This clinical study aims to evaluate the safety and efficacy of repeated dosing of recombinant human parathyroid hormone (rhPTH[1-84]) in Japanese participants with chronic hypoparathyroidism for a 26-week period.

Start Date31 Aug 2022

Sponsor / Collaborator

Shire Plc

ChiCTR2300067899 / RecruitingPhase 4IIT

Clinical study of recombinant human parathyroid hormone in the treatment of osteoradionecrosis of the jaws

Start Date30 Jun 2022

Sponsor / Collaborator-

NCT05137730 / CompletedPhase 1

A Randomized, Open-label, Single-center, Single-dose Study to Evaluate the Relative Bioavailability of a New Formulation Compared With the Approved Formulation of Recombinant Human Parathyroid Hormone (rhPTH[1-84]) and to Assess Dose Linearity of the New Formulation in Healthy Subjects

The main aim of Part I of this study is to evaluate the relative bioavailability of a new formulation compared with the approved formulation when a single dose of rhPTH(1-84) is given to healthy volunteers. Bioavailability is the ability of a drug to be absorbed and used by the body. In Part II, the main aim is to assess the dose linearity of the new formulation.
Participants will receive 2 doses in Part I and 4 doses in Part II.
Participants need to visit their doctor approximately 14 days and 30 days after the last dose of study drug.

Start Date29 Nov 2021

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Parathyroid Hormone(Shire Plc)

100 Translational Medicine associated with Parathyroid Hormone(Shire Plc)

100 Patents (Medical) associated with Parathyroid Hormone(Shire Plc)

8,909

Literatures (Medical) associated with Parathyroid Hormone(Shire Plc)

01 Apr 2024·Bioactive materials

A parathyroid hormone related supramolecular peptide for multi-functionalized osteoregeneration

Article

Author: Wang, Ying ; Guo, Xiaodong ; Wang, Junwu ; Chen, Tianhong ; Wang, Yi ; Hu, Yingkun ; Hao, Zhuowen ; Li, Jingfeng ; Yang, Zhiqiang ; Chen, Renxin ; Li, Hanke ; Chen, Jiayao ; Feng, Qinyu ; Lv, Xuan

Supramolecular peptide nanofiber hydrogels are emerging biomaterials for tissue engineering, but it is difficult to fabricate multi-functional systems by simply mixing several short-motif-modified supramolecular peptides because relatively abundant motifs generally hinder nanofiber cross-linking or the formation of long nanofiber. Coupling bioactive factors to the assembling backbone is an ideal strategy to design multi-functional supramolecular peptides in spite of challenging synthesis and purification. Herein, a multi-functional supramolecular peptide, P1R16, is developed by coupling a bioactive factor, parathyroid hormone related peptide 1 (PTHrP-1), to the basic supramolecular peptide RADA16-Ⅰ via solid-phase synthesis. It is found that P1R16 self-assembles into long nanofibers and co-assembles with RADA16-Ⅰ to form nanofiber hydrogels, thus coupling PTHrP-1 to hydrogel matrix. P1R16 nanofiber retains osteoinductive activity in a dose-dependent manner, and P1R16/RADA16-Ⅰ nanofiber hydrogels promote osteogenesis, angiogenesis and osteoclastogenesis in vitro and induce multi-functionalized osteoregeneration by intramembranous ossification and bone remodeling in vivo when loaded to collagen (Col) scaffolds. Abundant red blood marrow formation, ideal osteointegration and adapted degradation are observed in the 50% P1R16/Col scaffold group. Therefore, this study provides a promising strategy to develop multi-functional supramolecular peptides and a new method to topically administrate parathyroid hormone or parathyroid hormone related peptides for non-healing bone defects.

01 Feb 2024·Bone

Parathyroid hormone and trabectedin have differing effects on macrophages and stress fracture repair

Article

Author: Grewal, Jobanpreet ; Sinder, Benjamin P ; Roca, Hernan ; Batoon, Lena ; McCauley, Laurie K ; Woo, Cecilia ; Stephan, Chris ; Koh, Amy J ; Kozloff, Kenneth ; Do, Justin ; Ulrich, Emily ; Mishina, Yuji ; Zweifler, Laura E

Stress fractures occur as a result of repeated mechanical stress on bone and are commonly found in the load-bearing lower extremities. Macrophages are key players in the immune system and play an important role in bone remodeling and fracture healing. However, the role of macrophages in stress fractures has not been adequately addressed. We hypothesize that macrophage infiltration into a stress fracture callus site promotes bone healing. To test this, a unilateral stress fracture induction model was employed in which the murine ulna of four-month-old, C57BL/6 J male mice was repeatedly loaded with a pre-determined force until the bone was displaced a distance below the threshold for complete fracture. Mice were treated daily with parathyroid hormone (PTH, 50 μg/kg/day) starting two days before injury and continued until 24 h before euthanasia either four or six days after injury, or treated with trabectedin (0.15 mg/kg) on the day of stress fracture and euthanized three or seven days after injury. These treatments were used due to their established effects on macrophages. While macrophages have been implicated in the anabolic effects of PTH, trabectedin, an FDA approved chemotherapeutic, compromises macrophage function and reduces bone mass. At three- and four-days post injury, callus macrophage numbers were analyzed histologically. There was a significant increase in macrophages with PTH treatment compared to vehicle in the callus site. By one week of healing, treatments differentially affected the bony callus as analyzed by microcomputed tomography. PTH enhanced callus bone volume. Conversely, callus bone volume was decreased with trabectedin treatment. Interestingly, concurrent treatment with PTH and trabectedin rescued the reduction observed in the callus with trabectedin treatment alone. This study reports on the key involvement of macrophages during stress fracture healing. Given these observed outcomes on macrophage physiology and bone healing, these findings may be important for patients actively receiving either of these FDA-approved therapeutics.

01 Feb 2024·Biological trace element research

The Association Between Environmental Cadmium Exposure and Parathyroid Hormone Levels

Article

Author: Wang, Jiangchuan ; Wei, Zicheng ; Jin, Taiyi ; Wang, Rongzhou ; Zhu, Guoying ; Hu, Nandong ; Tang, Hongye ; Chen, Xiao

Cadmium exposure is associated with renal dysfunction and bone damage. Chronic kidney disease and bone loss are also related to parathyroid hormone (PTH). However, whether cadmium exposure affect PTH level is not completely understood. In this study, we observed the association between environmental cadmium exposure and PTH levels in a Chinese population. A ChinaCd study was performed in China in 1990s which included 790 subjects living in heavily, moderately and low cadmium polluted area. 354 of them (121 men and 233 women) also had the data of serum PTH. The cadmium levels in blood (BCd) and urine (UCd) were determined by flame atomic absorption spectrometry. Serum PTH was detected by immunoradiometric assay. Renal function was assessed based on urinary N-acetyl-β-d-glucosaminidase (UNAG), β₂-microglobulin (UBMG) and urinary albumin (UALB). The median BCd and UCd levels were 4.69 μg/L and 5.50 μg/g creatinine. The BCd, UCd, UNAG, UBMG and UALB levels in subjects with low PTH (< 5.0 ng/L) were significantly higher than those with PTH ≥ 5.0 ng/L (p < 0.05 or p < 0.01). Spearman correlation analysis also showed that UCd level was negatively correlated to PTH levels (r = -0.17, p = 0.008) in women. A weak correlation was also observed between PTH level and BCd in women (r = -0.11, p = 0.09) and UBMG in total population (r = -0.114, p = 0.07). Univariable and mutivariable logistic regression analysis both demonstrated that high BCd (> 10 μg/L) (odds ratio (OR) = 2.26, 95% confidence interval (CI):1.10-4.63; OR = 2.36, 95%CI: 1.11-5.05) and UCd level (> 20 μg/g cr) (OR = 2.84, 95% CI:1.32-6.10; OR = 2.97, 95%CI: 1.25-7.05) were associated with high risk of low PTH. Our data showed that environmental cadmium exposure was associated with low PTH level.

News (Medical) associated with Parathyroid Hormone(Shire Plc)

13 May 2024

·www.biospace.com

FDA Action Alert: Dynavax, Ascendis and BMS

Pictured: A scientist with pill bottles in front of FDA headquarters/Taylor Tieden for BioSpace May will be relatively slow for the FDA, with only four big target action dates. Among other announcements, the regulator is scheduled to release its verdicts on a hepatitis B vaccine for adults on hemodialysis and two potential indications for BMS's CAR-T therapy Breyanzi. Read below for more. Dynavax Proposes Hepatitis B Vaccine for Patients on Hemodialysis Today is the day by which the FDA is scheduled to publish its decision on Dynavax Technologies’ sBLA seeking to expand the label of its hepatitis B vaccine Heplisav-B for use in adults on hemodialysis. Heplisav-B won its initial U.S. approval in 2017 for the prevention of hepatitis B, caused by all known subtypes of the virus, in adults aged 18 years and above. According to its label, Heplisav is a recombinant protein vaccine comprised mainly of the hepatitis B surface antigen, which can prime the body to protect against the virus’ infection. Heplisav-B is designed to be administered in two doses, and is the only approved hepatitis B shot that completes the vaccination series in one month. The U.K.’s Medicines and Healthcare products Regulatory Agency granted Heplisav-B Marketing Authorization in February 2023. Dynavax reported that Heplisav-B brought in $213 million in net revenues in 2023, representing a 69% year-over-year increase. As of the end of December 2023, Heplisav-B controlled approximately 42% of the U.S. hepatitis B vaccine market, up from 35% at the end of 2022. In a statement accompanying the company’s full-year results, CEO Ryan Spencer said that Heplisav-B saw “record revenue growth” in 2023 and became the “market share leader in two largest growth segments.” These achievements will help Dynavax establish Hepliav-B as “the leading vaccine in the U.S. adult hepatitis B vaccine market,” he said. The company expects continued growth for Heplisav-B in 2024, anchored by the upcoming potential approval. Dynavax forecasts net product revenues of $265 million to $280 million for Heplisav-B this year. Ascendis Tries Again for Hypoparathyroidism Approval for TransCon PTH The FDA is scheduled on May 14 to release its verdict on Ascendis Pharma’s resubmission for its investigational drug TransCon PTH (palopegteriparatide), which is being proposed as a treatment for adults with hypoparathyroidism. Designed to be orally available and formulated to be long-acting, TransConPTH is a prodrug of the parathyroid hormone that works by restoring physiologic levels of the hormone for 24 hours each day. This mechanism of action could potentially allow it to counter hypoparathyroidism, a rare disorder characterized by the insufficiency of parathyroid hormone, in turn leading to low calcium and high phosphate levels. Patients with hypoparathyroidism experience weakness, muscle cramps and headaches, and the condition can lead to long-term complications such as calcium deposits in the eyes, brain and kidneys. Currently, hypoparathyroidism is managed through high-dose therapy with calcium and active vitamin D, which does not optimally control the condition. Ascendis first submitted a drug application for TransCon PTH in 2022, which the FDA rejected in May 2023, citing manufacturing concerns. The regulator did not identify problems with the drug’s safety or efficacy, and it did not ask for additional studies. Currently, TransCon PTH is approved in the U.K. and European Union, where it is marketed under the brand name Yorvipath. BMS Awaits Two Verdicts for CAR-T Therapy Breyanzi To close out the month, BMS is looking at two target action dates for its CAR-T therapy Breyanzi (lisocabtagene maraleucel): May 23 for relapsed or refractory follicular lymphoma (FL) and May 31 for relapsed or refractory mantle cell lymphoma (MCL). In FL, Breyanzi is backed by the Phase II single-arm TRASCEND FL study, which, with 213 enrolled patients, is the largest clinical trial so far to assess a CAR T therapy in relapsed or refractory indolent non-Hodgkin lymphoma, including FL. BMS presented data from TRANSCEND FL in December 2023, showing that Breyanzi elicited a 95.7% complete response rate in patients with high-risk relapsed or refractory FL when used in the second-line setting. Median progression-free survival had not been reached at the time. Meanwhile, BMS is backing Breyanzi’s MCL application with findings from the MCL cohort of the TRANSCEND NHL 001 study. Published in December 2023 in the Journal of Clinical Oncology, results from the pivotal Phase I trial demonstrated significant and clinically meaningful treatment responses in heavily pre-treated patients, most of whom achieved a complete response. Breyanzi is a CAR-T cell therapy that works by targeting the CD19 surface protein, which is commonly expressed on B cells. Once bound to CD19, Breyanzi proliferates, induces the release of proinflammatory cytokines and cell death in cancer cells. The FDA first approved Breyanzi in February 2021 for relapsed or refractory B-cell lymphoma. In March 2024, Breyanzi picked up two new approvals, one for chronic lymphocytic leukemia and the other for small lymphocytic leukemia. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Drug ApprovalClinical ResultPhase 2Phase 1Vaccine

09 May 2024

·www.globenewswire.com

Latest Clinical and Quality-of-Life Data for TransCon™ PTH (Palopegteriparatide)-Treated Adults with Chronic Hypoparathyroidism to Be Presented at ECE 2024

COPENHAGEN, Denmark, May 09, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that new TransCon PTH (palopegteriparatide) data supporting clinical and quality-of-life benefits in adult patients with chronic hypoparathyroidism will be presented at the European Congress of Endocrinology being held May 11-14, 2024, in Stockholm. Topics include an oral presentation of new 2-year results from a post-hoc analysis of the Phase 3 PaTHway Trial demonstrating sustained improvements in kidney function in adults with chronic hypoparathyroidism treated with TransCon PTH, as well as a symposium presentation on health and quality-of-life improvements in patients switching from rhPTH(1-84) to TransCon PTH as part of a compassionate use program. “We are pleased to partner with leading experts in endocrinology to present this new, groundbreaking data showing the health and quality-of-life benefits of initiating or switching to TransCon PTH treatment,” said Aimee Shu, M.D., Ascendis Pharma’s Senior Vice President of Clinical Development, Endocrine Medical Sciences. The full schedule of Ascendis presentations during ECE 2024 follow: Sunday, May 122:50 pm (2:40 pm session)Rooms A2-A3Oral PresentationSustained Improvement in Renal Function with Palopegteriparatide in Adults with Chronic Hypoparathyroidism: 2-Year Results from the Phase 3 PaTHway TrialDr. Peter SchwarzMonday, May 1312:40 – 1:55 pmRoom A7SymposiumReplacing What’s Missing in Chronic Hypoparathyroidism – Treatment with Palopegteriparatide Hypoparathyroidism, Current Management and Palopegteriparatide Dr. Andrea PalermoBone Metabolism & New 2-Year Renal Data Dr. Peter SchwarzPatient-Reported Outcomes & Initial Data from Compassionate Use of PalopegteriparatideDr. Heide Siggelkow 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 kidneys and indirectly on the intestines. 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 TransCon PTHTransCon PTH (palopegteriparatide) is a prodrug of parathyroid hormone (PTH 1-34) administered once daily, designed to provide parathyroid hormone levels within the normal physiological range across the 24-hour dosing period. TransCon PTH was granted marketing authorization under the brand name YORVIPATH® by the European Commission (EC) and the European Economic Area in November 2023 and by the United Kingdom’s Medicines & Healthcare Products Regulatory Agency (MHRA) in Great Britain in April 2024 as a PTH replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. In the United States, the U.S. Food & Drug Administration (FDA) has set a PDUFA date of May 14, 2024 to complete their review of Ascendis Pharma’s New Drug Application for TransCon PTH for adults with chronic hypoparathyroidism. TransCon PTH is also in development in Japan through Teijin Ltd. and in China through VISEN Pharmaceuticals. About Ascendis Pharma A/SAscendis 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) TransCon PTH’s PDUFA date of May 14, 2024, (ii) Ascendis’ ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company and (iii) 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 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. 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 7, 2024 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. © May 2024 Ascendis Pharma A/S. Investor Contacts: Media Contact:Tim Lee Melinda BakerAscendis Pharma Ascendis Pharma+1 (650) 374-6343 +1 (650) 709-8875tle@ascendispharma.com media@ascendispharma.com ir@ascendispharma.com Patti Bank ICR Westwicke +1 (415) 513-1284 patti.bank@westwicke.com

Phase 3Drug Approval

14 Mar 2024

·medcitynews.com

AstraZeneca Acquisition Brings Drug to Fill a Rare Disease Gap Left by Takeda

AstraZeneca is bolstering its rare disease pipeline with a deal to buy Amolyt Pharma, a biotech company in late-stage development with a therapy designed to treat a rare hormone deficiency whose only FDA-approved treatment will soon cease production. According to deal terms announced Thursday, AstraZeneca is paying Amolyt shareholders $800 million up front. Another $250 million is tied to the achievement of a regulatory milestone that was not disclosed. Considering that the drug is in Phase 3 testing, that milestone could be a regulatory approval. Lyon, France-based Amolyt is developing a therapy for hypoparathyroidism, a disease in which the parathyroid glands do not produce enough parathyroid hormone. This hormone is important for regulating calcium and phosphate levels in the blood. Disease symptoms include tingling or burning sensations in the fingertips and toes, muscle aches or cramps, muscle twitching or spasms, and fatigue. Hypoparathyroidism disproportionately affects women. Calcium and vitamin D supplements can help, but at high doses, calcium supplements can lead to gastrointestinal problems such as constipation. When supplements alone aren’t enough to manage hypoparathyroidism, the only FDA-approved therapy is Natpara, an engineered version of parathyroid hormone sold by Takeda Pharmaceutical. Amolyt could bring patients a different way to manage hypoparathyroidism. The biotech’s drug candidate, eneboparatide, is a peptide designed to bind to PTH receptor 1, the receptor that native parathyroid hormone binds to. In Phase 2 results reported in 2022, Amolyt said its drug led to normal calcium levels in the blood as well the potential to eliminate the need for daily calcium and vitamin D supplements. Furthermore, the drug preserved bone mineral density, which is important for patients at higher risk of developing bone problems such as osteopenia or osteoporosis. The market need for new hypoparathyroidism treatments is becoming urgent. Takeda’s Natpara (Natpara outside of the U.S.) has had a rocky commercialization history since its FDA approval in 2015. In 2019, the FDA issued a recall due to potential contamination from tiny rubber particles from the cartridge housing the injectable product. Takeda’s efforts to resolve the problem to the FDA’s satisfaction have been unsuccessful. In late 2022, Takeda said it planned to discontinue manufacturing of Natpara/Natpar by the end of 2024. After that, the company said it would supply the remaining doses of the drug until inventory is depleted or the product is expired. The Amolyt acquisition brings AstraZeneca into a group of companies vying to fill the hypoparathyroidism treatment need that will be left when Takeda’s drug is no longer available. Extend Biosciences is in Phase 1 testing with a drug derived from parathyroid hormone. MBX Biosciences has reached Phase 2 testing with a peptide drug. Both drug candidates are injectable. Septerna is developing an oral drug for hypoparathyroidism. Last year, the South San Francisco-based startup raised $150 million in financing to advance the small molecule to Phase 1 testing. Amolyt last raised money in early 2023, a €130 million (about $138 million) Series C financing to support its pipeline. Besides the hypoparathyroidism program, that pipeline includes AZP-3813, a potential treatment for acromegaly, a disease in which the body produces too much growth hormone. Phase 1 testing began last summer. Amolyt has said it expects preliminary data in the first half of 2024. AstraZeneca expects to complete the Amolyt acquisition by the end of the third quarter of this year. When the deal closes, Amolyt will become part of Alexion, AstraZeneca Rare Disease, the pharmaceutical giant’s Boston-based rare disease division. AstraZeneca said the acquisition will enable it to expand its rare disease research into endocrinology. “Chronic hypoparathyroid patients face a significant need for an alternative to current supportive therapies, which do not address the underlying hormone deficiency,” Marc Dunoyer, CEO of Alexion, AstraZeneca Rare Disease, said in a prepared statement. “As leaders in rare disease, Alexion is uniquely positioned to drive the late-stage development and global commercialization of eneboparatide, which has the potential to lessen the often debilitating impact of low parathyroid hormone and avoid the risks of high-dose calcium supplementation.”

AcquisitionPhase 2Phase 3Drug Approval

100 Deals associated with Parathyroid Hormone(Shire Plc)

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KEGG	Wiki	ATC	Drug Bank
-	Parathyroid Hormone(Shire Plc)	H05AA03	DB05829

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypoparathyroidism	EU	Takeda Pharmaceuticals International AG	24 Apr 2017
Hypoparathyroidism	IS	Takeda Pharmaceuticals International AG	24 Apr 2017
Hypoparathyroidism	LI	Takeda Pharmaceuticals International AG	24 Apr 2017
Hypoparathyroidism	NO	Takeda Pharmaceuticals International AG	24 Apr 2017
Hypocalcemia	US	Takeda Pharmaceuticals U.S.A., Inc.	23 Jan 2015
Osteoporosis, Postmenopausal	EU	NPS Pharma Holdings Ltd.	24 Apr 2006
Osteoporosis, Postmenopausal	IS	NPS Pharma Holdings Ltd.	24 Apr 2006
Osteoporosis, Postmenopausal	LI	NPS Pharma Holdings Ltd.	24 Apr 2006
Osteoporosis, Postmenopausal	NO	NPS Pharma Holdings Ltd.	24 Apr 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoporosis	Phase 3	US	Shire Plc	10 Jan 2004
Osteoporosis	Phase 3	AR	Shire Plc	10 Jan 2004
Osteoporosis	Phase 3	MX	Shire Plc	10 Jan 2004
Fractures, Bone	Phase 3	US	Shire Plc	27 Apr 2000
Fractures, Bone	Phase 3	AR	Shire Plc	27 Apr 2000
Fractures, Bone	Phase 3	BR	Shire Plc	27 Apr 2000
Fractures, Bone	Phase 3	BG	Shire Plc	27 Apr 2000
Fractures, Bone	Phase 3	CA	Shire Plc	27 Apr 2000
Fractures, Bone	Phase 3	IL	Shire Plc	27 Apr 2000
Fractures, Bone	Phase 3	MX	Shire Plc	27 Apr 2000

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03324880 (CTgov)	Phase 4	Hypoparathyroidism	93	Placebo (Placebo)	nslfwtrgbt(omfrhqxesz) = uakguayfrp almxflkqfc (twlfsqsxvh, oqygaplnxx - wucvbdaorc) View more	-	09 Jun 2023
				rhPTH (1-84) (rhPTH (1-84))	nslfwtrgbt(omfrhqxesz) = xucgygmctx almxflkqfc (twlfsqsxvh, obukusbanw - pqacadamow) View more
Pubmed	Not Applicable	Hypoparathyroidism	72	rhPTH(1-84)	ebvpfaqjpv(dbncwrplmz) = xnmwdoimdc qhulesyufc (fgosycjtzl )	Positive	26 Aug 2022
				rhPTH(1-84) (Control)	ebvpfaqjpv(dbncwrplmz) = lpdywjsdzi qhulesyufc (fgosycjtzl, 1.67 mL/min/1.73 m^2 per year)
REPLACE (NCT00732615), RELAY (NCT01268098), RACE (NCT01297309) (Pubmed)	Not Applicable	Hypoparathyroidism	113	rhPTH(1-84)	dlvkpuiivm(wntzlrjyqr) = rvvppmkexm qqptfccasc (nhhyxjamrs )	-	11 Jun 2022
				rhPTH(1-84) (Control)	dlvkpuiivm(wntzlrjyqr) = ssnoaayffi qqptfccasc (nhhyxjamrs )
MO541 (ERA2022)	Not Applicable	Hyperparathyroidism, Secondary PTH \| calcium \| phosphorus ... View more	210	Parathyroid Hormone	jqhxtycprs(rfvwyuirnp) = gfhlzsevie psbhxyyjkg (xfphzaixzk, 667 - 1078)	Positive	03 May 2022
				Parathyroid Hormone	jqhxtycprs(rfvwyuirnp) = mhokgzbvek psbhxyyjkg (xfphzaixzk, 225 - 400)
MO033 (ERA2022)	Not Applicable	Polycystic Kidney, Autosomal Dominant parathyroid hormone \| vitamin D \| tubular reabsorption of phosphates ... View more	87	Parathyroid hormone	rpndmofyso(jzqckgvyrs) = gculttkgpc yfcqnlvazc (rpgzscozow, 403 - 1184)	Positive	03 May 2022
				Parathyroid hormone	rpndmofyso(jzqckgvyrs) = dfeleeenqo yfcqnlvazc (rpgzscozow, 258 - 576)
ESC2021	Not Applicable	Hypertension, Pulmonary PTH	20	PTH treatment	rqtfcvbjzw(erkqkfhdgs) = czzfykyplx mhfsnrdsdb (gqmsexjohd )	-	27 Aug 2021
				Parathyroid hormone	rqtfcvbjzw(erkqkfhdgs) = emhpqiqwcc mhfsnrdsdb (gqmsexjohd )
NCT02910466 (CTgov)	Phase 4	Hypoparathyroidism	39	rhPTH(1-84)	ocmijssrng(ljrervgehr) = anzdwsrutr bmduytmdkb (qhwimizwmr, vecsnnxiii - pydtprhlnt) View more	-	28 Jul 2021
NCT03364738 (PARALLAX, CTgov)	Phase 3	Hypoparathyroidism	22	rhPTH(1-84)	jtyufryqll(ofphylcmdb) = uykvpqvoxr usbqfrbljx (jwwzxjrsyn, hgdvncfuxs - abichegbod) View more	-	16 Jun 2021
ASGCT2021	Not Applicable	Hypoparathyroidism	-	Synthetic PTH hormone	lodftvrwga(mcwxohnnjx) = bbsxnzjasx tlfcplmbzl (tnuqdqxiav )	-	27 Apr 2021
				Allogeneic cell-based therapy	lodftvrwga(mcwxohnnjx) = xqnclcdtpo tlfcplmbzl (tnuqdqxiav )

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