Parathyroid hormone (PTH) is an 84-amino acid peptide that regulates the function of osteoblasts and osteocytes and is secreted by the parathyroid gland in response to changes in the concentration of extracellular calcium. Parathyroid hormone is approved under the brand name NATPARA as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. It is also available for treatment of postmenopausal osteoporosis in many European countries. Parathyroid hormone is an activator of parathyroid hormone 2 receptor. In addition, was shown, that downregulation of Notch in osteoblasts and osteocytes may represent a mechanism contributing to the anabolic effects of parathyroid hormone in bone.
Approval Year
Targets
| Primary Target | Pharmacology | Condition | Potency |
|---|---|---|---|
Target ID: P49190 Gene ID: 5746.0 Gene Symbol: PTH2R Target Organism: Homo sapiens (Human) Sources: https://www.ncbi.nlm.nih.gov/pubmed/7797535 |
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Target ID: map04330 Sources: https://www.ncbi.nlm.nih.gov/pubmed/28676438 |
Conditions
| Condition | Modality | Targets | Highest Phase | Product |
|---|---|---|---|---|
| Palliative | NATPARA Approved UseNATPARA is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Because of the potential risk of osteosarcoma, NATPARA is recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone. NATPARA was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations. NATPARA was not studied in patients with acute post-surgical hypoparathyroidism. Launch Date2015 |
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| Palliative | Unknown Approved UseUnknown |
PubMed
| Title | Date | PubMed |
|---|---|---|
| Parathyroid Hormone-Related Protein Analogs as Osteoporosis Therapies. | 2016-04 |
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| The effect of parathyroid hormone and teriparatide on fracture healing. | 2015-01 |
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| Current perspectives on parathyroid hormone (PTH) and PTH-related protein (PTHrP) as bone anabolic therapies. | 2013-05-15 |
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| Mixed-treatment comparison of anabolic (teriparatide and PTH 1-84) therapies in women with severe osteoporosis. | 2012-03 |
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| Parathyroid hormone receptor internalization is independent of protein kinase A and phospholipase C activation. | 2001-09 |
Patents
Sample Use Guides
Initiate NATPARA ((parathyroid hormone) 50 mcg once daily as a subcutaneous njection in the thigh (alternate thigh very day). n patients using active forms of vitamine D decrease the dose of active vitamin D by 50%, if serum calcium is above 7.5 mg/dL. In patients using calcium supplements, maintain calcium supplement dose. Measure serum calcium concentration within 3 to 7 days.
Route of Administration:
Other
| Substance Class |
Protein
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| Protein Type | HORMONE |
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| Sequence Origin | HUMAN |
| Sequence Type | COMPLETE |
| Record UNII |
N19A0T0E5J
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Validated (UNII)
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EU-Orphan Drug |
EU/3/13/1210
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NDF-RT |
N0000180851
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N0000011221
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CFR |
21 CFR 862.1545
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WHO-ATC |
H05AA03
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NDF-RT |
N0000011221
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EMA ASSESSMENT REPORTS |
PREOTACT (WITHDRAWN: OSTEOPOROSIS, POSTMENOPAUSAL)
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WHO-VATC |
QH05AA03
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FDA ORPHAN DRUG |
246707
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| Name | Property Type | Amount | Referenced Substance | Defining | Parameters | References |
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| Biological Half-life | PHARMACOKINETIC |
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Elimination PHARMACOKINETIC |
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| Molecular Formula | CHEMICAL |
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| MOL_WEIGHT:FORMULA | CHEMICAL |
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| Volume of Distribution | PHARMACOKINETIC |
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| Vdss | PHARMACOKINETIC |
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