Natpara, Natpar(parathyroid hormone)
Natpar, Natpara (parathyroid hormone) is a protein pharmaceutical. Parathyroid hormone was first approved as Natpara on 2015-01-23. It is used to treat hypocalcemia and hypoparathyroidism in the USA. It has been approved in Europe to treat hypoparathyroidism. It is known to target prolactin-releasing peptide receptor, parathyroid hormone 2 receptor, and parathyroid hormone/parathyroid hormone-related peptide receptor.
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Commercial
Trade Name
FDA
EMA
Natpara
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Parathyroid hormone
Tradename | Proper name | Company | Number | Date | Products |
---|---|---|---|---|---|
Natpara | parathyroid hormone | Takeda | N-125511 RX | 2015-01-23 | 4 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
natpara (parathyroid hormone) | Biologic Licensing Application | 2020-07-09 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
hypocalcemia | HP_0002901 | D006996 | E83.51 |
hypoparathyroidism | — | D007011 | E20 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
parathyroid hormone, Natpara, Takeda Pharmaceuticals U.S.A., Inc. | |||
2122-01-23 | Orphan excl. |
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
80 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Osteoporosis | D010024 | EFO_0003882 | M81.0 | 4 | 7 | 7 | 3 | 2 | 22 |
Shoulder fractures | D012784 | S42.9 | — | — | — | 1 | — | 1 | |
Back pain | D001416 | HP_0003418 | M54 | — | — | — | 1 | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Digeorge syndrome | D004062 | D82.1 | 2 | 2 | — | — | — | 3 | |
Myeloid leukemia acute | D015470 | C92.0 | — | 1 | — | — | — | 1 | |
Primary myelofibrosis | D055728 | D47.4 | — | 1 | — | — | — | 1 | |
Lymphoma | D008223 | C85.9 | — | 1 | — | — | — | 1 | |
Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | — | 1 | — | — | — | 1 | |
B-cell chronic lymphocytic leukemia | D015451 | C91.1 | — | 1 | — | — | — | 1 | |
Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | — | — | — | 1 | |
Hodgkin disease | D006689 | C81 | — | 1 | — | — | — | 1 | |
Aplastic anemia | D000741 | HP_0001915 | D61.9 | — | 1 | — | — | — | 1 |
Phenylketonurias | D010661 | E70.0 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hyperparathyroidism | D006961 | EFO_0008506 | E21.3 | 3 | — | — | — | 3 | 6 |
Hypocalcemia | D006996 | HP_0002901 | E83.51 | 1 | — | — | — | 2 | 3 |
Endocrine bone diseases | D001849 | 2 | — | — | — | — | 2 | ||
Postmenopausal osteoporosis | D015663 | EFO_0003854 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Primary hyperparathyroidism | D049950 | EFO_0008519 | E21.0 | — | — | — | — | 5 | 5 |
Thyroid neoplasms | D013964 | EFO_0003841 | — | — | — | — | 4 | 4 | |
Parathyroid neoplasms | D010282 | — | — | — | — | 3 | 3 | ||
Parathyroid diseases | D010279 | E21.5 | — | — | — | — | 3 | 3 | |
Drug-related side effects and adverse reactions | D064420 | T88.7 | — | — | — | — | 2 | 2 | |
Intraoperative monitoring | D016343 | — | — | — | — | 1 | 1 | ||
Papillary thyroid cancer | D000077273 | — | — | — | — | 1 | 1 | ||
Lymphatic metastasis | D008207 | EFO_1001364 | — | — | — | — | 1 | 1 | |
Critical illness | D016638 | — | — | — | — | 1 | 1 | ||
Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | PARATHYROID HORMONE |
INN | parathyroid hormone |
Description | Parathyroid hormone (PTH), also called parathormone or parathyrin, is a peptide hormone secreted by the parathyroid glands that regulates the serum calcium concentration through its effects on bone, kidney, and intestine.
|
Classification | Protein |
Drug class | — |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | >3FFD:A|Monoclonal antibody, heavy chain, Fab fragment
EVQLVESGGDLVKPGGSLKLSCAASGFTFSSYGMSWIRQTPDKRLEWVATISSGGSYTYYPDSVKGRFTISRDNAKNTLY
LQMSSLKSEDTAMFYCARQTTMTYFAYWGQGTLVTVSAAKTTPPSVYPLAPGSAAQTNSMVTLGCLVKGYFPEPVTVTWN
SGSLSSGVHTFPAVLQSDLYTLSSSVTVPSSPRPSETVTCNVAHPASSTKVDKKIEPA
>3FFD:B|Monoclonal antibody, light chain, Fab fragment
QLVLTQSSSASFSLGASAKLTCTLSSQHSTYTIEWYQQQPLKPPKYVMDLKQDGSHSTGDGIPDRFSGSSSGADRYLSIS
NIQPEDEAMYICGVGDTIKEQFVYVFGGGTKVTVLGEPKSTPTLTVFPPSSEELKENKATLVCLISNFSPSGVTVAWKAN
GTPITQGVDTSNPTKEGNKFMASSFLHLTSDQWRSHNSFTCQVTHEGDTVEKSLSPAECL |
Identifiers
PDB | 1BL1, 1BWX, 1BZG, 1ET1, 1FVY, 1HPH, 1HPY, 1HTH, 1M5N, 1ZWA, 1ZWB, 1ZWC, 1ZWD, 1ZWE, 1ZWF, 1ZWG, 2L1X, 3C4M, 3FFD, 3H3G, 3L2J, 4YD8, 4Z8J, 5EMB, 6FJ3, 6NBF, 6NBH, 6NBI, 6XT9, 7F16, 7UZO, 7UZP, 7VVJ, 7VVK, 7VVL, 7VVM, 7VVN, 7VVO, 8D51, 8D52, 8FLQ, 8FLR, 8FLS, 8FLT, 8FLU, 8GW8, 8HA0, 8HAF, 8HAO |
CAS-ID | — |
RxCUI | — |
ChEMBL ID | CHEMBL2108078 |
ChEBI ID | — |
PubChem CID | — |
DrugBank | — |
UNII ID | N19A0T0E5J (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
PRLHR
PRLHR
PTH2R
PTH2R
PTH1R
PTH1R
Variants
Clinical Variant
No data
Financial
Natpara - Takeda
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Natpara - Shire
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 54,563 documents
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Safety
Black-box Warning
Black-box warning for: Natpara (parathyroid hormone)
Adverse Events
Top Adverse Reactions
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12,837 adverse events reported
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