{{위키데이터 속성 추적}}
{{약 정보
| drug_name = 오나셈노진아베파르보벡
| INN = 
| type = <!-- empty -->
| image =
| width =
| alt =
| caption =

<!-- Clinical data -->
| pronounce =
| tradename = 졸겐스마
| Drugs.com = {{drugs.com|ppa|onasemnogene-abeparvovec}}
| MedlinePlus =
| licence_CA = <!-- Health Canada may use generic or brand name (generic name preferred) -->
| licence_EU = <!-- EMA uses INN (or special INN_EMA) -->
| DailyMedID = Onasemnogene_abeparvovec
| licence_US = <!-- FDA may use generic or brand name (generic name preferred) -->
| pregnancy_AU = B2
| pregnancy_AU_comment =<ref name="Zolgensma APM summary" /><ref name="AusPAR: Onasemnogene abeparvovec" />
| pregnancy_category =
| routes_of_administration = [[혈관]] 내
| class =
| ATCvet =
| ATC_prefix = M09
| ATC_suffix = AX09
| ATC_supplemental =

<!-- Legal status -->
| legal_AU = S4
| legal_AU_comment =<ref name="Zolgensma APM summary">{{웹 인용| title=Zolgensma | website=Therapeutic Goods Administration (TGA) | date=10 March 2021 | url=https://www.tga.gov.au/apm-summary/zolgensma | access-date=8 September 2021 | archive-date=9 September 2021 | archive-url=https://web.archive.org/web/20210909035010/https://www.tga.gov.au/apm-summary/zolgensma | url-status=live }}</ref><ref name="AusPAR: Onasemnogene abeparvovec">{{웹 인용| title=AusPAR: Onasemnogene abeparvovec | website=Therapeutic Goods Administration (TGA) | date=22 April 2021 | url=https://www.tga.gov.au/auspar/auspar-onasemnogene-abeparvovec | access-date=8 September 2021 | archive-date=9 September 2021 | archive-url=https://web.archive.org/web/20210909040501/https://www.tga.gov.au/auspar/auspar-onasemnogene-abeparvovec | 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 / Schedule D
| legal_CA_comment =<ref>{{웹 인용| title=Summary Basis of Decision (SBD) for Zolgensma | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00521&lang=en | access-date=29 May 2022 | archive-date=30 May 2022 | archive-url=https://web.archive.org/web/20220530050206/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00521&lang=en | url-status=live }}</ref>
| legal_DE = <!-- Anlage I, II, III or Unscheduled-->
| legal_DE_comment =
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ_comment =
| legal_UK = POM
| legal_UK_comment =<ref name="EMC">{{웹 인용| title=Zolgensma 2 x 1013 vector genomes/mL solution for infusion - Summary of Product Characteristics (SmPC) | website=(emc) | date=30 June 2020 | url=https://www.medicines.org.uk/emc/product/11572/smpc | access-date=30 July 2020 | archive-date=28 October 2020 | archive-url=https://web.archive.org/web/20201028212724/https://www.medicines.org.uk/emc/product/11572/smpc | url-status=live }}</ref>
| legal_US = Rx-only
| legal_US_comment =<ref name="Zolgensma FDA label"/><ref name="FDA Zolgensma" />
| legal_EU = Rx-only
| legal_EU_comment =<ref name="Zolgensma EPAR"/> Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref>
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV-->
| legal_UN_comment =
| legal_status = Rx-only

<!-- Pharmacokinetic data -->
| bioavailability =
| protein_bound =
| metabolism =
| metabolites =
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| elimination_half-life =
| duration_of_action =
| excretion =

<!-- Identifiers -->
| CAS_number_Ref =
| CAS_number = 1922968-73-7
| CAS_supplemental =
| PubChem = 384585535
| IUPHAR_ligand =
| DrugBank_Ref =
| DrugBank = DB15528
| ChemSpiderID_Ref =
| ChemSpiderID =
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = MLU3LU3EVV
| KEGG_Ref =
| KEGG = D11559
| ChEBI_Ref =
| ChEBI =
| ChEMBL_Ref =
| ChEMBL =
| NIAID_ChemDB =
| PDB_ligand =
| synonyms = AVXS-101, onasemnogene abeparvovec-xioi

<!-- Chemical and physical data -->
| IUPAC_name =
| chemical_formula =
| C= | H= | Ag= | Al= | As= | Au= | B= | Bi= | Br= | Ca= | Cl= | Co= | F= | Fe= | Gd= | I=
| K= | Li= | Mg= | Mn= | N= | Na= | O= | P= | Pt= | S= | Sb= | Se= | Sr= | Tc= | Zn= | charge=
| molecular_weight =
| SMILES =
| StdInChI =
| StdInChI_comment =
| StdInChIKey =
| density =
| density_notes =
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| melting_high =
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| specific_rotation =

<!-- Gene therapy data -->
| gt_target_gene       = ''[[SMN1]]''
| gt_vector            = [[Adeno-associated virus|Adeno-associated virus serotype 9]]
| gt_nucleic_acid_type = 
| gt_editing_method    = 
| gt_delivery_method   = 
}}
'''오나셈노진아베파르보벡'''({{lang|en|Onasemnogene abeparvovec}}) 또는 상품명 '''졸겐스마'''({{lang|en|Zolgensma}})는 [[스위스]]의 [[노바티스]](Novartis)사가 개발한 [[척수성 근위축증]](SMA) 치료제이다.<ref name="Zolgensma FDA label">{{웹 인용|date=24 May 2019|title=Zolgensma- onasemnogene abeparvovec-xioi kit full prescribing information|url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=68cd4f06-70e1-40d8-bedb-609ec0afa471|access-date=18 November 2019|website=[[DailyMed]]|archive-date=19 November 2019|archive-url=https://web.archive.org/web/20191119005222/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=68cd4f06-70e1-40d8-bedb-609ec0afa471|url-status=live}}</ref><ref name="FDA Zolgensma">{{웹 인용|url=https://www.fda.gov/vaccines-blood-biologics/zolgensma|title=Zolgensma|date=6 August 2019|website=[[미국 식품의약국]] |access-date=1 November 2019|id=STN: 125694|archive-date=19 November 2019|archive-url=https://web.archive.org/web/20191119010100/https://www.fda.gov/vaccines-blood-biologics/zolgensma|url-status=live}} {{PD-notice}}</ref> 1회의 [[정맥 주사]]를 한다.<ref name="Zolgensma FDA label"/> 치료에는 최소 2개월의 [[코르티코스테로이드]]를 투여해야 한다. 일반적인 부작용으로는 [[구토]]와 간 효소 수치 증가가 있다.<ref name="Zolgensma FDA label" /><ref name="Zolgensma EPAR" />

오나셈노진아베파르보벡은 2019년 2세 미만 어린이 치료제로 미국에서 처음으로 의료용으로 승인됐다.<ref name="FDA PR2">{{웹 인용|date=24 May 2019|title=FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality|url=https://www.fda.gov/news-events/press-announcements/fda-approves-innovative-gene-therapy-treat-pediatric-patients-spinal-muscular-atrophy-rare-disease|access-date=18 November 2019|website=[[미국 식품의약국]] |archive-date=1 September 2019|archive-url=https://web.archive.org/web/20190901145211/https://www.fda.gov/news-events/press-announcements/fda-approves-innovative-gene-therapy-treat-pediatric-patients-spinal-muscular-atrophy-rare-disease|url-status=live}} {{PD-notice}}</ref><ref name="Zolgensma FDA label" />

== 부작용 ==
일반적인 부작용으로는 [[구토]]와 간 효소 증가가 있다.<ref name="Zolgensma FDA label" /><ref name="Zolgensma EPAR">{{웹 인용| title=Zolgensma EPAR | website=[[유럽 의약품청]] | date=24 March 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/zolgensma | access-date=30 July 2020 | archive-date=17 July 2020 | archive-url=https://web.archive.org/web/20200717170959/https://www.ema.europa.eu/en/medicines/human/EPAR/zolgensma | url-status=live }}</ref> 또한 간부전으로 인한 사망 2명이 보고되었다.<ref>{{뉴스 인용 |제목=졸겐스마 환자 2명 간부전 사망 첫 보고 |url=http://www.bosa.co.kr/news/articleView.html?idxno=2179121 |날짜=2022-08-12 |확인날짜=2022-08-23}}</ref>

== 각주 ==
<references />

== 외부 링크 ==
* {{웹 인용|url=https://druginfo.nlm.nih.gov/drugportal/name/onasemnogene%20abeparvovec | publisher = U.S. National Library of Medicine |work = Drug Information Portal| title =오나셈노진아베파르보벡 }}
* {{웹 인용|url=https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetail?itemSeq=202104217 | publisher =[[대한민국 식품의약품안전처]] |work =의약품상세정보 | title =오나셈노진아베파르보벡 }}

[[분류:혁신치료제]]
[[분류:약물 발견]]
[[분류:시험용 의약품]]
[[분류:유전자 치료]]
[[분류:노바티스의 제품]]
[[분류:희귀약]]
[[분류:척수성 근위축증]]