COMPANY
Shionogi
FDA-approved therapeutic company Clinical Phase 3
Hiring
| Title | Location (from posting) | Employer posted | First seen |
|---|---|---|---|
| Senior Manager Scientific Affairs ALS | Location not stated | Not stated | Oct 23, 2026 |
| Neurology Account Specialist - Columbus, OH | Location not stated | Not stated | Oct 22, 2026 |
| Associate Sales Representative/Sales Representative - Primary Care - San Diego, CA | Location not stated | Not stated | Oct 22, 2026 |
| Director, Trade Accounts (Remote) | Location not stated | Not stated | Oct 17, 2026 |
| Senior Manager, Regulatory Program Support (RPS) | Location not stated | Not stated | Oct 17, 2026 |
Trial and FDA signals
- Drug approval + hiring FDA novel approval for XOCOVA (NDA 220442, May 29, 2026); 29 manufacturing/quality or commercial roles open. FDA NDA 220442 (May 29, 2026)
Evidence (1 event)
- May 29, 2026 · FDA NDA 220442
openFDA drugsfda: application_number=NDA220442; sponsor_name='SHIONOGI'; submission_type=ORIG; submission_number=1; submission_status=AP; submission_status_date=20260529; submission_class_code=TYPE 1; brand_name=['XOCOVA']
- May 29, 2026 · FDA NDA 220442
Timeline
- Trial start Phase 1: A Study of S-606001 as Monotherapy in Participants With Late-onset Pompe Disease (LOPD) source ↗
- Trial start Phase 1: Study of Sulthiame (S-054502) in Participants With Renal Impairment and Matched Healthy Controls source ↗
- Trial start Phase 3: A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease source ↗
- Trial start Phase 2: An Extension Study of S-606001 in Participants With Late-onset Pompe Disease (LOPD) source ↗
- Trial start Phase 3: Study of Secutrelvir in Participants With COVID-19 source ↗
- FDA FDA New drug/biologic (novel): XOCOVA (ensitrelvir) — NDA220442, May 29, 2026. Applicant at approval: Shionogi Inc. source ↗
- Trial start Phase 2: A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease source ↗
- Trial start Phase 2: Study of S-606001 as an Add-on to Enzyme Replacement Therapy (ERT) in Participants With Late-onset Pompe Disease (LOPD) source ↗
- Trial start Phase 1: A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls source ↗
- Trial start 1: Phase 1 Study of BPN14770 in Participants With Hepatic Impairment and Healthy Controls source ↗
- Trial start Phase 1: Study of BPN14770 in Participants With Severe Renal Impairment and Healthy Controls source ↗
- Trial start Phase 1: Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants source ↗
- Trial start Phase 1: A Study to Assess the Effects of BPN14770 on Rosuvastatin source ↗
- Trial start Phase 2: A Study of S-892216 in Participants With COVID-19 source ↗
- Trial start Phase 2: Study of Zatolmilast (BPN14770) in Participants With PPP2R5D Neurodevelopmental Disorder (Jordan's Syndrome [JS]) source ↗
- Trial start Phase 2: Safety and Efficacy Study of Sivopixant, Acetazolamide and SASS-001 in Sleep Apnea source ↗
- Trial start —: A Study to Investigate How Respiratory Syncytial Virus (RSV) Infection Develops and Changes Over Time in Pediatric Participants source ↗
- Trial start Phase 1: A Study of S-740792 in Healthy Adult Study Participants source ↗
- Trial start Phase 2: A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants source ↗
- Trial start 2: A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke source ↗
- Trial start 3: Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection source ↗
- Trial start Phase 1/Phase 2: Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids source ↗
- Trial start Phase 3: Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS source ↗
- Trial start Phase 3: A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19 source ↗
- Trial start Phase 1/Phase 2: S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors source ↗
Upcoming milestones
- Dec 4, 2026 (ESTIMATED) · Phase 1 · Study of Sulthiame (S-054502) in Participants With Renal Impairment and Matched Healthy Controls · NCT07857837
- Dec 30, 2026 (ESTIMATED) · Phase 2 · A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease · NCT07214571
- Dec 31, 2026 (ESTIMATED) · Phase 2 · Safety and Efficacy Study of Sivopixant, Acetazolamide and SASS-001 in Sleep Apnea · NCT06776432
- Jul 31, 2027 (ESTIMATED) · Phase 3 · Study of Secutrelvir in Participants With COVID-19 · NCT07746544
- Aug 8, 2027 (ESTIMATED) · Phase 2 · Study of S-606001 as an Add-on to Enzyme Replacement Therapy (ERT) in Participants With Late-onset Pompe Disease (LOPD) · NCT07123155
- Dec 31, 2027 (ESTIMATED) · Phase 2 · Study of Zatolmilast (BPN14770) in Participants With PPP2R5D Neurodevelopmental Disorder (Jordan's Syndrome [JS]) · NCT06717438
- May 31, 2028 (ESTIMATED) · Phase 1/Phase 2 · S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors · NCT05101070
- Jun 15, 2028 (ESTIMATED) · Phase 1/Phase 2 · Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids · NCT05588323
Clinical trials (lead sponsor) Showing 50 of 105
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07743580 | A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease | Phase 3 | Recruiting | Sep 14, 2026 | Jun 30, 2028 (estimated) |
| NCT05897541 | Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection | 3 | Completed | Jun 9, 2023 | Aug 30, 2024 (actual) |
| NCT07093580 | Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants | Phase 1 | Recruiting | Jul 29, 2025 | Jun 30, 2028 (estimated) |
| NCT07857837 | Study of Sulthiame (S-054502) in Participants With Renal Impairment and Matched Healthy Controls | Phase 1 | Not yet recruiting | Sep 29, 2026 | Dec 4, 2026 (estimated) |
| NCT07214571 | A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease | Phase 2 | Recruiting | Dec 11, 2025 | Dec 30, 2026 (estimated) |
| NCT06928051 | A Study of S-892216 in Participants With COVID-19 | Phase 2 | Completed | Jun 6, 2025 | Sep 22, 2025 (actual) |
| NCT07746544 | Study of Secutrelvir in Participants With COVID-19 | Phase 3 | Recruiting | Aug 5, 2026 | Jul 31, 2027 (estimated) |
| NCT07217886 | A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls | Phase 1 | Completed | Oct 16, 2025 | Feb 13, 2026 (actual) |
| NCT07787650 | A Study of S-606001 as Monotherapy in Participants With Late-onset Pompe Disease (LOPD) | Phase 1 | Not yet recruiting | Sep 30, 2026 | Oct 31, 2028 (estimated) |
| NCT05305547 | A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19 | Phase 3 | Completed | Aug 3, 2022 | Jan 7, 2024 (actual) |
| NCT05151471 | Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS | Phase 3 | Terminated | Jan 11, 2022 | Sep 29, 2023 (actual) |
| NCT07750990 | An Extension Study of S-606001 in Participants With Late-onset Pompe Disease (LOPD) | Phase 2 | Not yet recruiting | Aug 31, 2026 | Aug 31, 2028 (estimated) |
| NCT05953480 | A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke | 2 | Completed | Jul 14, 2023 | Jun 15, 2026 (actual) |
| NCT00200356 | Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke | Phase 4 | Completed | Aug 31, 2004 | Oct 31, 2006 (actual) |
| NCT05588323 | Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids | Phase 1/Phase 2 | Recruiting | Jan 4, 2023 | Jun 15, 2028 (estimated) |
| NCT00415519 | Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III | Phase 3 | Completed | Dec 31, 2006 | Jul 31, 2008 (actual) |
| NCT04165824 | Safety Study of Oral Edaravone Administered in Subjects With ALS | Phase 3 | Completed | Nov 18, 2019 | Oct 7, 2021 (actual) |
| NCT05568615 | Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS | Phase 3 | Completed | Oct 26, 2022 | Jun 27, 2023 (actual) |
| NCT00330681 | Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) | Phase 3 | Completed | May 31, 2006 | Sep 30, 2008 (actual) |
| NCT01492686 | Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis | 3 | Completed | Dec 31, 2011 | Sep 30, 2014 (actual) |
| NCT00424463 | Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS) | Phase 3 | Completed | Jan 31, 2007 | May 31, 2009 (actual) |
| NCT04569084 | Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS | Phase 3 | Terminated | Nov 13, 2020 | Sep 29, 2023 (actual) |
| NCT04577404 | Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Phase 3 | Completed | Oct 29, 2020 | Aug 9, 2023 (actual) |
| NCT03346538 | Dose Finding Study of MCI-186 in Acute Ischemic Stroke | Phase 2 | Terminated | Nov 17, 2017 | May 14, 2018 (actual) |
| NCT00821821 | Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke | Phase 2 | Completed | Feb 28, 2009 | Nov 30, 2010 (actual) |
| NCT04254913 | Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy | Phase 1 | Completed | Jan 24, 2020 | Apr 16, 2020 (actual) |
| NCT04481750 | Study of Oral Edaravone in Healthy Adult Males | Phase 1 | Completed | Mar 20, 2018 | Aug 3, 2018 (actual) |
| NCT03289208 | Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment | Phase 1 | Completed | Oct 27, 2016 | Apr 16, 2018 (actual) |
| NCT04493281 | Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects | Phase 1 | Completed | Mar 22, 2019 | Apr 21, 2019 (actual) |
| NCT04481789 | Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study) | Phase 1 | Completed | Oct 17, 2018 | Dec 20, 2018 (actual) |
| NCT03664544 | PK Study in Subjects With Severe Hepatic Impairment | Phase 1 | Completed | Nov 6, 2018 | Mar 25, 2019 (actual) |
| NCT05342597 | Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Subjects (Food Effect Study) | Phase 1 | Completed | Jun 10, 2019 | Jul 24, 2019 (actual) |
| NCT04776135 | Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube | Phase 1 | Completed | Feb 26, 2021 | Apr 1, 2021 (actual) |
| NCT04029090 | 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 Subjects | Phase 1 | Completed | Sep 18, 2018 | Oct 20, 2018 (actual) |
| NCT03289234 | Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment | Phase 1 | Completed | Nov 16, 2016 | Jul 20, 2018 (actual) |
| NCT04176224 | Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis | Phase 1 | Completed | Apr 17, 2019 | Sep 4, 2019 (actual) |
| NCT04259255 | Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS) | Not listed | Completed | Oct 21, 2019 | Nov 24, 2023 (actual) |
| NCT07123155 | Study of S-606001 as an Add-on to Enzyme Replacement Therapy (ERT) in Participants With Late-onset Pompe Disease (LOPD) | Phase 2 | Recruiting | Oct 30, 2025 | Aug 8, 2027 (estimated) |
| NCT06717438 | Study of Zatolmilast (BPN14770) in Participants With PPP2R5D Neurodevelopmental Disorder (Jordan's Syndrome [JS]) | Phase 2 | Active, not recruiting | May 13, 2025 | Dec 31, 2027 (estimated) |
| NCT06776432 | Safety and Efficacy Study of Sivopixant, Acetazolamide and SASS-001 in Sleep Apnea | Phase 2 | Active, not recruiting | Apr 2, 2025 | Dec 31, 2026 (estimated) |
| NCT05101070 | S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors | Phase 1/Phase 2 | Recruiting | May 30, 2022 | May 31, 2028 (estimated) |
| NCT06086626 | A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants | Phase 2 | Completed | Mar 14, 2024 | Mar 31, 2025 (actual) |
| NCT07012005 | Study of BPN14770 in Participants With Severe Renal Impairment and Healthy Controls | Phase 1 | Completed | Aug 25, 2025 | Dec 15, 2025 (actual) |
| NCT04335539 | A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants | Phase 2 | Completed | Aug 21, 2020 | Feb 6, 2023 (actual) |
| NCT07018492 | Phase 1 Study of BPN14770 in Participants With Hepatic Impairment and Healthy Controls | 1 | Completed | Aug 30, 2025 | Nov 26, 2025 (actual) |
| NCT05212948 | A Study of S-268019 for the Prevention of COVID-19 | Phase 3 | Completed | Dec 25, 2021 | Dec 19, 2022 (actual) |
| NCT06724978 | A Study of S-740792 in Healthy Adult Study Participants | Phase 1 | Completed | Nov 21, 2024 | Sep 10, 2025 (actual) |
| NCT07011992 | A Study to Assess the Effects of BPN14770 on Rosuvastatin | Phase 1 | Completed | Jul 18, 2025 | Jul 31, 2025 (actual) |
| NCT04215991 | A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants | Phase 2 | Completed | Feb 19, 2020 | Sep 17, 2024 (actual) |
| NCT06746051 | A Study to Investigate How Respiratory Syncytial Virus (RSV) Infection Develops and Changes Over Time in Pediatric Participants | Not listed | Completed | Dec 9, 2024 | Mar 31, 2025 (actual) |
FDA records (last 2 years)
- FDA New drug/biologic (novel): XOCOVA (ensitrelvir) — NDA220442, May 29, 2026. Applicant at approval: Shionogi Inc. source ↗