TERIPARATIDE

First approved in 1987

Description
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21318_forteo_lbl.pdf

Teriparatide was manufactured under the brand name FORTEO. FORTEO contains recombinant human parathyroid hormone (1-34), [rhPTH(1-34)], which has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone, that regulates calcium and phosphate in the body. FORTEO is indicated for the treatment of postmenopausal women with severe osteoporosis who are at high risk of fracture or who have failed or are intolerant to previous osteoporosis therapy. In addition, Forteo is used for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in men and women who are at increased risk for fracture. The biological actions of teriparatide is mediated through binding to specific high-affinity cell-surface receptors. Teriparatide is not expected to accumulate in bone or other tissues.

Approval Year

Targets

Primary Target	Pharmacology	Condition	Potency
Parathyroid hormone/parathyroid hormone-related peptide receptor 2 Target ID: Q03431 Gene ID: 5745.0 Gene Symbol: PTH1R Target Organism: Homo sapiens (Human) Sources: https://www.ncbi.nlm.nih.gov/pubmed/10514480	Binding Agent 1064

Conditions

Condition	Modality	Targets	Highest Phase	Product
Postmenopausal Osteoporosis 4 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21318_forteo_lbl.pdf	Primary		Approved 8429	FORTEO Approved Use FORTEO is indicated for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture. These include women with a history of osteoporotic fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant of previous osteoporosis therapy, based upon physician assessment. In postmenopausal women with osteoporosis, FORTEO increases BMD and reduces the risk of vertebral and nonvertebral fractures. FORTEO is indicated to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. These include men with a history of osteoporotic fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant to previous osteoporosis therapy, based upon physician assessment. In men with primary or hypogonadal osteoporosis, FORTEO increases BMD. The effects of FORTEO on risk for fracture in men have not been studied. Launch Date 2002

PubMed

Title	Date	PubMed
Endocytosis of ligand-human parathyroid hormone receptor 1 complexes is protein kinase C-dependent and involves beta-arrestin2. Real-time monitoring by fluorescence microscopy.	1999 Oct 15	10514480

Sample Use Guides

In Vivo Use Guide

The recommended dosage is 20 mcg once a day.

Route of Administration: Other

Name

Type

Language

TERIPARATIDE

Official Name

English

TERIPARATIDE [HSDB]

Common Name

English

TERIPARATIDE [VANDF]

Common Name

English

TERIPARATIDE [ORANGE BOOK]

Common Name

English

Teriparatide [WHO-DD]

Common Name

English

ZT-034

Code

English

LY 333334

Code

English

TERIPARATIDE RECOMBINANT HUMAN

Common Name

English

TERIPARATIDE [USAN]

Common Name

English

TERIPARATIDE RDNA

Common Name

English

TERIPARATIDE [USP-RS]

Common Name

English

FORSTEO

Brand Name

English

TERIPARATIDE [EP MONOGRAPH]

Common Name

English

TERIPARATIDE RECOMBINANT HUMAN [ORANGE BOOK]

Common Name

English

PARATHYROID HORMONE (1-34)HUMAN SYNTHETIC

Common Name

English

TERIPARATIDE (GENETICAL RECOMBINATION)

Official Name

English

(1-34)-HUMAN PARATHYROID HORMONE

Common Name

English

PTH (1-34)

Common Name

English

1-34-HUMAN PTH

Common Name

English

TERIPARATIDE [MART.]

Common Name

English

FORTEO

Brand Name

English

TERIPARATIDE [USP MONOGRAPH]

Common Name

English

LY-333334

Code

English

LY333334

Code

English

TERIPARATIDE [EMA EPAR]

Common Name

English

TERIPARATIDE [JAN]

Common Name

English

BONSITY

Brand Name

English

SER-VAL-SER-GLU-ILE-GLN-LEU-MET-HIS-ASN-LEU-GLY-LYS-HIS-LEU-ASN-SER-MET-GLU-ARG-VAL-GLU-TRP-LEU-ARG-LYS-LYS-LEU-GLN-ASP-VAL-HIS-ASN-PHE

Common Name

English

HUMAN PARATHYROID HORMONE 1-34

Common Name

English

teriparatide [INN]

Common Name

English

SYNTHETIC HUMAN PARATHYROID HORMONE 1-34

Common Name

English

Classification Tree Code System Code

EMA ASSESSMENT REPORTS

FORSTEO (AUTHORIZED: OSTEOPOROSIS)