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Weekly treatment with MBX 2109, an experimental hormone replacement that MBX Biosciences is developing for chronic hypoparathyroidism, appears to be long-acting and to mimic natural parathyroid hormone (PTH) in healthy adults. Data come from a Phase 1 clinical trial (NCT05158335) where side effects reported with multiple doses…
Note: This story was updated Dec. 16, 2024, to correct errors in terminology from hyperparathyroidism to hypoparathyroidism. Reactive supplement use — giving oral supplements of calcium and vitamin D after total thyroidectomy, or the complete surgical removal of the thyroid gland — is safe and effective in patients experiencing…
People with hypoparathyroidism due to surgery have reduced levels of corticosteroids, or hormones produced by the adrenal gland, despite adequate treatment with calcium and vitamin D supplementation, a small study reported. Data showed that short-term replacement parathyroid hormone (PTH) therapy partly restored these hormones to normal levels. Low hormone…
Dosing is underway in a Phase 2 clinical trial of MBX 2109, an investigational hormone replacement therapy for people with hypoparathyroidism, according to the therapy’s developer, MBX Biosciences, with top-line expected around mid-2025. The trial, called Avail (NCT06465108), is evaluating the safety, effectiveness, and pharmacological properties…
Permanent hypoparathyroidism, which can occur when the parathyroid glands are accidentally removed along with the thyroid gland during a surgical procedure, increases the risk of kidney damage over time, according to a study by researchers in Hong Kong. “Careful patient selection and improvement in the identification and preservation of…
The U.S. Food and Drug Administration (FDA) has approved Ascendis Pharma’s Yorvipath (palopegteriparatide) as a parathyroid hormone replacement therapy for adults with hypoparathyroidism. The company expects to have the first supply ready in early 2025 after it completes manufacturing for the U.S. market. But if the FDA clears…
Long-lasting hypoparathyroidism following surgery is associated with more hospitalizations and higher healthcare-related medical costs compared with temporary hypoparathyroidism after surgery, a new U.S. study shows. The higher medical costs linked to such chronic disease were found to create a greater economic burden for patients, according to researchers. For one…
Even with conventional treatment, health complications including the formation of calcium deposits in the brain, cataracts in the eyes, and kidney stones are frequent among people with chronic hypoparathyroidism, especially those who’ve been living with the condition for a long time, according to an analysis of patients at a…
Treatment with Ascendis Pharma’s TransCon PTH (palopegteriparatide) for up to two years leads to sustained improvements in the kidney function of adults with chronic hypoparathyroidism. That’s according to an analysis of data from PaTHway (NCT04701203), a Phase 3 clinical trial of TransCon PTH. A decision from the…
The U.S. Food and Drug Administration (FDA) is delaying by three months its decision to approve Ascendis Pharma’s TransCon PTH (palopegteriparatide) as a hormone replacement therapy for adults with hypoparathyroidism. The FDA decided not to approve the investigational therapy in April 2023 over concerns about its manufacturing…
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