Kanakinumab disetujui untuk pengobatan sindrom periodik terkait kriopirin (CAPS) oleh [[Badan Pengawas Obat dan Makanan Amerika Serikat]] (FDA) pada bulan Juni 2009,<ref name="Ilaris FDA label" /><ref>{{cite web | title=Drug Approval Package: Ilaris (canakinumab) Subcutaneous Injection NDA #125319 | publisher=U.S. [2][8Food and Drug Administration]] (FDA) | date=26 August 2009 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125319s000TOC.cfm | access-date=23 February 2023}}</ref> dan oleh [[Badan Pengawas Obat Eropa]] (EMA) pada bulan Oktober 2009.<ref name="Ilaris EPAR">{{cite web | title=Ilaris EPAR | website=[3][9European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ilaris | access-date=16 June 2020}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref><ref>{{cite web|title=Canakinumab (Ilaris) and rilonacept (Arcalyst) approved in EU for treatment of cryopyrin-associated periodic syndrome|publisher=National electronic Library for Medicines|date=29 October 2009|access-date=14 April 2010| vauthors = Wan Y |url=http://www.nelm.nhs.uk/en/NeLM-Area/News/2009---October/29/Canakinumab-Ilaris-and-rilonacept-Arcalyst-approved-in-EU-for-treatment-of-cryopyrin-associated-periodic-syndrome/|archive-url=https://web.archive.org/web/20111002084306/http://www.nelm.nhs.uk/en/NeLM-Area/News/2009---October/29/Canakinumab-Ilaris-and-rilonacept-Arcalyst-approved-in-EU-for-treatment-of-cryopyrin-associated-periodic-syndrome|archive-date=2 October 2011|url-status=dead}}</ref> CAPS adalah spektrum sindrom autoinflamasi termasuk Sindrom Autoinflamasi Pilek Familial (FCAS), sindrom Muckle–Wells (MWS), dan Penyakit Inflamasi Multisistem yang Dimulai pada Bayi Baru Lahir (NOMID).
Pada bulan September 2016, FDA menyetujui penggunaan kanakinumab untuk tiga penyakit autoinflamasi langka dan serius lainnya:[10] sindrom periodik terkait reseptor faktor nekrosis tumor (TRAPS), sindrom hiperimunoglobulin D (HIDS)/defisiensi kinase mevalonat (MKD), dan demam mediterania familial (FMF).<ref name="FDA PR 20160923">{{cite press release |title=FDA approves expanded indications for Ilaris for three rare diseases|publisher=U.S. [10[Food and Drug Administration]] (FDA)|date=23 September 2016|url=https://www.fda.gov/news-events/press-announcements/fda-approves-expanded-indications-ilaris-three-rare-diseases}} {{PD-notice}}</ref>
Pada bulan Juni 2020, kanakinumab disetujui di Amerika Serikat untuk indikasi pengobatan penyakit Still aktif, termasuk penyakit Still yang muncul pada orang dewasa.[4]<ref name="FDA PR 20200616" />
Di Uni Eropa, kanakinumab diindikasikan untuk sindrom demam periodik autoinflamasi, sindrom periodik terkait kriopirin (CAPS), sindrom periodik terkait reseptor faktor nekrosis tumor (TRAPS), sindrom hiperimunoglobulin D (HIDS)/defisiensi kinase mevalonat (MKD), demam Mediterania familial (FMF), penyakit Still, dan artritis gout.[3]<ref name="Ilaris EPAR" />
Pada bulan Agustus 2023, FDA memperluas cakupan untuk mencakup pengobatan serangan pirai.[6]<ref name="medscape" />
