RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Orphan Drug (United Kingdom), Priority Review (United States)

Structure/Sequence

Sequence Code 4953

Source: *****

Clinical Trials associated with Palopegteriparatide

NCT07264634

/ Not yet recruitingNot Applicable

A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)

This is an observational, opportunistic lactation study to be conducted in lactating female participants who are currently receiving therapeutic doses of YORVIPATH as part of their usual care and who have chosen to breastfeed their infant(s). The potential transfer of palopegteriparatide into breast milk will be assessed.

Start Date01 Jan 2026

Sponsor / Collaborator

Ascendis Pharma A/S

NCT07345494

/ Not yet recruitingNot Applicable

A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding

The purpose of this registry study is to collect both prospective and retrospective data in women exposed to palopegteriparatide during pregnancy to assess risk of pregnancy and maternal complications, and adverse effects on the developing fetus, neonate, and infant and to assess infant outcomes through at least the first year of life.

Start Date01 Jan 2026

Sponsor / Collaborator

Ascendis Pharma A/S

NCT07081997

/ Not yet recruitingPhase 3

A Phase 3, Multicenter, Single Arm, Open-Label Trial Investigating the Safety, Tolerability and Efficacy of Palopegteriparatide Administered Subcutaneously Daily at Doses Greater Than 30 µg/Day in Adult Participants With Hypoparathyroidism

This trial has a duration of 78 weeks and will include adult participants already on treatment with palopegteriparatide at doses at or greater than 30 mcg/day. All participants will receive subcutaneous palopegteriparatide during the trial and will be individually and progressively titrated to an optimal dose at pre-specified dose levels. The primary purpose of the trial is to provide additional evidence of treatment effect and safety of palopegteriparatide at doses greater than 30 mcg/day in adults with hypoparathyroidism. The trial will be conducted in the US.

Start Date01 Nov 2025

Sponsor / Collaborator

Ascendis Pharma Bone Diseases A/S

100 Clinical Results associated with Palopegteriparatide

100 Translational Medicine associated with Palopegteriparatide

100 Patents (Medical) associated with Palopegteriparatide

7,341

Literatures (Medical) associated with Palopegteriparatide

01 Mar 2026·BIOELECTROCHEMISTRY

Carbon nanotubes/polythiophene composite anodes: Fabrication and electrochemical energy storage performance

Article

Author: Wang, Zhijie ; Duan, Guofeng ; Wang, Yuyang ; Zhang, Dongming ; Chen, Yuchu ; Zuo, Jinlong ; Song, Yu ; Kong, Xiangquan ; Ma, Su

This study presents a significant advancement in a capacitive carbon felt/carbon nanotube/polythiophene (CF/CNT/PTh) bioanode. The CF framework provides mechanical stability. CNTs form a mesoporous structure (Barrett-Joyner-Halenda (BJH) pore volume: 0.016991 cm³/g), which supports increased populations of electroactive microorganisms. High-throughput sequencing confirmed a 6.67-fold increase in the relative abundance of electroactive genera. The key innovation of the CF/CNT/PTh is the incorporation of PTh to redesign the bioelectrochemical interface. The hydrophobic surface of PTh (confirmed by Fourier-transform infrared spectroscopy and Brunauer-Emmett-Teller analysis) reduces interfacial water barriers. Consequently, the charge-transfer resistance decreases by 65.3 % (R_ct = 2.80 Ω), as measured via electrochemical impedance spectroscopy. Additionally, the pseudocapacitive properties of PTh enable the storage of 5842.55C/m² of charge and generate a stronger bioelectric field (-578 mV open-circuit potential (OCP)), which enhances microbial activity. These effects create an "energy hub" in the bioanode, as stored and real-time electrons merge during discharge. Therefore, the CF/CNT/PTh bioanode achieves a current density of 147.925 A/m² and a power density of 1216.03 mW/m², which is 1.64 times that of bare CF. This design establishes a novel system through a microbial habitat environment constructed with CNT and a polythiophene-enhanced electron transfer mechanism, offering an innovative solution for micropower applications.

01 Feb 2026·JOURNAL OF STEROID BIOCHEMISTRY AND MOLECULAR BIOLOGY

Calcitriol’s role in fetal bone and mineral metabolism: Evidence from human and animal studies

Review

Author: Kovacs, Christopher S

Fetal mineral and bone metabolism is regulated differently compared to the neonate, child, or adult. A fundamental design difference is that the fetal mineral supply comes from active transport across the placenta rather than the intestines. Calcium, phosphorus, and magnesium also circulate at higher concentrations in the fetal blood as compared to maternal or normal adult values, which facilitates rapid accretion of skeletal mineral content before birth. Given the dependence of postnatal mineral and bone homeostasis on calcitriol, it may be expected that calcitriol and the vitamin D receptor (VDR) would be critically required during fetal development. However, calcitriol circulates at low levels in the fetal circulation, kept suppressed by increased 24-hydroxylated catabolism and low parathyroid hormone (PTH). Calcitriol does not regulate placental mineral transport, while the intestines are a trivial route of mineral delivery in the fetus. Consequently, fetuses lacking vitamin D, calcitriol, or VDRs are born with normal serum mineral concentrations, PTH, and skeletal development/mineralization. After birth, serum calcium falls and phosphorus rises, and these events trigger an increase in PTH and a subsequent rise in calcitriol. The intestines become the main source of mineral supply and it is then that the neonatal may begin to suffer the consequences of disrupted vitamin D physiology. This review discusses key data arising from animal and human studies (clinical trials, case series, epidemiological studies, associational analyses) in order to address our current knowledge on the role of vitamin D, calcitriol, and VDR in regulating fetal mineral and bone homeostasis.

01 Jan 2026·AMERICAN JOURNAL OF SURGERY

Parathyroid hormone guided protocols for hypocalcemia management after thyroidectomy: A systematic review

Review

Author: Kasmirski, Julia ; Chen, Herbert ; Swaminathan, Niranjna ; Lindeman, Brenessa ; Anyagwa, Onyekachi Emmanuel ; ZhiXing, Song ; Roy, Raj ; Dream, Sophie ; Gillis, Andrea ; Babu, Abhirami

INTRODUCTION:

Hypocalcemia following total thyroidectomy remains a clinical challenge, often leading to preventable readmissions. Standardized PTH-based protocols offer a structured approach to postoperative management. This study examines institutional variations in such protocols and evaluates their effectiveness in minimizing unnecessary hospital visits.

METHODS:

A detailed search of published Parathyroid Hormone (PTH) based protocols at various institutions was conducted across Pubmed, Web of Science, Embase and Scopus. Variables such as mean hospital stay, PTH and calcium thresholds, supplementation guidelines, discharge criteria, ED visits and hospital readmissions were collected. This systematic review was PROSPERO registered with the ID CRD42024615865.

RESULTS:

Of 1178 studies screened, 10 met inclusion criteria. Most protocols recommended PTH measurement within 4 h postoperatively, without routine postoperative calcium testing. Risk stratification typically used thresholds of 10-15 pg/mL, with some adopting tiered PTH categories. Effective protocols avoided supplementation in low-risk patients while standardizing calcium carbonate (1000 mg TID) ± calcitriol (0.25-0.5 mcg BID) for medium/high-risk patients. Severe or refractory hypocalcemia was managed with intravenous calcium ± magnesium. Follow-up was typically within 1-4 weeks, with same-day discharge feasible in select low-risk patients. Reported readmission rates ranged from 0 to 7.0 %, with most <1 %.

CONCLUSIONS:

PTH-based protocols reduce readmissions after total or completion thyroidectomy by combining early PTH measurement, defined risk thresholds, selective supplementation, and timely follow-up. Adoption of these shared components across institutions could minimize unnecessary supplementation, improve safety, and standardize care.

131

News (Medical) associated with Palopegteriparatide

12 Jan 2026

·www.biospace.com

Ascendis Pharma Provides Business and Strategic Roadmap Update at 44th Annual J.P. Morgan Healthcare Conference

- Rapidly transforming into a leading global biopharma company COPENHAGEN, Denmark, Jan. 09, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today provided a business and strategic roadmap update, including planned 2026 key corporate milestones. Ascendis President and CEO Jan Mikkelsen will present this update on Monday, January 12, during the 44 th Annual J.P. Morgan Healthcare Conference. “With our proven TransCon ® technology platform, strong R&D capabilities, and a maturing commercial infrastructure and financial profile, Ascendis is rapidly transforming into a leading global biopharma company,” said Jan Mikkelsen, President and Chief Executive Officer at Ascendis Pharma. “Over the next year, this inflection will be driven by further global penetration and commercial expansion, a third potential TransCon product approval with blockbuster potential, and an advancing R&D pipeline of highly differentiated internal and external TransCon product candidates, all of which create the foundation for sustainable long-term growth.” Selected Key Updates and Milestones TransCon PTH (palopegteriparatide, marketed as YORVIPATH ® ) YORVIPATH fourth-quarter 2025 and full-year 2025 unaudited preliminary revenue expected to be ~€187 million and ~€477 million, respectively. More than 5,300 unique U.S. patient enrollments, with nearly 2,400 unique prescribing healthcare providers at year end. Outside the U.S., now available commercially or through named patient programs in more than 30 countries, with full commercial launches anticipated in 10 additional countries by year end 2026. Confirmed product pro once-weekly TransCon PTH targeting patients receiving stable YORVIPATH doses. Ongoing label expansion trials through PaTHway60 (adults) and PaTHway Adolescent. TransCon hGH (lonapegsomatropin, marketed as SKYTROFA ® ) SKYTROFA fourth-quarter 2025 and full year 2025 unaudited preliminary revenue expected to be ~€53 million and ~€206 million, respectively. Received first label expansion in July 2025 with U.S. Food & Drug Administration (FDA) approval for adult growth hormone deficiency (GHD). Initiated Phase 3 basket trial for additional indications: idiopathic short stature (ISS), SHOX deficiency, Turner syndrome, and small for gestational age (SGA). TransCon CNP (navepegritide) In the U.S., PDUFA goal date of February 28, 2026 for pediatric achondroplasia. Submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) in October 2025, with a regulatory decision on potential use in pediatric achondroplasia anticipated in the fourth quarter of 2026. TransCon CNP + TransCon hGH Combination Therapy (navepegritide plus lonapegsomatropin) On January 8, 2026, announced Week 52 topline results from Phase 2 COACH Trial, which demonstrated improvements in annualized growth velocity (AGV) across both TransCon CNP treatment-naïve and TransCon CNP-treated children that exceeded the 97 th percentile of average stature children, along with improvements in body proportionality and arm span, and a safety pro with those observed for monotherapies of TransCon CNP and TransCon hGH. In Q4 2025, Ascendis submitted a protocol and held an end of Phase 2 meeting with the FDA regarding a Phase 3 trial of TransCon CNP and TransCon hGH in pediatric achondroplasia. Week 78 COACH data update anticipated in second quarter of 2026. Planned new trials to support TransCon CNP + TransCon hGH treatment in additional indications, such as hypochondroplasia. TransCon IL-2 β/γ (onvapegleukin alfa) Expect to report median overall survival (OS) data for a cohort of 70 patients with late-line platinum-resistant ovarian cancer (PROC) from the IL-Believe Trial of TransCon IL-2 β/γ + weekly paclitaxel in the second quarter of this year. Strategic Collaborations & Investments Novo Nordisk A/S Ongoing multi-product collaboration with Novo Nordisk for TransCon technology-based therapies in obesity and metabolic diseases. Lead program TransCon semaglutide remains on track to enter the clinic as anticipated. Eyconis, Inc. Ascendis has granted Eyconis exclusive rights to develop and commercialize TransCon ophthalmology products globally and holds a 41% equity position in the company. Lead program TransCon aVEGF (EYC-0305) in development for wet AMD and other retinal diseases anticipated to enter the clinic in 2026. VISEN Pharmaceuticals Ascendis has granted VISEN Pharmaceuticals exclusive rights to develop and commercialize TransCon hGH, TransCon PTH, and TransCon CNP in Greater China and maintains a 39% ownership interest in the public company. Biologic License Application (BLA) for TransCon hGH (lonapegsomatropin) as a potential treatment for pediatric growth hormone deficiency (PGHD) was accepted by China’s National Medical Products Administration (NMPA) in March 2024, with an approval decision anticipated in the first quarter of 2026. Teijin Limited Ascendis has granted Teijin Limited an exclusive license agreement for the further development and commercialization of TransCon hGH, TransCon PTH, and TransCon CNP for rare endocrinology diseases in Japan. In August 2025, YORVIPATH received MAA approval from Japan’s Ministry of Health, Labour, and Welfare. Financial Update Unaudited preliminary estimate of 2025 financial results: Total full-year 2025 product revenue of ~€683 million: YORVIPATH full-year 2025 revenue of ~€477 million SKYTROFA full-year 2025 revenue of ~€206 million Total full-year 2025 revenue of ~€720 million Full-year 2025 gross margin expected to be ~87% Total full-year 2025 operating expenses of ~€762 million December 31, 2025 unaudited preliminary cash balance of ~€616 million Expect operating cash flow of ~€500 million in 2026, based on current plans, exchange rates and excluding any contribution from TransCon CNP Planned $120 million share repurchase program in 2026 Share Repurchase Program The Board of Directors of Ascendis has authorized a $120 million Share Repurchase Program. Purchases under the Share Repurchase Program may be made from time to time through a variety of methods, which may include open-market purchases, privately negotiated transactions, or other methods permitted under applicable securities laws. The timing and amount of any repurchases pursuant to the Share Repurchase Program will be determined based on market conditions, share price and other factors. The Share Repurchase Program does not require Ascendis to repurchase any specific number of shares, and may be modified, suspended or terminated at any time without notice. Presentation at J.P. Morgan Healthcare Conference on Monday, January 12 A live webcast of the event will be available via the Investors & News section of the Ascendis Pharma website at . The presentation will begin at 10:30 a.m. Eastern Time / 7:30 a.m. Pacific Time. A webcast replay will be available for 30 days. The Company’s slides from the J.P. Morgan presentation will be available on the same Investors & News website at . About Ascendis Pharma A/S Ascendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of Patients, Science, and Passion, Ascendis uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis’ potential to rapidly transform into a leading global biopharma company, (ii) anticipated commercial launches of TransCon PTH into additional countries, (iii) the PDUFA goal date of TransCon CNP for pediatric achondroplasia and EMA regulatory decision date on the potential use of TransCon CNP in pediatric achondroplasia, (iv) timing of week 78 COACH data and planned new trials to support TransCon CNP and TransCon hGH treatment in additional indications, (v) planned release of data from the IL-Believe Trial of TransCon IL-2 β/γ, (vi) clinical status of TransCon aVEGF, (vii) NMPA’s anticipated decision of TransCon hGH as a potential treatment for PGHD, (viii) the expected collaboration with Novo Nordisk and progress of TransCon semaglutide, (ix) expected full year 2025 SKYTROFA, YORVIPATH and total revenues, operating expense, cash balance and operating cash flow, (x) planned share repurchase program, (xi) Ascendis’ ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company, and (xii) Ascendis’ use of its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including, without limitation: dependence on third‑party manufacturers, distributors, and service providers for Ascendis’ products and product candidates; risks related to regulatory review and approval, including the possibility of delays, requests for additional data or analyses, restrictions or limitations on use, approval with labeling that is more limited than expected, or failure to obtain approval in the United States, European Union, or other jurisdictions; clinical development risks, including that results from ongoing or future trials may not confirm earlier data; unforeseen safety or efficacy findings in development programs or on‑market products; manufacturing, supply chain, quality, or logistics issues that could delay development or commercialization; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen research and development or selling, general and administrative expenses and other costs impacting Ascendis’ business generally; market acceptance, pricing, and reimbursement challenges, including payer coverage decisions and health technology assessments; competitive developments, including new or improved therapies; intellectual property protection, freedom‑to‑operate, and litigation risks; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; cybersecurity, data privacy, and information technology disruptions; and the impact of international economic, political, legal, compliance, public health, and business factors, including tariffs, trade policies, currency fluctuations, and geopolitical events. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 20-F filed with the SEC on February 12, 2025. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, TransCon, SKYTROFA ® , and YORVIPATH ® are trademarks owned by the Ascendis Pharma group. © January 2026 Ascendis Pharma A/S. Investor Contacts: Chad Fugere Ascendis Pharma ir@ascendispharma.com Media Contact: Melinda Baker Ascendis Pharma media@ascendispharma.com Patti Bank ICR Healthcare +1 (415) 513-1284 patti.bank@icrhealthcare.com

Clinical ResultPhase 3Drug ApprovalLicense out/in

27 Dec 2025

·www.globenewswire.com

Entera Bio Announces New Data Supporting Further Development of a Proprietary First-in-Class Oral, Long-Acting PTH Tablet for Patients with Hypoparathyroidism (EB612 Program)

Dec. 22, 2025 -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides and proteins replacement therapies, today announced new validating in vivo pharmacokinetic and pharmacodynamic data that supports further development of a proprietary long-acting parathyroid hormone (PTH) analog using its N-Tab® platform to create the first once-daily tablet treatment for patients with hypoparathyroidism (EB612 program). The positive preclinical findings showed the proprietary analog achieved a markedly longer plasma half-life and sustained calcium elevation for over three days - in contrast to unmodified PTH(1-34) controls, which showed no calcium response. Hypoparathyroidism is a heterogeneous, rare endocrine disorder characterized by deficient PTH production, hypocalcemia, and hyperphosphatemia. Historically, the standard of care included high dose calcium and calcitriol supplementation. However, raising serum calcium to normal physiological levels in the absence of PTH frequently leads to elevated urinary calcium and is often associated with ectopic calcification, including nephrocalcinosis and renal failure. Today, the only approved PTH replacement treatment (YORVIPATH®) requires patients to administer injections every day, while investigational candidates may require patients to take weekly injections. Entera previously demonstrated proof of concept data for its EB612 program using an unmodified PTH(1-34) analog and an earlier generation of its N-Tab® platform in a Phase 2, 16-week study which enrolled 19 patients with hypoparathyroidism. The Phase 2 study (JBMR, 2021) demonstrated a 42% reduction (p=0.001) from baseline in median calcium supplement use, while maintaining serum Ca levels above the lower limit for hypoparathyroidism patients (>7.5 mg/dL) throughout the study; however, the trial involved a QID regimen or 4 times a day dosing of tablets. The current preclinical data represent a key step toward addressing this dosing burden with a single, once-daily tablet. “Our focus for the EB612 program has been finding the right long-acting, proprietary PTH analog to develop a single, once-a-day PTH tablet treatment for patients with hypoparathyroidism. Given the heterogeneity of this condition which requires PTH as a replacement therapy, our goal is to provide a single, daily tablet at fixed doses to help patients and their caregivers personalize titration and long-term care,” said Miranda Toledano, Chief Executive Officer at Entera. Entera conducted in vitro and in vivo validation of a variety of proprietary long-acting PTH analogs with a new generation of its N-Tab® oral peptide platform. A confirmatory minipig study was recently completed in which a single oral tablet was administered to five animals and the PK–PD profile was monitored over five days, using an unmodified PTH(1‑34) tablet as control. The lead variant demonstrated a markedly longer plasma half-life compared to the unmodified PTH(1-34) control at the same dose, providing pharmacokinetic support for once-daily dosing Serum calcium levels increased for more than three days in all animals receiving the lead variant; the sustained elevation correlated with prolonged pharmacokinetic exposure Unmodified PTH(1-34) control tablets did not increase serum calcium levels No adverse events were observed Entera plans to present these data at an upcoming medical conference. Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab®) and its pipeline of first-in-class oral peptide programs targeting PTH(1-34), GLP-1 and GLP-2. The Company’s most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with osteoporosis at risk of fracture. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity and metabolic syndromes; and first oral GLP-2 peptide as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. The content above comes from the network. if any infringement, please contact us to modify.

Clinical Result

07 Nov 2025

·www.globenewswire.com

New Pooled 3-Year Analysis Confirms Sustained, Clinically Meaningful Improvements in Renal Function for TransCon® PTH (Palopegteriparatide)-Treated Adults with Hypoparathyroidism

COPENHAGEN, Denmark, Nov. 07, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that a new pooled analysis showed sustained and clinically meaningful improvements in renal function in adults with hypoparathyroidism treated with TransCon PTH (palopegteriparatide) through Year 3 of the Company’s Phase 2 PaTH Forward and Phase 3 PaTHway trials. The data, which confirm results for each individual trial presented at major endocrinology meetings earlier this year, were shared during Kidney Week 2025 in a poster presented by lead author Dr. Elvira Gosmanova, a nephrologist at Albany Medical College and Albany VAMC (New York). “The magnitude and trajectory of improvement in eGFR in patients treated with TransCon PTH were consistent across the individual trials and pooled analysis, confirming the robustness of these findings across a diverse population of adults with hypoparathyroidism,” said Dr. Stuart M. Sprague, Professor of Medicine at University of Chicago and Director of Nephrology Research at Endeavor Health, who was a co-author on the poster. “Compromised kidney function is a serious complication and I am confident that nephrologists, endocrinologists, and the broader hypoparathyroidism community will find value in these groundbreaking results.” The PaTH Forward and PaTHway trials included a combined 141 adults with hypoparathyroidism, 139 of whom (mean age 49 years) are represented in the pooled analysis. The PaTH Forward and PaTHway trials comprised randomized, double-blind, placebo-controlled periods through Weeks 4 and 26 and open-label extension periods through Weeks 266 and 182, respectively. An eGFR ≥30 mL/min/1.73 m2 was required for trial eligibility. The three-year data were analyzed post-hoc and included evaluation of the long-term impact of TransCon PTH on renal function as assessed by eGFR. Mean (SD) baseline eGFR in the trials was 69 (17) mL/min/1.73 m2. The pooled analysis included 41 patients with a mean baseline eGFR <60 mL/min/1.73 m2 and 98 patients with a mean baseline ≥60 mL/min/1.73 m2. Safety assessments included 24-hour urine calcium excretion and treatment-emergent adverse events (TEAEs). At Year 3, ≥91% of patients receiving palopegteriparatide in both trials were independent from conventional therapy (defined as taking no active vitamin D and ≤600 mg/day of calcium) and ≥84% patients had normocalcemia (8.3-10.6 mg/dL). Sustained and clinically meaningful improvements in eGFR (≥ 5 mL/ min / 1.73 m2) were observed in 70.3%, with numerically greater improvements observed in those with lower baseline eGFR. The greatest increases in eGFR were observed in the first 6 months of treatment with TransCon PTH, with a continued upward trend thereafter. Mean (SD) eGFR increased from baseline to Year 3 by 9.8 (10.9) mL/min/1.73 m2 in PaTH Forward and by 8.8 (11.9) mL/min/1.73 m2 in PaTHway. Reductions in 24-hour urinary calcium excretion were observed and maintained within the normal range through Year 3. In both trials, TransCon PTH was generally well tolerated, with no new safety signals identified. Most treatment-emergent adverse events (TEAEs) were mild to moderate (Grade 1 or 2) and no patients discontinued due to treatment-related TEAEs. “We are pleased to share this analysis of a larger group of patients, showing the reproducibility of the eGFR improvements over time. These observations further emphasize the importance of replicating normal PTH physiology with TransCon PTH in adults living with hypoparathyroidism,” said Aimee Shu, M.D. Executive Vice President of Endocrine & Rare Disease Medical Science and Chief Medical Officer at Ascendis Pharma. “This is our first such presentation at a nephrology-focused meeting, and we look forward to continuing the conversation about the significance of PTH replacement to overall kidney health in this patient population.” TransCon PTH is a prodrug of PTH (1-34), administered once daily, designed to provide active PTH within the physiological range for 24 hours/day, approved as YORVIPATH® in the United States, European Union, and European Economic Area as a treatment for adults with hypoparathyroidism. About HypoparathyroidismHypoparathyroidism is an endocrine disease caused by insufficient levels of parathyroid hormone (PTH), the primary regulator of calcium and phosphate balance in the body, acting directly on bone and kidney and indirectly on the intestine. Individuals with hypoparathyroidism may experience a range of severe and potentially life-threatening short-term and long-term complications, including neuromuscular irritability, renal complications, extra-skeletal calcifications, and cognitive impairment. Post-surgical hypoparathyroidism accounts for the majority of cases (70-80%), while other etiologies include autoimmune and idiopathic causes. About Ascendis Pharma A/SAscendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) nephrologists, endocrinologists, and the broader hypoparathyroidism community finding value in the results of the new pooled 3-year analysis of the Ascendis’ Phase 2 PaTH Forward and Phase 3 PaTHway trials, (ii) the significance of PTH replacement to overall kidney health, (iii) Ascendis’ ability to apply its TransCon technology platform to make a meaningful difference for patients, and (iv) Ascendis’ application of its TransCon technologies to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors, including tariffs and trade policies. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 12, 2025, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, TransCon, and YORVIPATH® are trademarks owned by the Ascendis Pharma group. © November 2025 Ascendis Pharma A/S. Investor Contacts:Chad FugereAscendis Pharmair@ascendispharma.comMedia Contact:Melinda BakerAscendis Pharmamedia@ascendispharma.com Patti BankICR Healthcare+1 (415) 513-1284patti.bank@icrhealthcare.com

Clinical ResultPhase 2Phase 3

100 Deals associated with Palopegteriparatide

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	H05AA	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypoparathyroidism	European Union	Ascendis Pharma Bone Diseases A/S	17 Nov 2023
Hypoparathyroidism	Iceland	Ascendis Pharma Bone Diseases A/S	17 Nov 2023
Hypoparathyroidism	Liechtenstein	Ascendis Pharma Bone Diseases A/S	17 Nov 2023
Hypoparathyroidism	Norway	Ascendis Pharma Bone Diseases A/S	17 Nov 2023

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04701203 (PaTHway, Company_Website) Manual	Phase 3	Hypoparathyroidism	73	Palopegteriparatide	dllahfagog(zfxxgcuvli) = njlqvxvvwx tgrycogqgh (iacbxjcbxw ) View more	Positive	14 Jul 2025
NCT04009291 (PaTH Forward, NEWS \| Corporate Publications) Manual	Phase 2	Hypoparathyroidism	56	Palopegteriparatide	gvzavstibq(jymddiesnv) = xrtvtcliha fheufbugxe (vjahaygmje ) View more	Positive	18 May 2025
NCT04701203 (PaTHway, CTgov)	Phase 3	Hypoparathyroidism	84	TransCon PTH (TransCon PTH)	pjmyzfwjpm = qvwcvmlrqz ystcmhqvze (xheuayzzgg, hebnzzmycu - tauxoafasg) View more	-	28 Feb 2025
				Placebo (Placebo)	pjmyzfwjpm = civvftkmtz ystcmhqvze (xheuayzzgg, syerznlzcr - hylbdtztrt) View more
NCT05387070 (PaTHway, PRNewswire) Manual	Phase 3	Hypoparathyroidism	-	Palopegteriparatide	osztncorji(kohblskwka) = ujosuwcwor wrapifxteq (irplwxvolz ) View more	Positive	12 Aug 2024
				Placebo	osztncorji(kohblskwka) = ygfgzwlnxv wrapifxteq (irplwxvolz )
NCT04701203 (FDA_CDER) Manual	Phase 3	Hypoparathyroidism	82	YORVIPATH	wqnlvbolze(tbvlqpqbor) = hqkamkwgsn lvlrfwrleg (evsbxrxadu ) View more	Positive	09 Aug 2024
				Placebo	wqnlvbolze(tbvlqpqbor) = hkfyhcucgv lvlrfwrleg (evsbxrxadu ) View more
NCT04701203 (PaTHway, Pubmed \| Adv Ther)	Phase 3	Hypoparathyroidism	82	Palopegteriparatide	zqtwnaqgzv(oyqhhvxnme) = One case of nephrolithiasis was reported for a participant in the placebo group during blinded treatment; none were reported through week 52 with palopegteriparatide vbvmblkckk (tzwbgudnzk )	Positive	01 Jun 2024
NCT04701203 (PaTHway, GlobeNewswire) Manual	Phase 3	Hypoparathyroidism	82	TransCon PTH (palopegteriparatide)	dvbhzrojnw(qsxdlhbshw) = toodnasjqn wmpyfabakm (kwjehyxeis ) View more	Positive	13 May 2024
				TransCon PTH (palopegteriparatide) (eGFR < 60 mL/min/1.73m2)	dvbhzrojnw(qsxdlhbshw) = bthylgwhxn wmpyfabakm (kwjehyxeis ) View more
NCT04009291 \| NCT04701203 \| NCT05387070 (PaTHway, ENDO2023)	Phase 3	Hypoparathyroidism	82	TransCon PTH	webgtgzlop(jwcbymdyer) = trended toward norms from baseline to Weeks 26 and 52 grytfaqhiv (kxozijikfg ) View more	Positive	05 Oct 2023
NCT04009291 (PaTHway \| PaTH Forward, CTgov)	Phase 2	Hypoparathyroidism	59	TransCon PTH (TransCon PTH 15 mcg)	yxjgkrikkp = jzvqhluoil ylitmqqfxo (icvrhiejwb, mapsbidvnp - ckojwaeyyh) View more	-	01 Sep 2023
				TransCon PTH (TransCon PTH 18 mcg)	yxjgkrikkp = lcoiziryqh ylitmqqfxo (icvrhiejwb, qgtrtetcuj - fhssiiszha) View more
PaTH Forward Trial (ENDO2022)	Phase 2	Hypoparathyroidism	59	TransCon PTH 15 mcg/d	udxxhvteyh(vlivawyvfz) = jkivwrrjol bylcofcump (qgmrlesvey ) View more	Positive	01 Nov 2022
				TransCon PTH 18 mcg/d	udxxhvteyh(vlivawyvfz) = vouyzgkmmb bylcofcump (qgmrlesvey ) View more

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