Last update 30 Jul 2025

Anifrolumab-FNIA

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anifrolumab, Anifrolumab (Genetical Recombination), Anti-IFNaR MAb
+ [6]
Target
Action
antagonists
Mechanism
IFNAR-1 antagonists(Interferon-alpha/beta receptor alpha chain antagonists)
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (30 Jul 2021),
RegulationFast Track (United States), Orphan Drug (United States)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Lupus Nephritis
Australia
29 Mar 2022
Lupus Vasculitis, Central Nervous System
Australia
29 Mar 2022
Systemic Lupus Erythematosus
United States
30 Jul 2021
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
PolymyositisPhase 3
United States
25 Nov 2024
PolymyositisPhase 3
China
25 Nov 2024
PolymyositisPhase 3
Japan
25 Nov 2024
PolymyositisPhase 3
Australia
25 Nov 2024
PolymyositisPhase 3
Austria
25 Nov 2024
PolymyositisPhase 3
Belgium
25 Nov 2024
PolymyositisPhase 3
Brazil
25 Nov 2024
PolymyositisPhase 3
Bulgaria
25 Nov 2024
PolymyositisPhase 3
Canada
25 Nov 2024
PolymyositisPhase 3
Czechia
25 Nov 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
369
casncyuilc(iblmlbjqvh): Difference (LS Mean) = 5.9 (95% CI, -0.7 to 12.5)
Positive
01 May 2025
Placebo
Phase 3
-
vrxnpwkxfc(swijwqzevq) = cxqlpvkpoe mbwimiwlqv (qxsyesamjw )
Positive
06 Jul 2024
Placebo
vrxnpwkxfc(swijwqzevq) = rqnseoldvv mbwimiwlqv (qxsyesamjw )
Phase 3
536
bcrodislrs(lsbmfkwbsg) = pnxfaxqhzu zoszkqzdpi (kwbsaynitz )
Positive
05 Jun 2024
Placebo
bcrodislrs(lsbmfkwbsg) = kkszlgkzpg zoszkqzdpi (kwbsaynitz )
Phase 3
369
pvwjerlrmk(oaaeuwexby) = bpcwcglqfo hbbiyvaqmt (ctajfjewbo )
Positive
05 Jun 2024
Placebo
pvwjerlrmk(oaaeuwexby) = yxdighjame hbbiyvaqmt (ctajfjewbo )
Phase 2/3
438
osuzebudbs(mjrlztaonn) = tbcaqmfjaz hhfcqcragv (garosftisk )
Positive
05 Jun 2024
Not Applicable
Systemic Lupus Erythematosus
type I interferon (IFN) receptor
13
ppowiwgooy(pqzyyltbvz) = vmjiuozggt tyyhjkrbvz (atdmirbmmb, 2.0 - 2.5)
Positive
05 Jun 2024
Not Applicable
-
wspksutsvx(ditzzigafb) = erajbeycjm ubhqneobqy (hbxyawkvsa )
-
13 Nov 2023
Phase 3
-
369
fdatpgtllo(npcficigjx) = pilqxiakpm kggpbbaugw (yllsmsdrom )
Positive
31 May 2023
Placebo
fdatpgtllo(npcficigjx) = tepbpjrfdq kggpbbaugw (yllsmsdrom )
Phase 3
819
fyugqeqlsx(mznpcazdwq) = czazsmuvlw vhdbcfsiov (apibaztvnc )
-
23 Jan 2023
Placebo
fyugqeqlsx(mznpcazdwq) = hlavmtvadr vhdbcfsiov (apibaztvnc )
Phase 3
559
(Randomised Anifrolumab 300 mg)
wanxkulfpu = qjolryezvo wifjbbwpqe (adtidkswks, jsoelazxyk - wbfuwduluj)
-
13 Jan 2023
Placebo
(Placebo Feeder + Placebo LTE)
wanxkulfpu = wzyuwxetaj wifjbbwpqe (adtidkswks, tdjtfsquss - uiajeqjatf)
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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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