Yorvipath (palopegteriparatide) / Ascendis, Teijin, Specialised Therap, Royalty - LARVOL DELTA

Patient-Reported Outcomes in Palopegteriparatide-Treated Adults with Hypoparathyroidism: PaTH Forward Trial Extension. (PubMed, J Clin Endocrinol Metab) - "Through week 110 of the PaTH Forward trial, PTH replacement therapy with palopegteriparatide was associated with significant improvements in disease-specific symptoms and impacts on daily functioning and well-being, as well as general health-related QoL."

Clinical • Journal • Endocrine Disorders • Hypoparathyroidism

Unveiling the complexities of hypoparathyroidism: a comprehensive review of clinical manifestations, diagnosis, and novel therapies. (PubMed, J Endocrinol Invest) - "By integrating clinical expertise with the latest research developments, this review offers an updated and holistic perspective on HypoPT management, aiming to support clinicians in delivering effective and individualized care to patients across the spectrum of disease severity."

Journal • Review • Endocrine Disorders • Hypoparathyroidism • Metabolic Disorders • Nephrology • Renal Disease

A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide) (clinicaltrials.gov) - P=N/A | N=10 | Not yet recruiting | Sponsor: Ascendis Pharma A/S

New trial • Endocrine Disorders • Hypoparathyroidism

Palopegteriparatide in Japanese adults with hypoparathyroidism: 52-week results from the phase 3 PaTHway Japan trial. (PubMed, Endocr J) - "These findings in Japanese adults are consistent with results of the pivotal phase 3 and phase 2 North American/European trials and demonstrate the reproducibility of the palopegteriparatide treatment benefit in diverse populations and geographies. Japan Registry of Clinical Trials ID: jRCT2051210058."

Journal • P3 data • Endocrine Disorders • Hypoparathyroidism

Sustained Improvement in Kidney Function with Palopegteriparatide in Adults with Chronic Hypoparathyroidism: Three-Year Results from the PaTH Forward and PaTHway Trials (KIDNEY WEEK 2025) - "Most TEAEs were grade 1 or 2, with no new safety signals identified. Conclusion Palopegteriparatide treatment showed sustained improvement in renal function, resolution of hypercalciuria, and continued safety and efficacy through Year 3 of PaTH Forward and PaTHway."

Clinical • Chronic Kidney Disease • Endocrine Disorders • Hypoparathyroidism • Orthopedics

Value Contribution of Palopegteriparatide in Adult Patients with Chronic Hypoparathyroidism using Multicriteria Decision Analysis (MCDA). (PubMed, Adv Ther) - "According to MCDA, palopegteriparatide represents a valuable therapeutic option for chronic hypoparathyroidism treatment, particularly due to its demonstrated efficacy, which had an impact on patients' QoL, and the current unmet needs in this therapeutic area."

Journal • Endocrine Disorders • Hypoparathyroidism • Rare Diseases

The Drug Update: Recent drug approvals, summer 2025 edition. (PubMed, Nurse Pract) - "This article highlights the following new medications: donanemab-azbt (Kisunla), nalmefene injection (Zurnai), epinephrine nasal spray (neffy), palopegteriparatide (Yorvipath), xanomeline and trospium chloride (Cobenfy), and sulopenem etzadroxil/probenecid (Orlynvah). Additionally, this article highlights the recent approval of obstructive sleep apnea as a new indication for tirzepatide (Zepbound) and chronic obstructive pulmonary disease as a new indication for dupilumab (Dupixent)."

Journal • Addiction (Opioid and Alcohol) • Allergy • Alzheimer's Disease • Chronic Obstructive Pulmonary Disease • CNS Disorders • Endocrine Disorders • Hypoparathyroidism • Immunology • Obstructive Sleep Apnea • Psychiatry • Pulmonary Disease • Respiratory Diseases • Schizophrenia • Sleep Disorder

Rebound Effect Following the Discontinuation of Palopegteriparatide. (PubMed, Calcif Tissue Int) - "This case highlights a potential rebound effect following the discontinuation of palopegteriparatide. While the hypocalcemia was mild and managed at the outpatient setting, this case emphasizes the need for close monitoring and possible adjustments in therapy upon discontinuation of palopegteriparatide."

Journal • Endocrine Disorders • Hypoparathyroidism • Metabolic Disorders • Nephrology • Renal Disease

Therapeutic Management of ADH1 in a 16-year Old Boy Using Palopegteriparatide. (ENDO 2025) - "Previously, the patient was receiving alfacalcidol (1.25 mcg/day), CaCO3 (600 mg Ca/day), hydrochlorothiazide (12.5-6.25 mg), MgSO4 (260 mg Mg/day), and KCl (782 mg K/day)...Calcilytics (e.g., encaleret) should be the drugs of choice in the treatment of ADH1, but they are currently still the subject of/ under investigation (CALIBRATE trial)...The long-term effects of using long-acting PTHR1 analogs are currently unknown. However, this treatment should be considered in cases of severe abnormalities in calcium and phosphate levels that lead to calcium salt precipitation and subsequent organ dysfunction."

Cataract • Endocrine Disorders • Hypoparathyroidism • Infectious Disease • Metabolic Disorders • Nephrology • Ophthalmology • Pain • Renal Disease

Improved Skeletal Dynamics in Adults Treated with Palopegteriparatide for Chronic Hypoparathyroidism: 214-Week Results from the Phase 2 PaTH Forward Trial (ASBMR 2025) - No abstract available

Clinical • P2 data • Endocrine Disorders • Hypoparathyroidism

Efficacy and Safety of Palopegteriparatide Treatment in Adults With Hypoparathyroidism: 3-Year Results From The Phase 3 PaTHway Trial (ENDO 2025) - "TEAEs were mostly grade 1 or 2, with no new safety signals identified. Conclusion Through year 3 of the PaTHway trial, retention rate was high and palopegteriparatide demonstrated consistent longer-term safety and efficacy, which included the maintenanceof serum and urine biochemistries within normal levels and sustained improvement in renal function."

Clinical • P3 data • Endocrine Disorders • Hypoparathyroidism

PaTHway60: A Phase 3 Clinical Trial to Investigate the Safety and Efficacy of Palopegteriparatide at Doses Greater Than 30 μg/Day in Adult Participants With Hypoparathyroidism (clinicaltrials.gov) - P3 | N=18 | Not yet recruiting | Sponsor: Ascendis Pharma Bone Diseases A/S

New P3 trial • Endocrine Disorders • Hypoparathyroidism

Early US Real-World Treatment Patterns and Outcomes in Palopegteriparatide Treatment for Patients with Hypoparathyroidism. (PubMed, Endocr Pract) - "This real-world analysis of palopegteriparatide treatment of hypoparathyroidism outside of a clinical trial setting reaffirms its efficacy and safety profile and provides insights into outcomes associated with different treatment transition practices."

HEOR • Journal • Real-world evidence • Endocrine Disorders • Hypoparathyroidism

Palopegteriparatide Treatment for Hypoparathyroidism in Three Women with Autoimmune Polyglandular Syndrome (ASBMR 2025) - No abstract available

Clinical • Endocrine Disorders • Hypoparathyroidism • Immunology

Switch From rhPTH1-84 to TransCon PTH With Individual Dose Adjustment in Adult Hypoparathyroidism-4-Week Results. (PubMed, J Endocr Soc) - "We hereby report the first clinical data on switching treatment from rhPTH1-84 to 18 µg TransCon PTH independent of the prior rhPTH1-84 dose. Our data support discrete adaptation of the starting dose depending on the prior rhPTH1-84 dosage."

Journal • Endocrine Disorders • Hypoparathyroidism

Chronic Hypoparathyroidism - Current and Emerging Therapies. (PubMed, Endocr Pract) - "Palopegteriparatide has a 60-hour half life and results in an infusion like PTH release profile...New molecules include an oral PTH1receptor agonist which is in phase 1 clinical trials. A weekly PTH molecule is also being evaluated in phase 2 clinical trials."

Journal • Review • Endocrine Disorders • Hypoparathyroidism

All Time Low: A Follow-Up Case Report On Basal Ganglia Calcification From Chronic Hypocalcemia Following Postsurgical Hypoparathyroidism (ENDO 2025) - "Palopegteriparatide and eneboparatide, both long-acting agents, are able to achieve normocalcemia while being independent from conventional therapy, and are well-tolerated. A newer and longer-acting agent, MBX 2109, in 2024 was on Phase 1 trial for tolerance and safety, aiming once-weekly PTH replacement. While Calcium and Vitamin D are the mainstay management in hypoPT, replacing PTH may now be considered in chronic hypocalcemia unresponsive to conventional treatment, aiming to avoid long-term and disabling complications."

Case report • Clinical • Endocrine Cancer • Endocrine Disorders • Hypoparathyroidism • Metabolic Disorders • Nephrology • Oncology • Renal Disease • Solid Tumor • Thyroid Gland Carcinoma

Chronic PTH deficiency leads to impaired neural plasticity (ENDO 2025) - "A patient subgroup had TMS recordings repeated after initiating PTH treatment [3 subjects on PTH(1-34) and 3 subjects on Palopegteriparatide]... our findings suggest that hypoPT present a functional impairment of neural plasticity mechanisms. PTH replacement therapy seems to restore this impairment, but we believe that further comprehensive studies are needed."

Alzheimer's Disease • Cognitive Disorders • Endocrine Disorders • Fatigue • Hypoparathyroidism • Pain

Asymptomatic Severe Recalcitrant Hypocalcemia treated with H1-34 teriparatide (ENDO 2025) - "Clinical Case: A 59-year-old woman with a history of multinodular goiter, osteoporosis, severe GERD on famotidine and gastric bypass surgery in 2020 presented for total thyroidectomy due to a Afirma suspicious nodule in May of 2024. While the hallmark of hypocalcemia is neuromuscular irritability our case demonstrates the importance of monitoring even in asymptomatic patients with low initial calcium and risk factors for decreased calcium absorption like gastric bypass and treated GERD with antacids. This case further supports use of teriparatide for refractory hypocalcemia. As new research emerges regarding the long-term safety of teriparatide, it may serve as a cost-effective alternative to recently approved but more expensive treatments like palopegteriparatide."

Cardiovascular • CNS Disorders • Endocrine Disorders • Epilepsy • Gastroesophageal Reflux Disease • Osteoporosis • Rheumatology

Best practice recommendations for the diagnosis and management of hypoparathyroidism. (PubMed, Metabolism) - "These best practice recommendations provide a framework for HypoPT diagnosis and management, emphasizing individualized care, role of DNA analysis in the diagnosis of nonsurgical HypoPT, and role of PTH or PTH analogue therapy as appropriate. They complement the 2022 international guidelines and incorporate updated therapeutic recommendations from the past 3 years including the positioning of the newly approved molecule palopegteriparatide based on recent clinical trial data and expert consensus."

Journal • Review • Endocrine Disorders • Hypoparathyroidism • Metabolic Disorders • Nephrology • Renal Disease

Sustained Improvement in Skeletal Dynamics and Renal Function With Palopegteriparatide in Adults With Chronic Hypoparathyroidism: 2-Year Results From the Phase 3 PaTHway Trial (AACE 2025) - P3 | "Conventional therapy for hypoparathyroidism (active vitamin D and elemental calcium) aims to alleviate hypocalcemia but does not address insufficient PTH. This analysis examines the efficacy and safety of palopegteriparatide treatment in adults with chronic hypoparathyroidism through week 104 of the PaTHway trial (NCT04701203)."

Clinical • P3 data • Endocrine Disorders • Hypoparathyroidism

PaTH Forward: A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism (clinicaltrials.gov) - P2 | N=59 | Completed | Sponsor: Ascendis Pharma A/S | Active, not recruiting ➔ Completed

Trial completion • Endocrine Disorders • Hypoparathyroidism

A CASE WITH SEVERE AND RESISTANT HYPOCALCEMIA AFTER THYROIDECTOMY AND PARATHYROIDECTOMY: UNRAVELING A DIAGNOSTIC ENIGMA (ESPE-ESE 2025) - "Due to persistent hypocalcemia, despite maximal oral conventional treatment and periodic intravenous calcium administration, injectable Palopegteriparatide was initiated resulting to gradual normalization of calcium levels (titration to maximum dose). Additionally, during hospitalization, the patient presented persistent hypokalemia (K =2.9 mmol/l) after the addition of hydrochlorothiazide, which in combination with her past medical history of resistant hypertension and borderline low potassium levels during the last two years, raised the suspicion of primary hyperaldosteronism...Adrenal CT revealed small bilateral adenomas (<10 HU) and spironolactone was added with normalization of both blood pressure and potassium levels... Multiple endocrine neoplasia syndromes are rare diseases, usually familial, caused by mutations in genes related to oncogenesis. A careful review of patient’s medical history and thorough clinical examination are key elements in the diagnostic..."

Clinical • Late-breaking abstract • Cardiovascular • Endocrine Cancer • Endocrine Disorders • Gastrointestinal Disorder • Genetic Disorders • Hypertension • Hypoparathyroidism • Obesity • Oncology • Rare Diseases • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma

Palopegteriparatide use for severe postoperative hypocalcemia (ESPE-ESE 2025) - "Palopegteriparatide can serve as a bridging therapy in patients with severe hypocalcemia due to hypoparathyroidism and HBS after total thyroidectomy for Graves’ disease in the period when satisfactory serum calcium levels cannot be maintained with high doses of calcium and vitamin D supplementation."

Endocrine Disorders • Grave’s Disease • Hypoparathyroidism • Metabolic Disorders • Nephrology • Renal Disease

Preliminary Results from a Prospective Cohort Study on Real-World Data of Chronic Hypoparathyroidism Treated with Trans-Con PTH (ESPE-ESE 2025) - "Background: Chronic hypoparathyroidism (HypoPT) is a rare endocrine disorder characterized by deficient parathyroid hormone (PTH) levels, leading to hypocalcemia and dependency on calcium and active vitamin D., Trans-conPTH 1-34 formulation (Yorvipath), has emerged as a potential therapeutic option for patients with uncontrolled hypoparathyroidism or those previously treated with rhPTH(1-84)...Additionally, 15 patients (40%) were on hydrochlorothiazide for hypercalciuria... Preliminary findings suggest that Yorvipath is effective in reducing or eliminating the need for calcium and activated vitamin-D treatment in patients with HypoPT. Most patients achieved Ca/active VitD independence within the first few weeks of treatment. Further studies with longer follow-up are warranted to confirm the long-term efficacy and safety of Yorvipath in this patient population."

Clinical • Real-world • Real-world evidence • Endocrine Cancer • Endocrine Disorders • Genetic Disorders • Hypoparathyroidism • Immunology • Metabolic Disorders • Oncology • Sarcoidosis • Solid Tumor • Thyroid Gland Carcinoma