Clinical trials: sponsored by Shionogi
SARS-CoV-2
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
The primary purpose of this study is to evaluate the efficacy and safety of secutrelvir in symptomatic nonhospitalized adult and adolescent participants with COVID-19 who are at high risk for progression to severe disease.
- Trial name
- NCT07743580
- Testing
- Secutrelvir
- Where
- 47 sites in United States, Bulgaria and 1 more
- Volunteers
- 2,000 people
- Sponsor
- Shionogi
Renal Impairment
A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls
The purpose of this study is to measure the pharmacokinetics, safety, and tolerability of S-892216 (S-892216-PO) in participants with mild, moderate, or severe renal impairment not on dialysis, or renal impairment requiring…
- Trial name
- NCT07217886
- Testing
- S-892216-PO
- Where
- 4 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shionogi
ALS
Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS
To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS), based on the time from the randomization date in Study MT-1186-A02 to at least a 12-point…
- Trial name
- NCT05151471
- Testing
- MT-1186
- Where
- 37 sites in United States, Canada and 4 more
- Volunteers
- 202 people
- Sponsor
- Shionogi
Respiratory Syncytial Virus Infections
A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease
The main purpose of this study is to investigate the antiviral effect of S-337395 compared with placebo among nonhospitalized adult participants with high-risk factors for progression to severe RSV infection starting intervention…
- Trial name
- NCT07214571
- Testing
- S-337395
- Where
- 89 sites in United States, Argentina and 6 more
- Volunteers
- 192 people
- Sponsor
- Shionogi
Cerebral Infarction
Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke
This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study on acute ischemic stroke. The primary endpoints were the rate of patients with modified Rankin Scale score of 0-1 at 3 months.
- Trial name
- NCT00200356
- Testing
- Edaravone, Sodium Ozagrel
- Volunteers
- 401 people
- Sponsor
- Shionogi
Healthy Participants
Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants
The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI in healthy adults.
- Trial name
- NCT07093580
- Testing
- S-892216-LAI
- Where
- 3 sites in United States
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Shionogi
Pompe Disease
An Extension Study of S-606001 in Participants With Late-onset Pompe Disease (LOPD)
The primary purpose of this study is to evaluate the long-term safety and tolerability profile of S-606001 in participants with LOPD.
- Trial name
- NCT07750990
- Testing
- S-606001, ERT
- Volunteers
- 60 people
- Sponsor
- Shionogi
Cryopyrin-associated Periodic Syndromes (CAPS)
Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of JTE-162 in Subjects With Cryopyrin-Associated Periodic Syndrome (CAPS)
This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-162 administered once daily for 2 weeks in subjects with cryopyrin-associated periodic syndrome (CAPS)
- Trial name
- NCT07247266
- Testing
- JTE-162
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Shionogi Inc.
Invasive Aspergillosis
Olorofim Aspergillus Infection Study
The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus…
- Trial name
- OASIS (NCT05101187)
- Testing
- Olorofim, AmBisome®
- Where
- 143 sites in United States, Australia and 19 more
- Volunteers
- 225 people
- Sponsor
- F2G Ltd
SARS-CoV-2 Infection
Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection
The purpose of this study is to measure the proportion of participants who are infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (positive reverse transcription polymerase chain reaction [RT-PCR] test)…
- Trial name
- SCORPIO-PEP (NCT05897541)
- Testing
- S-217622
- Where
- 178 sites in United States, Argentina and 3 more
- Volunteers
- 3,701 people, healthy volunteers welcome
- Sponsor
- Shionogi
Renal Impairment
Study of Sulthiame (S-054502) in Participants With Renal Impairment and Matched Healthy Controls
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of sulthiame in participants with mild and moderate renal impairment compared to those in healthy participants with normal renal…
- Trial name
- NCT07857837
- Testing
- Sulthiame
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Shionogi
Bacterial Infections
A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal Impairment
A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam (S-649228) in Participants with Renal Impairment
- Trial name
- NCT07104162
- Testing
- Cefiderocol/Xeruborbactam
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Qpex Biopharma, Inc.
Chronic Heart Failure
Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction
This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-861 administered once daily for 12 weeks in subjects with heart failure with reduced ejection fraction (HFrEF) who are on a stable…
- Trial name
- POWER-HF (NCT06017609)
- Testing
- JTT-861 Capsules
- Where
- 75 sites in United States, Bulgaria and 4 more
- Volunteers
- 314 people
- Sponsor
- Shionogi Inc.
COVID-19
A Study of S-892216 in Participants With COVID-19
The primary objective of this study is to investigate the antiviral effect of S-892216 in participants with coronavirus disease 2019 (COVID-19) due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
- Trial name
- NCT06928051
- Testing
- S-892216
- Where
- 57 sites in United States, Japan
- Volunteers
- 282 people
- Sponsor
- Shionogi
COVID-19
Study of Secutrelvir in Participants With COVID-19
The main purpose of this study is to compare secutrelvir to placebo with respect to resolution of clinical symptoms in nonhospitalized participants with Coronavirus Disease 2019 (COVID-19) starting intervention within 48 hours of…
- Trial name
- NCT07746544
- Testing
- Secutrelvir
- Where
- Japan
- Volunteers
- 1,200 people
- Sponsor
- Shionogi
Pompe Disease
A Study of S-606001 as Monotherapy in Participants With Late-onset Pompe Disease (LOPD)
The primary purpose of this study is to evaluate the safety and tolerability profile of S-606001 in participants with LOPD.
- Trial name
- NCT07787650
- Testing
- S-606001
- Volunteers
- 15 people
- Sponsor
- Shionogi
SARS-CoV-2 Infection
A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19
The main aim of this study is to evaluate the efficacy of S-217622 versus placebo among outpatient adults with mild and moderate COVID-19 starting intervention within 3 days of symptom onset.
- Trial name
- SCORPIO-HR (NCT05305547)
- Testing
- S-217622
- Where
- 196 sites in United States, Argentina and 15 more
- Volunteers
- 2,093 people
- Sponsor
- Shionogi
Acute Ischemic Stroke
A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke
The purpose of this study is to evaluate the efficacy and safety of redasemtide in adult participants with acute ischemic stroke (AIS). This study consists of 2 cohorts, Cohort A and Cohort B.
- Trial name
- Revive (NCT05953480)
- Testing
- Redasemtide
- Where
- 150 sites in United States, Australia and 15 more
- Volunteers
- 680 people
- Sponsor
- Shionogi
Opioid-Induced Constipation (OIC)
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive…
- Trial name
- NCT05588323
- Testing
- Naldemedine
- Where
- 16 sites in Albania, Armenia and 6 more
- Volunteers
- 24 people
- Sponsor
- Shionogi
ALS
Safety Study of Oral Edaravone Administered in Subjects With ALS
The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.
- Trial name
- NCT04165824
- Testing
- MT-1186
- Where
- 53 sites in United States, Canada and 4 more
- Volunteers
- 185 people
- Sponsor
- Shionogi