Parathyroid hormone
- Generic Name
- Parathyroid hormone
- Brand Names
- Natpara, Natpar
- Drug Type
- Biotech
- CAS Number
- 9002-64-6
- Unique Ingredient Identifier
- N19A0T0E5J
- Background
Parathyroid hormone (PTH) is a single-chain polypeptide composed of 84 amino acids. Available as Preotact, it is an identical form of human recombinant hormome which produced as a fusion protein undergoeing post-translational processing involving the cleavage of the OmpA leader sequence, leaving the mature protein as a single-chain 84 amino-acids polypeptide (9.4 kDa).
Preotact is used in the treatment of osteoporosis in postmenopausal women at high risk of osteoporotic fractures and is marketed in Europe by Nycomed. Preos is a registered trade mark owned by NPS Pharmaceuticals, Inc. The name Preos and the New Drug Application is pending approval by the U.S. Food and Drug Administration (FDA).
- Indication
For use/treatment in osteoporosis.
- Associated Conditions
- Hypocalcemia, Hypoparathyroidism
PaTHway CHINA TRIAL: A Trial to Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism
- Conditions
- Endocrine System DiseasesParathyroid DiseasesHypoparathyroidismParathyroid Hormone Deficiency
- Interventions
- Drug: placebo
- First Posted Date
- 2022-05-24
- Last Posted Date
- 2022-05-24
- Lead Sponsor
- Visen Pharmaceuticals (Shanghai) Co., Ltd.
- Target Recruit Count
- 76
- Registration Number
- NCT05387070
- Locations
- 🇨🇳
Peking Union Medical College Hospital, Beijing, Beijing, China
A Study of Relative Bioavailability of a New Formulation Compared With the Approved Formulation of rhPTH [1-84] and to Find Out Dose Linearity of the New Formulation in Healthy Adults
- First Posted Date
- 2021-11-30
- Last Posted Date
- 2023-12-15
- Lead Sponsor
- Takeda
- Target Recruit Count
- 96
- Registration Number
- NCT05137730
- Locations
- 🇺🇸
Celerion, Tempe, Arizona, United States
A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism
- First Posted Date
- 2019-03-18
- Last Posted Date
- 2022-10-10
- Lead Sponsor
- Shire
- Registration Number
- NCT03878953
- Locations
- 🇯🇵
Osaka City University Hospital, Osaka-shi, Osaka-Fu, Japan
🇯🇵Shimane University Hospital, Izumo-shi, Shimane-Ken, Japan
🇯🇵University of Tokyo Hospital, Bunkyo-ku, Tokyo-To, Japan
Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects
- First Posted Date
- 2017-05-12
- Last Posted Date
- 2021-06-08
- Lead Sponsor
- Shire
- Target Recruit Count
- 24
- Registration Number
- NCT03150108
- Locations
- 🇺🇸
Glendale Adventist Medical Center, Glendale, California, United States
A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism
- Conditions
- Chronic HypoparathyroidismHypoparathyroidism
- Interventions
- First Posted Date
- 2016-09-22
- Last Posted Date
- 2021-07-28
- Lead Sponsor
- Shire
- Target Recruit Count
- 39
- Registration Number
- NCT02910466
- Locations
- 🇺🇸
Columbia University Medical Center, New York, New York, United States
Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism
- Conditions
- Hypoparathyroidism
- Interventions
- First Posted Date
- 2016-05-25
- Last Posted Date
- 2021-05-25
- Lead Sponsor
- Shire
- Target Recruit Count
- 34
- Registration Number
- NCT02781844
- Locations
- 🇺🇸
Mayo Clinic - PPDS, Rochester, Minnesota, United States
🇭🇺Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged, Csongrád, Hungary
🇨🇦CHU de Quebec-Universite Laval, Quebec, Canada
MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint Project I
- Conditions
- Breast Cancer
- Interventions
- Drug: TAC chemotherapyDrug: TCH chemotherapyDrug: TC chemotherapyDrug: T + trastuzumab followed by CEF + trastuzumabDrug: Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapyDrug: Dose dense AC followed by T + trastuzumabDrug: Dose dense AC followed by T + trastuzumab + pertuzumab
- First Posted Date
- 2011-12-29
- Last Posted Date
- 2018-06-28
- Lead Sponsor
- Agendia
- Target Recruit Count
- 226
- Registration Number
- NCT01501487
- Locations
- 🇺🇸
University of Miami, Miami, Florida, United States
🇺🇸Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸University of South Alabama, Mitchell Cancer Institute, Mobile, Alabama, United States
Treatment With PTH After Sternotomy in Cardiac Surgery Patients
- Conditions
- Disruption or Dehiscence of Closure of Sternum or Sternotomy
- Interventions
- Drug: Placebo
- First Posted Date
- 2011-11-08
- Last Posted Date
- 2014-06-02
- Lead Sponsor
- University of Aarhus
- Target Recruit Count
- 20
- Registration Number
- NCT01466829
- Locations
- 🇩🇰
Dept. of Cardiothoracic & Vascular Surgery, AArhus University Hospital, Skejby, Aarhus N, Denmark
A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary
- First Posted Date
- 2011-10-19
- Last Posted Date
- 2021-06-11
- Lead Sponsor
- Shire
- Target Recruit Count
- 24
- Registration Number
- NCT01455181
- Locations
- 🇭🇺
Semmelweis University Medical School, Budapest, Hungary
🇭🇺University of Szeged, Szeged, Hungary
🇭🇺University of Pécs, School of Medicine, Pécs, Hungary
One Week Comparison Study of PTH and PTHrP Infusions
- Conditions
- HyperparathyroidismHypercalcemia of MalignancyBone Diseases, EndocrineOsteoporosis
- Interventions
- Drug: Parathyroid Hormone-related Protein (1-36)
- First Posted Date
- 2011-04-11
- Last Posted Date
- 2014-12-05
- Lead Sponsor
- University of Pittsburgh
- Registration Number
- NCT01333267
- Locations
- 🇺🇸
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Drug Development Updates
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