RegulationOrphan Drug (United States), Orphan Drug (European Union), 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

JPRN-jRCT2051210058

/ Not yet recruitingPhase 3IIT

A Phase 3, Multicenter, Single Arm, Open-Label Trial, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Japanese Adult Subjects with Hypoparathyroidism - PaTHway Japan Trial

Start Date02 Nov 2021

Sponsor / Collaborator-

NCT05387070

/ RecruitingPhase 3

PaTHway CHINA TRIAL: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, With an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults With Hypoparathyroidism

This study is limited to conduct in China only. The primary objective is to assess the treatment effect of daily TransCon PTH on serum calcium (sCa) levels within the normal range and stopping from therapeutic doses of active vitamin D (calcitriol) or active vitamin D analogue (alfacalcidol) and calcium at 26 weeks of treatment. All subjects will start with 18 mcg of study drug and will be individually and progressively titrated to an optimal dose over a 26-week double blind period, followed by an open label extension period up to 156 weeks. TransCon PTH or placebo will be administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors will know who has been assigned to each group. After the 26 weeks, participants will continue in the trial as part of a long-term extension study. During the extension, all participants will receive TransCon PTH, with the dose adjusted to their individual needs.

Start Date28 Jul 2021

Sponsor / Collaborator

VISEN Pharmaceuticals (Shanghai) Co., Ltd.

NCT04701203

/ CompletedPhase 3

PaTHway TRIAL: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, With an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults With Hypoparathyroidism

During the first 26 weeks of the trial, participants will be randomly assigned to one of two groups: one group will receive TransCon PTH and one group will receive placebo. All subjects will start with study drug at a dose of 18 mcg/day and will be individually and progressively titrated to an optimal dose in dose increments of 3 mcg/day. TransCon PTH or placebo will be administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors will know who has been assigned to each group. After the 26 weeks, participants will continue in the trial as part of a long-term extension study. During the extension, all participants will receive TransCon PTH, with the dose adjusted to their individual needs. This is a global trial that will be conducted in the United States, Canada, Germany, Denmark, Norway, Italy, and Hungary.

Start Date16 Feb 2021

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

7,513

Literatures (Medical) associated with Palopegteriparatide

01 Dec 2025·Current Pain and Headache Reports

Functional Magnetic Resonance Imaging of Post-Traumatic Headache: A Systematic Review

Review

Author: Ashina, Håkan ; Christensen, Rune H ; Szabo, Edina ; Al-Khazali, Haidar M ; Iljazi, Afrim

PURPOSE OF REVIEW:

To evaluate existing functional magnetic resonance imaging (fMRI) studies on post-traumatic headache (PTH) following traumatic brain injury (TBI).

RECENT FINDINGS:

We conducted a systematic search of PubMed and Embase databases from inception to February 1, 2024. Eligible fMRI studies were required to include adult participants diagnosed with acute or persistent PTH post-TBI in accordance with any edition of the International Classification of Headache Disorders. We identified five eligible fMRI studies: two on acute PTH and three on persistent PTH. These studies assessed resting-state functional connectivity involving comparisons with one or more of the following groups: people with migraine, those with mild TBI but no PTH, and healthy controls. In acute PTH, studies focused exclusively on functional connectivity between the periaqueductal gray or hypothalamus and other brain regions. In persistent PTH, evidence of altered functional connectivity was identified primarily within cingulate, sensorimotor, and visual regions, indicating a hypersensitivity to sensory stimuli in PTH. Despite these insights, the fMRI data remains sparse and is limited by inconsistent results and small samples. The paucity of fMRI studies on PTH limits our understanding of its neurobiological basis. The available evidence suggests that alterations in functional connectivity occur within brain areas involved in emotional and sensory discriminative aspects of pain processing. However, inconsistent results and small sample sizes underscore a critical need for larger, more rigorous fMRI studies. Future studies should also consider using task-based fMRI to investigate possible hypersensitivity to different sensory stimuli in PTH after TBI.

01 Dec 2025·Current Osteoporosis Reports

PTH Substitution Therapy for Chronic Hypoparathyroidism: PTH 1–84 and Palopegteriparatide

Review

Author: Tabacco, Gaia ; Palermo, Andrea ; Naciu, Anda Mihaela ; Donovan, Yu Kwang Tay ; Zavatta, Guido

PURPOSE OF REVIEW:

to describe and compare the efficacy and safety of the main PTH treatments, namely PTH(1-84) and palopegteriparatide, for the management of hypoparathyroidism.

RECENT FINDINGS:

neither PTH (1-84) nor PTH(1-34) have been shown a clear and consistent favorable impact on the 24 h urinary calcium excretion normalization, while the positive effect on quality of life is still debated. Recently, the Food & Drug Administration and the European Medicines Agency approved palopegteriparatide as the first true replacement therapy for hypoPT management. Palopegteriparatide is a prodrug of PTH(1-34), administered once daily, and designed to provide continuous exposure to released PTH over a 24-h dosing period. According to phase II and phase III studies, palopegteriparatide seems to fill the gaps identified in existing therapies for hypoPT. Palopegteriparatide is the first real replacement therapy for the management of hypoparathyroidism and seems to fill the gaps identified in existing therapies for hypoPT.

01 Dec 2025·Current Pain and Headache Reports

The Dual Burden of Post-Traumatic Headache: Health Consequences and Economic Impact

Review

Author: Cohen, Fred

PURPOSE OF REVIEW:

To review the history and impact and burden of post-traumatic headache (PTH).

RECENT FINDINGS:

PTH is a prevalent headache disorder that many healthcare providers encounter. Unlike more extensively researched primary headache disorders like migraines, PTH has not been as thoroughly studied, and there are fewer treatments specifically tested for it. A significant obstacle to conducting detailed population studies on PTH is the need for the headache to occur shortly after a traumatic event. Despite these challenges, PTH is recognized as a disabling condition with considerable effects on quality of life and economic impact. PTH is a distressing and debilitating condition. Although there have been efforts to evaluate its personal and economic effects, these studies are limited compared to the more extensive research conducted on other primary headache disorders. More comprehensive epidemiological studies are needed.

123

News (Medical) associated with Palopegteriparatide

05 May 2025

·www.globenewswire.com

Ascendis to Share Its Latest Endocrinology Rare Disease Data at ESPE & ESE 2025

COPENHAGEN, Denmark, May 05, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it will share the latest data from its hypoparathyroidism, achondroplasia, and growth hormone deficiency (GHD) programs during ESPE & ESE 2025, the joint congress of the European Society for Paediatric Endocrinology (ESPE) and the European Society of Endocrinology (ESE) being held May 10-13, 2025, in Copenhagen. Four oral presentations will feature Ascendis clinical trial results, including 4-year efficacy and safety data from the Phase 2 PaTH Forward Trial of TransCon PTH (palopegteriparatide) in adults with chronic hypoparathyroidism; Week 52 growth and bone morphometry data from the pivotal ApproaCH Trial of TransCon CNP (navepegritide) in children with achondroplasia; and efficacy and safety data from the Phase 3 foresiGHt Trial of TransCon hGH (lonapegsomatropin) in adults with growth hormone deficiency. “As new treatments and clinical practices transform the outlook for rare endocrine diseases, we are pleased to partner with trial investigators and leading experts to share new data highlighting clinical benefits of our novel therapies with attendees of ESPE & ESE 2025,” said Aimee Shu, M.D., Executive Vice President of Endocrine & Rare Disease Medical Science and Chief Medical Officer at Ascendis Pharma. The full range of Ascendis Pharma events and updates at ESPE & ESE 2025 include the following: Hypoparathyroidism Sunday, May 1109:55 - 10:25 CEST Congress TheaterFoyer F5Product TheaterRestoring Physiological Levels of PTH in Chronic HypoparathyroidismClick here to see the full session outline.Sunday, May 1116:55-17-55 CEST& Monday, May 1217:15-17:45 CESTPoster HallPoster P238Estimating the Risk of Chronic Kidney Disease Progression in Chronic Hypoparathyroidism: A Restrospective Matched Cohort Study, Using Real-World Data from England Monday, May 1213:00 - 14:30 CESTRoom D5SymposiumBeyond Conventional Care: Redefining Treatment Success in Chronic HypoparathyroidismClick here to see the full session outline.Monday, May 1215:55-16:05 CESTRoom C2Oral PresentationLong-Term Efficacy & Safety of Palopegteriparatide Treatment in Adults with Chronic Hypoparathyroidism: 4-Year Results from the Phase 2 PaTH Forward TrialPresented by Dr. Andrea PalermoAchondroplasiaSunday, May 1115:55-17:25 CESTRoom C2SymposiumAssessing HRQoL in Achondroplasia Across the Life CourseClick here to see the full session outline.Monday, May 1215:15-15:25 CESTRoom C2Oral PresentationEffects of Navepegritide on Bone Morphometry in Children with Achondroplasia: 52-Week Results from the ApproaCH Clinical TrialPresented by Dr. Leanne WardTuesday, May 1315:05-15:15 CESTRoom D2Oral PresentationEffects of Navepegritide on Growth in Children with Achondroplasia: 52-Week Results from the ApproaCH Clinical TrialPresented by Dr. Hanne HoveGrowth Hormone DeficiencyTuesday, May 1314:45-14:55 CESTRoom D2Oral PresentationResults of the foresiGH Trial Support the Efficacy and Safety of Once-Weekly Lonapegsomatropin in Adults with Growth Hormone Deficiency (GHD)Presented by Dr. Aleksandra Gilis-Januszewska More information about the events and presentations listed here is available to registered attendees of the Joint ESPE & ESE 2025 congress. 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 AchondroplasiaAchondroplasia is a rare genetic condition arising from a systemic fibroblast growth factor receptor 3 (FGFR3) variant that leads to an imbalance in the effects of the FGFR3 and CNP signaling pathways, estimated to affect more than 250,000 people worldwide. While historically considered a bone growth disorder, the FGFR3 variant seen in achondroplasia is expressed in tissues throughout the body, causing serious muscular, neurological, and cardiorespiratory complications in addition to skeletal dysplasia. Medical complications of achondroplasia vary across different stages of life. Throughout infancy and childhood, observed complications include spinal deformities, enlarged brain ventricles, impaired muscle strength and stamina, hearing deficits and chronic ear infections, upper airway obstructions, sleep-disordered breathing, hip problems, leg bowing, and chronic pain; many of these persist or worsen in adulthood. These medical complications can have detrimental effects on quality of life, physical functioning, and psychosocial function. Individuals with achondroplasia often require multiple surgeries and procedures to alleviate the condition’s many complications. About Adult Growth Hormone DeficiencyGrowth hormone plays an essential role in the health of children and adults, promoting normal growth in children and maintenance of normal body composition and cardiometabolic health throughout adulthood. In adults, growth hormone boosts protein production, promotes fat utilization, enhances muscle mass, and helps regulate blood sugar levels. Adult GHD is a condition in which an individual’s body does not produce enough growth hormone. Symptoms and morbidity can include central obesity, metabolic syndrome, decreased bone density, alterations in lipid profile and markers of cardiovascular risk, fatigue, general weakness, lack of muscle tone, and psychological symptoms such as cognitive impairment, social isolation, lack of motivation, and depression. 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) the clinical benefits of Ascendis’ novel therapies, (ii) Ascendis’ ability to apply its TransCon technology platform to make a meaningful difference for patients, and (iii) 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, and TransCon are trademarks owned by the Ascendis Pharma group. © May 2025 Ascendis Pharma A/S. Investor Contacts: Scott Smith Ascendis Pharma ir@ascendispharma.com Media Contact:Melinda BakerAscendis Pharmamedia@ascendispharma.com Patti BankICR Healthcare+1 (415) 513-1284patti.bank@icrhealthcare.com

Phase 2Clinical Result

21 Mar 2025

·www.fiercepharma.com

Biotech designed to commercialize Ascendis' endocrinology drugs in China files $86M IPO

Visen Pharmaceuticals is designed to develop and commercialize Ascendis’ endocrinology therapies in greater China. Endocrine-disease-focused Visen Pharmaceuticals is making its public market debut in Hong Kong, filing papers for an $86.5 million IPO.The China-based biotech was formed in 2018 by Ascendis Pharma and an investor syndicate led by Vivo Capital. The biotech is designed to develop and commercialize Ascendis’ endocrinology therapies in greater China.Now, Visen is going public, with expected gross proceeds of $100 million, according to March 20 regulatory filings (PDF). The company has previously raised about $190 million, closing a $150 million series B financing in early 2021. That fundraise included OrbiMed, Logos Capital, Ascendis Pharma, Vivo Capital and Sofinnova Investments, among others.The company hosts three programs in its pipeline: Yorvipath (palopegteriparatide) for adults with chronic hypoparathyroidism; Skytrofa (lonapegsomatropin) for pediatric growth hormone deficiency; and navepegritide, an investigational prodrug of C-type natriuretic peptide for achondroplasia.

IPO

17 Mar 2025

·endpts.com

AstraZeneca reports Phase 3 success for rare disease drug at heart of Amolyt deal

AstraZeneca’s $1.05 billion bet on French biotech Amolyt Pharma seems to be paying off. On Monday, the UK drugmaker reported a late-stage success for the hypoparathyroidism drug that sparked the acquisition deal between the companies, saying eneboparatide met the composite primary endpoint in the 202-patient Phase 3 CALYPSO trial. Hypoparathyroidism occurs when a lack of parathyroid hormone leads to poor regulation of calcium and phosphate. This dysregulation causes a variety of problems, from chronic kidney disease to osteoporosis. Despite being classified as a rare disease, it affects more than 200,000 people in the US and Europe, according to AstraZeneca. Eneboparatide is a parathyroid hormone receptor 1 agonist. The trial measured levels of albumin-adjusted serum calcium, which can fall out of line in hypoparathyroidism patients, as well as whether patients were able to stop using vitamin D and oral calcium therapy, which is used to treat the disease. AstraZeneca didn’t provide data from the results, but said the drug met the primary endpoint and that it plans to present details at a medical meeting and share the results with regulators. “We look forward to reviewing clinical results at 52 weeks to fully characterise the risk-benefit profile,” Marc Dunoyer, CEO of AstraZeneca’s rare disease unit Alexion, said in the release. The development of eneboparatide was at the center of Amolyt’s $138 million Series C fundraise in early 2023, alongside another candidate for acromegaly. AstraZeneca purchased all of Amolyt’s outstanding shares for $800 million in March 2024. The biotech could also get $250 million more if it achieves an undisclosed regulatory milestone. If approved, eneboparatide would compete with Ascendis Pharma’s parathyroid hormone analog Yorvipath, which won FDA approval in August 2024 after a rejection the previous year. Another drug, Takeda’s Natpara, was approved for hypoparathyroidism in the US in 2015, but the company pulled it after facing manufacturing and supply issues. Editor’s note: This story has been corrected to reflect the discontinuation of Takeda’s drug.

Phase 3Clinical ResultAcquisitionDrug Approval

100 Deals associated with Palopegteriparatide

External Link

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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

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04701203 (PaTHway, CTgov)	Phase 3	Hypoparathyroidism	84	TransCon PTH (TransCon PTH)	swkrayulzp = zmsfzezuby iconmnizzh (lfdligxgpq, bihxjoemii - bzerjmsyvs) View more	-	28 Feb 2025
				Placebo (Placebo)	swkrayulzp = evqitzlmmw iconmnizzh (lfdligxgpq, wjqlsdzwds - ncfwaclwmv) View more
NCT05387070 (PaTHway, PRNewswire) Manual	Phase 3	Hypoparathyroidism	-	Palopegteriparatide	yhwhxuplya(gekbwcjlrk) = rikdsbjvgv mwpjybhkbq (eckrgibmcq ) View more	Positive	12 Aug 2024
				Placebo	yhwhxuplya(gekbwcjlrk) = vozepxiupq mwpjybhkbq (eckrgibmcq )
NCT04701203 (FDA_CDER) Manual	Phase 3	Hypoparathyroidism	82	YORVIPATH	bafeuyoqfc(xiiclpyooc) = xviccvcrdd shsyxrzqct (dosxrobozb ) View more	Positive	09 Aug 2024
				Placebo	bafeuyoqfc(xiiclpyooc) = esvkpszoab shsyxrzqct (dosxrobozb ) View more
NCT04701203 (PaTHway, GlobeNewswire) Manual	Phase 3	Hypoparathyroidism	82	TransCon PTH (palopegteriparatide)	tcrvrsayxk(rksdwtivmr) = hacvhldtob quogtxtfdu (vhpnnrmxfu ) View more	Positive	13 May 2024
				TransCon PTH (palopegteriparatide) (eGFR < 60 mL/min/1.73m2)	tcrvrsayxk(rksdwtivmr) = pymfffakzl quogtxtfdu (vhpnnrmxfu ) View more
NCT04009291 \| NCT04701203 \| NCT05387070 (PaTHway, ENDO2023)	Phase 3	Hypoparathyroidism	82	TransCon PTH	ddnvgoguyl(muiqlsnppw) = trended toward norms from baseline to Weeks 26 and 52 juwwtrrdbn (uomfeqrceg ) View more	Positive	05 Oct 2023
NCT04009291 \| NCT04701203 \| NCT05387070 (PaTHway, ENDO2022)	Phase 3	Hypoparathyroidism	82	TransCon PTH 18 mcg/d	hbrwpheeqh(ifgsbclrzg) = The most commonly reported study drug-related AEs were headaches idkljztjhi (lrkgzyjuoh ) View more	Positive	01 Nov 2022
				Placebo
PaTH Forward Trial (ENDO2022)	Phase 2	Hypoparathyroidism	59	TransCon PTH 15 mcg/d	gjkhennfjc(txnxhonowd) = ahlttaakhh bhmthfhnlr (hvjuzettwb ) View more	Positive	01 Nov 2022
				TransCon PTH 18 mcg/d	gjkhennfjc(txnxhonowd) = gsoxbsjldw bhmthfhnlr (hvjuzettwb ) View more
NCT04009291 (PaTH Forward, Corporate Publications) Manual	Phase 2	-	57	TransCon™ PTH	xpbsfnldqz(uaoalnhshs) = tmpziyznti xrxvimactc (oblyqfascq ) View more	Positive	12 Sep 2022
WCO_IOF_ESCEO2022	Not Applicable	Acromegaly PTH \| serum vitamin D metabolites	-	PTH (Acromegaly group)	ogeihgwgey(rxlpmmpuhe) = lower baseline levels hdiqklcsyk (vccwvsxlax ) View more	-	24 Mar 2022
				PTH (Control group)
NCT04701203 (Corporate Publications) Manual	Phase 3	Hypoparathyroidism	82	Palopegteriparatide	dpbvhncbpx(wmgakcnoei) = rgamixtbvc bxvpovuoid (iyjsbzpqjf, 66.3 - 88.1) View more	Positive	13 Mar 2022
				Placebo	dpbvhncbpx(wmgakcnoei) = bgabaslfjv bxvpovuoid (iyjsbzpqjf, 0.1 - 23.8) View more

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