| Revision as of 14:25, 6 December 2011 editBeetstra (talk | contribs)Edit filter managers, Administrators172,031 edits Saving copy of the {{drugbox}} taken from revid 461256786 of page Sitagliptin for the Chem/Drugbox validation project (updated: ''). |
Latest revision as of 19:32, 13 November 2024 edit Ruslik0 (talk | contribs)Edit filter managers, Administrators54,758 editsm Reverted edit by 149.170.252.26 (talk) to last version by WhywhenwhohowTag: Rollback |
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{{Short description|Diabetes medication}} |
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{{ambox | text = This page contains a copy of the infobox ({{tl|drugbox}}) taken from revid of page ] with values updated to verified values.}} |
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{{Use mdy dates|date=September 2024}} |
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{{Drugbox |
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{{cs1 config |name-list-style=vanc |display-authors=6}} |
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{{Infobox drug |
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| verifiedrevid = 418851502 |
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| Watchedfields = changed |
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| IUPAC_name = (''R'')-4-oxo-4-triazolopyrazin-7(8''H'')-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine |
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| verifiedrevid = 464392221 |
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| image = Sitagliptin.svg |
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| image = Sitagliptin.svg |
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| width = 254 |
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| width = 254 |
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| alt = |
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| image2 = Sitagliptin 3D.png |
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| image2 = Sitagliptin 3D.png |
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| alt2 = |
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| caption = |
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<!--Clinical data--> |
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<!-- Clinical data --> |
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| pronounce = {{IPAc-en|audio=En-us-Sitagliptin.ogg|s|ɪ|t|ə|ˈ|g|l|ɪ|p|t|ɪ|n}} |
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| tradename = |
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| tradename = Januvia, Zituvio, others |
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| Drugs.com = {{drugs.com|monograph|januvia}} |
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| Drugs.com = {{drugs.com|monograph|sitagliptin}} |
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| MedlinePlus = a606023 |
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| MedlinePlus = a606023 |
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| DailyMedID = Sitagliptin |
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| licence_EU = Januvia |
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| pregnancy_AU = B3 |
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| licence_US = Sitagliptin |
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| pregnancy_AU_comment = |
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| pregnancy_US = B |
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| pregnancy_category= |
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| routes_of_administration = ] |
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| class = |
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| ATC_prefix = A10 |
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| ATC_suffix = BH01 |
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| ATC_supplemental = |
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<!-- Legal status --> |
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| legal_AU = S4 |
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| legal_AU_comment = |
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| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F --> |
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| legal_BR_comment = |
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| legal_CA = Rx-only |
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| legal_CA_comment = <ref>{{cite web | title=Product monograph brand safety updates | website=Health Canada | date=February 2024 | url=https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/label-safety-assessment-update/product-monograph-brand-safety-updates.html | access-date=March 24, 2024}}</ref> |
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| legal_DE = <!-- Anlage I, II, III or Unscheduled --> |
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| legal_DE_comment = |
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| legal_NZ = <!-- Class A, B, C --> |
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| legal_NZ_comment = |
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| legal_UK = POM |
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| legal_UK = POM |
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| legal_UK_comment = |
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| legal_US = Rx-only |
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| legal_US = Rx-only |
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| legal_US_comment = <ref name="Januvia FDA label">{{cite web | title=Januvia- sitagliptin tablet, film coated | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f85a48d0-0407-4c50-b0fa-7673a160bf01 | access-date=October 15, 2021 | archive-date=October 27, 2021 | archive-url=https://web.archive.org/web/20211027142052/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f85a48d0-0407-4c50-b0fa-7673a160bf01 | url-status=live }}</ref><ref>{{cite web | title=Zituvio- sitagliptin tablet | website=DailyMed | date=November 1, 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b2da9d77-154b-48f7-8793-3f4a24dfafc6 | access-date=December 25, 2023}}</ref><ref>{{cite web | title=Zituvio- sitagliptin tablet | website=DailyMed | date=November 1, 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=abfdea45-c0ca-41e3-a510-e89810bc9cfe | access-date=December 25, 2023}}</ref> |
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| routes_of_administration = Oral |
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| legal_EU = Rx-only |
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| legal_EU_comment = <ref name="Januvia EPAR">{{cite web | title=Januvia EPAR | website=European Medicines Agency | date=September 17, 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/januvia | access-date=October 15, 2021 | archive-date=October 23, 2021 | archive-url=https://web.archive.org/web/20211023091721/https://www.ema.europa.eu/en/medicines/human/EPAR/januvia | url-status=live }}</ref><ref>{{cite web | title=Xelevia EPAR | website=European Medicines Agency (EMA) | date=21 March 2007 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/xelevia | access-date=19 October 2024}}</ref> |
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| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV --> |
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| legal_UN_comment = |
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| legal_status = <!-- For countries not listed above --> |
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<!--Pharmacokinetic data--> |
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<!-- Pharmacokinetic data --> |
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| bioavailability = 87% |
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| bioavailability = 87% |
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| protein_bound = 38% |
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| protein_bound = 38% |
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| metabolism = ] (]- and ]-mediated) |
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| metabolism = ] (]- and ]-mediated) |
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| metabolites = |
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| elimination_half-life = 8 to 14 h<ref name=Herman>{{cite journal | author = Herman GA | coauthors = Stevens C, Van Dyck K, Bergman A, Yi B, De Smet M, Snyder K, Hilliard D, Tanen M, Tanaka W, Wang AQ, Zeng W, Musson D, Winchell G, Davies MJ, Ramael S, Gottesdiener KM, Wagner JA | title = Pharmacokinetics and pharmacodynamics of sitagliptin, an inhibitor of dipeptidyl peptidase IV, in healthy subjects: results from two randomized, double-blind, placebo-controlled studies with single oral doses | journal = Clin Pharmacol Ther | volume = 78 | issue = 6 | pages = 675–88 | year = 2005 | month = December | pmid = 16338283 | doi = 10.1016/j.clpt.2005.09.002}}</ref> |
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| onset = |
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| excretion = ] (80%)<ref name=Herman/> |
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| elimination_half-life = 8 to 14 h<ref name=Herman>{{cite journal | vauthors = Herman GA, Stevens C, van Dyck K, Bergman A, Yi B, De Smet M, Snyder K, Hilliard D, Tanen M, Tanaka W, Wang AQ, Zeng W, Musson D, Winchell G, Davies MJ, Ramael S, Gottesdiener KM, Wagner JA | display-authors = 6 | title = Pharmacokinetics and pharmacodynamics of sitagliptin, an inhibitor of dipeptidyl peptidase IV, in healthy subjects: results from two randomized, double-blind, placebo-controlled studies with single oral doses | journal = Clinical Pharmacology and Therapeutics | volume = 78 | issue = 6 | pages = 675–688 | date = December 2005 | pmid = 16338283 | doi = 10.1016/j.clpt.2005.09.002 | s2cid = 20935646 }}</ref> |
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| duration_of_action = |
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| excretion = ] (80%)<ref name=Herman/> |
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<!--Identifiers--> |
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<!-- Identifiers --> |
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| index2_label = as salt |
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| CASNo_Ref = {{cascite|correct|CAS}} |
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| CAS_number_Ref = {{cascite|correct|??}} |
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| CAS_number_Ref = {{cascite|correct|??}} |
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| CAS_number = 486460-32-6 |
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| CAS_number = 486460-32-6 |
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| ATC_prefix = A10 |
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| CAS_supplemental = |
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| ATC_suffix = BH01 |
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| PubChem = 4369359 |
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| PubChem = 4369359 |
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| IUPHAR_ligand = 6286 |
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| DrugBank_Ref = {{drugbankcite|correct|drugbank}} |
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| DrugBank_Ref = {{drugbankcite|correct|drugbank}} |
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| DrugBank = DB01261 |
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| DrugBank = DB01261 |
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| UNII_Ref = {{fdacite|correct|FDA}} |
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| UNII_Ref = {{fdacite|correct|FDA}} |
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| UNII = QFP0P1DV7Z |
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| UNII = QFP0P1DV7Z |
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| KEGG_Ref = |
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| ChEBI_Ref = {{ebicite|changed|EBI}} |
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| KEGG = D08516 |
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| KEGG2_Ref = |
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| KEGG2 = D06645 |
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| ChEBI_Ref = {{ebicite|correct|EBI}} |
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| ChEBI = 40237 |
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| ChEBI = 40237 |
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| ChEMBL_Ref = {{ebicite|correct|EBI}} |
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| ChEMBL_Ref = {{ebicite|correct|EBI}} |
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| ChEMBL = 1422 |
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| ChEMBL = 1422 |
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| NIAID_ChemDB = |
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| PDB_ligand = |
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| synonyms = |
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<!--Chemical data--> |
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<!-- Chemical and physical data --> |
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| IUPAC_name = (''R'')-4-oxo-4-triazolopyrazin-7(8''H'')-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine |
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| C=16 | H=15 | F=6 | N=5 | O=1 |
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| C=16 | H=15 | F=6 | N=5 | O=1 |
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| molecular_weight = 407.314 ]/] |
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| smiles = Fc1cc(c(F)cc1F)C(N)CC(=O)N3Cc2nnc(n2CC3)C(F)(F)F |
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| SMILES = Fc1cc(c(F)cc1F)C(N)CC(=O)N3Cc2nnc(n2CC3)C(F)(F)F |
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| StdInChI_Ref = {{stdinchicite|correct|chemspider}} |
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| StdInChI_Ref = {{stdinchicite|correct|chemspider}} |
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| StdInChI = 1S/C16H15F6N5O/c17-10-6-12(19)11(18)4-8(10)3-9(23)5-14(28)26-1-2-27-13(7-26)24-25-15(27)16(20,21)22/h4,6,9H,1-3,5,7,23H2/t9-/m1/s1 |
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| StdInChI = 1S/C16H15F6N5O/c17-10-6-12(19)11(18)4-8(10)3-9(23)5-14(28)26-1-2-27-13(7-26)24-25-15(27)16(20,21)22/h4,6,9H,1-3,5,7,23H2/t9-/m1/s1 |
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| StdInChI_comment = |
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| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}} |
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| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}} |
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| StdInChIKey = MFFMDFFZMYYVKS-SECBINFHSA-N |
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| StdInChIKey = MFFMDFFZMYYVKS-SECBINFHSA-N |
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| density = |
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}} |
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}} |
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<!-- Definition and medical uses --> |
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'''Sitagliptin''', sold under the brand name '''Januvia''' among others, is an ] used to treat ].<ref name=AHFS2019/> In the United Kingdom it is listed as less preferred than ] or a ].<ref name=BNF76/> It is taken ].<ref name=AHFS2019/> It is also available in the ] medication ] (Janumet, Janumet XR).<ref name=AHFS2019/> |
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<!-- Side effects and mechanisms --> |
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Common side effects include headaches, swelling of the legs, and ].<ref name=AHFS2019/> Serious side effects may include ], ], ], ], and ].<ref name=AHFS2019/> Whether use in ] or ] is safe is unclear.<ref name=Preg2019>{{cite web |title=Sitagliptin Pregnancy and Breastfeeding Warnings |url=https://www.drugs.com/pregnancy/sitagliptin.html |website=Drugs.com |access-date=March 3, 2019 |archive-date=March 6, 2019 |archive-url=https://web.archive.org/web/20190306044611/https://www.drugs.com/pregnancy/sitagliptin.html |url-status=live }}</ref> It is in the ] class and works by increasing the production of ] and decreasing the production of ] by the pancreas.<ref name=AHFS2019>{{cite web |title=Sitagliptin Monograph for Professionals |url=https://www.drugs.com/monograph/sitagliptin.html |website=Drugs.com |publisher=American Society of Health-System Pharmacists |access-date=March 3, 2019 |archive-date=March 4, 2016 |archive-url=https://web.archive.org/web/20160304075640/https://www.drugs.com/monograph/sitagliptin.html |url-status=live }}</ref> |
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<!-- Society and culture --> |
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Sitagliptin was developed by ] and approved for medical use in the United States in 2006.<ref name=AHFS2019/> In 2022, it was the 86th most commonly prescribed medication in the United States, with more than 7{{nbsp}}million prescriptions.<ref>{{cite web | title=The Top 300 of 2022 | url=https://clincalc.com/DrugStats/Top300Drugs.aspx | website=ClinCalc | access-date=August 30, 2024 | archive-date=August 30, 2024 | archive-url=https://web.archive.org/web/20240830202410/https://clincalc.com/DrugStats/Top300Drugs.aspx | url-status=live }}</ref><ref>{{cite web | title = Sitagliptin Drug Usage Statistics, United States, 2013 - 2022 | website = ClinCalc | url = https://clincalc.com/DrugStats/Drugs/Sitagliptin | access-date = August 30, 2024 }}</ref> It is available as a ].<ref>{{cite news |title=Generic Januvia Availability |url=https://www.drugs.com/availability/generic-januvia.html |access-date=December 1, 2023 |work=Drugs.com }}</ref><ref>{{cite press release | title=JAMP Pharma Group receives Health Canada approval for PrJAMP Sitagliptin, a new generic alternative for the treatment of type 2 diabetes | publisher=JAMP Pharma | via=Newswire | date=January 6, 2023 | url=https://www.newswire.ca/news-releases/jamp-pharma-group-receives-health-canada-approval-for-prjamp-sitagliptin-a-new-generic-alternative-for-the-treatment-of-type-2-diabetes-808743246.html | access-date=June 19, 2023}}</ref><ref>{{cite web | title=Sitagliptin SUN EPAR | website=European Medicines Agency (EMA) | date=December 9, 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/sitagliptin-sun | access-date=September 27, 2024}}</ref> |
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==Medical uses== |
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Sitagliptin is used to treat type 2 diabetes.<ref name=AHFS2019/> It is generally less preferred than ] or ].<ref name=BNF76>{{cite book|title=British national formulary : BNF 76|date=2018|publisher=Pharmaceutical Press|isbn=9780857113382|pages=681|edition=76}}</ref> It is taken by mouth.<ref name=AHFS2019/> It is also available as the ]s of ] (Janumet, Janumet XR)<ref name=AHFS2019/> and ] (Juvisync).<ref name=FDAJuvisyncApproval /> |
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Sitagliptin should not be used to treat type 1 diabetes. In December 2020, the US ] (FDA) approved labeling changes stating that Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride), and Janumet XR (sitagliptin and metformin hydrochloride extended-release) are not proven to improve glycemic (blood sugar) control in children aged 10 to 17 with type 2 diabetes.<ref name="FDA sitagliptin 20201204" /> The drugs are approved to improve blood sugar control in adults aged 18 and older with type 2 diabetes.<ref name="FDA sitagliptin 20201204">{{cite web | title=Diabetes drug not proven to improve blood sugar in pediatric patients | website=U.S. ] (FDA) | date=December 4, 2020 | url=https://www.fda.gov/drugs/drug-safety-and-availability/new-studies-show-diabetes-drug-not-proven-improve-blood-sugar-control-pediatric-patients | access-date=December 5, 2020 | archive-date=December 4, 2020 | archive-url=https://web.archive.org/web/20201204222229/https://www.fda.gov/drugs/drug-safety-and-availability/new-studies-show-diabetes-drug-not-proven-improve-blood-sugar-control-pediatric-patients | url-status=live }} {{PD-notice}}</ref> |
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==Adverse effects== |
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Adverse effects from sitagliptin are similar to ], except for rare ], ]-like symptoms, and photosensitivity.<ref name=RxList>{{cite web | url = http://www.rxlist.com/cgi/generic/januvia_ad.htm | title = Januvia Side Effects & Drug Interactions | year = 2007 | access-date = November 28, 2007 | publisher = RxList.com | url-status = dead | archive-url = https://web.archive.org/web/20071120121831/http://www.rxlist.com/cgi/generic/januvia_ad.htm | archive-date = November 20, 2007 }}</ref> It does not increase the risk of diarrhea.<ref>{{cite journal | vauthors = Zhao Q, Hong D, Zheng D, Xiao Y, Wu B | title = Risk of diarrhea in patients with type 2 diabetes mellitus treated with sitagliptin: a meta-analysis of 30 randomized clinical trials | journal = Drug Design, Development and Therapy | volume = 8 | pages = 2283–2294 | date = 2014 | pmid = 25419118 | pmc = 4234286 | doi = 10.2147/DDDT.S70945 | doi-access = free }}</ref> No ] difference exists in the occurrence of ] between placebo and sitagliptin.<ref name=RxList/><ref>{{cite journal | vauthors = Stricklin SM, Stoecker WV, Rader RK, Hood AF, Litt JZ, Schuman TP | title = Persistent edematous-plaque photosensitivity observed with sitagliptin phosphate (Januvia®) | journal = Dermatology Online Journal | volume = 18 | issue = 2 | pages = 9 | date = February 2012 | doi = 10.5070/D30D70K7B2 | pmid = 22398230 | url = https://escholarship.org/uc/item/0d70k7b2 | access-date = June 6, 2019 | url-status = live | archive-url = https://web.archive.org/web/20190408084349/https://escholarship.org/uc/item/0d70k7b2 | archive-date = April 8, 2019 }}</ref><ref>{{cite web|url=https://www.ehealthme.com/ds/januvia/photosensitivity-reaction/|title=Januvia side effect: Photosensitivity reaction - eHealthMe|website=www.ehealthme.com|access-date=June 6, 2019|archive-date=June 7, 2019|archive-url=https://web.archive.org/web/20190607003203/https://www.ehealthme.com/ds/januvia/photosensitivity-reaction/|url-status=live}}</ref> In those taking ]s, the risk of ] is increased.<ref>{{cite journal | vauthors = Salvo F, Moore N, Arnaud M, Robinson P, Raschi E, De Ponti F, Bégaud B, Pariente A | display-authors = 6 | title = Addition of dipeptidyl peptidase-4 inhibitors to sulphonylureas and risk of hypoglycaemia: systematic review and meta-analysis | journal = BMJ | volume = 353 | pages = i2231 | date = May 2016 | pmid = 27142267 | pmc = 4854021 | doi = 10.1136/bmj.i2231 }}</ref> |
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The existence of rare case reports of ] and hypersensitivity reactions is noted in the United States prescribing information, but a causative role for sitagliptin has not been established.<ref name="Januvia FDA label" /> |
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Several ] of ] (some fatal) have been made in people treated with sitagliptin and other DPP-4 inhibitors,<ref>{{cite journal | vauthors = Olansky L | title = Do incretin-based therapies cause acute pancreatitis? | journal = Journal of Diabetes Science and Technology | volume = 4 | issue = 1 | pages = 228–229 | date = January 2010 | pmid = 20167189 | pmc = 2825646 | doi = 10.1177/193229681000400129 }}</ref><ref>{{cite web | title=FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes | website=U.S. ] (FDA) | date=June 21, 2019 | url=https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-investigating-reports-possible-increased-risk-pancreatitis-and-pre | access-date=May 10, 2022 | archive-date=May 10, 2022 | archive-url=https://web.archive.org/web/20220510021433/https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-investigating-reports-possible-increased-risk-pancreatitis-and-pre | url-status=live }}</ref> and the US FDA package insert carries a warning to this effect,<ref name="Januvia FDA label" /> although the causal link between sitagliptin and pancreatitis has not yet been fully substantiated.<ref name=medupdate01>{{cite web |title=Sitagliptin for Type 2 Diabetes |author=National Prescribing Service |date=August 2010 |access-date=August 27, 2010 |url=http://www.nps.org.au/consumers/publications/medicine_update/issues/sitagliptin |url-status=dead |archive-url=https://web.archive.org/web/20100718022620/http://www.nps.org.au/consumers/publications/medicine_update/issues/sitagliptin |archive-date=July 18, 2010 }}</ref> One study with lab rats published in 2009 concluded that some of the possible risks of pancreatitis or pancreatic cancer may be reduced when it is used with metformin. However, while DPP-4 inhibitors showed an increase in such risk factors, as of 2009, no increase in pancreatic cancer has been reported in individuals taking DPP-4 inhibitors.<ref>{{cite journal | vauthors = Matveyenko AV, Dry S, Cox HI, Moshtaghian A, Gurlo T, Galasso R, Butler AE, Butler PC | display-authors = 6 | title = Beneficial endocrine but adverse exocrine effects of sitagliptin in the human islet amyloid polypeptide transgenic rat model of type 2 diabetes: interactions with metformin | journal = Diabetes | volume = 58 | issue = 7 | pages = 1604–1615 | date = July 2009 | pmid = 19403868 | pmc = 2699878 | doi = 10.2337/db09-0058 }}</ref> |
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In 2015, the US Food and Drug Administration (FDA) added a new warning and precaution about the risk of "severe and disabling" joint pain to the labels of all DPP-4 inhibitor medicines.<ref>{{cite web|title=DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication—May Cause Severe Joint Pain|url=https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-dpp-4-inhibitors-type-2-diabetes-may-cause-severe-joint-pain|website=U.S. ] (FDA)|access-date=September 1, 2015|date=August 28, 2015|archive-date=December 13, 2019|archive-url=https://web.archive.org/web/20191213203243/https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-dpp-4-inhibitors-type-2-diabetes-may-cause-severe-joint-pain|url-status=live}}</ref> |
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==Mechanism of action== |
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{{see also|Dipeptidyl peptidase-4 inhibitors}} |
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Sitagliptin works to ] the ] dipeptidyl peptidase 4 (DPP-4). This enzyme breaks down the ]s ] and GIP, ]s released in response to a meal.<ref>{{cite journal | vauthors = Herman GA, Bergman A, Liu F, Stevens C, Wang AQ, Zeng W, Chen L, Snyder K, Hilliard D, Tanen M, Tanaka W, Meehan AG, Lasseter K, Dilzer S, Blum R, Wagner JA | display-authors = 6 | title = Pharmacokinetics and pharmacodynamic effects of the oral DPP-4 inhibitor sitagliptin in middle-aged obese subjects | journal = Journal of Clinical Pharmacology | volume = 46 | issue = 8 | pages = 876–886 | date = August 2006 | pmid = 16855072 | doi = 10.1177/0091270006289850 | s2cid = 45849328 }}</ref> By preventing breakdown of GLP-1 and GIP, they are able to increase the secretion of insulin and suppress the release of glucagon by the alpha cells of the pancreas.{{medcn|date=May 2022}} This drives blood glucose levels towards normal.{{medcn|date=May 2022}} As the blood glucose level approaches normal, the amounts of insulin released and glucagon suppressed diminishes, thus tending to prevent an "overshoot" and subsequent low blood sugar (hypoglycemia), which is seen with some other oral hypoglycemic agents.{{medcn|date=May 2022}} |
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Sitagliptin has been shown to lower ] level by about 0.7% points versus placebo. It is slightly less effective than metformin when used as a ]. It does not cause weight gain and has less hypoglycemia compared to sulfonylureas. Sitagliptin is recommended as a second-line drug (in combination with other drugs) after the combination of diet/exercise and metformin fails.<ref name=Gadsby2009>{{cite journal| vauthors = Gadsby R |title=Efficacy and Safety of Sitagliptin in the Treatment of Type 2 Diabetes|journal=Clinical Medicine: Therapeutics |year=2009 |volume=1 |issue=1 |pages=53–62 |doi=10.4137/CMT.S2313 | doi-access = free }}</ref> |
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==History== |
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{{see also|Development of dipeptidyl peptidase-4 inhibitors}} |
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Sitagliptin was approved by the US ] (FDA) in October 2006,<ref name=FDAapproval>{{cite press release | title = FDA Approves New Treatment for Diabetes | publisher = U.S. ] (FDA) | date = October 17, 2006 | url = https://www.fda.gov/bbs/topics/NEWS/2006/NEW01492.html | archive-url = https://web.archive.org/web/20090228075200/https://www.fda.gov/bbs/topics/NEWS/2006/NEW01492.html | archive-date = February 28, 2009 | url-status = dead | access-date = October 17, 2006 }}</ref> and is sold under the brand name Januvia.<ref>{{cite web | title=Drug Approval Package: Januvia (Sitagliptin Phosphate) NDA #021995 | website=U.S. ] (FDA) | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021995s000TOC.cfm | access-date=September 27, 2024}}</ref> In April 2007, the FDA approved an oral combination of ] sold under the brand name Janumet.<ref>{{cite web | title=Drug Approval Package: Janumet (Sitagliptin/Metformin Hydrochloride) NDA #022044 | website=U.S. ] (FDA) | date=July 8, 2008 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022044TOC.cfm | access-date=September 27, 2024}}</ref> In October 2011, the FDA approved an oral combination of ] sold under the brand name Juvisync.<ref>{{cite web | title=Drug Approval Package: Juvisync (sitagliptin and simvastatin fixed-dose combination) Tablets NDA #202343 | website=U.S. ] (FDA) | date=July 13, 2012 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202343Orig1s000TOC.cfm | access-date=September 27, 2024}}</ref><ref name=FDAJuvisyncApproval>{{cite press release | title = FDA Approves Combination Therapy Juvisync | publisher = U.S. ] (FDA) | date = October 7, 2011 | url = https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm274748.htm | archive-url = https://web.archive.org/web/20140824195440/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm274748.htm | archive-date = August 24, 2014 | url-status = dead | access-date = November 17, 2013 }}</ref> The extended release version of sitagliptin/metformin was approved in February 2012.<ref>{{cite web | title=Drug Approval Package: Janumet XR (sitagliptin/metformin hydrochloride) NDA #202270 | website=U.S. ] (FDA) | date=September 3, 2013 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202270_janumet_xr_toc.cfm | access-date=September 27, 2024}}</ref> |
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{{-}} |
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==External links== |
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* {{commonscat-inline}} |
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== References == |
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{{reflist}} |
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{{Oral hypoglycemics}} |
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{{Merck&Co}} |
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{{Portal bar | Medicine}} |
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{{Authority control}} |
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