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Clinical trials
catalyst calendar across sponsors →Studies where 4507.T is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
97 interventional · 4 observational · 1 expanded access · 53 with posted results
government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| An Extension Study of S-606001 in Participants With Late-onset Pompe Disease (LOPD)NCT07750990Number of Participants With Treatment-emergent Adverse EventsOpen-label · Treatment | Phase 2 | Not yet recruiting | Drug: S-606001, ERT | Pompe Disease | 60 | 2028-08-31 | in 743 d | 2026-08-06 |
| A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe DiseaseNCT07743580Proportion of Participants Experiencing Any Component of the Following Composite Endpoint: Targeted Medically Attended Visits (tMAVs) Due to Worsening COVID-19, All-cause Hospitalizations, or All-cause DeathsRandomized · Double-masked · Treatment | Phase 3 | Not yet recruiting | Drug: Secutrelvir, Placebo | SARS-CoV-2 | 2,000 | 2028-06-30 | in 681 d | 2026-08-04 |
| Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving OpioidsNCT05588323Maximum Plasma Concentration (Cmax) of Naldemedine and Nor-naldemedineNon-randomized · Open-label · Supportive care | Phase 1/2 | Recruiting | Drug: Naldemedine | Opioid-Induced Constipation (OIC) | 24 | 2028-06-15 | in 666 d | 2026-07-28 |
| S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid TumorsNCT05101070Part A: Number of Participants with Treatment-emergent Adverse Events (TEAEs)Non-randomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: S-531011, Pembrolizumab, Bevacizumab | Solid Tumors | 282 | 2028-05-31 | in 651 d | 2026-03-18 |
| Study of Zatolmilast (BPN14770) in Participants With PPP2R5D Neurodevelopmental Disorder (Jordan's Syndrome [JS])NCT06717438Change From Baseline at Week 24 in Numerical Rating Scale Within the Domain of Language/CommunicationRandomized · Triple-masked · Treatment | Phase 2 | Active, not recruiting | Drug: BPN14770, Placebo | Jordan's Syndrome, PPP2R5D Neurodevelopmental Disorder | 30 | 2027-12-31 | in 499 d | 2026-06-09 |
| Study of S-606001 as an Add-on to Enzyme Replacement Therapy (ERT) in Participants With Late-onset Pompe Disease (LOPD)NCT07123155Change From Baseline in Percent Forced Vital Capacity (%FVC) at Week 52Randomized · Quadruple-masked · Treatment | Phase 2 | Recruiting | Drug: S-606001, Placebo | Pompe Disease | 45 | 2027-08-08 | in 354 d | 2026-06-23 |
| Study of Secutrelvir in Participants With COVID-19NCT07746544Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21Randomized · Quadruple-masked · Treatment | Phase 3 | Not yet recruiting | Drug: Secutrelvir, Placebo | COVID-19 | 1,200 | 2027-07-31 | in 346 d | 2026-08-05 |
| Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult ParticipantsNCT07093580Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Recruiting | Drug: S-892216-LAI, Placebo | Healthy Participants | 98 | 2027-05-26 | in 280 d | 2025-08-27 |
| Safety and Efficacy Study of Sivopixant, Acetazolamide and SASS-001 in Sleep ApneaNCT06776432Primary Endpoint - Change in apnea-hypopnea index (SASS-001 arm vs baseline at Visit 7 polysomnography). Scale is minimum -60 to max 60. Lower scores mean improvement from baseline.Randomized · Quadruple-masked · Treatment | Phase 2 | Active, not recruiting | Drug: Sivopixant, Placebo, Acetazolamide, SASS-001 | Sleep Apnea | 60 | 2026-12-31 | in 134 d | 2026-05-06 |
| A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe DiseaseNCT07214571Change From Baseline in RSV Ribonucleic Acid (RNA) Load by Quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) (Nasopharyngeal Swab) at Day 2Randomized · Quadruple-masked · Treatment | Phase 2 | Recruiting | Drug: S-337395, Placebo | Respiratory Syncytial Virus Infections | 192 | 2026-12-30 | in 133 d | 2026-08-11 |
| A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic StrokeNCT05953480Modified Rankin Scale (mRS) Score at Day 90Randomized · Double-masked · Treatment | Phase 2 | Completed | Biological: Redasemtide · Drug: Placebo | Acute Ischemic Stroke | 680 | 2026-06-15actual | — | 2026-07-30 |
| A Study of S-892216-PO in Participants With Renal Impairment and Matched ControlsNCT07217886Maximum Plasma Concentration (Cmax) of S-892216Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: S-892216-PO | Renal Impairment | 24 | 2026-02-13actual | — | 2026-07-13 |
| Study of BPN14770 in Participants With Severe Renal Impairment and Healthy ControlsNCT07012005Maximum Plasma Concentration (Cmax) of BPN14770Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: BPN14770 | Renal Impairment | 14 | 2025-12-15actual | — | 2026-02-27 |
| Phase 1 Study of BPN14770 in Participants With Hepatic Impairment and Healthy ControlsNCT07018492Area Under the Plasma Concentration Time Curve Extrapolated from Time 0 to Infinity (AUCinf) of BPN14770Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: BPN14770 | Hepatic Impairment | 32 | 2025-11-26actual | — | 2026-02-27 |
| A Study of S-892216 in Participants With COVID-19NCT06928051Change From Baseline in SARS-CoV-2 Viral RNA Level on Day 4 as Assessed by Quantitative Reverse-transcription Polymerase Chain Reaction (qRT-PCR) of Nasopharyngeal (NP) SwabsRandomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: S-892216, Placebo | COVID-19 | 282 | 2025-09-22actual | — | 2025-09-30 |
| A Study of S-740792 in Healthy Adult Study ParticipantsNCT06724978Parts 1 and 2: Number of Participants Experiencing Treatment-emergent Adverse EventsRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: S-740792 Suspension, Midazolam, Placebo, S-740792 Tablet | Healthy Participants | 99 | 2025-09-10actual | — | 2025-10-02 |
| A Study to Assess the Effects of BPN14770 on RosuvastatinNCT07011992Maximum Plasma Concentration (Cmax) of RosuvastatinOpen-label · Treatment | Phase 1 | Completed | Drug: Rosuvastatin, BPN14770 | Healthy Participants | 12 | 2025-07-31actual | — | 2025-08-14 |
| A Drug-Drug Interaction Study of S-217622 With Combined Oral Contraceptives in Healthy Adult Female ParticipantsNCT06775730Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol (EE)Open-label · Treatment | Phase 1 | Completed | Drug: Ensitrelvir | Healthy Adult Female Participants | 24 | 2025-04-03actual | — | 2025-05-04 |
| A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and InfantsNCT06086626Maximum Observed Plasma Concentration (Cmax) After a Single Dose of CefiderocolNon-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: Cefiderocol, Standard of Care | Gram-Negative Bacterial Infections | 30 | 2025-03-31actual | — | 2026-03-02 |
| A Study to Investigate How Respiratory Syncytial Virus (RSV) Infection Develops and Changes Over Time in Pediatric ParticipantsNCT06746051observationalChange From Baseline in RSV Viral Load Measurements | — | Completed | — | RSV Infections | 100 | 2025-03-31actual | — | 2025-05-04 |
| A Drug-drug Interaction Study of S-892216 Coadministered With Carbamazepime to Healthy Adult ParticipantsNCT06751017Plasma Concentration of S-892216Open-label · Treatment | Phase 1 | Completed | Drug: S-892216, Carbamazepine | COVID-19 | 16 | 2025-02-24actual | — | 2025-03-11 |
| A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric ParticipantsNCT04215991Number of Participants with Adverse Events in the Single Dose PhaseRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: Cefiderocol, Standard of Care | Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP), Complicated Urinary Tract Infection (cUTI), Ventilator Associated Bacterial Pneumonia (VABP) | 91 | 2024-09-17actual | — | 2025-05-25 |
| Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 InfectionNCT05897541Number of Participants in the Modified Intention-to-treat (mITT) Population with a Negative Screening SARS-CoV-2 Infection who are Infected with SARS-CoV-2 and Have COVID-19 Symptoms OnsetRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: S-217622, Placebo | SARS-CoV-2 Infection | 2,387 | 2024-08-30actual | — | 2025-08-06 |
| A Study to Investigate Different Formulations of S-337395 in Healthy Adult ParticipantsNCT06270511Part A: Plasma Concentration of S-337395Randomized · Open-label · Basic science | Phase 1 | Completed | Drug: S-337395, Placebo | Healthy Volunteers | 50 | 2024-05-30actual | — | 2024-07-10 |
| Safety and Efficacy Study of S-309309 in Obese AdultsNCT05925114Percent Change From Baseline in Body WeightRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: S-309309, Placebo | Obesity | 365 | 2024-04-15actual | — | 2025-04-16 |
| A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19NCT05305547Median Time to Sustained Symptom ResolutionRandomized · Double-masked · TreatmentInformed Consent Form ↗ | Phase 3 | Completed | Drug: S-217622, Placebo | SARS-CoV-2 Infection | 2,093 | 2024-01-07actual | — | 2025-09-16 |
| Effect of Administration of Itraconazole on the Pharmacokinetics of S-309309 in Healthy ParticipantsNCT06106334Area Under the Concentration-Time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) After Administration of S-309309Open-label · Treatment | Phase 1 | Completed | Drug: S309309, Itraconazole | Obesity, Healthy Volunteers | 14 | 2023-12-08actual | — | 2024-02-29 |
| Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)NCT04259255observationalChanges in levels of 8-F2 isoprostanes as a potential biomarker of oxidative stress, inflammation or neurodegeneration. | — | Completed | Drug: Edaravone (Radicava®/Radicava ORS®) | Amyotrophic Lateral Sclerosis, ALS | 74 | 2023-11-24actual | — | 2026-06-30 |
| Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALSNCT04569084results2025-03-27CAFS Score at Week 48Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Futility was met. | Drug: MT-1186, Placebo | ALS | 384 | 2023-09-29actual | — | 2026-07-20 |
| Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)NCT04577404results2024-08-28Number of Events of Treatment Emergency Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Severe TEAEs, TESEAs, TEAEs Leading to Discontinuation, Any TEAEs Leading to DeathOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: MT-1186 | Amyotrophic Lateral Sclerosis (ALS) | 124 | 2023-08-09actual | — | 2026-07-20 |
| Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALSNCT05568615results2025-02-03Number of Patients With AEs and Adverse Drug ReactionsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: MT-1186 | ALS | 15 | 2023-06-27actual | — | 2026-07-21 |
| Use of Cefiderocol in the Management of Gram-Negative InfectionsNCT05789199observationalRate Of Clinical Success | — | Completed | Drug: Cefiderocol | Gram-Negative Infection | 314 | 2023-06-16actual | — | 2023-06-26 |
| A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control ParticipantsNCT05409911Maximum Observed Plasma Concentration (Cmax) of S-217622Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: S-217622 | Hepatic Impairment | 25 | 2023-04-25actual | — | 2023-05-26 |
| A Study to Assess S-217622 in Participants With Renal Impairment and Healthy ParticipantsNCT05363215Maximum Observed Plasma Concentration (Cmax) of S-217622Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: S-217622 | Renal Impairment | 32 | 2023-04-12actual | — | 2023-04-24 |
| A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric ParticipantsNCT04335539results2026-02-27Single-Dose Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Cefiderocol, Standard of Care | Gram-negative Bacterial Infections, Bloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Hospital Acquired Pneumonia (HAP), Ventilator-acquired Pneumonia, Complicated Urinary Tract Infection (cUTI), Sepsis | 53 | 2023-02-06actual | — | 2026-02-27 |
| A Study of S-268019 for the Prevention of COVID-19NCT05212948results2025-11-28Number of Participants With First Occurrence of SARS-CoV-2 Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Positive Symptomatic COVID-19 With Onset at Least 14 Days Following Second Vaccination During the Initial Vaccination PeriodRandomized · Triple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: S-268019-b, Placebo | SARS-CoV-2 | 9,902 | 2022-12-19actual | — | 2025-11-28 |
| A Study to Assess S-309309 in Healthy and Obese ParticipantsNCT05247970Part 1 and 2: Number of Participants with Treatment Emergent Adverse Events (TEAEs)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: S-309309, Midazolam, Placebo | Obesity | 74 | 2022-10-20actual | — | 2023-01-11 |
| A Study to Assess the Effect of Cefiderocol on the Pharmacokinetics (PK) of Midazolam in Healthy ParticipantsNCT05395104results2023-12-14Maximum Observed Plasma Concentration (Cmax) of MidazolamOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: Midazolam, Cefiderocol | Healthy Volunteers | 14 | 2022-07-13actual | — | 2023-12-14 |
| Safety Study of Oral Edaravone Administered in Subjects With ALSNCT04165824results2022-08-29Number of Treatment Emergency Adverse EventsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: MT-1186 | ALS | 185 | 2021-10-07actual | — | 2026-07-21 |
| First-in-human Study of S-588210 (S-488210+S-488211)NCT04316689Number of Participants with Adverse EventsOpen-label · Treatment | Phase 1 | Completed | Biological: S-488210, S-488211 | Lung Cancer, Head and Neck Cancer, Bladder Cancer, Esophageal Cancer, Mesothelioma | 10 | 2021-09-22actual | — | 2022-01-26 |
| Women's Satisfaction and Adherence to Vulvovaginal Atrophy TreatmentsNCT04607707observationalPerception of Patient Satisfaction with Their Current Vulvovaginal Atrophy (VVA) Treatment by means of a questionnaire | — | Completed | — | Vulvovaginal Atrophy | 831 | 2021-04-30actual | — | 2021-06-21 |
| Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric TubeNCT04776135results2024-01-08Area Under the Concentration Versus Time Curve (AUC) of EdaravoneRandomized · Open-label · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: MT-1186 | Healthy Adult Subjects | 36 | 2021-04-01actual | — | 2026-07-15 |
| A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel TransectionNCT04355169results2022-01-18Time From the End of Surgery to Time to First Toleration of Solid Food and First Bowel Movement (GI2)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: This study was terminated before the planned sample size was enrolled due to very slow enrollment. | Drug: Naldemedine, Placebo | Postoperative Gastrointestinal Dysfunction | 2 | 2021-01-04actual | — | 2022-01-18 |
| Study in Healthy Adults to Quantify Lung Deposition and Distribution of Radio-labelled S-770108 Inhalation Powder Formulation Delivered by a Novel Inhaler DeviceNCT04631354Total lung deposition of 99mTc radio-labelled S-770108Randomized · Open-label · Other | Phase 1 | Completed | Drug: Radio-labelled S-770108 · Device: S-770108 Inhaler A1 | Healthy Volunteer | 12 | 2020-12-14actual | — | 2020-12-29 |
| Evaluation of S-600918 in Adults With Refractory Chronic CoughNCT04110054results2024-03-27Percent Change in Number of Coughs Per Hour in 24 Hours Following 4 Weeks of Study TreatmentRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: S-600918, Placebo to S-600918 | Chronic Cough | 406 | 2020-12-08actual | — | 2024-03-27 |
| Evaluation of Safety, Tolerability, Pharmacokinetics, Drug-Drug and Food Interactions of Single and Multiple Doses of S-648414 in Healthy AdultsNCT04147715results2021-10-20Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: S-648414, Placebo, Midazolam, Dolutegravir | Healthy Volunteer | 98 | 2020-09-22actual | — | 2021-11-01 |
| A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive DisorderNCT03395353results2021-06-18Percentage of Participants With Adverse Events (AEs), Drug Related Adverse Events (ADRs) or Any Serious Adverse Events (SAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Business decision | Drug: Duloxetine Hydrochloride | Depressive Disorder | 151 | 2020-07-04actual | — | 2021-06-18 |
| Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With GastrostomyNCT04254913results2024-01-24Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged EdaravoneOpen-label · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: MT-1186 | Japanese Patients With ALS | 6 | 2020-04-16actual | — | 2026-07-16 |
| A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive DisorderNCT03315793results2021-01-05Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) Total ScoreRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Duloxetine Hydrochloride, Placebo | Depressive Disorder | 149 | 2019-11-08actual | — | 2021-01-05 |
| Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial PneumoniaNCT03862040results2020-11-05Concentration of Cefiderocol in Epithelial Lining FluidOpen-label · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 1 | Terminatedsponsor's stated reason: Slow enrollment | Drug: Cefiderocol, Standard of Care Antibiotic | Bacterial Pneumonia | 7 | 2019-10-08actual | — | 2020-11-05 |
| Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral SclerosisNCT04176224results2024-01-24Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged EdaravoneOpen-label · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: MT-1186 | Japanese Patients With ALS | 9 | 2019-09-04actual | — | 2026-07-15 |
| Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Subjects (Food Effect Study)NCT05342597results2024-01-05Area Under the Concentration Versus Time Curve From Zero up to Infinity (AUC0-inf) of EdaravoneRandomized · Open-label · Basic scienceStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: MT-1186 | Healthy Adult Subjects | 16 | 2019-07-24actual | — | 2026-07-15 |
| Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult SubjectsNCT04493281results2024-01-18Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged Edaravone After Oral and Intravenous AdministrationRandomized · Open-label · Basic scienceStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: MT-1186, MCI-186 | Healthy Adult Subjects | 42 | 2019-04-21actual | — | 2026-07-15 |
| Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative PathogensNCT02714595results2020-12-17Percentage of Participants With Clinical Cure at Test of Cure (TOC) in Participants With HAP/VAP/HCAP or BSI/SepsisRandomized · Open-label · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 3 | Completed | Drug: Cefiderocol, Best Available Therapy | Healthcare-associated Pneumonia (HCAP), Bloodstream Infections (BSI), Hospital Acquired Pneumonia (HAP), Complicated Urinary Tract Infection (cUTI), Sepsis, Ventilator Associated Pneumonia (VAP) | 152 | 2019-04-01actual | — | 2021-01-12 |
| PK Study in Subjects With Severe Hepatic ImpairmentNCT03664544results2020-04-07Pharmacokinetic Parameters of MCI-186: Peak Drug Concentration (Cmax)Non-randomized · Open-label · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: MCI-186 | Severe Hepatic Impairment, Healthy | 12 | 2019-03-25actual | — | 2026-07-15 |
| Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative PathogensNCT03032380results2020-11-13All-cause Mortality Rate at Day 14Randomized · Triple-masked · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 3 | Completed | Drug: Cefiderocol, Meropenem, Linezolid | Healthcare-associated Pneumonia (HCAP), Hospital Acquired Pneumonia (HAP), Ventilator Associated Pneumonia (VAP) | 300 | 2019-02-26actual | — | 2020-11-13 |
| Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study)NCT04481789results2024-08-02Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Rosuvastatin, Sildenafil and Furosemide.Non-randomized · Open-label · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: MT-1186, Rosuvastatin, Sildenafil, Furosemide | Healthy Adult Subjects | 84 | 2018-12-20actual | — | 2026-07-15 |
| A Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT Interval(QT)/Corrected QT Interval(QTc) Interval in Healthy SubjectsNCT04029090results2024-11-21Change From Baseline in QTcF(ΔQTcF) With Placebo Adjustment (ΔΔQTcF) at Cmax of MCI-186Randomized · Double-masked · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: MCI-186, MCI-186, Placebo | Healthy Adult Subjects | 27 | 2018-10-20actual | — | 2026-07-15 |
| Study of Oral Edaravone in Healthy Adult MalesNCT04481750results2024-08-02Number of Participants With Adverse Events (Aes) and Adverse Drug Reactions (ADRs)Randomized · Single-masked · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: MT-1186, MT-1186-matching placebo | Healthy Adult Subjects | 74 | 2018-08-03actual | — | 2026-07-16 |
| Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic ImpairmentNCT03289234results2020-02-28CmaxNon-randomized · Open-label · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: MCI-186 | Hepatic Impairment, Healthy | 22 | 2018-07-20actual | — | 2026-07-15 |
| Dose Finding Study of MCI-186 in Acute Ischemic StrokeNCT03346538results2025-01-09Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score Improved.Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Business objectives have changed. | Drug: Continuous infusion high-dose MCI-186, Continuous infusion low-dose MCI-186, Continuous infusion placebo, Approved dosing regimen MCI-186, Approved dosing regimen placebo | Acute Ischemic Stroke | 17 | 2018-05-14actual | — | 2026-07-16 |
| Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal ImpairmentNCT03289208results2020-02-28CmaxNon-randomized · Open-label · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: MCI-186 | Renal Impairment, Healthy | 30 | 2018-04-16actual | — | 2026-07-15 |
| Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza ComplicationsNCT02949011results2019-11-06Time to Improvement of Influenza SymptomsRandomized · Double-masked · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 3 | Completed | Drug: Baloxavir Marboxil, Placebo to Baloxavir Marboxil, Oseltamivir, Placebo to Oseltamivir | Influenza | 2,184 | 2018-04-12actual | — | 2019-11-19 |
| Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to MenopauseNCT02638337results2019-04-02Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Week 12Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Ospemifene, Placebo | Vaginal Dryness | 631 | 2017-06-23actual | — | 2019-04-02 |
| Safety and Efficacy Study of Lusutrombopag for Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive ProceduresNCT02389621results2018-09-25Percentage of Participants Who Required No Platelet Transfusion Prior to the Primary Invasive Procedure and No Rescue Therapy For Bleeding From Randomization Through 7 Days After the Primary Elective ProcedureRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Lusutrombopag, Placebo | Chronic Liver Disease, Thrombocytopenia | 215 | 2017-04-05actual | — | 2018-10-30 |
| A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With InfluenzaNCT02954354results2018-12-14Time to Alleviation of Symptoms in Participants Randomized to Baloxavir or PlaceboRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Baloxavir Marboxil, Placebo to Baloxavir Marboxil, Oseltamivir, Placebo to Oseltamivir | Influenza | 1,436 | 2017-04-04actual | — | 2019-05-08 |
| A Study of Efficacy and Safety of Intravenous Cefiderocol (S-649266) Versus Imipenem/Cilastatin in Complicated Urinary Tract InfectionsNCT02321800results2019-12-12Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Test of CureRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Cefiderocol, Imipenem/cilastatin | Urinary Tract Infections | 452 | 2016-07-26actual | — | 2019-12-12 |
| Long Term Safety of NaldemedineNCT01965652results2017-05-30Number of Participants With Adverse EventsRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Naldemedine, Placebo | Opioid-induced Constipation | 1,246 | 2016-01-12actual | — | 2018-04-18 |
| Efficacy and Safety of Naldemedine in Treating Opioid-induced ConstipationNCT01993940results2017-05-30Percentage of Participants With a Spontaneous Bowel Movement (SBM) ResponseRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Naldemedine, Placebo | Opioid-induced Constipation | 553 | 2015-06-09actual | — | 2017-05-30 |
| Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced ConstipationNCT01965158results2017-05-30Percentage of Participants With a Spontaneous Bowel Movement (SBM) ResponseRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Naldemedine, Placebo | Opioid-induced Constipation | 547 | 2015-01-22actual | — | 2017-05-30 |
| Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral SclerosisNCT01492686results2018-12-31Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 WeeksRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: MCI-186, Placebo, MCI-186 in open label phase | Amyotrophic Lateral Sclerosis (ALS) | 137 | 2014-09-30actual | — | 2026-07-21 |
| Combination Study Of S-555739/Cetirizine HCl In Adult Patients With Seasonal Allergic RhinitisNCT01651871Change in average morning/evening (AM/PM) reflective Total Nasal Symptom Score (rTNSS)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: S-555739 Dose 1, S-555739 Dose 2, Cetirizine HCl Dose 1, S-555739 placebo, Cetirizine HCl placebo | Seasonal Allergic Rhinitis | 779 | Nov 2012actual | — | 2018-04-27 |
| A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid TherapyNCT01443403results2017-05-30Change From Baseline to Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per WeekRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Placebo, Naldemedine | Opioid-induced Constipation | 244 | 2012-08-22actual | — | 2017-06-26 |
| Safety and Efficacy of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin TherapyNCT01240759Change from Baseline to Week 12 in Hemoglobin A1c (HbA1c)Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: S-707106 Dose A, S-707106 Dose B, S-707106 Dose C, Placebo A tablet, Metformin | Type 2 Diabetes Mellitus | 218 | Dec 2011actual | — | 2018-05-15 |
| An Open-label Safety Study of Lusutrombopag (S-888711) in Adults With Chronic Immune Thrombocytopenia (ITP)NCT01129024results2021-02-26Number of Participants With Adverse EventsOpen-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: The study was terminated due to cessation of clinical development of S-888711 for chronic ITP based on a business decision by the Sponsor. | Drug: Lusutrombopag | Immune Thrombocytopenia | 19 | 2011-06-30actual | — | 2021-02-26 |
| Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic PainNCT01122030results2017-05-30Number of Participants With Adverse EventsRandomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: Naldemedine, Placebo | Opioid Induced Bowel Dysfunction | 72 | 2011-02-23actual | — | 2017-05-30 |
| 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 SubjectsNCT01126970The primary efficacy endpoint was the change from baseline in body weight (kg) over the 168-day (24-week) double-blind treatment period, where baseline body weight was defined as the last measurement prior to randomizationRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Velneperit 400 mg, Orlistat 120 mg, Orlistat Placebo, Velneperit Placebo · Other: Reduced Calorie Diet | Obesity | 486 | Jan 2011actual | — | 2018-05-09 |
| Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic StrokeNCT00821821results2014-05-12Number of Participants That Experienced Adverse EventsRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: MCI-186, Placebo | Acute Ischemic Stroke (AIS) | 36 | 2010-11-30actual | — | 2026-07-16 |
| 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 MellitusNCT01154348Safety and pharmacokinetics of multiple-dose oral administration of S-707106 in fed state in patients with type 2 diabetes mellitusRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: S-707106, Placebo, Metformin, S-707106 plus metformin, Metformin, placebo plus metformin | Type 2 Diabetes Mellitus | 34 | Nov 2010actual | — | 2018-04-27 |
| A Study to Investigate the Efficacy and Safety of Lusutrombopag (S-888711) Tablets Administered to Adults With Immune Thrombocytopenia (ITP)NCT01054443results2021-02-24Percentage of Participants With a ResponseRandomized · Quadruple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: This study was terminated before the planned sample size was enrolled because results indicated that a higher dose was necessary to elicit an efficacy effect. | Drug: Placebo, Lusutrombopag | Immune Thrombocytopenia (ITP) | 20 | 2010-11-24actual | — | 2021-03-18 |
| Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)NCT00723190results2012-02-27Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])Open-label · Treatment | Phase 3 | Completed | Drug: CLONICEL (Clonidine HCl sustained release) | Attention Deficit Hyperactivity Disorder | 303 | Mar 2010actual | — | 2018-04-18 |
| Open-Label Extension (OLE) Study for Safety and Efficacy of Velneperit (S-2367) in Obese SubjectsNCT00788528Efficacy assessment: The change in body weight over the 54-week active therapy phase of the study is the primary efficacy variableOpen-label · Treatment | Phase 2 | Completed | Drug: S-2367 (velneperit) | Obesity | 766 | Feb 2010actual | — | 2018-05-01 |
| Effect of Food and Calcium on Pharmacokinetics of a Single Dose of S-888711 in Healthy Adult VolunteersNCT03897413Maximum Observed Plasma Concentration of S-888711Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: S-888711 · Dietary supplement: Calcium Antacid | Healthy Volunteer | 15 | 2009-12-23actual | — | 2019-04-01 |
| Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual ActivityNCT00729469results2013-06-28Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)Randomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Ospemifene 60 mg, Placebo | Atrophy, Vaginal Diseases | 919 | Aug 2009actual | — | 2018-05-18 |
| A Clinical Study to Evaluate the Safety of OspemifeneNCT00566982results2013-06-28Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal SmearRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Ospemifene 60 mg, Placebo | Atrophy, Vaginal Diseases | 426 | Jul 2009actual | — | 2018-05-18 |
| Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)NCT00424463results2018-06-04Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 WeeksRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: MCI-186, Placebo of MCI-186 | Amyotrophic Lateral Sclerosis (ALS) | 181 | 2009-05-31actual | — | 2026-07-21 |
| A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 2 Doses of S-777469 in Patients With Atopic DermatitisNCT00703573Efficacy of S-777469 was assessed by Physician's Global Assessment (PGA) and Numerical Rating Scale (NRS)Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: S-777469 400 mg, S-777469 800 mg, Placebo | Atopic Dermatitis | 209 | May 2009actual | — | 2018-05-08 |
| Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Reduced Calorie DietNCT00747929The change in body weight over the 54-week active therapy phase of the studyRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: S-2367 Placebo, S-2367 800 mg, S-2367 1600 mg · Other: Reduced Calorie Diet | Obesity | 724 | Nov 2008actual | — | 2018-05-11 |
| Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Initial 6-Week Low Calorie DietNCT00748605The change in body weight over the 60-week active therapy phase of the studyRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: S-2367 Placebo, S-2367 1600 mg q.d. 54 Weeks, S-2367 1600 mg q.d. 60 weeks · Other: LCD (low calorie diet), RCD (reduced calorie diet) | Obesity | 842 | Nov 2008actual | — | 2018-05-11 |
| Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a UterusNCT01586364results2013-06-28Incidence of Adverse Events (AEs)Open-label · Treatment | Phase 3 | Completed | Drug: Ospemifene 60Mg Oral Tablet | Atrophy, Vaginal Diseases | 301 | 2008-11-21actual | — | 2018-05-21 |
| Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)NCT00330681results2017-05-17Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 WeeksRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: MCI-186, Placebo of MCI-186 | Amyotrophic Lateral Sclerosis (ALS) | 206 | 2008-09-30actual | — | 2026-07-21 |
| Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact UterusNCT01585558results2013-06-28Incidence of Adverse Events (AEs)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Ospemifene (Dose 1), Ospemifene (Dose 2), Placebo | Atrophy, Vaginal Diseases | 180 | 2008-08-19actual | — | 2018-05-21 |
| Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification IIINCT00415519results2017-12-20Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 WeeksRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: MCI-186, Placebo of MCI-186 | Amyotrophic Lateral Sclerosis (ALS) | 25 | 2008-07-31actual | — | 2026-07-21 |
| 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 ConditionsNCT00491894results2012-07-09Proportion of Responders According to the Modified Teacher's Drooling Scale (mTDS)Non-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Oral Glycopyrrolate Liquid | Cerebral Palsy, Neurological Conditions, Mental Retardation, Sialorrhea | 137 | May 2008actual | — | 2012-07-09 |
| A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined HyperlipidemiaNCT00459745Primary endpoints will assess differences in change from baseline in non-HDL-C, for the patients receiving Pravafen versus the patients receiving Pravastatin or Fenofibrate at the end of the 12-week portion of the study.Randomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Pravafen, Pravastatin, Fenofibrate | Combined Hyperlipidemia | 481 | Apr 2008actual | — | 2018-04-24 |
| A Phase Ib/IIa, Double-Blind, Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of S-777469 in Subjects With Atopic DermatitisNCT00697710Safety AssessmentsRandomized · Double-masked · Treatment | Phase 1/2 | Completed | Drug: 50 mg S-777469, 200 mg S-777469, 800 mg S-777469, Placebo | Atopic Dermatitis | 37 | Feb 2008actual | — | 2018-05-01 |
| A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal WomenNCT00630539results2013-06-28Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal SmearRandomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: Placebo, Ospemifene 5 mg, Ospemifene 15 mg, Ospemifene 30 mg | Atrophy, Vaginal Diseases | 126 | Jan 2008actual | — | 2013-06-28 |
| Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic StrokeNCT00200356results2013-01-15the Rate of Patients With a Modified Rankin Scale Score of 0-1Randomized · Open-label · Treatment | Phase 4 | Completed | Drug: Edaravone, Sodium Ozagrel | Cerebral Infarction | 401 | 2006-10-31actual | — | 2026-07-30 |
| Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung CancerNCT00078390Randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: S-3304 · Other: Chemo-irradiation | Non Small Cell Lung Cancer, Lung Cancer, Stage IIIA Non Small Cell Lung Cancer, Stage IIIB Non Small Cell Lung Cancer | 9 | 2006-09-28actual | — | 2018-05-02 |
| A Phase 1 Study of S-3304 in Patients With Solid TumorsNCT00033215Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: S-3304 | Solid Tumors | 32 | 2003-02-13actual | — | 2018-04-26 |
| A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal WomenNCT00276094results2013-06-28Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal DrynessRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Ospemifene 30 mg, Ospemifene 60 mg, Placebo, Nonhormonal vaginal lubricant | Atrophy, Vaginal Diseases | 826 | — | — | 2013-06-28 |
| Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial InfectionsNCT03780140expanded access | — | Approved for marketing | Drug: Cefiderocol | Bacterial Infections | — | — | — | 2020-02-28 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19