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{{Short description|Pharmaceutical drug for treating osteoporosis}}
{{Use dmy dates|date=May 2022}}
{{cs1 config |name-list-style=vanc |display-authors=6}}
{{Drugbox {{Drugbox
| Verifiedfields = changed
| verifiedrevid = 444216523
| Watchedfields = changed
| IUPAC_name =
| verifiedrevid = 447111676
| image = Teriparatide.png
| image = Teriparatide structure.svg
| width = 250


<!--Clinical data--> <!--Clinical data-->
| tradename = Forteo | tradename = Forteo, Forsteo
| Drugs.com = {{drugs.com|monograph|teriparatide}} | Drugs.com = {{drugs.com|monograph|teriparatide}}
| MedlinePlus = a603018
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_US = <!-- A / B / C / D / X --> | licence_EU = yes
| DailyMedID = Teriparatide
| pregnancy_category = C
| pregnancy_AU = B3
| legal_AU = <!-- Unscheduled / S2 / S3 / S4 / S5 / S6 / S7 / S8 / S9 -->
| pregnancy_AU_comment = <ref>{{cite web | title=Terrosa | website=Therapeutic Goods Administration (TGA) | date=26 May 2022 | url=https://www.tga.gov.au/resources/auspmd/terrosa | access-date=7 July 2024 | archive-date=30 September 2022 | archive-url=https://web.archive.org/web/20220930050000/https://www.tga.gov.au/resources/auspmd/terrosa | url-status=live }}</ref><ref name="Drugs.com pregnancy">{{cite web | title=Teriparatide Use During Pregnancy | website=Drugs.com | date=25 November 2019 | url=https://www.drugs.com/pregnancy/teriparatide.html | access-date=14 September 2020 | archive-date=27 October 2020 | archive-url=https://web.archive.org/web/20201027190535/https://www.drugs.com/pregnancy/teriparatide.html | url-status=live }}</ref>
| legal_CA = <!-- / Schedule I, II, III, IV, V, VI, VII, VIII -->
| pregnancy_category =
| legal_UK = <!-- GSL / P / POM / CD / Class A, B, C -->
| routes_of_administration = ]
| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
| ATC_prefix = H05
| legal_status =
| ATC_suffix = AA02
| routes_of_administration = SubQ
| biosimilars = Bonsity,<ref name="FDA Bonsity approval" /> Kauliv,<ref name="Kauliv EPAR" /> Livogiva,<ref name="Livogiva EPAR" /> Osnuvo,<ref name="Osnuvo SBD" /> Qutavina,<ref name="Qutavina EPAR" /> Sondelbay,<ref name="Sondelbay EPAR" /> Teribone,<ref>{{cite web|url=http://www.minsa.gob.pa/sites/default/files/alertas/nota_seguridad_teriparatida.pdf|title=Nota de Seguridad de Medicamentos|author=Lisbeth Tristan de Brea|date=18 September 2018|location=Panama|publisher=Directora Nacional de Farmacia y Drogas|access-date=30 September 2018|archive-date=4 December 2020|archive-url=https://web.archive.org/web/20201204111956/http://www.minsa.gob.pa/sites/default/files/alertas/nota_seguridad_teriparatida.pdf|url-status=live}}</ref>

<!-- Legal status -->
| legal_AU = S4
| legal_AU_comment = <ref>{{cite web | title=Forteo teriparatide (rbe) 250 microgram solution for injection cartridge, Eli Lilly Australia Pty Ltd, CON-1240 | website=Therapeutic Goods Administration (TGA) | date=17 June 2024 | url=https://www.tga.gov.au/resources/section-14-consents/forteo-teriparatide-rbe-250-microgram-solution-injection-cartridge-eli-lilly-australia-pty-ltd-con-1240 | access-date=17 June 2024 | archive-date=17 June 2024 | archive-url=https://web.archive.org/web/20240617032302/https://www.tga.gov.au/resources/section-14-consents/forteo-teriparatide-rbe-250-microgram-solution-injection-cartridge-eli-lilly-australia-pty-ltd-con-1240 | url-status=live }}</ref><ref>{{cite web | title=Ritosa teriparatide 250 microgram/mL solution for injection pre-filled cartridge (408423) | website=Therapeutic Goods Administration (TGA) | date=3 May 2024 | url=https://www.tga.gov.au/resources/artg/408423 | access-date=17 June 2024 | archive-date=17 June 2024 | archive-url=https://web.archive.org/web/20240617032302/https://www.tga.gov.au/resources/artg/408423 | url-status=live }}</ref>
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->
| legal_BR_comment =
| legal_CA = Rx-only
| legal_CA_comment = /&nbsp;Schedule D
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE_comment =
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ_comment =
| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C -->
| legal_UK_comment =
| legal_US = Rx only
| legal_US_comment = <ref name="Forteo FDA label">{{cite web | title=Forteo- teriparatide injection, solution | website=DailyMed | date=29 April 2021 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aae667c5-381f-4f92-93df-2ed6158d07b0 | access-date=8 March 2023 | archive-date=19 January 2022 | archive-url=https://web.archive.org/web/20220119181715/http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aae667c5-381f-4f92-93df-2ed6158d07b0 | url-status=live }}</ref>
| legal_EU = Rx only
| legal_EU_comment = <ref name="Forsteo EPAR" /><ref name="Sondelbay EPAR" /><ref name="Kauliv EPAR" />
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN_comment =
| legal_status = <!-- For countries not listed above -->


<!--Pharmacokinetic data--> <!--Pharmacokinetic data-->
| bioavailability = 95% | bioavailability = 95%
| protein_bound = | protein_bound =
| metabolism = Hepatic (nonspecific proteolysis) | metabolism = ] (nonspecific proteolysis)
| elimination_half-life = SubQ: 1 hour | elimination_half-life = Subcutaneous: 1 hour
| excretion = Renal (metabolites) | excretion = ] (metabolites)


<!--Identifiers--> <!--Identifiers-->
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 52232-67-4
| CAS_number = 52232-67-4
| ATC_prefix = H05
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| ATC_suffix = AA02
| IUPHAR_ligand = 4448
| PubChem = 16133850
| DrugBank = DB06285
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| UNII_Ref = {{fdacite|correct|FDA}}
| DrugBank = DB06285
| UNII = 10T9CSU89I
| UNII_Ref = {{fdacite|correct|FDA}}
| KEGG_Ref = {{keggcite|correct|kegg}}
| UNII = 10T9CSU89I
| ChEMBL = 525610
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D06078 | KEGG = D06078
| PubChem = 16132393
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = 17289052


<!--Chemical data--> <!--Chemical data-->
| IUPAC_name =
| chemical_formula =
| C=181 | H=291 | N=55 | O=51 | S=2 | C = 181
| H = 291
| molecular_weight = 4117.72 g/mol
| N = 55
| O = 51
| S = 2
| smiles = /N=C(\N)/NCCC(C(=O)N(C(C)C)C(=O)N(CCC(=O)O)C(=O)N(Cc1cc2c1cccc2)C(=O)N(CC(C)C)C(=O)N(CCCN/C(=N/)/N)C(=O)N(CCCCN)C(=O)N(CCCCN)C(=O)N(CC(C)C)C(=O)N(CCC(=O)N)C(=O)N(CC(=O)O)C(=O)N(C(C)C)C(=O)N(Cc3cnc3)C(=O)N(CC(=O)N)C(=O)N(Cc4ccccc4)C(=O)O)NC(=O)(CCC(=O)O)NC(=O)(CCSC)NC(=O)(CO)NC(=O)(CC(=O)N)NC(=O)(CC(C)C)NC(=O)(Cc5cnc5)NC(=O)(CCCCN)NC(=O)CNC(=O)(CC(C)C)NC(=O)(CC(=O)N)NC(=O)(Cc6cnc6)NC(=O)(CCSC)NC(=O)(CC(C)C)NC(=O)(CCC(=O)N)NC(=O)((C)CC)NC(=O)(CCC(=O)O)NC(=O)(CO)NC(=O)(C(C)C)NC(=O)(CO)N
| StdInChI_Ref = {{stdinchicite|changed|chemspider}}
| StdInChI = 1S/C181H291N55O51S2/c1-21-96(18)146(236-160(267)114(48-53-141(250)251)212-174(281)132(84-239)232-177(284)143(93(12)13)233-147(254)103(185)82-237)178(285)216-111(45-50-134(187)241)155(262)219-119(65-90(6)7)163(270)213-116(55-62-289-20)158(265)224-124(71-100-79-196-86-203-100)167(274)226-126(73-135(188)242)169(276)217-117(63-88(2)3)148(255)201-81-138(245)205-105(39-27-30-56-182)149(256)223-123(70-99-78-195-85-202-99)166(273)221-121(67-92(10)11)164(271)225-128(75-137(190)244)171(278)231-131(83-238)173(280)214-115(54-61-288-19)157(264)210-112(46-51-139(246)247)153(260)208-109(43-34-60-199-181(193)194)159(266)234-144(94(14)15)175(282)215-113(47-52-140(248)249)156(263)222-122(69-98-77-200-104-38-26-25-37-102(98)104)165(272)220-120(66-91(8)9)161(268)209-108(42-33-59-198-180(191)192)151(258)206-106(40-28-31-57-183)150(257)207-107(41-29-32-58-184)152(259)218-118(64-89(4)5)162(269)211-110(44-49-133(186)240)154(261)228-129(76-142(252)253)172(279)235-145(95(16)17)176(283)229-125(72-101-80-197-87-204-101)168(275)227-127(74-136(189)243)170(277)230-130(179(286)287)68-97-35-23-22-24-36-97/h22-26,35-38,77-80,85-96,103,105-132,143-146,200,237-239H,21,27-34,39-76,81-84,182-185H2,1-20H3,(H2,186,240)(H2,187,241)(H2,188,242)(H2,189,243)(H2,190,244)(H,195,202)(H,196,203)(H,197,204)(H,201,255)(H,205,245)(H,206,258)(H,207,257)(H,208,260)(H,209,268)(H,210,264)(H,211,269)(H,212,281)(H,213,270)(H,214,280)(H,215,282)(H,216,285)(H,217,276)(H,218,259)(H,219,262)(H,220,272)(H,221,273)(H,222,263)(H,223,256)(H,224,265)(H,225,271)(H,226,274)(H,227,275)(H,228,261)(H,229,283)(H,230,277)(H,231,278)(H,232,284)(H,233,254)(H,234,266)(H,235,279)(H,236,267)(H,246,247)(H,248,249)(H,250,251)(H,252,253)(H,286,287)(H4,191,192,198)(H4,193,194,199)/t96-,103-,105-,106-,107-,108-,109-,110-,111-,112-,113-,114-,115-,116-,117-,118-,119-,120-,121-,122-,123-,124-,125-,126-,127-,128-,129-,130-,131-,132-,143-,144-,145-,146-/m0/s1
| StdInChIKey_Ref = {{stdinchicite|changed|chemspider}}
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}} }}
'''Teriparatide''' ('''Forteo''', also available in generic form<ref>http://www.usvindia.com/htmls/products/injectables.html</ref>) is a ] form of ], used in the treatment of some forms of ].<ref name="pmid18003959">{{cite journal |author=Saag KG, Shane E, Boonen S, ''et al.'' |title=Teriparatide or alendronate in glucocorticoid-induced osteoporosis |journal=The New England journal of medicine |volume=357 |issue=20 |pages=2028–39 |year=2007 |month=November |pmid=18003959 |doi=10.1056/NEJMoa071408 |url=http://content.nejm.org/cgi/pmidlookup?view=short&pmid=18003959&promo=ONFLNS19}}</ref> It is manufactured and marketed by ].


'''Teriparatide''', sold under the brand name '''Forteo''', is a form of ] (PTH) consisting of the first (]) 34 ]s, which is the bioactive portion of the hormone.<ref name="Forteo FDA label" /> It is an effective ] (promoting bone formation) agent<ref name="Riek">{{cite journal | vauthors = Riek AE, Towler DA | title = The pharmacological management of osteoporosis | journal = Missouri Medicine | volume = 108 | issue = 2 | pages = 118–23 | year = 2011 | pmid = 21568234 | pmc = 3597219 }}</ref> used in the treatment of some forms of ].<ref name="Forteo FDA label" /><ref name="pmid18003959">{{cite journal | vauthors = Saag KG, Shane E, Boonen S, Marín F, Donley DW, Taylor KA, Dalsky GP, Marcus R | title = Teriparatide or alendronate in glucocorticoid-induced osteoporosis | journal = The New England Journal of Medicine | volume = 357 | issue = 20 | pages = 2028–39 | date = November 2007 | pmid = 18003959 | doi = 10.1056/NEJMoa071408 | doi-access = free }}</ref> Teriparatide is a recombinant human parathyroid hormone analog (PTH 1-34).<ref name="Forteo FDA label" /> It has an identical sequence to the 34 N-terminal amino acids of the 84-amino acid human parathyroid hormone.<ref name="Forteo FDA label" />
==Administration==
Teriparatide is administered by injection once a day in the thigh or abdomen. The recommended dose is 20 μg per day.
Coming in the form of a penfill designed for self injection like this of insulin,2 units or 20ug is given daily, subcutaneous.


==Uses== ==Medical uses==
Teriparatide is ] for the treatment of postmenopausal women with osteoporosis;<ref name="Forteo FDA label" /> for the increase of bone mass in men with primary or hypogonadal osteoporosis;<ref name="Forteo FDA label" /> and treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy.<ref name="Forteo FDA label" />


It is effective in growing bone (e.g., 8% increase in bone density in the spine after one year)<ref name="Kawai">{{cite journal | vauthors = Kawai M, Mödder UI, Khosla S, Rosen CJ | title = Emerging therapeutic opportunities for skeletal restoration | journal = Nature Reviews. Drug Discovery | volume = 10 | issue = 2 | pages = 141–56 | date = February 2011 | pmid = 21283108 | pmc = 3135105 | doi = 10.1038/nrd3299 }}</ref> and reducing the risk of fragility fractures.<ref name="Rizzoli">{{cite journal | vauthors = Rizzoli R, Reginster JY, Boonen S, Bréart G, Diez-Perez A, Felsenberg D, Kaufman JM, Kanis JA, Cooper C | title = Adverse reactions and drug-drug interactions in the management of women with postmenopausal osteoporosis | journal = Calcified Tissue International | volume = 89 | issue = 2 | pages = 91–104 | date = August 2011 | pmid = 21637997 | pmc = 3135835 | doi = 10.1007/s00223-011-9499-8 }}</ref><ref name="Murad">{{cite journal | vauthors = Murad MH, Drake MT, Mullan RJ, Mauck KF, Stuart LM, Lane MA, Abu Elnour NO, Erwin PJ, Hazem A, Puhan MA, Li T, Montori VM | title = Clinical review. Comparative effectiveness of drug treatments to prevent fragility fractures: a systematic review and network meta-analysis | journal = The Journal of Clinical Endocrinology and Metabolism | volume = 97 | issue = 6 | pages = 1871–80 | date = June 2012 | pmid = 22466336 | doi = 10.1210/jc.2011-3060 | doi-access = free | title-link = doi }}</ref>
Teriparatide is indicated for use in patients with severe osteoporosis. The drug also has an ongoing clinical trial to evaluate its effectiveness in treating the symptoms of ].<ref name="Ref_"></ref>


Teriparatide cuts the risk of hip fracture by more than half but does not reduce the risk of arm or wrist fracture.<ref>{{cite journal | vauthors = Díez-Pérez A, Marin F, Eriksen EF, Kendler DL, Krege JH, Delgado-Rodríguez M | title = Effects of teriparatide on hip and upper limb fractures in patients with osteoporosis: A systematic review and meta-analysis | journal = Bone | volume = 120 | pages = 1–8 | date = March 2019 | pmid = 30268814 | doi = 10.1016/j.bone.2018.09.020 | doi-access = free | title-link = doi | hdl = 10230/36878 | hdl-access = free }}</ref>
Teriparatide should not be prescribed for patients who are at increased risks for osteosarcoma. This includes those with ] of bone or unexplained elevations of serum alkaline phosphate, open ], or prior radiation therapy involving the skeleton.


==Contraindications==
==Side effects==
Teriparatide is contraindicated for those with open epiphyses, metabolic bone diseases, ], bone metastases, history of skeletal malignancies, or prior external beam or implant radiation therapy involving the skeleton.<ref name="Forteo FDA label" /> In the animal studies and in one human case report, it was found to potentially be associated with developing osteosarcoma in test subjects after over two years of use.<ref name="pmid17129179">{{cite journal | vauthors = Harper KD, Krege JH, Marcus R, Mitlak BH | title = Osteosarcoma and teriparatide? | journal = Journal of Bone and Mineral Research | volume = 22 | issue = 2 | pages = 334 | date = February 2007 | pmid = 17129179 | doi = 10.1359/jbmr.061111 | s2cid = 36420876 | doi-access = free }}</ref>
The most commonly reported side effects are nausea, leg cramps and dizziness. The main risk of teriparatide is an increased risk of ], at least as seen in rat studies. Cases of bone tumor and osteosarcoma have been reported rarely in the postmarketing period.<ref name="Ref_a">http://www.drugs.com/pro/forteo.html</ref>

==Adverse effects==
Adverse effects of teriparatide include headache, nausea, dizziness, and limb pain.<ref name="Rizzoli"/> Teriparatide has a theoretical risk of ], which was found in rat studies but not confirmed in humans.<ref name="Riek"/> This may be because, unlike humans, rat bones grow for their entire life.<ref name="Riek"/> The tumors found in the rat studies were located on the end of the bones which grew after the injections began.<ref name="Ref_a">{{cite web |title=Forteo |url=https://www.drugs.com/pro/forteo.html |work=drugs.com |access-date=23 January 2018 |archive-date=15 June 2018 |archive-url=https://web.archive.org/web/20180615135231/https://www.drugs.com/pro/forteo.html |url-status=live }}</ref> After nine years on the market, there were only two cases of osteosarcoma reported.<ref name="Kawai"/> This risk was considered by the FDA as "extremely rare" (1 in 100,000 people)<ref name="Rizzoli"/> and is only slightly more than the incidence in the population over 60 years old (0.4 in 100,000).<ref name="Rizzoli"/>


==Mechanism of action== ==Mechanism of action==
Teriparatide is the portion of human ] (PTH), amino acid sequence 1 through 34, of the complete molecule (containing 84 amino acids). Endogenous PTH is the primary regulator of calcium and phosphate metabolism in bone and kidney. PTH increases serum calcium, partially accomplishing this by increasing bone resorption. Thus, chronically elevated PTH will deplete bone stores. However, intermittent exposure to PTH will activate osteoblasts more than osteoclasts. Thus, once-daily injections of teriparatide have a net effect of stimulating new bone formation leading to increased bone mineral density.<ref name="Ref_b">Bauer E, Aub JC, Albright F. Studies of calcium and phosphorus metabolism: V. Study of the bone trabeculae as a readily available reserve supply of calcium. J Exp Med. 1929;49:145-162.</ref><ref name="Ref_c">Selye H. On the stimulation of new bone formation with parathyroid extract and irradiated ergosterol. Endocrinology. 1932;16:547-558.</ref><ref name="Ref_d"> Dempster, D.W., Cosman, F., Parisien, M., Shen, V., & R. Lindsay. (1993). Endocrine Review: 14(6): 690-709.</ref> Teriparatide is a portion of human ] (PTH), amino acid sequence 1 through 34, of the complete molecule (containing 84 amino acids). Endogenous PTH is the primary regulator of calcium and phosphate metabolism in bone and kidney. PTH increases serum calcium, partially accomplishing this by increasing bone resorption. Thus, chronically elevated PTH will deplete bone stores. However, intermittent exposure to PTH will activate osteoblasts more than osteoclasts. Thus, once-daily injections of teriparatide have a net effect of stimulating new bone formation leading to increased bone mineral density.<ref name="Ref_b">{{cite journal | vauthors = Bauer W, Aub JC, Albright F | title = Studies of calcium and phosphorus metabolism: V. Study of the bone trabeculae as a readily available reserve supply of calcium | journal = The Journal of Experimental Medicine | volume = 49 | issue = 1 | pages = 145–62 | date = January 1929 | pmid = 19869533 | pmc = 2131520 | doi = 10.1084/jem.49.1.145 }}</ref><ref name="Ref_c">{{cite journal | vauthors = Selye H | year = 1932 | title = On the stimulation of new bone formation with parathyroid extract and irradiated ergosterol | journal = Endocrinology | volume = 16 | issue = 5| pages = 547–558 | doi=10.1210/endo-16-5-547| doi-access = free | title-link = doi }}</ref><ref name="Dempster">{{cite journal | vauthors = Dempster DW, Cosman F, Parisien M, Shen V, Lindsay R | title = Anabolic actions of parathyroid hormone on bone | journal = Endocrine Reviews | volume = 14 | issue = 6 | pages = 690–709 | date = December 1993 | pmid = 8119233 | doi = 10.1210/edrv-14-6-690 | author-link2 = Felicia Cosman }}</ref>


== Society and culture ==
Teriparatide is the first, and to date only, FDA approved agent for the treatment of osteoporosis that stimulates new bone formation.<ref name="Ref_e"></ref>
=== Legal status ===
Teriparatide was approved for medical use in the United States in 1987.<ref name="Forteo FDA label" /><ref>{{cite web | title=Teriparatide injection, solution | website=DailyMed | date=1 November 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b007339-dd0d-f019-5e0a-9b1b0f75011c | access-date=8 March 2023 | archive-date=25 May 2022 | archive-url=https://web.archive.org/web/20220525190844/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b007339-dd0d-f019-5e0a-9b1b0f75011c | url-status=live }}</ref> Teriparatide (Forteo) was approved by the FDA in November 2002, for the treatment of ] in men and ] women who are at high risk for having a fracture.<ref>{{cite web | title=Drug Approval Package: Forteo Injection; NDA #021318 | website=U.S. ] (FDA) | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-318_Forteo.cfm | access-date=14 September 2020 | archive-date=31 March 2021 | archive-url=https://web.archive.org/web/20210331171441/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-318_Forteo.cfm | url-status=live }}</ref> In October 2019, the US FDA approved the recombinant teriparatide product with brand name Bonsity.<ref name="FDA Bonsity approval" />


==FDA approval== === Biosimilars ===
Recombinant teriparatide is sold by ] under the brand names Forteo and Forsteo. In June 2020, Alvogen, Inc, Pfenex Inc.'s commercialization partner, launched teriparatide injection (Bonsity) in the United States. Teriparatide injection was developed by Pfenex Inc and approved by the US ] (FDA) in October 2019.<ref name="FDA Bonsity approval">{{cite web | title=Drug Approval Package: Bonsity | website=U.S. ] (FDA) | date=26 February 2020 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211939Orig1s000TOC.cfm | access-date=14 September 2020 | archive-date=2 April 2021 | archive-url=https://web.archive.org/web/20210402095857/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211939Orig1s000TOC.cfm | url-status=live }}</ref> Teriparatide injection is pharmaceutically equivalent to Forteo (that is, has the same active ingredient in the same strength, dosage form and route of administration) and has been shown to have comparable bioavailability. These characteristics allowed the product to be approved under a 505(b)(2) NDA for which Forteo was the reference drug. It may provide a lower-cost teriparatide option for increasing bone density in patients at high risk for fracture, and is FDA-approved for the same indications as Forteo, which means it can be used for the same patients as Forteo, including new patients and those currently responding to treatment.<ref>{{cite press release |publisher=Pfenex Inc |title=Pfenex Announces U.S. Commercial Launch of Teriparatide Injection |url=https://www.globenewswire.com/news-release/2020/06/12/2047405/0/en/Pfenex-Announces-U-S-Commercial-Launch-of-Teriparatide-Injection.html |via=GlobeNewswire |date=12 June 2020 |access-date=13 October 2020 |archive-date=7 April 2021 |archive-url=https://web.archive.org/web/20210407124159/http://www.globenewswire.com/news-release/2020/06/12/2047405/0/en/Pfenex-Announces-U-S-Commercial-Launch-of-Teriparatide-Injection.html |url-status=live }}</ref>
Teriparatide was approved by the ] (FDA) on 26 November 2002, for the treatment of ] in men and ] women who are at high risk for having a fracture. The drug is also approved to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture.


Teriparatide was approved for medical use in the European Union in June 2003.<ref name="Forsteo EPAR">{{cite web | title=Forsteo EPAR | website=] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/forsteo | access-date=26 June 2020 | archive-date=27 June 2020 | archive-url=https://web.archive.org/web/20200627011444/https://www.ema.europa.eu/en/medicines/human/EPAR/forsteo | url-status=live }}</ref> A synthetic teriparatide from Teva Generics has been authorized for marketing in the European Union.<ref>{{cite web|url=https://mri.cts-mrp.eu/Human/Downloads/DE_H_4292_001_PAR.pdf|title=PUBLIC ASSESSMENT REPORT - Decentralised Procedure - Teriparatid-ratiopharm 20 µg / 80ml, Solution for injection|last=BfArM|date=8 May 2017|access-date=24 June 2019|archive-date=24 June 2021|archive-url=https://web.archive.org/web/20210624203342/https://mri.cts-mrp.eu/Human/Downloads/DE_H_4292_001_PAR.pdf|url-status=live}}</ref> Biosimilar product from ] has been authorized in the European Union.<ref>{{cite web|url=https://www.ema.europa.eu/en/medicines/human/EPAR/terrosa|title=Summary of the European public assessment report (EPAR) for Terrosa.|date=17 September 2018 |access-date=14 August 2019|archive-date=14 August 2019|archive-url=https://web.archive.org/web/20190814064635/https://www.ema.europa.eu/en/medicines/human/EPAR/terrosa|url-status=live}}</ref> In October 2019, the US FDA approved a recombinant teriparatide product.<ref name="FDA Bonsity approval" />
== References ==
{{reflist}}
One randomized trial of postmenopausal women who had already fractured vertebra compared teriparatide at either 20 or 40 micrograms per day with placebo. After about 19 months, 14% of the women taking placebo had new vertebral fractures, as compared with 5% of the women taking 20 micrograms of teriparatide and 4% of the women taking 40 micrograms. There were also a statistically significant lower number of non-vertebral fractures in the teriparatide treated group. 20 micrograms of teriparatide increased spine and hip bone mineral density. no


In June 2020, the ] (CHMP) of the ] (EMA) recommended the approval of the biosimilar products Qutavina and Livogiva.<ref name="Qutavina EPAR" /><ref name="Livogiva EPAR" /> Qutavina and Livogiva were approved for medical use in the European Union in August 2020.<ref name="Qutavina EPAR">{{cite web | title=Qutavina EPAR | website=] (EMA) | date=26 May 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/qutavina | access-date=25 January 2021 | archive-date=30 January 2021 | archive-url=https://web.archive.org/web/20210130154226/https://www.ema.europa.eu/en/medicines/human/EPAR/qutavina | url-status=live }}</ref><ref name="Livogiva EPAR">{{cite web | title=Livogiva EPAR | website=] (EMA) | date=26 May 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/qutavina | access-date=25 January 2021 | archive-date=30 January 2021 | archive-url=https://web.archive.org/web/20210130154226/https://www.ema.europa.eu/en/medicines/human/EPAR/qutavina | url-status=live }}</ref>
N Engl J Med. 2001 May 10;344(19):1434-41.


Osnuvo was approved for medical use in Canada in January 2020.<ref name="Osnuvo SBD">{{cite web | title=Summary Basis of Decision (SBD) for Osnuvo | website=] | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00470&lang=en | access-date=29 May 2022 | archive-date=30 May 2022 | archive-url=https://web.archive.org/web/20220530223828/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00470&lang=en | url-status=live }}</ref>
== External links ==
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Sondelbay was approved for medical use in the European Union in March 2022.<ref name="Sondelbay EPAR">{{cite web | title=Sondelbay EPAR | website=European Medicines Agency | date=24 January 2022 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/sondelbay-0 | access-date=3 March 2023 | archive-date=4 March 2023 | archive-url=https://web.archive.org/web/20230304090507/https://www.ema.europa.eu/en/medicines/human/EPAR/sondelbay-0 | url-status=live }}</ref><ref>{{cite web | title=Sondelbay Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1628.htm | access-date=3 March 2023 | archive-date=4 March 2023 | archive-url=https://web.archive.org/web/20230304090507/https://ec.europa.eu/health/documents/community-register/html/h1628.htm | url-status=live }}</ref>
{{Calcium homeostasis}}


On 10 November 2022, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Kauliv, intended for the treatment of osteoporosis.<ref name="Kauliv: Pending EC decision" /> The applicant for this medicinal product is Strides Pharma Cyprus.<ref name="Kauliv: Pending EC decision">{{cite web | title=Kauliv: Pending EC decision | website=European Medicines Agency | date=11 November 2022 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/kauliv | access-date=3 March 2023 | archive-date=31 December 2022 | archive-url=https://web.archive.org/web/20221231003109/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/kauliv | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Kauliv was approved for medical use in the European Union in February 2023.<ref>{{cite web | title=Kauliv Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1710.htm | access-date=3 March 2023 | archive-date=27 January 2023 | archive-url=https://web.archive.org/web/20230127225411/https://ec.europa.eu/health/documents/community-register/html/h1710.htm | url-status=live }}</ref><ref name="Kauliv EPAR">{{cite web | title=Kauliv EPAR | website=] (EMA) | date=18 July 2022 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/kauliv | access-date=8 March 2023 | archive-date=9 March 2023 | archive-url=https://web.archive.org/web/20230309063241/https://www.ema.europa.eu/en/medicines/human/EPAR/kauliv | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref>
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== Research ==
Teriparatide is undergoing a clinical trial with ] as a treatment for ] to reduce the risk of broken bones.<ref>{{cite news|date=16 January 2017|title=New trial for people with brittle bone disease|work=BBC News|url=https://www.bbc.com/news/uk-scotland-edinburgh-east-fife-38636309|access-date=31 August 2021|archive-date=31 August 2021|archive-url=https://web.archive.org/web/20210831184959/https://www.bbc.com/news/uk-scotland-edinburgh-east-fife-38636309|url-status=live}}</ref>

=== Combined teriparatide and denosumab ===
Combined teriparatide and ] increased BMD more than either agent alone and more than has been reported with approved therapies. Combination treatment might, therefore, be useful to treat patients at high risk of fracture by increasing BMD. However, there is no evidence of fracture rate reduction in patients taking a teriparatide and denosumab combination. The first such trial was published by Leder et al. in Lancet in 2013 with further data subsequently published in JCEM in a trial of post menopausal osteoporotic women demonstrating larger bone mineral density increases in the spine and hip with combination therapy compared to either drug alone.<ref>{{cite journal | vauthors = Leder BZ, Tsai JN, Uihlein AV, Burnett-Bowie SA, Zhu Y, Foley K, Lee H, Neer RM |date=May 2014 |title=Two Years of Denosumab and Teriparatide Administration in Postmenopausal Women With Osteoporosis (The DATA Extension Study): A Randomized Controlled Trial|url= |journal=The Journal of Clinical Endocrinology and Metabolism |volume=99|issue=5|pages=1694–1700|doi=10.1210/jc.2013-4440|pmid=24517156|pmc=4010689}}</ref><ref>{{cite journal | vauthors = Tsai JN, Uihlein AV, Lee H, Kumbhani R, Siwila-Sackman E, McKay EA, Burnett-Bowie SA, Neer RM, Leder BZ |date=July 2013|title=Teriparatide and denosumab, alone or combined, in women with postmenopausal osteoporosis: the DATA study randomised trial|url= |journal=The Lancet|volume=382|issue=9886|pages=50–56|doi=10.1016/s0140-6736(13)60856-9|pmid=23683600|pmc=4083737 }}</ref>

== References ==
{{reflist}}

{{Calcium homeostasis}}
{{Eli Lilly and Company}}
{{Portal bar | Medicine}}


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