Drugs / Parathyroid Hormone
Parathyroid Hormone
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Natpar | — | 2026-07-01 | europa.eu ↗ |
| Approved · conditional | EU (EMA) | Natpar | — | 2017-04-24 | europa.eu ↗ |
| Approved | US (FDA) | NATPARA | — | 2015-01-23 | fda.gov ↗ |
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT05137730 | Nov 2021 → Apr 2022 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT03150108 | May → Jun 2017 | hypoparathyroidism | Shire | Completed | No outcome recorded |
| Phase 1 | NCT02781844 | Apr 2017 → Mar 2019 | hypoparathyroidism | Shire | Completed | No outcome recorded |
| Phase 1 | NCT02478879 | Jun → Nov 2015 | postmenopausal osteoporosis | Zosano Pharma Corporation | Completed | No outcome recorded |
| Phase 1 | NCT00299780 | Jul 2004 → Apr 2007 | acute myeloid leukemia, plasma cell myeloma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00007306 | Jan 2000 → Apr 2005 | psoriasis | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00172107 | May 1995 → Mar 1997 | osteoporosis | Shire | Completed | No outcome recorded |
| Phase 313 trials · 5 met primary | ||||||
| Phase 3 | NCT03878953 | Aug 2022 → May 2023 | hypoparathyroidism | Shire | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT03364738 | Sep 2018 → Apr 2020 | hypoparathyroidism | Shire | Terminated | No outcome recorded |
| Phase 3 | NCT01455181 | Aug 2011 → Apr 2012 | hypoparathyroidism | Shire | Completed | Met primary |
| Phase 3 | NCT01297309 | Apr 2011 → Jun 2018 | hypoparathyroidism | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01268098 | Feb → Sep 2011 | hypoparathyroidism | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01199614 | Dec 2009 → Jun 2017 | hypoparathyroidism | Columbia University | Completed | No outcome recorded |
| Phase 3 | NCT00732615 | Dec 2008 → Sep 2011 | hypoparathyroidism | Shire | Completed | Met primary |
| Phase 3 | NCT00365456 | Jul 2006 → Jan 2011 | osteoporosis | Takeda | Completed | Met primary |
| Phase 3 | NCT00172120 | Jan 2005 → Oct 2006 | osteoporosis | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00172172 | Jan 2004 → Mar 2005 | osteoporosis | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00172133 | Oct 2001 → Apr 2005 | osteoporosis | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00172081 | Apr 2000 → Nov 2003 | osteoporosis | Shire | Completed | Met primary |
| Phase 3 | NCT00000427 | Sep 1999 → Oct 2005 | osteoporosis | Massachusetts General Hospital | Completed | Met primary |
| Phase 43 trials · 1 met primary | ||||||
| Phase 4 | NCT03324880 | Jan 2018 → May 2022 | hypoparathyroidism | Shire | Completed | Met primary |
| Phase 4 | NCT02910466 | Oct 2016 → Dec 2019 | hypoparathyroidism | Shire | Completed | No outcome recorded |
| Phase 4 | NCT00583518 | Nov 2007 → Nov 2011 | postmenopausal osteoporosis | Nycomed | Completed | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 2 | NCT03516773 Comparator | Jun → Dec 2018 | hypoparathyroidism | Entera Bio Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00730210 Comparator | Jun 2008 → Aug 2010 | hypoparathyroidism | University of Aarhus | Completed | No outcome recorded |
| Phase 2 | NCT00005006 Comparator | Sep 1987 → Feb 2003 | osteoporosis | Helen Hayes Hospital | Completed | No outcome recorded |
| Phase 2/3 | NCT00683163 Comparator | May 2008 → Apr 2011 | osteoporosis | University of California, San Francisco | Completed | No outcome recorded |
| Phase 3 | NCT01466829 Comparator | Oct 2012 → Mar 2014 | — | University of Aarhus | Completed | No outcome recorded |
| Phase 3 | NCT00856401 Background | Sep 2010 → Dec 2020 | hypoparathyroidism | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Unknown | No outcome recorded |
| Phase 4 | NCT00479037 Comparator | Apr 2007 → Feb 2009 | osteoporosis | Nycomed | Completed | No outcome recorded |
| Phase 4 | NCT00221299 Comparator | Sep 2005 → Mar 2009 | osteoporosis | University of California, Davis | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2019-09-05 | Takeda | Regulatory Takeda Issues US Recall of NATPARA ® (parathyroid hormone) for Injection Due to the Potential for Rubber Particulate takeda.com ↗
Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that the company is issuing a US recall for all doses of NATPARA ® (parathyroid hormone) for Injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg). |
| 2019-03-26 | Takeda | Results Takeda Presents New Data at the Endocrine Society's 2019 Annual Meeting about the Patient Burden and Long-Term Impact of Chronic Hypoparathyroidism takeda.com ↗
Final outcomes of 6 year study into continuous use of rhPTH(1-84) shows improvements in key measurements of mineral homeostasis |
| 2018-11-08 | Entera Bio Ltd. | Results Entera Bio Reports Positive Results from Part 1 of a Phase 2 PK/PD Study of Oral PTH (1-34) in Patients with Hypoparathyroidism enterabio.com ↗
In addition to positively impacting the levels of serum calcium, phosphate, and active vitamin D (1,25-dihydroxy vitamin D), we also observed a significant decrease in 24-hour urinary calcium levels in hypoparathyroid patients treated for one day with Oral PTH (1-34). |
| 2018-05-22 | Takeda | Results Shire announces new hypoparathyroidism data at the 2018 European Congress of Endocrinology takeda.com ↗
Shire furthers the understanding of chronic hypoparathyroidism with data presented on new hypotheses about long-term treatment effects in patients as well as with safety and efficacy data for rhPTH (1-84) from the Open-Label RACE Study |
| 2018-03-20 | Takeda | Results New Data Presented at the Endocrine Society’s 2018 Annual Meeting Advances Understanding of the Rare Disease Chronic Hypoparathyroidism takeda.com ↗
The analysis outcomes revealed that the efficacy composite endpoint was achieved by 28 of 40 patients* (70.0%) at month 60. |
| 2017-04-26 | Takeda | Regulatory Shire Granted EU Conditional Marketing Authorisation for Natpar®▼ (Parathyroid Hormone) for the Treatment of Patients with Chronic Hypoparathyroidism takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the European Commission (EC) has granted Conditional Marketing Authorisation for Natpar (rhPTH[1-84]), the first recombinant human protein with the full length 84-amino acid sequence of endogenous parathyroid hormone (PTH). |
| 2017-02-24 | Takeda | Regulatory CHMP Recommends EU Conditional Marketing Authorisation for Natpar® (Parathyroid Hormone) for Patients with Chronic Hypoparathyroidism takeda.com ↗ |
| 2015-01-23 | Takeda | Regulatory Shire Comments On Press Release From NPS Pharma Regarding FDA Approval Of NATPARA® (Parathyroid Hormone) takeda.com ↗
The FDA’s approval of NATPARA provides a new treatment option for patients with hypoparathyroidism – a devastating rare disease with significant unmet need. |
All press releases naming this drug 9 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | parathyroid hormone | “The effects of treatment with 100 μg parathyroid hormone (PTH) (1-84) or an identical placebo on muscle function and quality of life (QoL) was studied in hypoparathyroid patients.” PMID 24687385 ↗ Apr 20149“The purpose of this study is to determine which of two delivery methods of Parathyroid Hormone (PTH) is preferred by patients after 14 days of use for each.” NCT02478879 ↗ “Phase I Study of Parathyroid Hormone in Combination With G-CSF in Patients Requiring Additional Stem Cell Mobilization” NCT00299780 ↗ |
| Known as | ALX1-11 | “Recombinant Human Parathyroid Hormone (ALX1-11) in Postmenopausal Women With Osteoporosis” NCT00172172 ↗ |
| Known as | Full Length Parathyroid Hormone | “Drug: Full Length Parathyroid Hormone, PTH(1-84)” NCT00479037 ↗ |
| Known as | NATPARA/NATPAR | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03516773 ↗ |
| Known as | NPSP558 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01297309 ↗ |
| Known as | parathyroid hormone (1-84) | “Postmenopausal women treated with combination parathyroid hormone (1-84) and ibandronate demonstrate different microstructural changes at the radius vs. tibia: the PTH and...” PMID 23589163 ↗ Apr 2013 |
| Known as | PTH | “Topical Administration of Parathyroid Hormone (PTH) in Psoriasis” NCT00007306 ↗4“Parathyroid hormone (PTH) is a well known anabolic drug” NCT01466829 ↗ “full length Parathyroid Hormone (PTH 1-84)” NCT00365456 ↗ “human parathyroid hormone (PTH)” NCT00005006 ↗ “Parathyroid hormone (PTH)” NCT00583518 ↗ |
| Known as | PTH (1-84) | “full length Parathyroid Hormone (PTH 1-84)” NCT00365456 ↗ |
| Known as | recombinant human parathyroid hormone | “This is an Open Label Extension Study (OLES) for patients who participated in the 18 month double-blind, placebo-controlled, Phase III trial (Protocol ALX1 11 93001 the TOP...” NCT00172133 ↗1“Recombinant Human Parathyroid Hormone (rhPTH [1-84])” NCT02781844 ↗ |
| Known as | recombinant human parathyroid hormone (1-84) | “PARALLAX was a mandatory post-marketing trial assessing pharmacokinetics and pharmacodynamics of different dosing regimens of recombinant human parathyroid hormone 1-84...” PMID 38741607 ↗ Jan 20243“Recombinant human parathyroid hormone (1-84) (rhPTH[1-84]) is a therapy targeting the pathophysiology of HypoPT by replacing parathyroid hormone.” PMID 32738041 ↗ Oct 2020 “NPS Allelix Corp. is developing ALX1-11, recombinant human parathyroid hormone (1-84), for the treatment of osteoporosis.” NCT00172081 ↗ “Patients received recombinant human parathyroid hormone (1-84) or placebo.” PMID 41847596 ↗ Mar 2026 |
| Known as | rhPTH [1-84] | “This is an Open Label Extension Study (OLES) for patients who participated in the 18 month double-blind, placebo-controlled, Phase III trial (Protocol ALX1 11 93001 the TOP...” NCT00172133 ↗13“CONTEXT: Chronic hypoparathyroidism (HypoPT) is conventionally managed with oral calcium and active vitamin D. Recombinant human parathyroid hormone (1-84) (rhPTH[1-84]) is a...” PMID 32738041 ↗ Oct 2020 “PARALLAX was a mandatory post-marketing trial assessing pharmacokinetics and pharmacodynamics of different dosing regimens of recombinant human parathyroid hormone 1-84...” PMID 38741607 ↗ Jan 2024 “NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism” NCT01297309 ↗ “recombinant human parathyroid hormone (1-84) [rhPTH(1-84)] compared with placebo” PMID 40711996 ↗ Jul 2025 “fixed 25- or 50-μg/d doses of subcutaneous rhPTH(1-84)” PMID 28942334 ↗ Sep 2017 “Recombinant Human Parathyroid Hormone (rhPTH [1-84])” NCT02781844 ↗ |
| Action | Restore | “Recombinant human parathyroid hormone (1-84) (rhPTH[1-84]) is a therapy targeting the pathophysiology of HypoPT by replacing parathyroid hormone.” PMID 32738041 ↗ Oct 2020 |
| Modality | Protein / enzyme biologic | “PTH is a protein hormone that increases the calcium and phosphorus release from bone, leading to formation of new bone.” NCT00000427 ↗ |
| Route | Subcutaneous | “PTH alone by daily injection under the skin” NCT00000427 ↗ |