{{위키데이터 속성 추적}}
{{Infobox drug
| Verifiedfields = changed
| verifiedrevid = 428116657
| image = Nintedanib.svg
| width             = 
| alt = Nintedanib
| caption = Nintedanib

<!-- Clinical data -->
| pronounce         = 
| tradename = 바르가테프(Vargatef), 오페브(Ofev) 등
| Drugs.com = {{Drugs.com|monograph|nintedanib-esylate}}
| MedlinePlus       = a615009
| DailyMedID        = Nintedanib
| pregnancy_AU      = D
| pregnancy_AU_comment =<ref name="Drugs.com pregnancy">{{웹 인용| title=Nintedanib (Ofev) Use During Pregnancy | website=Drugs.com | date=16 September 2019 | url=https://www.drugs.com/pregnancy/nintedanib.html | access-date=9 March 2020 | archive-date=27 January 2021 | archive-url=https://web.archive.org/web/20210127233039/https://www.drugs.com/pregnancy/nintedanib.html | url-status=live }}</ref>
| pregnancy_category =
| routes_of_administration = [[경구 투여]]
| class             = 
| ATC_prefix = L01
| ATC_suffix = EX09
| ATC_supplemental  =

<!-- Legal status -->
| legal_AU = S4
| legal_AU_comment =<ref>{{웹 인용| title=Prescription medicines: registration of new chemical entities in Australia, 2015 | website=Therapeutic Goods Administration (TGA) | date=21 June 2022 | url=https://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia-2015 | access-date=10 April 2023 | archive-date=10 April 2023 | archive-url=https://web.archive.org/web/20230410065829/https://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia-2015 | 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  =<ref>{{웹 인용| title=Health Canada New Drug Authorizations: 2015 Highlights | website=[[Health Canada]] | date=4 May 2016 | url=https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-canada-new-drug-authorizations-2015-highlights.html | access-date=7 April 2024}}</ref>
| 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="Ofev FDA label">{{웹 인용| title=Ofev- nintedanib capsule | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9 | access-date=22 April 2021 | archive-date=23 April 2021 | archive-url=https://web.archive.org/web/20210423033006/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9 | url-status=live }}</ref>
| legal_EU = Rx-only
| legal_EU_comment =<ref name="Vargatef EPAR" />
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV-->
| legal_UN_comment = 
| legal_status      = Rx-only

<!-- Pharmacokinetic data -->
| bioavailability = 4.7%
| protein_bound = 97.8%
| metabolism = [[에스터화효소]], [[글루쿠론산화]]
| metabolites       = 
| onset             = 
| elimination_half-life = 10~15시간
| duration_of_action = 
| excretion = 93% [[대변]]

<!-- Identifiers -->
| index2_label = as esylate
| CAS_number_Ref = {{cascite|changed|??}}
| CAS_number = 656247-17-5
| CAS_number2 = 656247-18-6
| CAS_supplemental  = 
| PubChem = 9809715
| PubChem2 = 135476717
| IUPHAR_ligand = 5936
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB09079
| DrugBank2 = DBSALT001111
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = 7985471
| ChemSpiderID2 = 7985470
| UNII_Ref = {{fdacite|changed|FDA}}
| UNII = G6HRD2P839
| UNII2 = 42F62RTZ4G
| KEGG_Ref          = 
| KEGG = D10481
| KEGG2 = D10396
| ChEBI_Ref = {{ebicite|correct|EBI}}
| ChEBI = 85164
| ChEBI2 = 85170
| ChEMBL_Ref        = 
| ChEMBL = 502835
| ChEMBL2 = 3039504
| NIAID_ChemDB      = 
| PDB_ligand        = XIN
| synonyms = BIBF 1120

<!-- Chemical and physical data -->
| IUPAC_name = Methyl (3Z)-3-<nowiki/>{[(4-<nowiki/>{methyl[(4-methylpiperazin-1-yl)acetyl]amino}phenyl)amino](phenyl)methylidene}-2-oxo-2,3-dihydro-1H-indole-6-carboxylate
| C=31 | H=33 | N=5 | O=4
| SMILES = COC(=O)c1ccc2c(c1)NC(=O)/C2=C(\Nc1ccc(N(C)C(=O)CN2CCN(C)CC2)cc1)c1ccccc1
| StdInChI = 1S/C31H33N5O4/c1-34-15-17-36(18-16-34)20-27(37)35(2)24-12-10-23(11-13-24)32-29(21-7-5-4-6-8-21)28-25-14-9-22(31(39)40-3)19-26(25)33-30(28)38/h4-14,19,32H,15-18,20H2,1-3H3,(H,33,38)/b29-28-
| StdInChI_comment  = 
| StdInChIKey=XZXHXSATPCNXJR-ZIADKAODSA-N
| density           = 
| density_notes     = 
| melting_point     = 
| melting_high      = 
| melting_notes     = 
| boiling_point     = 
| boiling_notes     = 
| solubility        = 
| sol_units         = 
| specific_rotation = 
}}

<!-- Definition and uses -->
'''닌테다닙'''(Nintedanib)은 '''오페브'''(Ofev)와 '''바르가테프'''(Vargatef)라는 [[특발성 폐 섬유증]]과 일부 [[비소세포 폐암]](NSCLC) 치료에 사용하는 약물이다.<ref name="Vargatef EPAR">{{웹 인용| title=Vargatef EPAR | website=[[European Medicines Agency]] (EMA) | date=20 January 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/vargatef | access-date=9 March 2020 | archive-date=9 August 2020 | archive-url=https://web.archive.org/web/20200809021527/https://www.ema.europa.eu/en/medicines/human/EPAR/vargatef | url-status=live }}</ref> 2020년 3월에는 미국에서 진행성 표현형인 만성 섬유화 [[간질성 폐질환]](ILD) 치료 목적으로도 사용 승인되었다.<ref name="FDA PR 20200309">{{보도자료 인용| title=FDA Approves First Treatment for Group of Progressive Interstitial Lung Diseases | website=U.S. [[Food and Drug Administration]] (FDA) | date=9 March 2020 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-group-progressive-interstitial-lung-diseases | access-date=9 March 2020 | archive-date=10 March 2020 | archive-url=https://web.archive.org/web/20200310040745/https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-group-progressive-interstitial-lung-diseases | url-status=live }} {{PD-notice}}</ref> 이는 시간이 지날수록 악화되기만 하는 해당 종류의 폐 섬유증에 대해, [[미국 식품의약국]](FDA)이 허가한 최초의 치료제이다.<ref name="FDA PR 20200309" />

<!-- Side effects and mechanism -->
흔한 부작용은 [[복통]], [[구토]], [[설사]]이다.<ref>{{웹 인용|title=Nintedanib Side Effects|url=https://www.drugs.com/sfx/nintedanib-side-effects.html|access-date=24 October 2015|archive-date=10 April 2019|archive-url=https://web.archive.org/web/20190410020244/https://www.drugs.com/sfx/nintedanib-side-effects.html|url-status=live}}</ref> 닌테다닙은 소분자 [[티로신 인산화효소 억제제]]에 속하며, 억제하는 표적 분자는 [[혈관내피 성장인자 수용체]](VEGFR), [[섬유아세포 성장인자 수용체]](FGFR), [[혈소판 유래 성장인자 수용체]](PDGFR)이다.<ref name="Vargatef EPAR" />

<!-- History, society and culture -->
[[베링거인겔하임]]에서 개발했으며, 특발성 폐 섬유증 치료 목적으로 2014년 미국에서 사용 허가를 받았다. 현재까지 특발성 폐 섬유증 치료제로 허가를 받은 약물은 닌테다닙과 [[피르페니돈]]뿐이다. 여러 연구에서 닌테다닙이 진행성 말기 폐 질환의 악화 속도를 늦출 수 있다는 것을 입증했다.<ref>{{웹 인용|title=Nintedanib|url=https://www.boehringer-ingelheim.us/press-release/efficacy-and-safety-ofev-nintedanib-reinforced-new-presentations-ats-2018|access-date=24 December 2019|archive-date=28 February 2021|archive-url=https://web.archive.org/web/20210228030824/https://www.boehringer-ingelheim.us/press-release/efficacy-and-safety-ofev-nintedanib-reinforced-new-presentations-ats-2018|url-status=live}}</ref>

== 각주 ==
{{각주}}

[[분류:메틸 에스터]]
[[분류:피페라진]]
[[분류:희귀약]]
[[분류:티로신 인산화효소 억제제]]