Jubilant Therapeutics

Pipeline & Clinical Trials

Rubidium Elution System Performance Testing

Coronary Artery Disease

N/A

Clinical Trials (1)

NCT02117284Rubidium Elution System Performance Testing

N/A

I-131 MIBG

Neuroblastoma

N/A

Clinical Trials (1)

NCT01590680Expanded Access Protocol Using 131I-MIBG

N/A

The Mycophenolate Pregnancy Registry

Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases

N/A

Clinical Trials (1)

NCT01733082The Mycophenolate Pregnancy Registry

N/A

Rb-82 Radioisotope

Ischemic Heart Disease

N/A

Clinical Trials (1)

NCT05037799Dose Optimization for Rubidium PET Imaging in Patients With Known or Suspected Ischemic Heart Disease

N/A

JBI-778

NSCLC Patients With EGFR Activating Mutation

Phase 1

Clinical Trials (1)

NCT07755397First in Human Multicenter Open Name Dose-increase, Consolidation Method to Study Safety Drug-level in Blood & Drug Metabolism Clinical Activity of Oral JBI-778 in Lung Cancer Patients With, Without Brain Metastasis IDH Mutated WHO Grade 3,4 Recurrent Glioma, Salivary Glands Tumor

Phase 1

124I-Metaiodobenzylguanidine

Neuroblastoma

Phase 1

Clinical Trials (1)

NCT01583842124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study

Phase 1

JBI-778

Brain Metastases From Solid Tumors

Phase 1/2

Clinical Trials (1)

NCT07751744Phase 1/2 Study Evaluating the Safety, PK/PD, and Clinical Activity of Oral JBI-778 in Patients With Brain Metastases, Leptomeningeal Disease, or Recurrent High Grade Glioma

Phase 1/2

JI-101

Cancer

Phase 1/2

Clinical Trials (1)

NCT01149434Study of JI-101 in Patients With Advanced Low Grade Endocrine Tumors, Ovarian Cancers or K-RAS Mutant Colon Cancers

Phase 1/2

JI-101

Advanced Solid Tumors

Phase 1/2

Clinical Trials (1)

NCT00842335A Phase 1/2, Open-Label, Dose-Escalation Study of JI-101, in Patients With Advanced Solid Tumors

Phase 1/2

JBI-802

Locally Advanced Solid Tumor

Phase 1/2

Clinical Trials (2)

NCT07612280Phase 1/ Phase 2 Study to Assess Safety and Efficacy of Orally Administered JBI-802 in Subjects With Myeloproliferative Neoplasms (MPN) and Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) With Thrombocytosis

Phase 1/2

NCT05268666A Study of Orally Administered JBI-802, an LSD1/HDAC6 Inhibitor, in Patients With Advanced Solid Tumors

Radiation: 131I-MIBG

Neuroblastoma

Phase 2

Clinical Trials (1)

NCT07261241NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab

Phase 2

131I-MIBG

Neuroblastoma

Phase 2

Clinical Trials (1)

NCT03561259A Study of Therapeutic Iobenguane (131-I) and Vorinostat for Recurrent or Progressive High-Risk Neuroblastoma Subjects

Phase 2

BUMETANIDE

bumetanide

Post-LOE

ORAL · TABLET

CLINICAL PHARMACOLOGY Bumetanide is a loop diuretic with a rapid onset and short duration of action. Pharmacological and clinical studies have shown that 1 mg bumetanide has a diuretic potency equivalent to approximately 40 mg furosemide. The major site of bumetanide action is the ascending limb of the loop of Henle. The mode of action has been determined through various clearance studies in both humans and experimental animals. Bumetanide inhibits sodium reabsorption in the ascending limb of the loop of Henle, as shown by marked reduction of free-water clearance (CH 2 O) during hydration and tubular free-water reabsorption (T H 2 O) during hydropenia. Reabsorption of chloride in the ascending limb is also blocked by bumetanide, and bumetanide is somewhat more chloruretic than natriuretic. Potassium excretion is also increased by bumetanide, in a dose-related fashion. Bumetanide may have an additional action in the proximal tubule. Since phosphate reabsorption takes place largely in the proximal tubule, phosphaturia during bumetanide induced diuresis is indicative of this additional action. This is further supported by the reduction in the renal clearance of bumetanide by probenecid, associated with diminution in the natriuretic response. This proximal tubular activity does not seem to be related to an inhibition of carbonic anhydrase. Bumetanide does not appear to have a noticeable action on the distal tubule. Bumetanide decreases uric acid excretion and increases serum uric acid. Following oral administration of bumetanide the onset of diuresis occurs in 30 to 60 minutes. Peak activity is reached between 1 and 2 hours. At usual doses (1 mg to 2 mg) diuresis is largely complete within 4 hours; with higher doses, the diuretic action lasts for 4 to 6 hours. Diuresis starts within minutes following an intravenous injection and reaches maximum levels within 15 to 30 minutes. Several pharmacokinetic studies have shown that bumetanide, administered orally or parenterally, is eliminated rapidly in humans, with a half-life of between 1 and 1½ hours. Plasma protein-binding is in the range of 94% to 96%. Oral administration of carbon-14 labeled bumetanide to human volunteers revealed that 81% of the administered radioactivity was excreted in the urine, 45% of it as unchanged drug. Urinary and biliary metabolites identified in this study were formed by oxidation of the N-butyl side chain. Biliary excretion of bumetanide amounted to only 2% of the administered dose. Pediatric Pharmacology Elimination of bumetanide appears to be considerably slower in neonatal patients compared with adults, possibly because of immature renal and hepatobiliary function in this population. Small pharmacokinetic studies of intravenous bumetanide in preterm and full-term neonates with respiratory disorders have reported an apparent half-life of approximately 6 hours, with a range up to 15 hours and a serum clearance ranging from 0.2 mL/min/kg to 1.1 mL/min/kg. In a population of

2025

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