Registration and Synopses of our Clinical Trials/Clinical Study Reports
Registration and Synopses of our Clinical Trials
Shionogi registers and discloses the synopses of our clinical trials through the World Health Organization (WHO) International clinical trials registry platforms in compliance with applicable laws and regulations.
Click the link below to go to an external website.
| jRCT (in Japan) | https://jrct.niph.go.jp/search (External website) |
|---|---|
| JAPIC (in Japan) | https://www.clinicaltrials.jp/cti-user/common/Top.jsp (External website) |
| ClinicalTrials.gov (in the United States) | https://ClinicalTrials.gov (External website) |
| EU Clinical Trial Register (in Europe) | https://www.clinicaltrialsregister.eu/ctr-search/search (External website) |
Clinical Study Reports
We will disclose the clinical study reports synopses which were used in the regulatory new drug approval processes and/or the clinical trials of investigational drugs that have been discontinued. This applies to the medicinal products that is approved after the day of enactment of “Clinical Trial Data Privacy Policy” (December 5th, 2018).
Information provided on this website is not intended to promote or advertise Shionogi products.
Please read the Clinical Study Reports after understanding and consenting to the above.
B
| Product Generic Name | Protocol No. | Study title | Clinical Study Reports Synopsis |
|---|---|---|---|
| baloxavir marboxil | 1602T0832 | Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 Compared with Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Patients with Influenza at High Risk of Influenza Complications | EN |
| baloxavir marboxil | 1705T0833 | An Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of S-033188 2% Granules after Administration of a Single Dose to Otherwise Healthy Pediatric Patients with Influenza | EN |
| baloxavir marboxil | 1719T0834 | A phase 3 randomized, double-blind, placebo-controlled study to confirm the efficacy of a single dose of baloxavir marboxil in the prevention of influenza virus infection | EN |
C
| Product Generic Name | Protocol No. | Study title | Clinical Study Reports Synopsis |
|---|---|---|---|
| Cefiderocol | 1203R2111 | A phase 1, randomized, double-blind, single-center, placebo-controlled, ascending single and multiple dose study of S-649266 in healthy adult subjects | EN |
| Cefiderocol | 1214R2112 | A Phase 1, Single-Center, Open-Label, Intrapulmonary Pharmacokinetics Study after Single Dose of S-649266 in Healthy Adult Subjects | EN |
| Cefiderocol | 1222R2113 | An Open-label, Non-Randomized Study to Evaluate the Pharmacokinetics, and Safety and Tolerability of S-649266 in Subjects with Varying Degrees of Renal Impairment and in Matched Control Subjects With Normal Renal Function | EN |
| Cefiderocol | 1409R2121 | A Multicenter, Double-blind, Randomized, Clinical Study to Assess the Efficacy and Safety of Intravenous S-649266 in Complicated Urinary Tract Infections With or Without Pyelonephritis or Acute Uncomplicated Pyelonephritis Caused by Gram-negative Pathogens in Hospitalized Adults in Comparison with Intravenous Imipenem/Cilastatin | EN |
| Cefiderocol | 1424R2131 | A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens | EN |
| Cefiderocol | 1516R2114 | A Study to Characterize Metabolism, Excretion,and Mass Balance of S-649266 after Intravenous Administration of a 1000 mg (100 μCi) Dose of [14C]-S-649266 in Healthy Adult Male Subjects | EN |
| Cefiderocol | 1521R2115 | A Study to Assess the Effect of S-649266 on the Pharmacokinetics of Furosemide, Metformin, and Rosuvastatin in Healthy Adult Subjects | EN |
| Cefiderocol | 1603R2116 | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of Single-Ascending Doses of S-649266 (Part 1) and a Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Period Crossover Study to Assess the Effect of S-649266 on the QT/QTc Interval (Part 2) in Healthy Adult Subjects | EN |
| Cefiderocol | 1615R2132 | A Multicenter, Randomized, Double-blind, Parallel-group, Clinical Study of S-649266 Compared with Meropenem for the Treatment of Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, or Healthcare-associated Bacterial Pneumonia Caused by Gram-negative Pathogens (APEKS-NP) | EN |
| Cefiderocol | 1713R2117 | An Open-label, Multicenter, Single-arm, Phase 1 Study to Assess the Intrapulmonary Concentrations of Cefiderocol at Steady State in Hospitalized Subjects with Known or Suspected Bacterial Pneumonia on Treatment with Standard of Care Antibiotics and Requiring Mechanical Ventilation | EN |
| Cefiderocol | 2136R2118 | A Phase 1, open-label, 1-sequence crossover, drug-drug interaction study to assess the effect of repeated doses of cefiderocol on the pharmacokinetics of midazolam in healthy adult participants | EN |
E
| Product Generic Name | Protocol No. | Study title | Clinical Study Reports Synopsis |
|---|---|---|---|
| Ensitrelvir | 2102T1211 | A Phase 1 Study of S-217622 in Healthy Adult Participants | EN |
| Ensitrelvir | 2127T1213 | A Phase 1, open-label, parallel-group study to assess the pharmacokinetics, safety, and tolerability of ensitrelvir in participants with mild and moderate hepatic impairment and healthy control participants | EN |
| Ensitrelvir | 2128T1214 | A Phase 1, open-label, parallel-group study to assess the pharmacokinetics, safety, and tolerability of S-217622 in participants with mild, moderate, and severe renal impairment and healthy control participants | EN |
| Ensitrelvir | 2130T1215 | Drug-Drug Interaction Study of S-217622 in Healthy Adult Participants | EN |
| Ensitrelvir | 2135T1216 | A Single-group, phase 1, Open-label Study to Investigate the Absorption, Distribution, Metabolism and Excretion of [14C]-S-217622 Following Oral Dose Administration as a Suspension in Healthy Adult Male Participants | EN |
| Ensitrelvir | 2305T1218 | A Phase 1 Drug-Drug Interaction Study of Ensitrelvir With Itraconazole or Carbamazepine in Healthy Adult Participants | EN |
| Ensitrelvir | 2108T1221 | A Phase 2/3 Study of S-217622 in Participants Infected with SARS-CoV-2 (Phase 2a Part) | EN |
| Ensitrelvir | 2108T1221 | A Phase 2/3 Study of S-217622 in Participants Infected with SARS-CoV-2 (Phase 2b Part) | EN |
| Ensitrelvir | 2108T1221 | A Phase 2/3 Study of S-217622 in Participants Infected with SARS-CoV-2 (Phase 2b3 Part) | EN |
| Ensitrelvir | 2108T1221 | A Phase 2/3 Study of S-217622 in Participants Infected with SARS-CoV-2 (Phase 3 Part) | EN |
G
| Product Generic Name | Protocol No. | Study title | Clinical Study Reports Synopsis |
|---|---|---|---|
| Guanfacine hydrochloride | 1506A3112 | A Phase 1 Pharmacokinetics Study of Multiple-Doses of S-877503 in Japanese Healthy Adult Subjects | JP |
| Guanfacine hydrochloride | 1522A3132 | Phase III Study of S-877503 in Adult Patients with Attention-deficit/Hyperactivity Disorder | JP |
| Guanfacine hydrochloride | 1523A3133 | Phase III Study of S-877503 in Adult Patients with Attention-deficit/Hyperactivity Disorder -long term extension study- | JP |
L
| Product Generic Name | Protocol No. | Study title | Clinical Study Reports Synopsis |
|---|---|---|---|
| Lisdexamfetamine mesilate | 1411A3223 | Phase II/III Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder | JP |
| Lisdexamfetamine mesilate | 1309A3221 | Phase II Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder | JP |
| Lisdexamfetamine mesilate | 1318A3222 | Phase II Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder -Long term Extension Study- | JP |
| Lisdexamfetamine mesilate | 1412A3231 | Long-term Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder | JP |
| Lusutrombopag | 1017M0623 | Phase 2 study of S-888711 in thrombocytopenic patients with chronic liver disease | |
| Lusutrombopag | 1208M0626 | Phase 2b study of S-888711 in thrombocytopenic patients with chronic liver disease | |
| Lusutrombopag | 1304M0631 | Phase 3 study of S-888711 in thrombocytopenic patients with chronic liver disease (L-PLUS 1) | |
| Lusutrombopag | 1338M0633 | A Phase 3b Open-label Study of S-888711 in Thrombocytopenic Patients with Chronic Liver Disease | EN |
| Lusutrombopag | 0713M0611 | Phase I single-dose, double-blind, placebo-controlled study in healthy adult male subjects to assess the safety and pharmacokinetics of S-888711 | |
| Lusutrombopag | 0801M0612 | A crossover study to investigate the relative bioavailability and the effect of food on the pharmacokinetics of a single dose of S-888711 in healthy male subjects | |
| Lusutrombopag | 0806M0613 | Phase I multiple-dose, dose-ranging, double-blind, placebo-controlled study to assess the safety and pharmacokinetics of S-888711 in healthy adult male subjects | |
| Lusutrombopag | 0820M0614 | A Pharmacokinetics Study of S-888711 in Caucasian Healthy Adult Male Subjects | EN |
| Lusutrombopag | 0823M0615 | A Phase I Multiple-dose, Double-blind Placebo-controlled Study to Assess the Safety and Pharmacokinetics of S-888711 in Healthy Subjects | EN |
| Lusutrombopag | 0911M0616 | A Phase 1, Open-Label, Case-Matched Cohort Design, Non-Randomized Pharmacokinetic and Safety Study of a Single Oral Dose of 0.75 mg S-888711 in Healthy Subjects and in Subjects with Mild or Moderate Hepatic Impairment | EN |
| Lusutrombopag | 0912M0617 | A Phase 1, Open-label, One-sequence Crossover, Drug-drug Interaction Study to Evaluate the Effect of Repeated Doses of S-888711 on the Pharmacokinetics of the CYP3A4 Substrate, Midazolam, in Healthy Subjects | EN |
| Lusutrombopag | 0924M0618 | An Open-label, Randomized, Three-period, Crossover Study to Assess the Effect of Food and Calcium on S-888711 0.25-mg Tablet Pharmacokinetics in Healthy, Adult Volunteer Subjects Following a Single 0.75-mg Oral Dose of S-888711 | EN |
| Lusutrombopag | 1012M0619 | A Phase 1 Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of [14C]-S-888711 Following Oral Dose Administration in Healthy Male Subjects | EN |
| Lusutrombopag | 1218M061A | A three-way crossover study to assess the relative bioavailability of 1-mg and 4-mg tablets of S-888711 and the effect of high-fat meals on the pharmacokinetics of the 4-mg tablet in healthy male subjects | |
| Lusutrombopag | 1301M061B | Evaluation of platelet functions in thrombocytopenic patients with chronic liver disease treated with S-888711 | |
| Lusutrombopag | 1303M061D | A phase 1, randomized, double-blind, placebo- and positive-controlled, 4-period crossover, thorough QT/QTc study of S-888711 in healthy subjects | |
| Lusutrombopag | 1514M061E | A Phase 1, Open-label, Randomized, Three-period Crossover Drug-drug Interaction Study to Evaluate the Effect of Cyclosporine and/or Quinidine Sulfate on the Pharmacokinetics of S-888711 in Healthy Adult Subjects | EN |
| Lusutrombopag | 0913M0621 | A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of S-888711 tablets administered once-daily for 42 days to adult subjects with relapsed persistent or chronic immune thrombocytopenia with or without prior splenectomy | EN |
| Lusutrombopag | 0914M0622 | An open-label safety study of S-888711 in adult subjects with relapsed persistent or chronic immune thrombocytopenia with or without prior splenectomy | EN |
| Lusutrombopag | 1112M0625 | A phase 2 higher-dose study of S-888711 in thrombocytopenic patients with chronic liver disease | |
| Lusutrombopag | 1525M0627 | A Clinical Pharmacology Study of S-888711 in Thrombocytopenic Patients with Child-Pugh Class C Liver Disease | EN |
| Lusutrombopag | 1423M0634 | A Phase 3 randomised, double-blind, placebo-controlled study to assess the safety and efficacy of S-888711 (lusutrombopag) for the treatment of thrombocytopenia in patients with chronic liver disease undergoing elective invasive procedures (L-PLUS 2) | EN |
N
| Product Generic Name | Protocol No. | Study title | Clinical Study Reports Synopsis |
|---|---|---|---|
| Naldemedine | 1331V9236 | A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of naldemedine in cancer patients with opioid-induced constipation | EN |
| Naldemedine | 1332V9237 | A phase 3, multicenter, open-label study of naldemedine in cancer patients with opioid-induced constipation - extension study - | EN |
| Naldemedine | 1336V9238 | A phase 3, open-label study of naldemedine in patients with non-malignant chronic pain and opioid-induced constipation | EN |
| Naldemedine | 0824V9211 | Phase 1 single dose clinical study of S-297995 in healthy Japanese adult males | |
| Naldemedine | 0909V9212 | An open-label, crossover study to assess the bioavailability and the food effect on the pharmacokinetics of a single dose of S-297995 in healthy Japanese adult males | |
| Naldemedine | 0917V9213 | Phase I multiple dose clinical study of S-297995 in healthy Japanese adult males | |
| Naldemedine | 1007V9214 | A Randomized, Double-blind, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Efficacy of S-297995 for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain | EN |
| Naldemedine | 1016V9215 | A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-S-297995 Following Oral Dose Administration in Healthy Male Subjects | EN |
| Naldemedine | 1101V9216 | A Phase 1, Randomized, Double-Blind, Single Dose, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of S-297995 in the Reduction of Opioid-induced Nausea and Emesis in Healthy Subjects | EN |
| Naldemedine | 1202V9218 | A Phase 1, Open-label, Randomized, 2-way Crossover Study to Evaluate the Drug-drug Interaction of the P-gp inhibitor Cyclosporine with the Pharmacokinetics of S-297995 in Healthy Adult Subjects | EN |
| Naldemedine | 1204V9219 | A Randomized, Double-blind, Placebo- and Positive-controlled, 4-Period, Cross-over Study to Assess the Effect of S-297995 on ECG Parameters in Healthy Volunteers | EN |
| Naldemedine | 1311V921A | A Phase 1, Randomized, Open-label, Three-way Crossover Bioavailability Study to Evaluate the S-297995 Phase 3 Tablet Compared with the Phase 2 Tablet and the Food Effect for the Phase 3 S-297995 Tablet in Healthy Adult Subjects | EN |
| Naldemedine | 1401V921B | Phase 1, Open-label, Non-randomized Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Naldemedine in Subjects with Varying Degrees of Renal Impairment and in Matched Control Subjects with Normal Renal Function | EN |
| Naldemedine | 1402V921C | Phase 1, Open-label, Non-randomized, Single-dose, Parallel-group Study to Evaluate the Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics and Safety of 0.2 mg Naldemedine Compared with Healthy Demographically-matched Subjects with Normal Hepatic Function | EN |
| Naldemedine | 1403V921D | An Open-Label, One-Sequence, Two Period, Crossover, Drug-Drug Interaction Study to Evaluate the Effect of Repeated Administration of Rifampin on the Pharmacokinetics of Naldemedine in Healthy Adult Subjects | EN |
| Naldemedine | 1502V921E | An Open-label, One-sequence, Two-period, Crossover, Drug-drug Interaction Study to Evaluate the Effect of Repeated Administration of Itraconazole or Fluconazole on the Pharmacokinetics of Naldemedine in Japanese Healthy Adult Subjects | EN |
| Naldemedine | 1107V9221 | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of S-297995 for the Treatment of Opioid-Induced Constipation in Subjects with Non-Malignant Chronic Pain Receiving Opioid Therapy | EN |
| Naldemedine | 1108V9222 | A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of S-297995 for the Treatment of Opioid-induced Constipation (OIC) in Cancer Patients | EN |
| Naldemedine | 1314V9231 | A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy | EN |
| Naldemedine | 1315V9232 | A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy | EN |
| Naldemedine | 1326V9235 | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study to Evaluate the Long-term Safety of Naldemedine for the Treatment of Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy | EN |
| Naldemedine | 1339V9239 | A phase 3, multicenter, open-label study of naldemedine in patients with non-malignant chronic pain and opioid-induced constipation receiving S-8117 (oxycodone hydrochloride hydrate) | EN |
O
| Product Generic Name | Protocol No. | Study title | Clinical Study Reports Synopsis |
|---|---|---|---|
| Oxycodone Hydrochloride Hydrate | 1211V9431 | A double-blind, placebo-controlled study of S-8117 in patients with chronic low back pain | JP |
| Oxycodone Hydrochloride Hydrate | 1212V9432 | An extension study of S-8117 in patients with chronic low back pain | JP |
| Oxycodone Hydrochloride Hydrate | 1220V9433 | An Open-label, Long-term Administration Study of S-8117 in Patients with Chronic Pain | JP |
| Oxycodone Hydrochloride Hydrate | 1720V9831 | An open-label, efficacy, safety and pharmacokinetic study for S-8117 (OTR) switched from oxycodone hydrochloride controlled-release tablets in patients with chronic pain |
|
R
| Product Generic Name | Protocol No. | Study title | Clinical Study Reports Synopsis |
|---|---|---|---|
| Recombinant Protein COVID-19 Vaccine | 2025U0231 | A Phase 3, Randomized, Observer-Blind, Active-Controlled Study to Compare Immunogenicity against COVID-19 of S-268019 to the ChAdOx1 nCoV-19 vaccine | EN |
| Recombinant Protein COVID-19 Vaccine | 2026U0221 | A Double blind Phase 1/2 study of S-268019 | EN |
| Recombinant Protein COVID-19 Vaccine | 2114U0222 | An Open-Label Phase 2/3 Study of S-268019 | EN |
| Recombinant Protein COVID-19 Vaccine | 2124U0223 | A Phase 2/3, Randomized, Observer-Blind, Active-Controlled Study to Evaluate the Immunogenicity of a Booster Dose of S-268019 or COMIRNATY | EN |
| Recombinant Protein COVID-19 Vaccine | 2126U0232 | A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Cross-over Study to Evaluate the Efficacy, Safety, and Immunogenicity of S-268019 for the Prevention of COVID-19 | EN |
| Recombinant Protein COVID-19 Vaccine | 2140U0224 | A Phase 3, Open-label Study to Evaluate Safety of a Booster Dose of S-268019 in Adults and Older Adults Who Have Completed COVID-19 Vaccine as a Primary Series | EN |
S
| Product Generic Name | Protocol No. | Study title | Clinical Study Reports Synopsis |
|---|---|---|---|
| S-637880 | 2004VA421 | A phase 2a study of S-637880 in patients with neuropathic low back pain | EN |