Clinical Trials Sponsored by Niiki Pharma Inc.

Total 2354 results

Astellas Pharma Global Development, Inc.

Completed

A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT) (HELIOS)

Cytomegalovirus (CMV)-Positive Recipients | Allogeneic, Hematopoietic Cell Transplant (HCT)

Japan, Korea, Republic of, United States, Canada, Australia, Belgium, France, Germany, Spain, Sweden, Taiwan
Astellas Pharma Global Development, Inc.

Completed

A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation

United States
Astellas Pharma Global Development, Inc.

Completed

Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including Assessment of a Food Effect

Healthy Volunteers

United States
Astellas Pharma Global Development, Inc.

Completed

A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication

Schizophrenia

United States
Astellas Pharma Global Development, Inc.

Completed

A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma

Metastatic Renal Cell Carcinoma

United States, Canada
Astellas Pharma Global Development, Inc.

Approved for marketing

Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

Acute Myeloid Leukemia (AML) | FMS-like Tyrosine Kinase-3 (FLT3) Mutations

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

Completed

A Study to Assess the Analgesic Efficacy and Safety of ASP0819 in Patients With Fibromyalgia

Fibromyalgia

United States
Astellas Pharma Global Development, Inc.

Completed

A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants

Healthy Subjects

United States
Astellas Pharma Global Development, Inc.

Completed

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies

Relapsed Lymphoid Malignancy | Refractory Lymphoid Malignancy

United States, Canada
Astellas Pharma Global Development, Inc.

Completed

A Study to Assess Potential Interaction Between ASP8062 and Alcohol in Healthy Adult Subjects

Healthy Volunteers

United States
Astellas Pharma Global Development, Inc.

Completed

A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB) (PREFER)

Overactive Bladder (OAB)

United States, Canada
Astellas Pharma Global Development, Inc.

Completed

A Dose Escalation Study of ASP8273 in Subjects With Non-Small-Cell Lung Cancer (NSCLC) Who Have Epidermal Growth Factor Receptor (EGFR) Mutations

Non-Small-Cell Lung Cancer (NSCLC) | Epidermal Growth Factor Receptor Mutations

United States
Astellas Pharma Global Development, Inc.

Completed

Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer (PILOT)

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

Germany, Latvia
Astellas Pharma Global Development, Inc.

Withdrawn

A Study to Assess ASP2713 in Healthy Subjects

Healthy Volunteers
Astellas Pharma Global Development, Inc.

Completed

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate

Rheumatoid Arthritis (RA)

United States, Poland
Astellas Pharma Global Development, Inc.

Completed

A Dose Escalation and Expansion Study of ASP4132 to Subjects With Advanced Refractory Tumors and Lymphoma

Lymphoma | Advanced Cancer | Refractory Solid Tumors

United States
Astellas Pharma Global Development, Inc.

Completed

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MA-0211 in Healthy Adult Subjects Including a Food Effect Cohort

Healthy Volunteers

United States
Astellas Pharma Global Development, Inc.

Completed

A Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Moldova, Republic of
Astellas Pharma Global Development, Inc.

Completed

A Study to Look at How a Single Oral Dose of 14C-OSI-906 is Absorbed, Broken Down and Eliminated in the Body

Advanced Solid Tumors | Pharmacokinetics of 14C-OSI-906

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

Completed

An Open-label Phase I Study of Orally Available Novel Small-molecule Fibroblast Growth Factor Receptors (FGFR) 1,2,3 and 4 Inhibitor, ASP5878 at Single and Multiple Doses in Patients With Solid Tumors

Solid Tumors

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

No longer available

Early Access Program (EAP) of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or With FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

Acute Myeloid Leukemia (AML) | FMS-like Tyrosine Kinase-3 (FLT3) Mutations

Australia, Italy, United Kingdom
Astellas Pharma Global Development, Inc.

Terminated

A Study of ASP8273 in Subjects With Non-small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Mutations

Non-small Cell Lung Cancer (NSCLC) | Epidermal Growth Factor Receptor (EGFR) Mutations

United States
Astellas Pharma Global Development, Inc.

Completed

Study of the Pharmacokinetics of ASP1941 and the Effect on Glucose Concentrations in Male and Female Young and Elderly Healthy Adults

Healthy Volunteers | Pharmacokinetics of ASP1941

United States
Astellas Pharma Inc

Recruiting

A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors

Solid Tumor

United States
InnoCare Pharma Inc.

Not yet recruiting

Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies

Mature B-cell Malignancies
Telios Pharma, Inc.

Recruiting

A Study of TL-925 Ophthalmic Emulsion as a Treatment for Dry Eye Disease

Dry Eye Disease

United States
Astellas Pharma Inc

Recruiting

A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause (Starlight 3)

Hot Flashes

Japan
SpyGlass Pharma, Inc.

Recruiting

Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution (Tigris)

Ocular Hypertension | Glaucoma | Cataract

United States
Vincerx Pharma, Inc.

Recruiting

Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

Acute Myeloid Leukemia | B-cell Acute Lymphoblastic Leukemia | High-risk Myelodysplastic Syndrome

United States
Lantern Pharma Inc.

Recruiting

Study of LP-184 in Patients With Advanced Solid Tumors

Advanced Solid Tumor

United States
CinDome Pharma, Inc.

Recruiting

A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis

Diabetic Gastroparesis

United States
Lavior Pharma Inc.

Recruiting

Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds (RENEW)

Diabetic Foot Ulcer

United States
Sinew Pharma Inc.

Recruiting

A Partial Randomized, Single-blind or Open-label, Dose-escalation With Multiple-dose Design Study to Evaluate the Pharmacokinetics of Acetaminophen and Its Toxic Metabolites With Panadol® and SafeTynadol® in Healthy Volunteers

Hepatitis | Pharmacology

Taiwan
OBI Pharma, Inc

Recruiting

To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (EGFR)

Non-small Cell Lung Cancer

Taiwan
Telios Pharma, Inc.

Recruiting

Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

Primary Myelofibrosis | Myelofibrosis | Post-PV MF | Post-ET Myelofibrosis

Spain, United States, France, Poland, Italy, Germany
Binacea Pharma, Inc.

Recruiting

Safety and Preliminary Efficacy of BNA035 in Patients With Advanced Solid Tumors

Refractory Solid Tumors

Australia
Telios Pharma, Inc.

Recruiting

Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis

Myelofibrosis | Indolent Systemic Mastocytosis

United States, Spain, Belgium, Australia, Taiwan, Germany, Poland, Korea, Republic of, Hungary, Brazil, Bulgaria, France, Italy
Ocellaris Pharma, Inc.

Recruiting

A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers

Sarcoma | Neoplasms | Renal Cell Carcinoma | Cervical Cancer | Cancer | Hepatocellular Carcinoma | Gastric Cancer | Ovarian Cancer | Non Small Cell Lung Cancer | Metastatic Cancer | Squamous Cell Carcinoma of Head and Neck | Bladder Cancer | Triple Negative Breast Cancer | Urothelial Carcinoma | Merkel Cell Carcinoma | Squamous... and other conditions

Canada
Tris Pharma, Inc.

Completed

Cebranopadol Effects on Ventilatory Drive, Central Nervous System (CNS) and Pain.

Pain

Netherlands
Astellas Pharma Inc

Active, not recruiting

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

Acute Myeloid Leukemia | FLT3-mutated Acute Myeloid Leukemia

Japan, Korea, Republic of, Taiwan
Astellas Pharma Inc

Active, not recruiting

An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants

Progressive Metastatic Prostate Cancer

China, Hong Kong, Korea, Republic of, Taiwan
OBI Pharma, Inc

Terminated

A Phase I/II Study of OBI-3424 in Subjects With Advanced Solid Tumors

Pancreatic Adenocarcinoma | Solid Tumor

United States
Astellas Pharma Inc

Completed

A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy

Metastatic Castration Resistant Prostate Cancer

India
aTyr Pharma, Inc.

Completed

Study to Evaluate the Long-Term Safety, Tolerability, and Biological Activity of ATYR1940 in Participants With Limb Girdle and Facioscapulohumeral Muscular Dystrophy (FSHD) (FSHD)

Facioscapulohumeral Muscular Dystrophy | Limb Girdle Muscular Dystrophy

United States, Denmark, Italy
Astellas Pharma Inc

Completed

A Study to Find the Best Dose of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause (Starlight)

Hot Flashes

Japan
UBI Pharma Inc.

Completed

Study to Compare the Safety and Efficacy of UB-851 and Eprex®

Renal Anemia
Telios Pharma, Inc.

Completed

A Study of TL-925 as a Treatment for Dry Eye Disease

Dry Eye Disease

United States
Ocuphire Pharma, Inc.

Completed

Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia

Presbyopia

United States
Ocuphire Pharma, Inc.

Completed

Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects (MIRA-4)

Mydriasis | Dilation

United States
Vincerx Pharma, Inc.

Active, not recruiting

Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer

Neoplasms

United States, Chile, Spain

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