Clinical Trials Sponsored by Niiki Pharma Inc

Total 2354 results

Astellas Pharma Global Development, Inc.

Active, not recruiting

Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

Age-Related Macular Degeneration | Geographic Atrophy

United States, Italy, Latvia, France, Israel, Germany, Spain, Hungary, Brazil, Canada, Argentina, Colombia, Croatia, Australia, Austria, Belgium, Czechia
Astellas Pharma Global Development, Inc.

Active, not recruiting

A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer (Spotlight)

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer | Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer | Metastatic Gastric Adenocarcinoma or Cancer | Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

United States, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, France, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, Peru, Poland, Spain, Taiwan, United Kingdom
Astellas Pharma Global Development, Inc.

Active, not recruiting

Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen

Advanced Cancer | Advanced Malignancies

United States
Astellas Pharma Global Development, Inc.

Completed

A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants

Invasive Aspergillosis | Invasive Mucormycosis

United States, Belgium, Spain
Astellas Pharma Global Development, Inc.

Terminated

A Study to Evaluate ASP0367 in Participants With Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction

Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction

United States
Astellas Pharma Global Development, Inc.

Completed

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

Myelodysplastic Syndrome | Acute Myeloid Leukemia (AML)

United States, Japan
Astellas Pharma Global Development, Inc.

Completed

A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause (Skylight 1)

Hot Flashes

United States, Canada, Czechia, Hungary, Poland, Spain, United Kingdom
Astellas Pharma Global Development, Inc.

Completed

A Study of ASP0367 in People With Kidneys That do Not Work Well and in Healthy People

Renal Impairment | Healthy Volunteers

United States
Astellas Pharma Global Development, Inc.

Completed

A Study to Evaluate Safety, Tolerability and Immune Response in Adolescents Allergic to Peanut After Receiving Intradermal Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine

Peanut Allergy

United States
Astellas Pharma Global Development, Inc.

Completed

A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia

Acute Myeloid Leukemia

United States
Astellas Pharma Global Development, Inc.

Completed

A Study to Evaluate Safety, Tolerability and Immune Response in Adults Allergic to Peanut After Receiving Intradermal or Intramuscular Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine

Peanut Allergy

United States
Astellas Pharma Global Development, Inc.

Completed

A Study to Assess the Effect of Food With Fezolinetant in Healthy Female Participants

Healthy Subjects

United States
Astellas Pharma Global Development, Inc.

Completed

Treatment Patterns and Key Healthcare Resource Use in Acute Myeloid Leukemia (AML) With or Without FMS-like Tyrosine Kinase-3 (FLT3) Mutation Study Based on Retrospective Chart Review

Acute Myeloid Leukemia (AML)

United States
Astellas Pharma Global Development, Inc.

Completed

A Study to Assess the Safety and Efficacy of ASP1650, a Monoclonal Antibody Targeting Claudin 6 (CLDN6), in Male Subjects With Incurable Platinum Refractory Germ Cell Tumors

Tumors | Incurable Platinum Refractory Germ Cell Tumors

United States
Astellas Pharma Global Development, Inc.

Terminated

A Study to Evaluate Escalating Doses of ASP1235 (AGS62P1) Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia

Canada, United States
Astellas Pharma Global Development, Inc.

Completed

A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP4345 in Patients With Schizophrenia

Schizophrenia

United States
Astellas Pharma Global Development, Inc.

Completed

Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB) (PILLAR)

Overactive Bladder (OAB)

United States, Canada
Astellas Pharma Global Development, Inc.

Completed

A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215

Healthy | Hepatic Impairment

United States
Astellas Pharma Global Development, Inc.

Completed

Registry of Patients Treated With Systemic Mold-Active Triazoles

Invasive Fungal Infection

United States
Astellas Pharma Global Development, Inc.

Completed

A Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With OAB Symptoms While Taking Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) (PLUS)

Overactive Bladder | Benign Prostatic Hyperplasia

United States, Canada, Czechia, France, Germany, Italy, Poland, Spain, United Kingdom
Astellas Pharma Global Development, Inc.

Completed

Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer (FAST)

CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction | CLDN18.2-positive Adenocarcinoma of Esophagus | CLDN18.2-positive Gastric Adenocarcinoma

Bulgaria, Czechia, Germany, Latvia, Russian Federation, Ukraine
Astellas Pharma Global Development, Inc.

Completed

A Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia

Fibromyalgia

United States
Astellas Pharma Global Development, Inc.

Completed

A Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of ASP6981 in Subjects With Schizophrenia

Schizophrenia

United States
Astellas Pharma Global Development, Inc.

Completed

A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis

Arthritis, Rheumatoid

United States, Poland, Czechia, Bulgaria, Hungary, Mexico
Astellas Pharma Global Development, Inc.

Terminated

A Phase 1, Dose Escalation Study to Assess the Safety and Tolerability of ASP9853 With Either Docetaxel or Paclitaxel in Patients With Advanced Non-hematologic Malignancies

Non-hematologic Malignancies | Pharmacokinetics of ASP9853

United States
Astellas Pharma Global Development, Inc.

Completed

Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Acute Myeloid Leukemia

United States, Germany, Italy
Astellas Pharma Global Development, Inc.

Terminated

Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy

Painful Diabetic Peripheral Neuropathy (PDPN)

United States
Astellas Pharma Global Development, Inc.

Completed

A Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial

Advanced Solid Tumors

Germany, Czechia, United States, Brazil, Poland, Singapore, Thailand
Astellas Pharma Global Development, Inc.

Withdrawn

A Study for Subjects Who Are Participating in an Astellas-sponsored ASP8273 Study

Subjects With NSCLC With an EGFR Activating Mutation
Astellas Pharma Global Development, Inc.

Completed

A Study to Evaluate a Single Intravenous (IV) Dose Using a New Manufactured Clone and Single Ascending Doses of Subcutaneous (SC) Injections

Healthy Subjects | Pharmacokinetics of ASP2408

United States
Astellas Pharma Global Development, Inc.

Completed

A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP4058 Following Single Oral Doses

Healthy Subjects | Pharmacokinetics of ASP4058 | Food Effect of ASP4058

United States
gicare Pharma Inc.
Algorithme Pharma Inc; JSS Medical Research Inc.

Completed

A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy

Pain | Cancer | Colonic Diseases

United States, Canada
Astellas Pharma Global Development, Inc.
Medivation, Inc.

Approved for marketing

Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

Metastatic Castration-Resistant Prostate Cancer
Astellas Pharma Global Development, Inc.

Recruiting

A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats (OPTION-VMS)

Hot Flashes

United States
Astellas Pharma Global Development, Inc.

Recruiting

A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery in People With or Without Kidney Disease

Intraoperative Ureter Visualization | Abdominolpelvic Surgery

United States
Astellas Pharma Global Development, Inc.

Recruiting

A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease

Chronic Kidney Disease | Renal Anemia

Romania, Spain, Belgium, Germany, Norway, Slovakia, Denmark
Astellas Pharma Global Development, Inc.

Recruiting

A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery

Intraoperative Ureter Visualization | Abdominolpelvic Surgery

United States
Astellas Pharma Global Development, Inc.

Recruiting

A Study of ASP2138 in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, Pancreatic Cancer

Pancreatic Adenocarcinoma | Gastric Adenocarcinoma | Gastroesophageal Junction (GEJ) Adenocarcinoma

United States, Japan, Korea, Republic of
Astellas Pharma Global Development, Inc.

Recruiting

A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants With Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma and Locoregional Gastric or GEJ Adenocarcinoma (ILUSTRO)

Gastric Cancer | Pharmacokinetics of Zolbetuximab | Gastro-esophageal Junction (GEJ) Cancer | Pharmacokinetics of Oxaliplatin | Pharmacokinetics of Fluorouracil Bolus (5-FU)

United States, Japan, Italy, Korea, Republic of, Taiwan, France
Astellas Pharma Global Development, Inc.

Available

Early Access Program for Zolbetuximab

Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma | Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer | Locally Advanced Unresectable Gastric Adenocarcinoma Cancer | Metastatic Gastric Adenocarcinoma Cancer

United States, Germany
Astellas Pharma Global Development, Inc.

Active, not recruiting

A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW)

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer | Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer | Metastatic Gastric Adenocarcinoma or Cancer | Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

United States, Korea, Republic of, China, Spain, Taiwan, Japan, Argentina, Canada, Croatia, Greece, Ireland, Malaysia, Netherlands, Portugal, Romania, Thailand, Turkey, United Kingdom
Astellas Pharma Global Development, Inc.

Active, not recruiting

A Study to Assess the Efficacy and Safety of IMAB362 in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

Pancreatic Cancer | Metastatic Pancreatic Adenocarcinoma | Metastatic Pancreatic Cancer

United States, Korea, Republic of, Japan, China, France, Turkey, Italy, Australia, Brazil, Ireland, Mexico, Spain, Taiwan
Astellas Pharma Global Development, Inc.

Completed

A Study About How ASP5354 Affects the Body in Healthy Adults and in Adults Whose Kidneys do Not Work Well

Renal Impairment | Healthy Volunteers

United States, Japan
Astellas Pharma Global Development, Inc.

Completed

A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Renal Function

Renal Impairment | Healthy Volunteers

United States
Astellas Pharma Global Development, Inc.

Completed

A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Hepatic Function

Healthy Volunteers | Hepatic Impairment

United States
Astellas Pharma Global Development, Inc.

Completed

A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission

Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation

Taiwan, Poland, Serbia, United States, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Portugal, Romania, Spain, Sweden, United Kingdom
Astellas Pharma Global Development, Inc.

Completed

A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause (Skylight 4)

Hot Flashes

United States, Czechia, Canada, Latvia, Poland, Spain, Ukraine, United Kingdom
Astellas Pharma Global Development, Inc.

Completed

A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)

Hot Flashes | Menopause

United States
Astellas Pharma Global Development, Inc.

Completed

A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2 (Skylight 2)

Hot Flashes

United States, Canada, Czechia, United Kingdom, Latvia, Poland, Spain
Astellas Pharma Global Development, Inc.

Completed

A Study to Evaluate ASP0367 in Participants With Mild/Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function

Healthy Volunteers | Hepatic Impairment

United States

Clinical Trials Sponsored by Niiki Pharma Inc

Sponsors and Collaborators

Medical Conditions

Drug Interventions

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CROs in Turkmenistan

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Rare Diseases

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