Hyperphosphatemia
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CLINICAL_TRIALS trial_result · 2024-11-05Clinical Trial Update: Single and Multiple Dosing Study in Hemodialysis Patients With Hyperphosphatemia in Japan [Phase 1]
Astellas-sponsored Phase 1 single- and multiple-dose study in Japanese patients with hyperphosphatemia undergoing hemodialysis (in the conte…
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FDA approval · 2024-10-24FDA Approved: SEVELAMER CARBONATE — Original Application (AiPing Pharmaceutical, Inc.)
FDA approved AiPing Pharmaceutical's sevelamer carbonate through an original application as a phosphate binder to control serum phosphate in…
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CLINICAL_TRIALS trial_result · 2024-10-22Clinical Trial Update: Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphatemia Receiving Peritoneal Dialysis
Post-marketing surveillance study evaluating long-term safety and real-world use of bixalomer (Kiklin) capsules for hyperphosphatemia in pat…
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FDA approval · 2024-08-29FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Fosrenol (lanthanum carbonate) filed by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2024-08-29FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Fosrenol (lanthanum carbonate) from Takeda Pharmaceuticals America, Inc.
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FDA label_change · 2024-08-27FDA Approved: VELPHORO — Supplemental Application (Fresenius Medical Care Renal Therapies Group, LLC)
FDA approved a supplemental application for Velphoro (sucroferric oxyhydroxide) to update the product labeling.
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CLINICAL_TRIALS trial_result · 2024-08-06Clinical Trial Update: Efficacy and Safety of Cholestyramine in the Management of Hyperphosphatemia in Adult Hemodialysis Patients [Phase 4]
Phase 4 clinical trial update evaluating cholestyramine for managing hyperphosphatemia in adults undergoing hemodialysis.
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FDA approval · 2024-07-01FDA Approved: VELPHORO — Supplemental Application (Fresenius Medical Care Renal Therapies Group, LLC)
The FDA approved a supplemental application for Velphoro (sucroferric oxyhydroxide) submitted by Fresenius Medical Care Renal Therapies Grou…
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CLINICAL_TRIALS trial_result · 2024-05-17Clinical Trial Update: Explore the Effectors of The Transtheoretical Model on Nutritional Education in Patients on Hemodialysis [NA]
A completed trial evaluating the effect of applying the transtheoretical model on nutritional education for patients on hemodialysis with en…
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FDA approval · 2024-05-09FDA Approved: SEVELAMER CARBONATE — Original Application (Strides Pharma Science Limited)
FDA approved the original application for Sevelamer carbonate from Strides Pharma Science Limited. The product is a phosphate binder used to…
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FDA approval · 2024-04-30FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for sevelamer carbonate filed by Aurobindo Pharma Limited, enabling a supplemental approval for …
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CLINICAL_TRIALS research · 2024-04-29Clinical Trial Update: Post Marketing Surveillance Study to Observe Safety and Effectiveness of NEPHOXIL ® in S. Korea Patients
Post-marketing surveillance study in South Korea to monitor safety and effectiveness of NEPHOXIL for hyperphosphatemia, sponsored by Kyowa K…
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CLINICAL_TRIALS research · 2024-04-29Clinical Trial Update: Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule
A multicenter, open, prospective observational study evaluating the safety and efficacy of Nephoxil Capsule for hyperphosphatemia, currently…
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FDA approval · 2024-04-25FDA Approved: SEVELAMER CARBONATE — Original Application (NorthStar RxLLC)
FDA approved NorthStar RxLLC's generic sevelamer carbonate (ANDA 207291) for the treatment of hyperphosphatemia in adults with chronic kidne…
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CLINICAL_TRIALS trial_result · 2024-04-17Clinical Trial Update: Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis [Phase 3]
Phase 3 trial evaluating ferric citrate for treating hyperphosphatemia in patients with chronic kidney disease on hemodialysis has completed…
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FDA approval · 2024-04-10FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA granted supplemental approval for Sevelamer Carbonate from Macleods Pharmaceuticals Limited under an ANDA.
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CLINICAL_TRIALS trial_result · 2024-03-07Clinical Trial Update: Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients [Phase 2]
Phase 2 clinical trial update for a phosphate binder combination (KHK7791) in hyperphosphatemia patients has completed.
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CLINICAL_TRIALS trial_result · 2024-03-07Clinical Trial Update: A Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on HD [Phase 2]
Phase 2 clinical trial update for KHK7791 in hyperphosphatemia patients on hemodialysis has been completed.
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CLINICAL_TRIALS trial_result · 2024-03-07Clinical Trial Update: Dose-finding Study of KHK7791 in Hyperphosphatemia Patients [Phase 2]
Phase 2 dose-finding study of KHK7791 for hyperphosphatemia has completed.
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FDA approval · 2024-01-19FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Ferric Citrate by Mylan Pharmaceuticals Inc., marking regulatory authorization for an updated su…
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CLINICAL_TRIALS trial_result · 2024-01-10Clinical Trial Update: A Study to Evaluate Safety and Efficacy of AP-306 in Hyperphosphatemia Patients [Phase 2]
Phase 2 trial evaluating safety and efficacy of AP-306 in patients with hyperphosphatemia due to chronic kidney disease has completed.
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FDA approval · 2023-12-22FDA Approved: SEVELAMER HYDROCHLORIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application for sevelamer hydrochloride submitted by Sanofi-Aventis U.S. LLC.
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FDA approval · 2023-12-12FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Fosrenol (lanthanum carbonate) from Takeda Pharmaceuticals America, Inc., resulting in changes t…
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FDA approval · 2023-12-06FDA Approved: LANTHANUM CARBONATE — Supplemental Application (Cipla USA Inc.)
FDA approved a supplemental application for lanthanum carbonate (Cipla USA Inc.). This action updates the product's regulatory approval stat…
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CLINICAL_TRIALS trial_result · 2023-11-07Clinical Trial Update: Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol [Phase 4]
Phase 4 trial comparing calcitriol versus paricalcitol for management of mineral and bone disorders in hemodialysis, terminated with posted …