 results

Shionogi

Recruiting

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants

Gram-Negative Bacterial Infections

United States, South Africa, Taiwan
Shionogi

Recruiting

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants

Gram-negative Bacterial Infections | Complicated Urinary Tract Infection (cUTI) | Hospital Acquired Bacterial Pneumonia (HABP) | Ventilator Associated Bacterial Pneumonia (VABP)

United States, Australia, Greece, Lithuania, Mexico, Philippines, Spain, Ukraine, Panama
Shionogi

Completed

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants

Sepsis | Gram-negative Bacterial Infections | Bloodstream Infections (BSI) | Complicated Intra-abdominal Infection (cIAI) | Hospital Acquired Pneumonia (HAP) | Ventilator-acquired Pneumonia | Complicated Urinary Tract Infection (cUTI)

Spain, Belgium, Latvia, Russian Federation, Estonia, Georgia, Hungary, Thailand, Ukraine
Shionogi

Terminated

A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection

Postoperative Gastrointestinal Dysfunction

United States
Shionogi

Terminated

An Open-label Safety Study of Lusutrombopag (S-888711) in Adults With Chronic Immune Thrombocytopenia (ITP)

Immune Thrombocytopenia

United States
Shionogi

Approved for marketing

Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections

Bacterial Infections
Shionogi

Completed

Effect of Food and Calcium on Pharmacokinetics of a Single Dose of S-888711 in Healthy Adult Volunteers

Healthy Volunteer

United States
Shionogi

Completed

Safety and Efficacy Study of Lusutrombopag for Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive Procedures (L-PLUS 2)

Thrombocytopenia | Chronic Liver Disease
Shionogi

Completed

Safety and Efficacy of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy

Type 2 Diabetes Mellitus

United States
Shionogi

Completed

A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 2 Doses of S-777469 in Patients With Atopic Dermatitis

Atopic Dermatitis

United States
Shionogi

Completed

Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer

Lung Cancer | Non Small Cell Lung Cancer | Stage IIIA Non Small Cell Lung Cancer | Stage IIIB Non Small Cell Lung Cancer

United States
Shionogi

Completed

Open-Label Extension (OLE) Study for Safety and Efficacy of Velneperit (S-2367) in Obese Subjects (OLE)

Obesity

United States
Shionogi

Completed

A Phase Ib/IIa, Double-Blind, Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of S-777469 in Subjects With Atopic Dermatitis

Atopic Dermatitis

United States
Shionogi

Completed

Combination Study Of S-555739/Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis

Seasonal Allergic Rhinitis
Shionogi

Completed

Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder

United States
Shionogi

Completed

Safety and Efficacy Study of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age With Cerebral Palsy or Other Neurologic Conditions

Cerebral Palsy | Sialorrhea | Mental Retardation | Neurological Conditions

United States
Shionogi

Recruiting

A Study to Investigate Different Formulations of S-337395 in Healthy Adult Participants

Healthy Volunteers

United States
Shionogi

Recruiting

Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection (SCORPIO-PEP)

SARS-CoV-2 Infection

Japan, United States
Shionogi

Recruiting

Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

Opioid-Induced Constipation (OIC)

France
Shionogi

Completed

A Study of S-268019 for the Prevention of COVID-19

SARS-CoV-2

Vietnam
Shionogi

Completed

Use of Cefiderocol in the Management of Gram-Negative Infections (PERSEUS)

Gram-Negative Infection

Spain
Shionogi

Completed

A Study to Assess S-309309 in Healthy and Obese Participants

Obesity

United States
Shionogi

Completed

First-in-human Study of S-588210 (S-488210+S-488211)

Head and Neck Cancer | Esophageal Cancer | Lung Cancer | Mesothelioma | Bladder Cancer

United Kingdom
Shionogi

Completed

Women's Satisfaction and Adherence to Vulvovaginal Atrophy Treatments (CRETA)

Vulvovaginal Atrophy

Spain
Shionogi

Terminated

A Study to Investigate the Efficacy and Safety of Lusutrombopag (S-888711) Tablets Administered to Adults With Immune Thrombocytopenia (ITP)

Immune Thrombocytopenia (ITP)

United States
Shionogi

Completed

Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens (CREDIBLE - CR)

Sepsis | Bloodstream Infections (BSI) | Hospital Acquired Pneumonia (HAP) | Complicated Urinary Tract Infection (cUTI) | Healthcare-associated Pneumonia (HCAP) | Ventilator Associated Pneumonia (VAP)

United States, Brazil, Croatia, France, Germany, Greece, Guatemala, Israel, Italy, Japan, Korea, Republic of, Spain, Taiwan, Thailand, Turkey, United Kingdom
Shionogi

Completed

Study in Healthy Adults to Quantify Lung Deposition and Distribution of Radio-labelled S-770108 Inhalation Powder Formulation Delivered by a Novel Inhaler Device

Healthy Volunteer

United Kingdom
Shionogi

Completed

A Study of Efficacy and Safety of Intravenous Cefiderocol (S-649266) Versus Imipenem/Cilastatin in Complicated Urinary Tract Infections (APEKS-cUTI)

Urinary Tract Infections
Shionogi

Completed

A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza (CAPSTONE 1)

Influenza
Shionogi

Completed

Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause

Vaginal Dryness
Shionogi

Completed

Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Initial 6-Week Low Calorie Diet

Obesity

United States
Shionogi

Completed

Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Reduced Calorie Diet

Obesity

United States
Shionogi

Completed

Double-Blind, Multi-Center, Randomized Study to Assess the Efficacy and Safety of Velneperit (S-2367) and Orlistat Administered Individually or Combined With a Reduced Calorie Diet (RCD) in Obese Subjects

Obesity

United States
Shionogi

Completed

A Phase 1 Study of S-3304 in Patients With Solid Tumors

Solid Tumors

United States
Shionogi

Completed

Long Term Safety of Naldemedine

Opioid-induced Constipation

United States, Australia, Austria, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Poland, South Africa, Spain, Sweden, United Kingdom
Shionogi

Completed

Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation

Opioid-induced Constipation

United States
Shionogi

Recruiting

A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke (REvive)

Acute Ischemic Stroke

Japan, Israel, United States, Australia, Hong Kong
Shionogi

Completed

Evaluation of S-600918 in Adults With Refractory Chronic Cough

Chronic Cough

United States, United Kingdom, Japan, Ukraine, Poland, Czechia
Shionogi

Completed

Effect of Administration of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Participants

Obesity | Healthy Volunteers

United States
Shionogi

Completed

A Study to Assess the Effect of Cefiderocol on the Pharmacokinetics (PK) of Midazolam in Healthy Participants

Healthy Volunteers

United States
Shionogi

Active, not recruiting

Safety and Efficacy Study of S-309309 in Obese Adults

Obesity

United States
Shionogi

Completed

A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants

Hepatic Impairment

United States
Shionogi

Completed

A Study to Assess S-217622 in Participants With Renal Impairment and Healthy Participants

Renal Impairment

United States
Shionogi

Completed

Evaluation of Safety, Tolerability, Pharmacokinetics, Drug-Drug and Food Interactions of Single and Multiple Doses of S-648414 in Healthy Adults

Healthy Volunteer

United States, Japan
Shionogi

Completed

Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens (APEKS-NP)

Hospital Acquired Pneumonia (HAP) | Healthcare-associated Pneumonia (HCAP) | Ventilator Associated Pneumonia (VAP)

Israel, Spain, United States, Belgium, Canada, Czechia, Estonia, France, Georgia, Germany, Hungary, Japan, Latvia, Philippines, Puerto Rico, Russian Federation, Serbia, Taiwan, Ukraine
Shionogi

Terminated

Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia

Bacterial Pneumonia

United States
Shionogi

Completed

Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications (CAPSTONE 2)

Influenza
Shionogi

Completed

Study to Assess Safety and Pharmacokinetics of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus

United States
Shionogi

Completed

A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy

Opioid-induced Constipation

United States
Shionogi

Completed

Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain

Opioid Induced Bowel Dysfunction

United States

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