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

Treatment of hypoparathyroidism (HypoPT): Position Statement of the Expert Group for Polish Society of Endocrinology - update 2026. (PubMed, Endokrynol Pol) - "PTH replacement therapy offers a more physiologic approach to treating HypoPT than conventional therapy. Palopegteriparatide can lead to eucalcemia, more effectively than conventional treatment, lowers serum phosphate and urinary calcium, and improves renal function and quality of life."

Clinical guideline • Journal • Endocrine Disorders • Hypoparathyroidism

Reflections on prevention and treatment of post-thyroidectomy hypoparathyroidism: current management approaches and future prospects. (PubMed, Front Endocrinol (Lausanne)) - "Moreover, methodologies for the precise recognition and preservation (naked eye, near-infrared autofluorescence, indocyanine green, carbon nanoparticles, and mitoxantrone hydrochloride) of the parathyroid gland during thyroid surgery have been explored, along with recent therapeutic innovations (palopegteriparatide and parathyroid organoids). Finally, this review prospects and interventions via organoids are contemplated. The aim of the literature is to recapitulate the knowledge and the gaps in this field, increasing awareness of postoperative hypoparathyroidism, and improve the prognosis for patients afflicted with hypoparathyroidism."

Journal • Review • Endocrine Disorders • Hypoparathyroidism

Palopegteriparatide Treatment in Adults With Hypoparathyroidism: Efficacy and Safety Results Through Year 3 of The Phase 3 PaTHway Trial (AACE 2026) - "Through year 3 of the PaTHway trial, retention rate was high and palopegteriparatide demonstrated consistent longer-term safety and efficacy, including the maintenance of serum and urine biochemistries within normal levels and sustained improvement in renal function and quality of life measurements."

Clinical • P3 data • Endocrine Disorders • Hypoparathyroidism

ASND0035: A study to test the effects and safety of palopegteriparatide in adolescents with long-term hypoparathyroidism (clinicaltrialsregister.eu) - P2/3 | N=6 | Not yet recruiting | Sponsor: Ascendis Pharma Bone Diseases A/S

New P2/3 trial • Endocrine Disorders • Hypoparathyroidism

Neural plasticity impairment in chronic post-surgical hypoparathyroidism: a cross-sectional and prospective pilot study. (PubMed, Endocr Connect) - "In a prospective observational phase, a subgroup of six HypoPT patients (3- palopegteriparatide and 3-teriparatide) was reassessed after 48 months of PTH therapy...The primary outcome was the change in MEP amplitude after iTBS as an index of cortical plasticity...Although limited by small sample size, the findings suggest that PTH therapy may modulate cortical plasticity. Further research is needed to clarify the clinical relevance and potential central nervous system effects of PTH in HypoPT."

Journal • Alzheimer's Disease • Cognitive Disorders • Endocrine Disorders • Hypoparathyroidism

THE KEY DATA FROM THE 2025 ESE/ESPE CONGRESS: Chronic hypoparathyroidism in adults. (PubMed, Ann Endocrinol (Paris)) - No abstract available

Journal • Endocrine Disorders • Hypoparathyroidism • Immunology

PaTHway60: A Phase 3 Randomized 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=36 | Not yet recruiting | Sponsor: Ascendis Pharma Bone Diseases A/S | N=18 ➔ 36 | Trial completion date: Dec 2027 ➔ Jun 2028 | Initiation date: Nov 2025 ➔ Apr 2026 | Trial primary completion date: Dec 2026 ➔ Jun 2027

Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Endocrine Disorders • Hypoparathyroidism

A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: Ascendis Pharma A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Disorders • Hypoparathyroidism

Advancing hypoparathyroidism treatment: FDA approval of Palopegteriparatide as a promising orphan drug. (PubMed, Ann Med Surg (Lond)) - "Continued investigation is warranted to optimize patient outcomes and further define its risk-benefit profile. This approval marks a critical milestone in endocrine therapeutics and offers renewed hope for patients struggling with the burdens of chronic HypoPT."

FDA event • Journal • Orphan drug • Endocrine Disorders • Hypoparathyroidism • Metabolic Disorders • Nephrology • Renal Disease

Palopegteriparatide for Adults with Chronic Hypoparathyroidism: Skeletal Dynamics Through 3 yr of the Phase 2 paTH Forward Trial. (PubMed, J Bone Miner Res) - "At week 162, mean serum and median urine calcium remained within normal ranges and 91% of participants were independent from conventional therapy. These results suggest that long-term palopegteriparatide therapy in adults with chronic hypoparathyroidism gradually returns the skeleton toward its natural state thereby enhancing the skeleton's contribution to calcium homeostasis."

Journal • P2 data • Endocrine Disorders • Hypoparathyroidism

PaTHway CHINA TRIAL: A Trial to Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism (clinicaltrials.gov) - P3 | N=81 | Completed | Sponsor: Visen Pharmaceuticals (Shanghai) Co., Ltd. | Recruiting ➔ Completed

Trial completion • Endocrine Disorders • Hypoparathyroidism

A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding (clinicaltrials.gov) - P=N/A | N=50 | Not yet recruiting | Sponsor: Ascendis Pharma A/S

New trial • Endocrine Disorders • Hypoparathyroidism

PaTHreal: Palopegteriparatide in Chronic Hypoparathyroidism (clinicaltrials.gov) - P=N/A | N=90 | Completed | Sponsor: National and Kapodistrian University of Athens

New trial • Real-world evidence • Endocrine Disorders • Hypoparathyroidism

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