{{위키데이터 속성 추적}}
{{Infobox drug
| drug_name          = 
| INN                = 
| type               = <!-- empty -->
| image              = PF-07321332.svg
| width              = 
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| tradename          = 
| Drugs.com          = 
| MedlinePlus        = 
| licence_EU         = <!-- EMA uses INN (or special INN_EMA) -->
| DailyMedID         = <!-- DailyMed may use generic or brand name (generic name preferred) -->
| licence_US         = <!-- FDA may use generic or brand name (generic name preferred) -->
| pregnancy_AU       = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU_comment = 
| pregnancy_category = 
| dependency_liability = 
| addiction_liability = 
| routes_of_administration = 
| class              = 
| ATCvet             = 
| ATC_prefix         = None
| ATC_suffix         = 
| ATC_supplemental   = <!-- Legal status -->
| legal_AU           = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->
| legal_AU_comment   = 
| legal_BR           = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->
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| 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 -->
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| legal_US           = Rx-only, 긴급사용승인
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<!-- Pharmacokinetic data -->| bioavailability    = 
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| CAS_number         = 2628280-40-8
| CAS_supplemental   = 
| PubChem            = 155903259
| IUPHAR_ligand      = 
| DrugBank           = 
| ChemSpiderID       = 
| UNII               = 7R9A5P7H32
| KEGG               = D12244
| ChEBI              = 170007
| ChEMBL             = 
| NIAID_ChemDB       = 
| PDB_ligand         = 
| synonyms           = PF-07321332

<!-- Chemical and physical data -->| IUPAC_name         = (1R,2S,5S)-N-[(1S)-1-cyano-2-[(3S)-2-oxopyrrolidin-3-yl]ethyl]-3-[(2S)-3,3-dimethyl-2-[(2,2,2-trifluoroacetyl)amino]butanoyl]-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide
| C                  = 23
| H                  = 32
| F                  = 3
| N                  = 5
| O                  = 4
| SMILES             = CC1([C@@H]2[C@H]1[C@H](N(C2)C(=O)[C@H](C(C)(C)C)NC(=O)C(F)(F)F)C(=O)N[C@@H](C[C@@H]3CCNC3=O)C#N)C
| StdInChI           = 1S/C23H32F3N5O4/c1-21(2,3)16(30-20(35)23(24,25)26)19(34)31-10-13-14(22(13,4)5)15(31)18(33)29-12(9-27)8-11-6-7-28-17(11)32/h11-16H,6-8,10H2,1-5H3,(H,28,32)(H,29,33)(H,30,35)/t11-,12-,13-,14-,15-,16+/m0/s1
| StdInChI_comment   = 
| StdInChIKey        = LIENCHBZNNMNKG-OJFNHCPVSA-N
| density            = 
| density_notes      = 
| melting_point      = 192.9
| melting_high       = 
| melting_notes      =<ref name=Owen />
| boiling_point      = 
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| specific_rotation  = 
}}

[[파일:Xray crystal structure PDB-7si9.png|alt=Xray crystal structure PDB:7si9|섬네일|바이러스 3CLpro(Mpro) 단백질분해효소(viral [[3CLpro]] (Mpro) protease enzyme)에 얽혀 있는 SARS-CoV-2 단백질분해효소 억제제(protease inhibitor) 니르마트렐비르(nirmatrelvir)의 엑스레이 수정 구조([https://www.rcsb.org/structure/7SI9 PDB:7SI9] and [https://www.rcsb.org/structure/7VH8 7VH8]). 막대처럼 보이는 약물과 함께 있는 단백질 리본 도상. 노란 막대는 촉매 잔기(catalytic residue)(His41, Cys145)이다.]]

'''니르마트렐비르(Nirmatrelvir)'''는 [[화이자]](Pfizer)가 개발한 항바이러스제(antiviral drug)로, 경구 3CL 단백질분해효소 억제제(3C-like protease inhibitor)이다.<ref>{{저널 인용|vauthors=Şimşek-Yavuz S, Komsuoğlu Çelikyurt FI|date=August 2021|title=Antiviral treatment of COVID-19: An update|journal=Turkish Journal of Medical Sciences|doi=10.3906/sag-2106-250|pmid=34391321|s2cid=237054672}}</ref><ref>{{저널 인용|vauthors=Ahmad B, Batool M, Ain QU, Kim MS, Choi S|date=August 2021|title=Exploring the Binding Mechanism of PF-07321332 SARS-CoV-2 Protease Inhibitor through Molecular Dynamics and Binding Free Energy Simulations|journal=International Journal of Molecular Sciences|volume=22|issue=17|page=9124|doi=10.3390/ijms22179124|pmc=8430524|pmid=34502033|doi-access=free}}</ref><ref name="pfizer2" /><ref name=":0">{{저널 인용|vauthors=Vandyck K, Deval J|date=August 2021|title=Considerations for the discovery and development of 3-chymotrypsin-like cysteine protease inhibitors targeting SARS-CoV-2 infection|journal=Current Opinion in Virology|volume=49|pages=36–40|doi=10.1016/j.coviro.2021.04.006|pmc=8075814|pmid=34029993}}</ref> 2021년 12월, 니르마트렐비르와 [[CYP3A4]] 억제제 [[리토나비르]](ritonavir)의 혼합제가 '''팍스로비드(Paxlovid)'''라는 제품명으로 [[코로나19 바이러스]](COVID-19) 중증도 환자 치료제로서 [[미국식품의약국]](Food and Drug Administration)의 [[긴급사용승인]](Emergency Use Authorization)을 받았다.
<ref name=":1">{{웹 인용|date=2021-12-22|title=Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treatment of COVID-19|url=https://www.fda.gov/media/155052/download|url-status=live|publisher=FDA}}</ref><ref name=":2">{{뉴스 인용|last=Robbins|first=Rebecca|last2=Zimmer|first2=Carl|date=2021-12-22|title=F.D.A. Clears Pfizer’s Covid Pill for High-Risk Patients 12 and Older|language=en-US|work=The New York Times|url=https://www.nytimes.com/2021/12/22/health/pfizer-covid-pill-fda-paxlovid.html|access-date=2021-12-22|issn=0362-4331}}</ref>

== 개발 ==
=== 약학 ===
코로나바이러스 단백질분해효소 바이러스 복합단백질(viral polyprotein) 내 여러 군데에 달라붙는데, 보통은 [[글루타민]] [[잔기]](glutamine residue) 뒤에 붙는다. 인간의 [[리노바이러스]](rhinovirus)에 관한 초기 연구에서는 유연한 글루타민 곁사슬(flexible glutamine side chain)은 응고된 [[피롤리돈]](rigid pyrrolidone)으로 교체될 수 있다는 것을 밝혔다.<ref>{{저널 인용| vauthors = Anand K, Ziebuhr J, Wadhwani P, Mesters JR, Hilgenfeld R | title = Coronavirus Main Proteinase (3CLpro) Structure: Basis for Design of Anti-SARS Drugs | journal = Science | volume = 300 | issue = 5626 | pages = 1763–1767 | date = June 2003 | pmid = 12746549 | doi = 10.1126/science.1085658 | bibcode = 2003Sci...300.1763A | s2cid = 13031405 }}</ref><ref>{{저널 인용| vauthors = Dragovich PS, Prins TJ, Zhou R, Webber SE, Marakovits JT, Fuhrman SA, Patick AK, Matthews DA, Lee CA, Ford CE, Burke BJ, Rejto PA, Hendrickson TF, Tuntland T, Brown EL, Meador JW, Ferre RA, Harr JE, Kosa MB, Worland ST | display-authors = 6 | title = Structure-based design, synthesis, and biological evaluation of irreversible human rhinovirus 3C protease inhibitors. 4. Incorporation of P1 lactam moieties as L-glutamine replacements | journal = Journal of Medicinal Chemistry | volume = 42 | issue = 7 | pages = 1213–1224 | date = April 1999 | pmid = 10197965 | doi = 10.1021/jm9805384 }}</ref> 이 약물들은 사스-코로나 바이러스 팬데믹(the SARS CoV2 pandemic)이 있기에 앞서 [[중증급성호흡기증후군|사스]](SARS) 치료제로 개발되었다.<ref>{{저널 인용| vauthors = Pillaiyar T, Manickam M, Namasivayam V, Hayashi Y, Jung SH | title = An Overview of Severe Acute Respiratory Syndrome-Coronavirus (SARS-CoV) 3CL Protease Inhibitors: Peptidomimetics and Small Molecule Chemotherapy | journal = Journal of Medicinal Chemistry | volume = 59 | issue = 14 | pages = 6595–6628 | date = July 2016 | pmid = 26878082 | pmc = 7075650 | doi = 10.1021/acs.jmedchem.5b01461 }}</ref> 2018년 GC373의 [[전구체|약물전구체]](prodrug)인 [[GC376]]이 [[펠린 코로나바이러스]](Feline coronavirus)가 유발하는 치명적인 고양이 코로나바이러스 질병인 [[고양이 복막염|펠린 감염 복막염]](feline infectious peritonitis, 일명 '고양이 복막염')을 100% 치료하는데 사용됨으로써, 3CL 단백질분해효소 타겟팅의 유용성이 실제로 증명되었다.<ref>{{저널 인용| vauthors = Pedersen NC, Kim Y, Liu H, Galasiti Kankanamalage AC, Eckstrand C, Groutas WC, Bannasch M, Meadows JM, Chang KO | display-authors = 6 | title = Efficacy of a 3C-like protease inhibitor in treating various forms of acquired feline infectious peritonitis | journal = Journal of Feline Medicine and Surgery | volume = 20 | issue = 4 | pages = 378–392 | date = April 2018 | pmid = 28901812 | pmc = 5871025 | doi = 10.1177/1098612X17729626 | doi-access=free | title-link=doi }}</ref>

화이자가 개발한 약은 GC373의 유사체(analog)로서, 알데히드 공유결합 시스테인 수용체(aldehyde covalent cysteine acceptor)가 [[니트릴]](nitrile)로 대체되었다.<ref>{{저널 인용| vauthors = Halford B | date = 7 April 2021 | title = Pfizer unveils its oral SARS-CoV-2 inhibitor | journal = Chemical & Engineering News | volume = 99 | issue = 13 | pages = 7 | doi = 10.47287/cen-09913-scicon3 | s2cid = 234887434 | doi-access=free | title-link=doi }}</ref><ref>{{저널 인용| vauthors = Vuong W, Khan MB, Fischer C, Arutyunova E, Lamer T, Shields J, Saffran HA, McKay RT, van Belkum MJ, Joyce MA, Young HS, Tyrrell DL, Vederas JC, Lemieux MJ | display-authors = 6 | title = Feline coronavirus drug inhibits the main protease of SARS-CoV-2 and blocks virus replication | journal = Nature Communications | volume = 11 | issue = 1 | pages = 4282 | date = August 2020 | pmid = 32855413 | pmc = 7453019 | doi = 10.1038/s41467-020-18096-2 | doi-access = free }}</ref>

니르마트렐비르는 초기 임상 후보물질인 [[루포트렐비르]](lufotrelvir)의 개량을 통해 개발되었다.<ref>{{ClinicalTrialsGov|NCT04535167|First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19 }}</ref><ref>{{저널 인용| vauthors = Boras B, Jones RM, Anson BJ, Arenson D, Aschenbrenner L, Bakowski MA, Beutler N, Binder J, Chen E, Eng H, Hammond H, Hammond J, Haupt RE, Hoffman R, Kadar EP, Kania R, Kimoto E, Kirkpatrick MG, Lanyon L, Lendy EK, Lillis JR, Logue J, Luthra SA, Ma C, Mason SW, McGrath ME, Noell S, Obach RS, O'Brien MN, O'Connor R, Ogilvie K, Owen D, Pettersson M, Reese MR, Rogers TF, Rossulek MI, Sathish JG, Shirai N, Steppan C, Ticehurst M, Updyke LW, Weston S, Zhu Y, Wang J, Chatterjee AK, Mesecar AD, Frieman MB, Anderson AS, Allerton C | display-authors = 6 | title = Discovery of a Novel Inhibitor of Coronavirus 3CL Protease for the Potential Treatment of COVID-19 | journal = bioRxiv | pages = 2020.09.12.293498 | date = February 2021 | pmid = 32935104 | pmc = 7491518 | doi = 10.1101/2020.09.12.293498 }}</ref> 이는 공유결합 억제제(covalent inhibitor)이기도 하지만, 탄두는 [[하이드록시케톤]](hydroxyketone)의 인산염 전구체(phosphate prodrug)이다. 그러나 루포트렐비르는 병원에서 용량을 제한하여 정맥주사로 복용해야 한다. 트리펩타이드 단백질 모방체(tripeptide protein mimetic)의 점진적 개량으로 경구용 니르마트렐비르가 나오게 되었다.<ref name=Owen>{{저널 인용| vauthors = Owen DR, Allerton CM, Anderson AS, Aschenbrenner L, Avery M, Berritt S, Boras B, Cardin RD, Carlo A, Coffman KJ, Dantonio A, Di L, Eng H, Ferre R, Gajiwala KS, Gibson SA, Greasley SE, Hurst BL, Kadar EP, Kalgutkar AS, Lee JC, Lee J, Liu W, Mason SW, Noell S, Novak JJ, Obach RS, Ogilvie K, Patel NC, Pettersson M, Rai DK, Reese MR, Sammons MF, Sathish JG, Singh RS, Steppan CM, Stewart AE, Tuttle JB, Updyke L, Verhoest PR, Wei L, Yang Q, Zhu Y | display-authors = 6 | title = An oral SARS-CoV-2 Mpro inhibitor clinical candidate for the treatment of COVID-19 | journal = Science | pages = eabl4784 | date = November 2021 | pmid = 34726479 | doi = 10.1126/science.abl4784 | doi-access=free | s2cid = 240422219 | title-link=doi }}</ref> 핵심 변화는 초기 억제제에서 발견되는 류신 잔기(leucine residue)와 유사한 형태인 경직 이환 비천연 아미노산(rigid bicyclic noncanonical amino acid) 유도를 통한 [[수소 결합]](hydrogen bond) 수와 회전결합(rotatble vond) 수의 감소에 있다. 류신 잔기는 [[보세프레비르]](boceprevir) 합성에 사용되었다.<ref name="pmid18193821">{{저널 인용| vauthors = Njoroge FG, Chen KX, Shih NY, Piwinski JJ | title = Challenges in modern drug discovery: a case study of boceprevir, an HCV protease inhibitor for the treatment of hepatitis C virus infection | journal = Accounts of Chemical Research | volume = 41 | issue = 1 | pages = 50–59 | date = January 2008 | pmid = 18193821 | doi = 10.1021/ar700109k | s2cid = 2629035 }}</ref> 니르마트렐비르 P3위(P3 position)에 사용된 테르트 류신(Tert-leucine)은 처음엔 혼성 결합 기질 도서관 기술(Hybrid Combinatorial Substrate Library technology)을 이용하여 SARS-CoV-2-Mpro 타겟팅의 잠재약(potential drug)에서 최적 비천연 아미노산으로 밝혀졌고,<ref>{{저널 인용|vauthors=Poreba M, Salvesen GS, Drag M |title=Synthesis of a HyCoSuL peptide substrate library to dissect protease substrate specificity |journal=Nature Protocols |pages=2189-2214 |date=October 2017 |doi=10.1038/nprot.2017.091 |url=}}</ref> 러트(W. Rut) 등이<ref>{{저널 인용|vauthors=Rut W, Groborz K, Zhang L, Sun X, Zmudzinski M, Hilgenfeld R, Drag M |title=Substrate specificity profiling of SARS-CoV-2 Mpro protease provides basis for anti-COVID-19 drug design |journal=biorxiv |date=March 2020 |doi=10.1101/2020.03.07.981928 |url=}}</ref><ref>{{저널 인용|vauthors=Rut W, Groborz K, Zhang L, Sun X, Zmudzinski M, Pawlik B, Wang X, Jochmans D, Neyts J, Młynarski W, Hilgenfeld R, Drag M |title=SARS-CoV-2 M pro inhibitors and activity-based probes for patient-sample imaging |journal=Nature Chemical Biology |date=October 2020 |doi=10.1038/s41589-020-00689-z |url=}}</ref> 2020년 3월 8일 CC BY-NC-ND 4.0 license (https://creativecommons.org/licenses/by-nc-nd/4.0/) 하에 공표하였다.

=== 임상적 ===
2021년 4월, 화이자는 1상 임상 실험을 개시하였다.<ref>{{뉴스 인용| vauthors = Nuki P | date = 26 April 2021 |url= https://nationalpost.com/news/world/pfizer-is-testing-a-pill-that-if-successful-could-become-first-ever-home-cure-for-covid-19 |title= Pfizer is testing a pill that, if successful, could become first-ever home cure for COVID-19 |archive-url= https://archive.today/20210427114348/https://nationalpost.com/news/world/pfizer-is-testing-a-pill-that-if-successful-could-become-first-ever-home-cure-for-covid-19 |archive-date=27 April 2021 |work=National Post}}</ref> 2021년 9월, 화이자는 2/3상 실험을 개시하였다.<ref name="trials">{{웹 인용|date=2 September 2021 |title=Pfizer begins dosing in Phase II/III trial of antiviral drug for Covid-19. |url=https://www.clinicaltrialsarena.com/news/pfizer-antiviral-covid-trial/ |website=Clinical Trials Arena}}</ref> 2021년 11월, 화이자는 중증도 환자에게 증상 발병 3일 내로 투여할 경우, 입원율이 89%가 감소한다는 사실을 공포하였다.<ref name="pfizer-paxlovid">{{보도자료 인용| url=https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate | title=Pfizer's Novel COVID-19 Oral Antiviral Treatment Candidate Reduced Risk Of Hospitalization Or Death By 89% In Interim Analysis Of Phase 2/3 EPIC-HR Study | publisher=Pfizer Inc | date=5 November 2021}}</ref><ref>{{저널 인용| vauthors = Mahase E | title = Covid-19: Pfizer's paxlovid is 89% effective in patients at risk of serious illness, company reports | journal = BMJ | volume = 375 | pages = n2713 | date = November 2021 | pmid = 34750163 | doi = 10.1136/bmj.n2713 | s2cid = 243834203 | doi-access=free | title-link=doi }}</ref>

2021년 12월 14일, 화이자는 2,246명 고위험군 참가자 내에서, 증상 발병 3일 내로 니르마트렐비르와 리토나비르 혼합제를 제공하면 위약군에 비하여 입원율이나 사망률이 89%까지 감소한다는 사실을 공포하였다.<ref name="pfizer2">{{보도자료 인용|date=14 December 2021 |title=Pfizer Announces Additional Phase 2/3 Study Results Confirming Robust Efficacy of Novel COVID-19 Oral Antiviral Treatment Candidate in Reducing Risk of Hospitalization or Death | url = https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-additional-phase-23-study-results }}</ref> 2021년 12월 22일, 니르마트렐비르-리토나비르 혼합제는 12세 이상 고위험 환자에게 코비드19치료제로서 미국식품의약국으로부터 긴급사용승인을 받았다.<ref name=":1" /><ref name=":2" />

== 화학 및 약학 ==
니르마트렐비르 합성제의 상세 내용은 화이자 소속 과학자들이 처음 출간하였다.
:[[파일:PF-07321332 synthesis.svg|650px]]
마지막 두번째 단계에서, 합성 호모카이랄 아미노산(synthetic homochiral amino acid)은 수용성 카르보디이미드(water-soluble carbodiimide)인 [[EDCI]]를 사용하여 [[커플링제]](coupling agent)로 사용하여, 호모카이랄 아미노 아미드(homochiral amino amide)와 커플링된다. 이후 결과적 매개자(resulting intermediate)는 [[버지스시약]](Burgess reagent)으로 다뤄지는데, 이는 아미드집단을 산물의 니트릴로 건조시킨다.<ref name=Owen />

니르마트렐비르는 공유결합 억제제로, 시스테인 단백질분해효소(cysteine protease enzyme)의 촉매 시스테인 잔기(catalytic cysteine (Cys145) residue)에 직접 결합된다.<ref>{{저널 인용|vauthors=Pavan M, Bolcato G, Bassani D, Sturlese M, Moro S |title=Supervised Molecular Dynamics (SuMD) Insights into the mechanism of action of SARS-CoV-2 main protease inhibitor PF-07321332 |journal=J Enzyme Inhib Med Chem |volume=36 |issue=1 |pages=1646–1650 |date=December 2021 |pmid=34289752 |pmc=8300928 |doi=10.1080/14756366.2021.1954919 |url=}}</ref>

약제 혼합에 있어, 리토나비르는 시토크롬효소(cytochrome enzyme)를 통하여 니르마트렐비르 신진대사를 늦춰 주약(main drug)의 순환 농도(circulating concentration)를 높게 유지시킨다.<ref>{{웹 인용| vauthors = Woodley M |date=19 October 2021|title=What is Australia's potential new COVID treatment?|url= https://www1.racgp.org.au/newsgp/clinical/what-is-australia-s-potential-new-covid-treatment |url-status=live |access-date=6 November 2021 |website=The Royal Australian College of General Practitioners (RACGP)}}</ref>

== 사회•문화 ==
=== 구입 ===
2021년 10월 화이자의 언론 보도 후, 영국은 25만회분을 주문하였다.<ref>{{웹 인용|date=5 November 2021|title=Pfizer Covid pill 'can cut hospitalisations and deaths by nearly 90%'|url=https://www.theguardian.com/business/2021/nov/05/pfizer-covid-pills-highly-effective-at-preventing-deaths-trial-suggests|access-date=17 November 2021|website=The Guardian}}</ref><ref>{{저널 인용| vauthors = Mahase E | title = Covid-19: UK stockpiles two unapproved antiviral drugs for treatment at home | journal = BMJ | volume = 375 | pages = n2602 | date = October 2021 | pmid = 34697079 | doi = 10.1136/bmj.n2602 | s2cid = 239770104 }}</ref> 호주는 50만회분을 선주문했다.<ref>{{뉴스 인용|date=17 October 2021|title=What are the two new COVID-19 treatments Australia has gained access to?|work=ABC News (Australia)|url=https://www.abc.net.au/news/2021-10-17/what-are-new-covid-19-treatments-ronapreve-pf-07321332/100545708|access-date=5 November 2021}}</ref>

=== 라이센스 ===
2021년 11월, 화이자는 영국 정부가 후원하는 [[의약품특허풀]](Medicines Patent Pool, MPP)과 라이센스 계약을 맺어, 니르마트렐비르를 생산하여 95개국에 팔 수 있게 되었다.<ref>{{보도자료 인용| title=Pfizer and The Medicines Patent Pool (MPP) Sign Licensing Agreement for COVID-19 Oral Antiviral Treatment Candidate to Expand Access in Low- and Middle-Income Countries | publisher=Pfizer | via=Business Wire | date=16 November 2021 | url=https://www.businesswire.com/news/home/20211116005353/en/ | access-date=17 November 2021}}</ref> 화이자는 협약을 통하여 지역 약물 제조업계가 '전지구가 약을 용이하게 접할 수 있는 목표'를 가지고 생산할 수 있다고 말하였다. 그러나 브라질, 중국, 러시아, 아르헨티나, 태국 등 코비드19 급증 국가들은 거래에서 제외되었다.<ref>{{뉴스 인용|title=Covid-19: Pfizer to allow developing nations to make its treatment pill |url=https://www.bbc.com/news/world-us-canada-59310582 |access-date=17 November 2021 |work=[[BBC News]] |date=16 November 2021 |archive-url=https://web.archive.org/web/20211116203444/https://www.bbc.com/news/world-us-canada-59310582 |archive-date=16 November 2021|url-status=live}}</ref><ref>{{뉴스 인용| title=Pfizer Will Allow Its Covid Pill to Be Made and Sold Cheaply in Poor Countries | website=The New York Times | date=16 November 2021 | url=https://www.nytimes.com/2021/11/16/health/covid-pill-pfizer.html | access-date=17 November 2021}}</ref>

=== 긴급 사용 승인 ===
2021년 11월 16일, 화이자는 니르마트렐비르와 리토나비르 혼합제의 긴급사용 승인에 있어 미국식품의약국에의 적용을 수용하였다.<ref>{{보도자료 인용| title=Pfizer Seeks Emergency Use Authorization for Novel COVID-19 Oral Antiviral Candidate | publisher=Pfizer | via=Business Wire | date=16 November 2021 | url=https://www.businesswire.com/news/home/20211116006258/en/ | access-date=17 November 2021}}</ref><ref>{{웹 인용| vauthors = Kimball S |date=16 November 2021|title=Pfizer submits FDA application for emergency approval of Covid treatment pill|url=https://www.cnbc.com/2021/11/16/pfizer-plans-to-submit-fda-application-for-emergency-approval-of-covid-treatment-pill-today-ceo-says.html|access-date=17 November 2021|website=CNBC}}</ref><ref>{{뉴스 인용| vauthors = Robbins R  |date=5 November 2021 |title=Pfizer Says Its Antiviral Pill Is Highly Effective in Treating Covid |work=The New York Times |url=https://www.nytimes.com/2021/11/05/health/pfizer-covid-pill.html |url-access=registration |access-date=9 November 2021 |issn=0362-4331 |archive-url=https://web.archive.org/web/20211108134000/https://www.nytimes.com/2021/11/05/health/pfizer-covid-pill.html |archive-date=8 November 2021}}</ref> 이 승인은 2021년 12월 22일 내려졌다. 승인은 Sars-CoV-2 확진자 중 고위험군 환자에게 팍스로비드 투약에 대한 것이다.<ref name=":1">{{웹 인용|date=2021-12-22|title=Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treatment of COVID-19|url=https://www.fda.gov/media/155052/download|url-status=live|publisher=FDA}}</ref> [[유럽의약청]](European Medicines Agency)은 공식 승인에 앞서 2021년 12월 16일 중증환자에게 사용을 허락하였다.<ref>{{웹 인용|date=2021-12-16|title=EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19: rolling review starts in parallel|url=https://www.ema.europa.eu/en/news/ema-issues-advice-use-paxlovid-pf-07321332-ritonavir-treatment-covid-19-rolling-review-starts|url-status=live|publisher=EMA}}</ref>

=== 이버맥틴과의 비교 오류 ===
니르마트렐비르와 리토나비르의 혼합제는 구충제 [[이버멕틴]](ivermectin)의 재포장 버전이라고 잘못 알려지기도 한다. 이버맥틴은 코비드19 치료법으로 쩡되었지만 효능에 있어서는 의문이 제기된다. '화이자멕틴(Pfizermectin)'이란 별명이 붙기도 하는 이런 주장들은<ref>{{웹 인용| vauthors = Bloom J |date=2 December 2021 | url= https://www.acsh.org/news/2021/12/02/how-does-pfizers-pavloxid-compare-ivermectin-15967 | title=How Does Pfizer's Pavloxid Compare With Ivermectin? |publisher=American Council on Science and Health |access-date=12 December 2021 }}</ref> 두 약물의 [[약물동태학]](pharmacokinetics)의 피상적 유사성과 함께 화이자가 이버멕틴의 수익을 압박하고자 한다는 루머가 결합되어 나타난 것이다.<ref>{{웹 인용|publisher=[[Science-Based Medicine]] |vauthors=Gorski D |date=15 November 2021 |title=Pfizer's new COVID-19 protease inhibitor drug is not just 'repackaged ivermectin' |url=https://sciencebasedmedicine.org/pfizer-new-covid-19-protease-inhibitor-drug-is-not-just-repackaged-ivermectin/}}</ref>

== 같이 보기 ==
* [[리토나비르]]
* [[몰누피라비르]]

== 각주 ==
{{각주}}

[[분류:아마이드]]
[[분류:사이클로프로페인]]
[[분류:나이트릴]]
[[분류:피롤리돈]]
[[분류:트라이플루오로메틸 화합물]]
[[분류:코로나19 치료제 개발]]
[[분류:화이자의 제품]]