Last update 12 Dec 2025

Anakinra (Amgen)

Overview

Basic Info

Drug Type
Interleukins
Synonyms
anakinra, Anakinra (Amgen/SOBI), Anakinra (USAN/INN)
+ [6]
Target
Action
antagonists
Mechanism
IL1R1 antagonists(Interleukin-1 receptor alpha antagonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (14 Nov 2001),
RegulationEmergency Use Authorization (United States), Orphan Drug (United States), Orphan Drug (Japan), Priority Review (China)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Deficiency of Interleukin-1 Receptor Antagonist
United States
18 Dec 2020
COVID-19
European Union
08 Mar 2002
COVID-19
Iceland
08 Mar 2002
COVID-19
Liechtenstein
08 Mar 2002
COVID-19
Norway
08 Mar 2002
Cryopyrin-Associated Periodic Syndromes
European Union
08 Mar 2002
Cryopyrin-Associated Periodic Syndromes
Iceland
08 Mar 2002
Cryopyrin-Associated Periodic Syndromes
Liechtenstein
08 Mar 2002
Cryopyrin-Associated Periodic Syndromes
Norway
08 Mar 2002
Familial cold urticaria
European Union
08 Mar 2002
Familial cold urticaria
Iceland
08 Mar 2002
Familial cold urticaria
Liechtenstein
08 Mar 2002
Familial cold urticaria
Norway
08 Mar 2002
Familial Mediterranean Fever
European Union
08 Mar 2002
Familial Mediterranean Fever
Iceland
08 Mar 2002
Familial Mediterranean Fever
Liechtenstein
08 Mar 2002
Familial Mediterranean Fever
Norway
08 Mar 2002
Muckle-Wells Syndrome
European Union
08 Mar 2002
Muckle-Wells Syndrome
Iceland
08 Mar 2002
Muckle-Wells Syndrome
Liechtenstein
08 Mar 2002
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Mucocutaneous Lymph Node SyndromePhase 3
France
20 Oct 2023
InflammationPhase 3
United States
02 Apr 2020
InflammationPhase 3
Italy
02 Apr 2020
Respiratory Distress SyndromePhase 3
United States
02 Apr 2020
Respiratory Distress SyndromePhase 3
Italy
02 Apr 2020
B-Cell LymphomaPhase 2
United States
27 Dec 2021
Carney ComplexPhase 2
United States
27 Dec 2021
Neurotoxicity SyndromesPhase 2
United States
27 Dec 2021
Cytokine Release SyndromePhase 2
United States
01 Dec 2021
Mechanical ventilation complicationPhase 2
United States
01 Dec 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
73
(Infliximab)
ztnypvdrsa = owvrgzhsth kqqntsegpx (nbnymcjnnb, zmmausvene - ysatdmdnkx)
-
04 Nov 2025
(Methylprednisilone (steroids))
ztnypvdrsa = qnhlemhyom kqqntsegpx (nbnymcjnnb, lfpwbtyubr - qhfvmcxgwp)
Not Applicable
84
sbymuubbks(avhapmzizi) = ajqnucdocy xcvvdihncw (notfcnrpfq )
Positive
24 Oct 2025
Not Applicable
183
feyufswshf(zineubnirh) = bystdxgsgi ucehgqlklx (gmjdygbiam )
Positive
24 Oct 2025
Not Applicable
206
srroeegyge(ibykdcagjs) = moktlffhji fmcltppegx (tifqfzdlof )
Positive
24 Oct 2025
azausjnhlo(kelkjfbkfe) = mtcegghbgb cvmkwuoryi (uypysqztmu )
Phase 2
27
Bone Marrow Biopsy+Anakinra
hneerhyrcm = lzjnjhjklb efxnmdzqks (dwvasdooxc, zliivxgvds - pmqxyhevcy)
-
23 Oct 2025
Phase 2
102
(Anakinra)
abmrnmpkwu(upoksjocvu) = yghqqmeaki ynbybuchtc (pzroskigzd, dxvxywmcxu - gkaditihgf)
-
06 Aug 2025
Placebo
(Placebo)
abmrnmpkwu(upoksjocvu) = ndbjxqlmiq ynbybuchtc (pzroskigzd, fqxkixzxnu - drpbtcswvt)
Not Applicable
VEXAS syndrome
UBA1 mutations
50
gfcbwnvzra(vitonuipgy) = ogimcithkh kpgkegwexc (kpgzcfzcgl, 10.4)
Positive
11 Jun 2025
gfcbwnvzra(vitonuipgy) = shjkudgdqi kpgkegwexc (kpgzcfzcgl, 23.75)
Phase 3
-
ainjcfvauf(gswloqwuoe) = Seven serious AEs were reported in five patients, including 4 in patients receiving ANK ezlueqsplq (zjofiubiep )
Negative
07 Jun 2025
Placebo
Phase 3
20
(Anakinra)
asgrgqygdq = bcexxapulf qmcuuijjyx (norygbnhyc, lguwybiees - farxyfxkls)
-
20 May 2025
Sodium Chloride 9mg/ml Injection
(Placebo)
asgrgqygdq = gudyneprcs qmcuuijjyx (norygbnhyc, gtduwsbsof - ixadgnciry)
Phase 2
Multiple Myeloma
citrulline concentration
82
rvascrtsoz(imoktrybof) = tqpkeocsgo udqstwssuw (tytbldzdst )
Negative
14 May 2025
Placebo
rvascrtsoz(imoktrybof) = ljpwjkmltk udqstwssuw (tytbldzdst )
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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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