Parathyroid hormone

Natpara, Preotact(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

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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	2025-07-11

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

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

713 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	13	13	27	20	80	150
Osteoporosis	D010024	EFO_0003882	M81.0	14	32	28	26	29	123
Secondary hyperparathyroidism	D006962	EFO_1001173	—	5	7	23	18	23	75
Hypoparathyroidism	D007011	—	E20	9	16	15	4	36	74
Chronic renal insufficiency	D051436	—	N18	3	5	23	12	20	61
Primary hyperparathyroidism	D049950	EFO_0008519	E21.0	4	4	8	3	42	58
Kidney diseases	D007674	EFO_0003086	N08	2	3	22	6	23	55
Parathyroid neoplasms	D010282	—	—	3	7	7	2	33	50
Thyroid diseases	D013959	—	E00-E07	3	2	2	2	41	50
Postmenopausal osteoporosis	D015663	EFO_0003854	—	7	6	12	16	8	48

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	12	—	1	—	2	15
Endocrine system diseases	D004700	EFO_0001379	E34.9	2	1	4	—	5	12
Carcinoma	D002277	—	C80.0	—	1	2	—	5	8
Osteoporotic fractures	D058866	—	—	—	3	1	—	3	7
Hip fractures	D006620	EFO_0003964	S72.00	—	2	1	—	3	6
Digeorge syndrome	D004062	—	D82.1	2	2	1	—	—	4
Menopause	D008593	EFO_0003922	N95	—	1	1	—	2	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	1	—	—	4	11
Papillary thyroid cancer	D000077273	—	—	2	1	—	—	8	11
Head and neck neoplasms	D006258	—	—	1	2	—	—	4	7
Headache	D006261	—	R51	—	4	—	—	3	7
Post-traumatic headache	D051298	—	G44.3	—	4	—	—	2	6
Prostatic neoplasms	D011471	—	C61	2	1	—	—	2	5
Endocrine gland neoplasms	D004701	EFO_0003769	D35	—	1	—	—	4	5
Neuroendocrine tumors	D018358	EFO_1001901	D3A.8	—	1	—	—	3	4
Lymphoma	D008223	—	C85.9	3	1	—	—	—	4
Laryngeal diseases	D007818	—	J38.7	—	2	—	—	1	3

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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
Liver neoplasms	D008113	EFO_1001513	C22.0	1	—	—	—	1	2
Periodontitis	D010518	EFO_0000649	K05.3	1	—	—	—	1	2
Anaplastic thyroid carcinoma	D065646	—	—	2	—	—	—	—	2
Bone neoplasms	D001859	EFO_0003820	D16	1	—	—	—	—	1
Glycosuria	D006029	—	R81	1	—	—	—	—	1
Acne vulgaris	D000152	EFO_0003894	L70	1	—	—	—	—	1
Stem cell transplantation	D033581	—	—	1	—	—	—	—	1
Multiple myeloma	D009101	—	C90.0	1	—	—	—	—	1
Myeloid leukemia	D007951	—	C92	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pseudohypoparathyroidism	D011547	—	E20.1	—	—	—	—	5	5
Pseudopseudohypoparathyroidism	D011556	—	—	—	—	—	—	4	4
Hyperthyroidism	D006980	—	E05.9	—	—	—	—	4	4
Calcium metabolism disorders	D002128	EFO_0005769	E83.5	—	—	—	—	3	3
Covid-19	D000086382	—	U07.1	—	—	—	—	3	3
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	—	—	—	3	3
Parathyroidectomy	D016105	—	—	—	—	—	—	3	3
Premature birth	D047928	EFO_0003917	O60	—	—	—	—	3	3
Sickle cell anemia	D000755	EFO_0000697	D57	—	—	—	—	2	2
Papillary carcinoma	D002291	—	—	—	—	—	—	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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4,844 adverse events reported

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