Hypoparathyroidism
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CLINICAL_TRIALS trial_result · 2024-01-31Clinical Trial Update: AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With Hypoparathyroidism [Phase 1, Phase 2]
AZP-3601 completed single-ascending-dose and multiple-ascending-dose studies in healthy subjects and patients with hypoparathyroidism, with …
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CLINICAL_TRIALS trial_result · 2023-09-01Clinical Trial Update: A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism [Phase 2]
Phase 2 trial of TransCon PTH in adults with hypoparathyroidism has completed, with results posted in 2023 evaluating safety, tolerability, …
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CLINICAL_TRIALS trial_result · 2023-06-09Clinical Trial Update: A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE) [Phase 4]
Phase 4 trial assessing rhPTH(1-84) for symptom improvement and metabolic control in adults with hypoparathyroidism has completed with resul…
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CLINICAL_TRIALS withdrawal · 2022-10-10Clinical Trial Update: A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism [Phase 3]
A Phase 3 clinical trial evaluating rhPTH(1-84) in Japanese participants with chronic hypoparathyroidism was withdrawn.
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CLINICAL_TRIALS trial_result · 2021-07-28Clinical Trial Update: A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism [Phase 4]
Phase 4 study evaluating extended use of rhPTH(1-84) in hypoparathyroidism has completed with results posted.
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CLINICAL_TRIALS trial_result · 2021-06-28Clinical Trial Update: Recombinant Human rhPTH(1-34) VS Association Alfacalcidol/Hydrochlorothiazide in Severe Primary Hypoparathyroidism [Phase 2]
Phase 2 trial comparing recombinant human rhPTH(1-34) to alfacalcidol/hydrochlorothiazide in severe primary hypoparathyroidism with hypercal…
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CLINICAL_TRIALS trial_result · 2021-06-16Clinical Trial Update: Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism [Phase 3]
Phase 3 safety and efficacy study of rhPTH(1-84) in hypoparathyroidism was terminated.
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CLINICAL_TRIALS trial_result · 2020-04-09Clinical Trial Update: Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism [Phase 1]
Phase 1 study assessing blood concentrations and actions of recombinant human parathyroid hormone (rhPTH 1-84) given once vs twice daily in …
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CLINICAL_TRIALS trial_result · 2020-04-03Clinical Trial Update: Efficacy of Calcium Citrate Versus Calcium Carbonate for the Management of Chronic Hypoparathyroidism [Phase 4]
Phase 4 trial update comparing calcium citrate to calcium carbonate for chronic hypoparathyroidism; study completed.
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CLINICAL_TRIALS trial_result · 2019-08-06Clinical Trial Update: A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE) [Phase 3]
Open-label extension study assessing safety and tolerability of rhPTH (1-84) for adults with hypoparathyroidism; completed Phase 3 trial.
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CLINICAL_TRIALS trial_result · 2019-07-12Clinical Trial Update: Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects [Phase 1]
Phase 1 study comparing rhPTH(1-84) in Japanese healthy subjects versus matched Caucasian healthy adults; completed with results posted.
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CLINICAL_TRIALS trial_result · 2019-03-26Clinical Trial Update: Oral PTH(1-34) PK and PD Study in Patients With Hypoparathyroidism [Phase 2]
Phase 2 study update evaluating the pharmacokinetics and pharmacodynamics of oral PTH(1-34) in patients with hypoparathyroidism.
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FDA approval · 2019-02-21FDA Approved: CALCITRIOL — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approves a generic calcitriol product from Sun Pharmaceutical Industries under an original ANDA, enabling another generic calcitriol opt…
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CLINICAL_TRIALS trial_result · 2019-01-08Clinical Trial Update: Effects of PTH Replacement on Bone in Hypoparathyroidism [Phase 3]
Phase 3 trial investigating parathyroid hormone replacement effects on bone in hypoparathyroidism; terminated with results posted in 2019.
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FDA approval · 2018-11-21FDA Approved: CALCITRIOL — Original Application (Rising Pharma Holdings, Inc.)
FDA approved an original Abbreviated New Drug Application for calcitriol by Rising Pharma Holdings, Inc., providing a generic version of the…
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CLINICAL_TRIALS research · 2018-05-02Clinical Trial Update: Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery [NA]
Clinical trial update describing the study on applying suturing parathyroid markers during thyroid cancer surgery.
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CLINICAL_TRIALS research · 2018-02-28Clinical Trial Update: ADD-ON Study to Existing Hypoparathyroidism Studies [Phase 3]
An update on a Phase 3 ADD-ON clinical trial for hypoparathyroidism sponsored by NIDDK; trial status is not reported in the document.
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CLINICAL_TRIALS research · 2017-10-27Clinical Trial Update: Corticosteroid Rhythms in Hypoparathyroid Patients [EARLY_Phase 1]
An early Phase 1 clinical trial sponsored by the University of Bergen investigates corticosteroid rhythms in patients with hypoparathyroidis…
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CLINICAL_TRIALS research · 2017-08-31Clinical Trial Update: Intra-operative Rapid Identification of Lymph Node and Parathyroid [NA]
A clinical trial update from Xijing Hospital on rapid intraoperative identification of lymph nodes and parathyroid during thyroid cancer and…
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CLINICAL_TRIALS research · 2017-07-02Clinical Trial Update: Physiologic Regulation of FGF-23
A completed clinical trial from the National Institute of Dental and Craniofacial Research (NIDCR) examining the physiological regulation of…
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FDA approval · 2017-06-15FDA Approved: CALCIUM GLUCONATE — Original Application (Fresenius Kabi USA, LLC)
The FDA approved Fresenius Kabi USA, LLC's calcium gluconate product under an original NDA.
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FDA approval · 2017-06-14FDA Approved: CALCITRIOL — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals' generic calcitriol (1,25-dihydroxyvitamin D3). The approval is an Original Application for this generic…
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CLINICAL_TRIALS research · 2016-11-30Clinical Trial Update: New Transporting Solution in Parathyroid Allotransplantation [NA]
Clinical trial update describing a new transporting solution used in parathyroid allotransplantation. The sponsor is Sisli Hamidiye Etfal Tr…
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CLINICAL_TRIALS trial_result · 2016-04-05Clinical Trial Update: Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy [Phase 4]
Phase 4 clinical trial update evaluating steroids to prevent postoperative transient hypoparathyroidism after total thyroidectomy.
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CLINICAL_TRIALS trial_result · 2015-12-15Clinical Trial Update: Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34 [Phase 2]
Phase 2 clinical trial evaluating synthetic human parathyroid hormone 1-34 for treating hypoparathyroidism has completed with results posted…