SAT-744 - Real World Adverse Events Associated with Palopegteriparatide- A Pharmacovigilance Study

Palopegteriparatide is a long-acting parathyroid hormone analog approved by the US Food and Drug Administration(FDA) in 2024 for treatment of hypoparathyroidism. The drug is designed to provide sustained systemic exposure to active parathyroid hormone through enzymatic cleavage of its pegylated moiety, thereby improving calcium homeostasis while reducing dosing frequency compared to traditional therapies. While the drug has demonstrated promising results in clinical trials, realworld post marketing data on its safety profile is limited. We aim to evaluate its adverse event (AE) profile by using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). A retrospective pharmacovigilance analysis was conducted by including individual case safety reports listing Palopegteriparatide as a suspect drug. Reported AEs were extracted and categorized. Descriptive statistical analysis was performed to summarize AE frequencies, reporter characteristics, and year-wise distribution of the reports. A total of 132 case reports associated with Palopegteriparatide were identified between 2024 and 2026. Reports were submitted by healthcare professionals in 79 cases (59.8%) and by patients in 53 cases (40.2%). Year-wise distribution showed 5 reports in 2024, 65 reports in 2025, and 62 reports in 2026. The most frequently reported AE was hypocalcemia (17 cases, 12.9%), followed by injection site reactions (13 cases, 9.8%) and hypercalcemia (13 cases, 9.8%). Other commonly reported events included headache (11 cases, 8.3%), nausea (9 cases, 6.8%), and arthralgia (7 cases, 5.3%), increased fatigue (6 cases, 4.5%), dizziness (6 cases, 4.5%), and pruritus (6 cases, 4.5%), paraesthesia (6 cases, 4.5%), amongst others. Notably, there were no reported deaths related to Palopegteriparatide use during this period. Overall, early post marketing data shows that Palopegteriparatide provides a generally favorable safety profile with calcium related adverse events and injection site reactions as the most reported reactions. These findings align with its mechanism of sustained parathyroid hormone exposure and underscore the importance of ongoing pharmacovigilance to monitor for potential long term effects and rare adverse events. Continued post marketing surveillance is needed to further characterize its long term safety and associated clinical outcomes across diverse patient populations, ensuring an optimal benefit risk assessment as its clinical use expands.

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