Parathyroid hormone

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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FDA approval date

EMA approval date

Patent expiration date

Study first post date

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Completion date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
nutritional and metabolic diseases	D009750
endocrine system diseases	D004700

Trade Name

FDA

EMA

Natpara

Drug Products

FDA

EMA

Reference product - 351(a)

Interchangeable 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	2023-05-22

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hypocalcemia	HP_0002901	D006996	E83.51
hypoparathyroidism	HP_0000829	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

ATC Codes

H: Systemic hormonal preparations, excl. sex hormones and insulins

— H05: Calcium homeostasis

— H05A: Parathyroid hormones and analogues

— H05AA: Parathyroid hormones and analogues

— H05AA03: Parathyroid hormone

HCPCS

No data

Clinical

Clinical Trials

469 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hyperparathyroidism	D006961	EFO_0008506	E21.3	14	14	29	15	68	136
Osteoporosis	D010024	HP_0000939	M81.0	13	18	12	7	14	60
Secondary hyperparathyroidism	D006962	EFO_1001173	—	5	7	20	11	18	60
Hypoparathyroidism	D007011	HP_0000829	E20	8	10	14	4	27	59
Kidney diseases	D007674	EFO_0003086	N08	2	5	24	6	17	53
Primary hyperparathyroidism	D049950	EFO_0008519	E21.0	4	4	8	3	32	48
Chronic renal insufficiency	D051436	—	N18	2	5	21	6	13	46
Parathyroid neoplasms	D010282	—	—	1	6	7	2	26	40
Neoplasm metastasis	D009362	EFO_0009708	—	3	7	17	5	9	40
Thyroid diseases	D013959	HP_0000820	E00-E07	2	1	2	2	32	39

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Endocrine system diseases	D004700	EFO_0001379	E34.9	2	1	3	—	5	11
Healthy volunteers/patients	—	—	—	8	—	1	—	1	10
Carcinoma	D002277	—	C80.0	—	2	2	—	4	8
Digeorge syndrome	D004062	—	D82.1	2	2	1	—	—	4
Dialysis	D003956	—	—	—	—	1	—	3	4
Metabolic bone diseases	D001851	HP_0000938	—	—	1	2	—	2	4
Rickets	D012279	HP_0002748	E55.0	1	—	1	—	1	3
Familial hypophosphatemic rickets	D053098	—	—	1	—	1	—	—	2
Hypophosphatemic rickets	D063730	—	E83.31	1	—	1	—	—	2
Recurrence	D012008	—	—	—	1	1	—	1	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369	—	C80	6	2	—	—	4	12
Head and neck neoplasms	D006258	—	—	1	2	—	—	3	6
Endocrine gland neoplasms	D004701	EFO_0003769	D35	—	1	—	—	5	6
Kidney transplantation	D016030	—	—	—	3	—	—	2	5
Lymphoma	D008223	—	C85.9	3	1	—	—	—	4
Syndrome	D013577	—	—	2	2	—	—	1	4
Breast neoplasms	D001943	EFO_0003869	C50	2	1	—	—	—	3
Neuroendocrine tumors	D018358	EFO_1001901	D3A.8	—	1	—	—	2	3
Diabetes mellitus	D003920	HP_0000819	E08-E13	1	1	—	—	2	3
Myeloid leukemia acute	D015470	—	C92.0	1	1	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Endocrine bone diseases	D001849	—	—	2	—	—	—	1	3
Prostatic neoplasms	D011471	—	C61	1	—	—	—	1	2
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	1	—	—	—	1	2
Periodontitis	D010518	EFO_0000649	K05.3	1	—	—	—	1	2
Bone neoplasms	D001859	EFO_0003820	D16	1	—	—	—	—	1
Stem cell transplantation	D033581	—	—	1	—	—	—	—	1
Multiple myeloma	D009101	—	C90.0	1	—	—	—	—	1
Osteopetrosis	D010022	HP_0011002	Q78.2	1	—	—	—	—	1
Colorectal neoplasms	D015179	—	—	1	—	—	—	—	1
Kidney neoplasms	D007680	EFO_0003865	C64	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Papillary thyroid cancer	D000077273	—	—	—	—	—	—	5	5
Pseudopseudohypoparathyroidism	D011556	—	—	—	—	—	—	4	4
Pseudohypoparathyroidism	D011547	—	E20.1	—	—	—	—	4	4
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	—	—	—	3	3
Hyperthyroidism	D006980	—	E05.9	—	—	—	—	3	3
Parathyroidectomy	D016105	—	—	—	—	—	—	3	3
Metabolic diseases	D008659	EFO_0000589	E88.9	—	—	—	—	2	2
Covid-19	D000086382	—	—	—	—	—	—	2	2
Papillary carcinoma	D002291	—	—	—	—	—	—	2	2
Overweight	D050177	—	E66.3	—	—	—	—	2	2

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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, 7Y35, 7Y36, 8BIA, 8BJ0, 8D51, 8D52, 8FLQ, 8FLR, 8FLS, 8FLT, 8FLU, 8GW8, 8HA0, 8HAF, 8HAO, 8JR9, 8T5F
CAS-ID	—
RxCUI	—
ChEMBL ID	CHEMBL2108078
ChEBI ID	—
PubChem CID	—
DrugBank	—
UNII ID	N19A0T0E5J (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

PRLHR

PTH2R

PTH1R

Organism

Homo sapiens

Gene name

PRLHR

Gene synonyms

GPR10, GR3

NCBI Gene ID

2834

Protein name

prolactin-releasing peptide receptor

Protein synonyms

G-protein coupled receptor 10, hGR3, prRP receptor

Uniprot ID

Q5VXR9

Mouse ortholog

Prlhr (226278)

prolactin-releasing peptide receptor (Q6VMN6)

Variants

No data

Financial

Revenue by drug

€

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Natpara – Takeda

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Natpara – Shire

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Estimated US medical usage

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Trends

PubMed Central

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Safety

Black-box Warning

Black-box warning for: Natpara (parathyroid hormone)

Adverse Events

Top Adverse Reactions

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4,425 adverse events reported

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